Pilot and Feasibility Studies最新文献

{"title":"Mamas in Harmony: protocol for a pilot RCT and process evaluation of a music and social support intervention establishing the feasibility of reducing anxiety and stress in postnatal mothers.","authors":"Corinna A Colella, Jenny McNeill, Una McCann, Fiona A Lynn","doi":"10.1186/s40814-025-01629-1","DOIUrl":"https://doi.org/10.1186/s40814-025-01629-1","url":null,"abstract":"<p><strong>Background: </strong>Postnatal mothers can experience anxiety, stress and difficulty with mother-infant attachment with potential to lead to an anxiety disorder/depression. There has been an increase in interest in non-pharmacological interventions involving music, with limited evidence assessing effectiveness in this population within randomised controlled trials (RCTs). Mamas in Harmony is a novel music/social support intervention. The objective is to assess the feasibility/acceptability of conducting a full RCT to test the effect and cost-effectiveness of Mamas in Harmony compared with usual care.</p><p><strong>Methods: </strong>The pilot RCT aims to recruit 60 mother-infant dyads through social media, community organisations and stakeholder networks, randomly allocated on a 2:1 ratio to the intervention and control group. The intervention group will receive eight 1 h weekly Mamas in Harmony sessions plus usual care, and the control group will receive usual care only. Feasibility measures include recruitment, retention and attendance at intervention sessions. The process evaluation aims to establish acceptability of the intervention involving survey evaluation and semi-structured interviews. A priori guidelines have been agreed to establish criteria for progression to a definitive RCT.</p><p><strong>Discussion: </strong>The current evidence supports the use of music in reducing anxiety and stress with the recommendation for inclusion of social support. This study has potential to provide robust evidence of the feasibility and acceptability of a music and social support mother-infant group intervention in preparation for a future definitive trial, should progression criteria be met.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov ID: NCT05930990 , registered retrospectively on 5 July 2023. Recruitment commenced on 16 March 2023.</p><p><strong>Protocol version: </strong>30 October 2023 Vn 1.0.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"44"},"PeriodicalIF":1.5,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11984032/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144050031","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and testing of mobile phone text messages for improving maternal and newborn care practice in Jimma Zone, Ethiopia: a user-centered design approach.","authors":"Hordofa Gutema Abdissa, Gebeyehu Bulcha Duguma, Josef Noll, Demisew Amenu Sori, Zewdie Birhanu Koricha","doi":"10.1186/s40814-025-01632-6","DOIUrl":"https://doi.org/10.1186/s40814-025-01632-6","url":null,"abstract":"<p><strong>Background: </strong>Mobile phone-based messaging for maternal education has indicated promising outcomes in promoting maternal and newborn care practices. However, most mobile phone-based messaging interventions are not tested before their implementation, and the evidence on the message content development process and methods is limited and underreported. The aim of this study was to develop and test text messages for interventions designed to improve maternal services utilization and newborn care practices.</p><p><strong>Methods: </strong>The development process has 4 phases: engaging pregnant mothers and experts in selected districts of the Jimma Zone, Ethiopia. During phase 1, the draft messages were developed based on the message framing concept, and the number of messages was reduced after review. In phase 2, 12 mothers participated in card sorting and the messages were refined. In phase 3, 8 experts evaluated the messages using 10 items with a 5-point Likert scale. In phase 4, a pilot study (n = 30) was conducted to evaluate the messages and their delivery when they were sent to individuals' mobile telephones. In this phase, a system usability scale was also used to assess the usability of the planned intervention.</p><p><strong>Results: </strong>An initial bank of 120 messages was developed, 42 of which were discarded during the development process. Of these, 32 were discarded by the research team at phase 1, and 10 were discarded during the card sorting at phase 2. Based on the experts' evaluations, 14 messages were reworded and refined in phase 3. During the pilot testing phase, the majority (80%) of the participants mentioned that the time they had been receiving the message was early, and 66.7% of the participants preferred the time to receive text messages about health. The mean SUS score was 72.26, which is acceptable for the usability of the mobile phone-based messaging intervention.</p><p><strong>Conclusion: </strong>A final bank of 78 (39 for each framing type) messages was obtained after refinement according to feedback from participants. The SUS showed an acceptable score for the planned intervention. This message development process confirms that the messages are acceptable, and important for improving maternal and newborn health care practices.