Pilot and Feasibility Studies最新文献

{"title":"Supporting couples' perinatal sexual well-being: a feasibility study of the introductory modules of a novel prevention program (STORK).","authors":"Inês M Tavares, Samantha J Dawson, Erin T Fitzpatrick, Greta E Jang, Kyle R Stephenson, Natalie O Rosen","doi":"10.1186/s40814-026-01878-8","DOIUrl":"10.1186/s40814-026-01878-8","url":null,"abstract":"<p><strong>Background: </strong>Most new parents will experience changes to their sexual relationship during the perinatal period, yet no accessible prevention programs exist to support couples in navigating these changes. Our aim was to assess the feasibility of the introductory modules of an online couple-based program (STORK) designed to promote perinatal sexual well-being. The program is grounded in empirically established risk and protective factors associated with couples' perinatal sexual well-being.</p><p><strong>Methods: </strong>We conducted a single-group feasibility study with eleven couples (22 individuals) expecting their first child (mean gestation 20 weeks). Couples completed the orientation and first STORK modules during a 2-h online session with a researcher. Participants then completed an online survey evaluating the program's feasibility and content. Qualitative semi-structured interviews and online questionnaires assessed participants' experiences with the platform, focusing on usability, acceptability, clarity, relevance, and overall satisfaction.</p><p><strong>Results: </strong>Participants reported high acceptability, rating both modules as clear and logical (mean = 5.6-5.9/7), enjoyable (mean = 4.7-6.1/7), helpful (mean = 5.0-5.7/7), and relevant (mean = 6.1/7). The platform was rated as easy to navigate (mean = 5.6/7) and highly inclusive (mean = 6.0-6.1/7). Most participants found the time commitment reasonable (95.5%), and 91% considered weekly completion with their partner feasible. Qualitative feedback highlighted usability, well-structured content, inclusivity, and support for personal and relationship reflection.</p><p><strong>Conclusions: </strong>The findings suggest that the STORK program is a feasible and acceptable resource to support couples' perinatal sexual well-being, warranting further evaluation of its effectiveness. A pilot randomized controlled trial is warranted and may facilitate a shift toward couple-focused perinatal prevention programs. The STORK program has the potential to fill a critical gap in perinatal healthcare by providing an accessible, evidence-based prevention program to support couples navigating sexual changes during pregnancy and postpartum.</p><p><strong>Trial registration: </strong>This feasibility study was prospectively registered on June 17, 2025 (reg #2023-6719), and the registration can be found here: https://clinicaltrials.gov/study/NCT07036484.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13670602/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148536712","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":"Resistance Exercise and Peer Support with Bands/Balls and Digitally-based Supervision: (REPS w/BANDS): a feasibility study for women with PCOS.","authors":"Pamela J Wright, Cynthia F Corbett","doi":"10.1186/s40814-026-01887-7","DOIUrl":"10.1186/s40814-026-01887-7","url":null,"abstract":"<p><strong>Background: </strong>Exercise is a first-line treatment for women with polycystic ovary syndrome (PCOS). However, research findings reveal that women with PCOS report low exercise motivation due to PCOS stigma-related stress and lack of social connection, inhibiting exercise in public and group settings. The purpose of this study was to assess the feasibility and acceptability of an in-home resistance exercise program supervised in real time by personal trainers using smart home video devices (SHVDs) with peer support through a buddy system.</p><p><strong>Methods: </strong>This one-arm feasibility study incorporated strategies from self-determination theory to meet participants' psychological needs of autonomy, competence, and relatedness. Participants (N = 10) received an SHVD and exercise equipment (bands, stability ball). Personal trainers supervised 2 individual RE sessions per week for 12 weeks per participant via the SHVD's video feature. Participants were randomly paired with a buddy and encouraged to connect weekly for peer support. Feasibility, acceptability, depressive symptoms, anthropometrics, and muscular endurance were measured using surveys, fitness testing, and interviews. Quantitative data were analyzed using t-tests. Qualitative data were analyzed via thematic analysis.