</p><p><strong>Trial registration: </strong>PACTR202201753436676.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"46"},"PeriodicalIF":1.5,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11983728/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144037047","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Determining the feasibility and acceptability of a randomized telehealth pilot study for veterans with chronic multisymptom illness.","authors":"Charity B Breneman, Kamila Pollin, Timothy Chun, Lucas Crock, Walter Jachimowicz, Rebecca A McCullers, Ryan C Brewster, Adil Alaoui, Anas Belouali, Michael J Roy, Matthew J Reinhard, Michelle E Costanzo","doi":"10.1186/s40814-025-01628-2","DOIUrl":"https://doi.org/10.1186/s40814-025-01628-2","url":null,"abstract":"<p><strong>Background: </strong>The shift toward a patient-centered and whole health care model offers a promising approach for the management of symptoms among veterans with chronic multisymptom illness (CMI). A behavioral intervention aimed at reducing cognitive control dysregulation which is a component of impairments common among veterans with CMI may be helpful. Therefore, a pilot study was conducted to explore the feasibility, safety, and acceptability of a telehealth mental and physical (MAP) training intervention among veterans with CMI.</p><p><strong>Methods: </strong>Utilizing a two-arm randomized trial, participants were either randomized to 8 weeks of a directed MAP training protocol (dMAP) that received weekly guidance via text messaging or 8 weeks of self-guided MAP training (sgMAP) which did not receive guidance aside from the intervention goals. The MAP intervention was the same for both groups except for the delivery and consisted of two MAP training sessions and one telephone health coaching session per week. The primary aim of the study was to evaluate the feasibility (e.g., recruitment, retention, and adherence rates; amount of missing data), safety (e.g., adverse events), and acceptability (e.g., satisfaction) of a telehealth MAP intervention.</p><p><strong>Results: </strong>Out of 44 potentially eligible veterans, 26 were randomized to either the dMAP group (n = 13) or the sgMAP group (n = 13), resulting in a recruitment rate of 59% (26/44 patients). Two participants withdrew after randomization, resulting in 24 participants used for analyses. The retention rates at endpoint and 3-month follow-up were 79.2% (19/24; dMAP:sgMAP = 9:10) and 62.5% (15/24; dMAP:sgMAP = 7:8), respectively. Participants completed an average of 48.2% of the MAP sessions (7.7/16 sessions; dMAP:sgMAP = 7.9:7.5 sessions) and 82.8% of the health coaching sessions (6.6/8 sessions; dMAP:sgMAP = 7.2:6.2 sessions). Missing data was minimal, and no adverse events related to the study were reported. Acceptability was high as veterans were satisfied with the wearables and valued the health coaching support.</p><p><strong>Conclusions: </strong>This pilot study provides insights into the feasibility of a large-scale randomized control trial that promotes meditation and physical activity to augment cognitive control to facilitate self-regulation. Future efforts should expand recruitment strategies and add internal data quality monitoring.</p><p><strong>Trial registration: </strong>NCT04164667, retrospectively registered November 12, 2019, https://clinicaltrials.gov/study/NCT04164667.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"43"},"PeriodicalIF":1.5,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11983819/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144011283","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A pilot sequential multiple assignment randomized trial for developing a biobehavioral adaptive intervention to improve insulin sensitivity in patients with stage 1 obesity.","authors":"Aseel El Zein, Katie M Ellison, Julianne G Clina, Chelsi Reynolds, Caroline W Cohen, James O Hill, Gareth R Dutton, Tapan S Mehta, R Drew Sayer","doi":"10.1186/s40814-025-01618-4","DOIUrl":"10.1186/s40814-025-01618-4","url":null,"abstract":"<p><strong>Background: </strong>Intervention packages targeting obesity-related conditions often include multiple behavioral and pharmacological components, yet the independent and synergistic effects of these strategies on disease progression remain largely unexplored. Adaptive interventions offer a structured approach to tailoring treatments based on individual responses, but feasibility data in primary care settings are limited. The objective of this pilot Sequential Multiple Assignment Randomized Trial (SMART) was to investigate the feasibility of a 25-week adaptive biobehavioral intervention designed to improve insulin sensitivity among patients with stage 1 obesity.</p><p><strong>Methods: </strong>Forty participants were initially randomized to either nutrition counseling (NC) or exercise counseling (EC), both employing a weight-neutral approach. At week 8, insulin sensitivity was reassessed using the Quantitative Insulin Sensitivity Check Index (QUICKI). Participants with a > 5% improvement were classified as responders, while non-responders were re-randomized to either augment their first-stage intervention with metformin or switch to weight loss counseling (WLC). Feasibility outcomes included recruitment and retention, adherence to intervention components, and preliminary treatment effect estimates.