</p><p><strong>Results: </strong>Participants were 26.6 (8.8) years, mostly White (70%), educated (90% some college or more), and diagnosed with ≥ 1 comorbidity. Data yielded 100% recruitment, 74% attendance, 80% retention, and a 4.8 rating (excellent on 5-point scale) for acceptability. Further findings revealed pre-post signals of improvements in depressive symptoms, muscular endurance, and waist circumference. Only one buddy pair (20%) made consistent contact. Participants preferred a buddy with similar life experiences in terms of life phase (e.g., student, mother) along with the shared PCOS identity.</p><p><strong>Conclusions: </strong>REPS w/BANDS is feasible and has potential to improve mental and physical health outcomes. Participants reported increased exercise motivation due to rapport with the personal trainer and the personal trainer's PCOS knowledge, use of SDT strategies, and interest in the participants' fitness progress. REPS w/BANDS was revised based on findings and will be piloted as a larger randomized controlled trial.</p><p><strong>Trial registration: </strong>The study was retrospectively registered at ClinicalTrials.gov (NCT06629883) on September 20, 2024.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13670454/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148536623","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":"SalT supplementation in Older adults with Orthostatic intolerance Disorders (STOOD) trial: a study protocol for a feasibility randomised controlled trial.","authors":"Catriona Reddin, Andrew Smyth, Suzanne McDermott, Clodagh McDermott, Edel Mannion, Naomi Davies, Alberto Alvarez Iglesias, Robert Sheldon, Michelle Canavan, Rose Anne Kenny, Martin O'Donnell","doi":"10.1186/s40814-026-01885-9","DOIUrl":"10.1186/s40814-026-01885-9","url":null,"abstract":"<p><strong>Background: </strong>Orthostatic hypotension (OH) is a common cause of falls, and key source of morbidity and mortality due to injury (e.g. hip fracture). Current guidelines recommend increasing salt intake in patients with symptomatic orthostatic hypotension. However, the evidence underpinning this recommendation is poor, based primarily on small trials with very short-term follow-up (<8 weeks). High salt intake might improve quality of life and reduce the risk of falls, but might also increase the long-term risk of cardiovascular disease, in patients with OH.</p><p><strong>Methods: </strong>STOOD is a two-group, parallel, open-label, randomised controlled, single centre trial. Adults aged ≥65 years with symptomatic orthostatic hypotension, and estimated moderate salt intake (based on screening questions) will be eligible. Exclusion criteria include uncontrolled hypertension (>180/110 mmHg), heart failure (NYHA class III/IV, or ejection fraction < 30%), loop diuretic use, chronic kidney disease (eGFR < 30 ml/min/1.73m²), hyponatraemia (serum sodium < 125 mmol), evidence based clinician recommendation of high or low salt diet, and inability to provide informed consent. Participants will be randomised to receive salt supplementation of 5 g encapsulated sodium chloride per day (in addition to usual care) or usual care alone. The primary feasibility outcome will be recruitment and retention of the target sample size of 48 participants. The primary efficacy outcome is change in orthostatic hypotension questionnaire score from baseline to 6-month follow-up.</p><p><strong>Discussion: </strong>A recommendation for long-term higher salt intake may have adverse cardiovascular consequences, which necessitates robust evidence of efficacy and identification of the optimal range of salt intake associated with the greatest reduction in falls risk and lowest cardiovascular risk. Our study will establish the feasibility and acceptability of evaluating the intervention (salt supplementation) in a single centre, and provide preliminary evidence of treatment effect of salt supplementation for management of orthostatic hypotension.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT06188663. Registered on 17th December 2023.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13656359/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148472131","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 and acceptability of whole-body electromyostimulation in pulmonary rehabilitation for patients with chronic respiratory disease: a pilot study protocol.","authors":"Atsuhito Nakazawa, Yuki Takahashi, Taichi Sano, Suzukaze Itakura, Yohei Arayama, Hikaru Machiguchi, Takamasa Morimoto, Takashi Fukushima, Takashi Niwa, Shigeru Komatsu, Takashi Ogura","doi":"10.1186/s40814-026-01883-x","DOIUrl":"10.1186/s40814-026-01883-x","url":null,"abstract":"<p><strong>Background: </strong>Evidence on the effectiveness of electromyostimulation (EMS) has been reported in pulmonary rehabilitation, but the benefits have been limited in chronic obstructive pulmonary disease, and clinical trials in advanced idiopathic pulmonary fibrosis were not considered feasible. Recently, whole-body EMS (WB-EMS) has been developed and applied in the area of non-medical commercial application. To date, there are no reports on the application of medical WB-EMS for respiratory diseases. The aim of this study is to investigate the feasibility and acceptability of WB-EMS as an adjunct to pulmonary rehabilitation in patients with chronic respiratory disease.</p><p><strong>Methods: </strong>This is a protocol for a pilot, single group, feasibility trial. The e-skin is an EMS suit that can simultaneously load the muscles of the entire body (Xenoma Inc., Tokyo, Japan). Participants will conduct one session per day, once a week for 4 weeks. They perform resistance exercise trainings during EMS under the supervision and guidance of a trained physiotherapist or respiratory physician as a trainer. A physiotherapist controls the HUB attached to the suit with a dedicated mobile application. Each setting of EMS is determined by each segment of electrical stimulation and meets the recommended regimen and guideline criteria for WB-EMS operation. Outcome measures will include Modified Medical Research Council Dyspnoea Scale, pulmonary function test, health-related quality of life, exercise tests including six-minute walk test and one-minute sit-to-stand-test, Barthel Index, muscle strength, body composition analysis, and blood tests such as muscle markers and renal function markers. To assess the feasibility and acceptability of the intervention, participant adherence, retention, and perceived burden will be evaluated.</p><p><strong>Discussion: </strong>WB-EMS can stimulate both type I and type II muscle fibers and may help counteract preferential type II fiber atrophy frequently observed in CRD. This pilot study focuses on verifying the feasibility and acceptability of WB-EMS as an adjunct to pulmonary rehabilitation. By providing a physiologically distinct, time-efficient training modality that minimizes cardiopulmonary load, WB-EMS could become a promising rehabilitation option for patients with limited exercise tolerance.</p><p><strong>Trial registration: </strong>UMIN-CTR, UMIN000057270. Retrospectively registered 12 March 2025.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13656423/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148472025","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 and acceptability of home-based computerised cognitive training after cardiac surgery.","authors":"Tracey Bowden, Julie Sanders, Catherine S Hurt, Mandeep Sekhon, Leanne M Aitken","doi":"10.1186/s40814-026-01882-y","DOIUrl":"10.1186/s40814-026-01882-y","url":null,"abstract":"<p><strong>Aims: </strong>Cognitive decline is common after cardiac surgery and is associated with poor postoperative outcomes. The aim of this study was to evaluate the feasibility and acceptability of a home-based computerised cognitive training programme to improve POCD following cardiac surgery; this study was not designed to assess the efficacy of the intervention.</p><p><strong>Methods: </strong>This single-arm, non-blinded, feasibility and acceptability study included patients ≥ 18 years undergoing first-time elective cardiac surgery using standard extracorporeal circulation. Participants were required to complete an 8-week computerised cognitive training (CCT) programme (20 min/day; 5 days/week), commencing 1 week after surgery. The Montreal Cognitive Assessment (MoCA) was administered preoperatively and after programme completion. Feasibility outcomes included recruitment and retention rates and programme adherence. Acceptability was assessed by the Theoretical Framework of Acceptability Questionnaire (TFA-Q).</p><p><strong>Results: </strong>Twenty-nine participants were recruited: 7 (24%) were female and 20 (69%) were White British. Study recruitment was deemed to be feasible (61% of eligible patients) and the CCT was acceptable to 94% of participants who completed the TFA-Q (n = 16), noting that this does not reflect the full recruited cohort. Intervention adherence (n = 9, 31%) and study retention (n = 17, 59%) were limited.