</p><p><strong>Results: </strong>Findings support the overall feasibility of the SMART design, with high adherence to virtual counseling sessions and favorable participant retention. The study effectively differentiated responders from non-responders at week 8, with responders showing greater improvements in insulin sensitivity. Among non-responders, WLC and metformin provided a potential rescue effect, but overall insulin sensitivity remained lower than at of responders. While NC and WLC were preferred over EC and metformin, adherence to counseling sessions remained high across all interventions, regardless of preference. Metformin adherence posed challenges due to frequent gastrointestinal side effects and difficulties tracking usage.</p><p><strong>Conclusions: </strong>This pilot study supports the feasibility of an adaptive biobehavioral intervention for improving insulin sensitivity among adults with obesity in a primary care setting. However, further refinement is needed to enhance clinical integration, optimize intervention messaging, and improve medication tracking. Findings from this study will inform a second pilot SMART, laying the foundation for a full-scale primary-care embedded intervention delivering personalized, adaptive strategies for improving cardiometabolic health.</p><p><strong>Trial registration: </strong>NCT04392283 on April 19th, 2020.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"40"},"PeriodicalIF":1.5,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11971893/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143788768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tailoring registered dietitian and occupational therapy services for home-delivered meal recipients: feasibility study protocol for a randomized controlled trial.","authors":"Lisa A Juckett, Shivam Joshi, J Madison Hyer, Govind Hariharan, Kali S Thomas, Tejeswini Siva Sathya, Mequeil L Howard, Leah E Bunck, Melinda L Rowe, Andrea Devier, Kelly Parrett","doi":"10.1186/s40814-025-01623-7","DOIUrl":"10.1186/s40814-025-01623-7","url":null,"abstract":"<p><strong>Background: </strong>Home-delivered meal recipients often present with complex nutritional and functional needs that place them at elevated risk for health decline and potential institutionalization. To address these complex needs, clinical services-namely registered dietitian and occupational therapy services-may be warranted to reduce the risk of health decline and maximize outcomes of this vulnerable older adult population. Accordingly, this study will explore the feasibility of testing four different clinical service models with home-delivered meal recipients. In particular, this study will determine the feasibility of recruiting and retaining participants from one home-delivered meal provider, determine challenges and opportunities to improve data collection procedures, assess resources needed to conduct study activities, and identify if service models can be implemented as intended.</p><p><strong>Methods: </strong>This is a feasibility RCT with 1:1:1:1 allocation to four service arms: (a) meals only, (b) meals + registered dietitian services, (c) meals + occupational therapy services, or (d) meals + registered dietitian services + occupational therapy services. Study activities will be conducted in collaboration with one, large community-based agency in the Midwest United States. We will recruit 60 participants who meet the following inclusion criteria: is eligible to receive home-delivered meals funded through Title 3 of the Older Americans Act, has a self-reported diagnosis of diabetes and/or heart disease, is at risk for falling, and can store and reheat up to 14 frozen meals per week. Data collection will occur at baseline and at 3 months after informed consent to assess malnutrition risk, self-management of health conditions, and fall risk.</p><p><strong>Discussion: </strong>While tailored dietitian and occupational therapy services may be warranted to address the nutritional and functional needs of home-delivered meal recipients, the effect of these services on recipient outcomes has yet to be rigorously examined. This feasibility study will identify the degree to which our service models can be tested with one community-based agency and identify opportunities to improve study procedures prior to conducting a definitive, stage III randomized controlled trial.</p><p><strong>Trial registration: </strong>NCT06059404.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"41"},"PeriodicalIF":1.5,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11971902/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143788775","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The feasibility and acceptability of delivering and evaluating a physical activity intervention (ACCEPTANCE) for cervical cancer survivors.","authors":"Nessa Millet, Hilary J McDermott, Fehmidah Munir, Charlotte L Edwardson, Tatiana Plekhanova, Esther L Moss","doi":"10.1186/s40814-025-01622-8","DOIUrl":"10.1186/s40814-025-01622-8","url":null,"abstract":"<p><strong>Background: </strong>Cervical cancer treatment can be associated with long-term physical, psychological and emotional issues leading to compromised quality of life (QOL). Physical activity (PA) may improve QOL in cervical cancer survivors.