</p><p><strong>Conclusions: </strong>The findings of this feasibility study suggest that home-based CCT is deliverable and acceptable to patients following cardiac surgery, though strategies to improve retention and adherence will need to be strengthened before progression to an efficacy study.</p><p><strong>Trial registration: </strong>NCT05298540.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13651069/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148456405","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":"PROTECTIVE-D-a feasibility randomised controlled trial examining the effect of a positive mood intervention and vitamin D supplementation on the immunological responses to influenza vaccination in older adults.","authors":"Simon Royal, Kieran Ayling, Georgina Hopkins, Lucy C Fairclough, Kavita Vedhara","doi":"10.1186/s40814-026-01881-z","DOIUrl":"10.1186/s40814-026-01881-z","url":null,"abstract":"<p><strong>Background: </strong>The effectiveness of vaccines in protecting against disease wanes with increasing age. There is some evidence that psychological wellness and vitamin D supplementation can increase vaccine effectiveness in older people. This study was designed to pilot the acceptability of, and compliance with, study procedures intended for a future large randomised controlled trial (RCT). The procedures included a positive mood intervention (PMI), the use of vitamin D supplements and self-collection of finger-prick blood samples.</p><p><strong>Methods: </strong>Twenty-eight adults aged > 65 years were randomised to one of four conditions: (1) PMI and vitamin D supplements, (2) PMI only, (3) Vitamin D supplements only and (4) Usual care. Blood samples were taken before vaccination with the standard seasonal influenza vaccine and again after 28 days. Vitamin D levels and antibodies to influenza were compared before and after the participants received the allocated intervention.</p><p><strong>Results: </strong>Good compliance with study procedures, as measured by participant responses to a Short Message Service (SMS) text or email, suggest methods were acceptable and feasible in this population. Self-collection of finger-prick samples to measure antibody responses was accomplished by 16 out of 26 participants (62%).</p><p><strong>Conclusions: </strong>This study demonstrates that a large-scale RCT to evaluate two interventions promoting vaccine effectiveness in older adults is feasible. Simple methods of determining patient-reported outcomes and limiting study visits are acceptable to participants and may reduce costs. The finger-prick capillary sampling procedure requires refinement before wider deployment.</p><p><strong>Trial registration: </strong>ISRCTN 12950625 08 FEB 2024 (registered retrospectively).</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13643965/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148437447","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":"Cognitive analytic therapy for self-harm with young people: protocol for the RELATE-YP feasibility randomized controlled trial.","authors":"Peter Taylor, Isabel Adeyemi, Martin Eden, Samantha Hartley, Mark Hann, Cameron Latham, Sarah Parry, Catherine Robinson, Stephen Kellett","doi":"10.1186/s40814-026-01880-0","DOIUrl":"10.1186/s40814-026-01880-0","url":null,"abstract":"<p><strong>Background: </strong>Self-harm is a major health concern amongst young people that is increasing in prevalence. Cognitive analytic therapy (CAT) is a relational, integrative psychotherapy that is theoretically consistent with our growing understanding of self-harm. The aim of this study was to ascertain the feasibility and acceptability of evaluating brief CAT in young people aged 13-17 who self-harm using a randomised controlled trial (RCT) design.</p><p><strong>Method: </strong>Sixty young people with experiences of self-harm will be recruited from child and adolescent mental health services. Participants will be randomly allocated (1:1 ratio) to brief CAT plus treatment as usual (TAU) or TAU alone. Assessors will be blind to treatment allocation. Assessments will occur at baseline, 8, 16, and 20 weeks after randomisation. A qualitative process evaluation will investigate experiences of the therapy and trial procedures. The primary outcome for this study is feasibility, judged against a priori progression criteria relating to recruitment, retention, adherence to therapy, and missing data.</p><p><strong>Discussion: </strong>Brief CAT may help young people struggling with self-harm, but research is needed. In order to undertake a definitive RCT, it is first necessary to resolve a number of feasibility uncertainties. The planned feasibility trial will help inform a larger definitive trial focused on the efficacy of brief CAT for young people who self-harm.