</p><p><strong>Methods: </strong>A one-arm pre/post-feasibility study with parallel process evaluation was conducted to test the feasibility and acceptability of a 12-week PA intervention (ACCEPTANCE). Feasibility was determined by using pre-established criteria relating to inclusion criteria, recruitment and retention, compliance with intervention components and compliance with evaluation measures. The 12-week intervention consisted of (1) an online education session on the benefits of PA and a barrier identification and problem-solving session; (2) a Fitbit monitor; (3) daily and weekly diary entries; (4) brief fortnightly online health coaching sessions; and (5) organising and participating in group walks; (6) online social interaction via a messaging group. Measures included accelerometer assessed PA and sleep, quality-of-life and PA behaviour change questionnaires distributed at 4-time points (baseline, week 6, week 12, and week 24). Process evaluation measures were questionnaires on the acceptance of intervention components and semi-structured interviews with participants after completion.</p><p><strong>Results: </strong>Thirty participants were recruited with a retention rate of 77% at week 24. The education session, health coaching and Fitbit PA monitor were deemed to be feasible based on compliance rates whilst the online messaging group, diary and group walking compliance suggested that modifications would be needed for these components. Accelerometer and questionnaires were deemed to be feasible evaluation measures based on compliance rates. Process evaluation results suggest that the Fitbit and health coaching sessions were perceived to be the most beneficial aspects of the programme as they enabled self-monitoring of behaviour and goal setting. Unexpected mechanisms of behaviour change were the integration of a small change approach and formation of habits to facilitate PA, whilst barriers to behaviour change included the online, virtual nature of the programme, poor mental health, and environmental challenges. PA levels were higher after the intervention, whilst global QOL was seen to worsen throughout the study, and depression and anxiety symptoms improved.</p><p><strong>Conclusions: </strong>The ACCEPTANCE study is deemed to be feasible based on criteria established a priori, and only minor modifications would needed to implement in a definitive randomised control trial. The intervention showed potential to increase PA, through hypothesised mechanisms of self-monitoring behaviour and problem solving and unexpected mechanisms such as habit formation.</p><p><strong>Trial registration: </strong>ISRCTN16349793, Registered 30 September 2020.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"42"},"PeriodicalIF":1.5,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11971866/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143788776","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Support for young people who are distressed by hearing voices: protocol for an uncontrolled feasibility evaluation of a psychological intervention package delivered within secondary schools (the ECHOES study).","authors":"Mark Hayward, Mary John, Sarah Parry, Anna-Marie Bibby-Jones, Faith Orchard, Fiona Malpass, Clare Dixon, Akira Naito","doi":"10.1186/s40814-025-01611-x","DOIUrl":"10.1186/s40814-025-01611-x","url":null,"abstract":"<p><strong>Background: </strong>Hearing voices is a common experience for young people and can cause significant distress. There are no evidence-based psychological interventions for distressing voices in young people, although a focus on coping strategies has been suggested as a useful approach. We have developed and evaluated a brief 1:1 coping intervention for young people who hear distressing voices. This intervention has been successfully piloted within Child and Adolescent Mental Health Services (CAMHS), together with a psychoeducational workshop for parents. The 1:1 intervention and the workshop will be combined into an intervention package and offered within schools to maximise accessibility.</p><p><strong>Methods: </strong>This study will be an uncontrolled feasibility evaluation addressing the following questions: is the intervention package acceptable to young people, those who support them, and staff and practitioners within secondary schools? What is the optimum content, structure, and duration for the intervention package? Is delivery of the intervention package feasible for the practitioners and what are their requirements for training and supervision? What tools can be used to evaluate the impact of the intervention package? The study will be guided by the MRC Framework for the development of complex interventions and consist of an iterative process over four phases: phase 1-adaptation of the intervention package with young people, parents, and school staff; phase 2-delivery of the intervention package through Mental Health Support Teams to students, supporters who have been nominated by the students and school staff; phase 3-analysis of quantitative and qualitative data collected from participants and practitioners; phase 4-further adaptation of the intervention package with young people, parents and school staff.