</p><p><strong>Trial registration: </strong>The trial was pre-registered (01/08/25) on ISR CTN (ISRCTN code: ISRCTN11505839).</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13602529/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148448715","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 and tolerability of Musa sp. pseudo-stem core powder as a dietary supplement with gut microbiota-modulating potential: a pilot randomised controlled trial.","authors":"Hajara Aslam, Mojtaba Loftalani, Martin O'Hely, Michael Berk, Russell Keast, Simone Lewin, Shirani Gamlath, Heidi Staudacher, Felice N Jacka","doi":"10.1186/s40814-026-01877-9","DOIUrl":"10.1186/s40814-026-01877-9","url":null,"abstract":"<p><strong>Background: </strong>The gut microbiota is increasingly recognised as a therapeutic target for mental disorders, with nutritional supplements providing a direct approach to modulating the gut microbiota. However, existing evidence largely focuses on single nutrients or phytochemicals, highlighting the need for novel multi-component interventions. This pilot study evaluated the feasibility and tolerability of a dietary supplement powder derived from Musa sp. pseudo-stem core that contains a combination of microbiota-modulating nutrients and phytochemicals.</p><p><strong>Methods: </strong>We recruited 30 healthy adults, aged between 18 and 65 years, from the community to a triple-blinded, 4-week randomised placebo-controlled pilot trial. Participants were randomised to receive either 10 g/day of the Musa sp. pseudo-stem core powder or maltodextrin placebo. Supplement feasibility was defined as consuming at least 80% of the allocated supplement along with habitual diet. Tolerability was defined as no changes in gastrointestinal (GI) symptoms and stool consistency compared with placebo. Exploratory outcomes included psychological symptoms, quality of life, urinary hippurate measured using nuclear magnetic resonance spectroscopy, and stool gut microbiota profiling using 16S rRNA sequencing.</p><p><strong>Results: </strong>At the end of the study, 86% of the participants in the supplement group met the 80% consumption threshold, demonstrating intervention feasibility. There were no observed differences in the changes in GI symptoms or stool consistency between the supplement and placebo groups over the period of the study, indicating supplement tolerability. There were no observed differences in the changes in psychological symptoms, quality of life, and urine hippurate levels between groups at week 4. The weighted UniFrac distance showed a structural difference of the gut microbiota community between the supplement and placebo groups at week 4, although no observed differences were found in alpha diversity. Differences in the changes of two bacterial taxa each belonging to the family Anaerovoracaceae and Prevotellaceae were observed in the supplement group compared with the placebo group at week 4.</p><p><strong>Conclusion: </strong>Our pilot study showed that Musa sp. pseudo-stem core powder was feasible and well-tolerated as a dietary supplement, with potential for modulating the gut microbiota. Future adequately powered trials are warranted to evaluate its effect on mental health and to elucidate underlying biological mechanisms.</p><p><strong>Trial registration: </strong>The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12623000454673) on 2 May 2023.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13656367/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148423327","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":"Evaluating the feasibility and preliminary effects of a group-based telerehabilitation program in individuals with persistent dyspnea after COVID-19 (TEPCO): a pilot randomized controlled study.","authors":"Marie-Claude Lehoux, Mariève Houle, Didier Saey, Charles Tétreau, Alice Lefebvre, Eva Mathieu, Christine Drapeau","doi":"10.1186/s40814-026-01876-w","DOIUrl":"10.1186/s40814-026-01876-w","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Many COVID-19 survivors have been shown to experience at least one persistent symptom or deficit following infection, impacting their functioning and quality of life. However, knowledge about the appropriate care and rehabilitation needs of individuals with Long COVID remains fragmented. More research is needed to understand the impact of rehabilitation or telerehabilitation programs on Long COVID symptoms, quality of life, and work ability. This is a pilot randomized controlled trial to evaluate the feasibility of the study procedures and to compare the preliminary effects of a rehabilitation program delivered remotely (experimental group) or in-person (control group) for an adult (≥ 18 years) with confirmed COVID-19 and persistent dyspnea at least eight weeks post-infection.