</p><p><strong>Discussion: </strong>If the findings from the study suggest that a future trial is warranted, a feasibility Randomised Controlled Trial will be designed to establish the parameters for a definitive trial.</p><p><strong>Trial registration: </strong>Current Controlled Trials ISRCTN registration number: 16395888. Registered on 11 January 2024. 10.1186/ISRCTN16395888.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"39"},"PeriodicalIF":1.5,"publicationDate":"2025-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11971772/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143788773","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Findings from a cluster randomised feasibility study of a school-based physical activity role model intervention (CHARMING) for 9-10-year-old girls.","authors":"Kelly Morgan, Jordan Van Godwin, Rebecca Cannings-John, Rhiannon Tudor Edwards, Rachel Granger, Britt Hallingberg, Graham Moore, Bethan Pell, Esther van Sluijs, Holly Whiteley, Jemma Hawkins","doi":"10.1186/s40814-025-01615-7","DOIUrl":"10.1186/s40814-025-01615-7","url":null,"abstract":"<p><strong>Background: </strong>Girls' physical activity levels decline to a greater extent than boys as they enter adolescence. Role model interventions offer a potential solution to combat this public health issue. This study reports findings of a feasibility study of the CHARMING (CHoosing Active Role Models to INspire Girls) programme, a 6-week after-school primary school-based, community linked, role-model intervention.</p><p><strong>Methods: </strong>Between January 2021 and August 2022, a feasibility cluster randomised controlled trial (cRCT), with process and health economic evaluations was conducted in South Wales. Secondary schools were recruited, along with their adjoining primary schools to recruit Year 5 girls (aged 9-10 years). Role models were recruited from the surrounding school community (community role models) and from each secondary school (peer role models). A survey of self-reported outcome measures and accelerometers were administered at baseline and at 12 months. Following baseline, six primary schools were randomly allocated to intervention or control (usual practice) on a 2:1 basis. Post-intervention delivery, observations (n = 30), focus groups (n = 13) and interviews (n = 22) were conducted to explore study and intervention acceptability, feasibility and fidelity. Five pre-specified progression criteria included: implementation, attendance rates, and acceptability of the intervention, as well as completion of the primary outcome, including levels of completeness.</p><p><strong>Results: </strong>One hundred and fifty-six girls from six primary schools (four intervention and two control) were eligible to take part. Of these, 96 (62%) and 97 (62%) Year 5 girls took part in the survey and accelerometer measures respectively, with 78 (81%) and 77 (79%) participating in the 12-month follow-up. Findings indicate that it is feasible to collect health-related quality of life information from 9- to 10-year-olds using a digital self-report survey completed in schools. Despite the impacts of the COVID-19 pandemic, three of the five criteria (implementation, acceptability and completion of primary outcome) for progressing to a full-scale evaluation were met. Process evaluation data provide understandings of why two criteria (attendance and completeness of the primary outcome) were not met. Overall, data suggest that acceptability and feasibility of the intervention were high, and that the intervention was broadly delivered as intended. Alterations to the study measures and the intervention were suggested to increase intervention acceptability and feasibility, including recruitment and retention and extending the length of delivery in line with original intentions (12 weeks).</p><p><strong>Conclusions: </strong>Findings suggest the CHARMING intervention and cRCT design are likely to be acceptable and feasible, subject to further intervention and evaluation design optimisation.</p><p><strong>Trial registration: </strong>ClinicalTrial","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"38"},"PeriodicalIF":1.5,"publicationDate":"2025-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11969858/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143788771","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Four-week Nordic hamstring exercise intervention for individuals with ACL reconstruction via hamstrings tendon autograft: feasibility of a pilot randomized controlled trial.","authors":"Grant E Norte, Neal R Glaviano, David A Sherman, Justin L Rush, Amanda M Murray","doi":"10.1186/s40814-025-01624-6","DOIUrl":"10.1186/s40814-025-01624-6","url":null,"abstract":"<p><strong>Background: </strong>The Nordic hamstring exercise (NHE) has been widely used among uninjured, athletic populations to mitigate the risk of hamstring injury, yet little is known about its utility as an intervention for individuals who undergo ACL reconstruction with hamstring tendon autograft (ACLR-HT). Understanding the feasibility of NHE as a means of enhancing hamstring function may aid in the development of evidence-based recommendations to guide hamstring recovery. Our aim was to determine the feasibility of conducting a pilot NHE trial among individuals with ACLR-HT.</p><p><strong>Methods: </strong>We used a single-blind randomized controlled trial with parallel arms to investigate individuals 18-35 years with primary, unilateral ACLR-HT. Twenty-three participants were randomized to a standardized, 4-week (10 session) progressive NHE intervention (n = 17) or usual care control (n = 6) group at a 3:1 ratio. Those randomized to the control group were eligible to open-enroll in the intervention group at the completion of the original study period. Primary feasibility outcomes included recruitment uptake, protocol adherence, dose goal attainment, and retention. Exercise perceptions and safety were also assessed. Summary statistics were used to descriptively report all findings.</p><p><strong>Results: </strong>Two control participants were open-enrolled in the intervention group after completing their original study period (n = 19). All participants (88.5% recruitment uptake) adhered to the exercise protocol (100%) and 18 participants (94.7%) attained the total exercise dosage goal. A 100% retention rate was observed, as all participants (intervention 17 randomized, 2 open-enrolled; control 6) returned for their follow-up assessment.</p><p><strong>Conclusions: </strong>A standardized, 4-week progressive NHE protocol is feasible for individuals with ACLR-HT. Positive perceptions of exercise, minimal exercise-related discomfort, and no reported adverse events further support the acceptability of this protocol and the likelihood of successful implementation in future efficacy trials.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT05738200. Registered 2 November 2022-retrospectively registered, https://clinicaltrials.gov/study/NCT05738200 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"37"},"PeriodicalIF":1.5,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11969947/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143780811","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Feasibility of an exercise program in endocrine-treated metastatic breast cancer patients with overweight: protocol for the FEMA study.","authors":"May Wissing, Pernille Skovlund, Susanne Drysdale, Ali Amidi, Robert Zachariae, Tinne Laurberg, Signe Borgquist","doi":"10.1186/s40814-025-01621-9","DOIUrl":"10.1186/s40814-025-01621-9","url":null,"abstract":"<p><strong>Background: </strong>Many patients with metastatic breast cancer can live relatively long lives but are challenged by treatment- and cancer-related side effects such as weight gain, physical deconditioning, and reduced quality of life, possibly affecting survival. In particular, endocrine treatments are associated with an increased risk of weight gain and adverse metabolic effects. There is a need for interventions to prevent side effects among patients with disseminated breast cancer. Exercise is found to be effective in improving quality of life, metabolic health, and body composition in the curative setting, yet evidence in the metastatic setting is sparse. The aim of this study is to assess feasibility of a 12-week exercise intervention for metastatic breast cancer patients with overweight receiving endocrine therapy and to explore potential effects on metabolic health, body composition, physical performance, obesity-related biomarkers, and patient-reported outcomes.</p><p><strong>Methods: </strong>The FEMA study is a randomized controlled feasibility trial in which 21 endocrine-treated patients with metastatic breast cancer and overweight will be randomly assigned in a 2:1 ratio to either a 12-week training program with three weekly training sessions (intervention), or usual care (control), which includes standard clinical follow-up and supportive care without structured exercise. Feasibility will be assessed based on recruitment rate, adherence, retention, and acceptability, employing both quantitative and qualitative approaches for data collection. Participants' experiences will be explored by interviews and analyzed based on content analysis. Data are collected from blood samples, bioelectrical impedance analysis, physical performance tests, blood pressure measurements, and validated questionnaires on health-related quality of life, self-efficacy for coping with cancer, and sleep quality for explorative analyses.</p><p><strong>Discussion: </strong>The planned study will allow us to determine whether this 12-week exercise intervention is feasible in endocrine-treated metastatic breast cancer patients with overweight and explore potential effects on metabolic health, body composition, physical performance, obesity-related biomarkers, and patient-reported outcomes. Information from feasibility outcomes will inform the design of a future definitive randomized controlled trial.</p><p><strong>Trial registration: </strong>Retrospectively registered on March 6, 2024, at ClinicalTrials.gov (NCT06343987).</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"36"},"PeriodicalIF":1.5,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11963278/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143772873","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}