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Participants were randomly assigned to either the telerehabilitation or in-person group using a computer-generated allocation sequence. An 8-week rehabilitation program, including cardiovascular, muscular, balance training, and respiratory exercises, was provided to both groups. Outcomes assessed included feasibility (recruitment rate, dropout rate, adherence rate, occurrence of adverse events, and patient satisfaction). Secondary outcomes comprised preliminary effect measures including exercise capacity, functional capacity, functional independence in daily life, quality of life, and clinical frailty.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Twenty-one participants aged between 29 and 75 (median age 52) were recruited to the study. Thirty-nine (39) eligible individuals were approached, and 22 participants consented to participate in the study (56.4% consent rate). One participant withdrew before the start of the program due to scheduling issues, resulting in 21 participants included in the analysis. Eight participants in the in-person group and ten participants in the telerehabilitation group attended at least 75% of the sessions. No adverse events related to the intervention were reported during the study period. Participants' satisfaction levels were high, with 90% strongly agreeing to the quality of services received in the telerehabilitation group. For the exercise capacity (pedaling time), there was a Group*Time interaction (F&lt;sub&gt;(1, 16)&lt;/sub&gt; = 6.1, ηp&lt;sup&gt;2&lt;/sup&gt; = .28) and a main effect of time (F&lt;sub&gt;(1, 16)&lt;/sub&gt; = 20.9, ηp&lt;sup&gt;2&lt;/sup&gt; = .57). A main effect of time was also detected for the One-Minute Sit-to-Stand Test (F(1, 16) = 8.1, ηp&lt;sup&gt;2&lt;/sup&gt; = .34) in both groups.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This pilot randomized controlled study demonstrated the feasibility and safety of delivering a supervised group-based rehabilitation intervention remotely compared with in-person delivery to individuals with Long COVID characterized by persistent dyspnea eight weeks post-infection. These findings apply to a relatively young, non-hospitalized population and may not be generalizable to all Long COVID pheno","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13625322/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148405444","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":"Immersive physical and occupational therapy in the neonatal intensive care unit: a non-randomized comparative cohort trial protocol.","authors":"Dana B McCarty, Sabrina Zadrozny, Kathryn Tarnai, Catherine Ustby, Meredith Soucie, Stacey C Dusing","doi":"10.1186/s40814-026-01874-y","DOIUrl":"10.1186/s40814-026-01874-y","url":null,"abstract":"<p><strong>Background: </strong>Infants in the Neonatal Intensive Care Unit (NICU) benefit most from occupational therapy (OT) and physical therapy (PT) when delivered at high frequencies. However, implementing these recommendations in clinical practice remains challenging. This study will investigate the impact of different therapy care delivery models on extremely preterm infants and their mothers.</p><p><strong>Methods: </strong>This pilot study uses a non-randomized comparative cohort design with historical controls. A retrospective cohort of 30 infants will represent usual care therapies (UCT). Two prospective cohorts (n = 30 each) will be enrolled following the launch of a new Small Baby Unit (SBU) at a Level IV NICU. The first prospective group will receive UCT within the SBU (SBU + UCT), while the second will receive an Immersive Therapy Model (SBU + ITM). Mothers of infants in the prospective groups will be invited to participate. The SBU introduces developmentally supportive medical and environmental protocols, with ITM adding structured, high-frequency therapy as well as parent-delivered developmental activities. As a pilot study, primary outcomes include the following: (1) feasibility of ITM implementation, measured by changes in therapy frequency and parent-administered activities and (2) comparisons of infant motor and neurobehavioral outcomes, as well as maternal stress and parenting competence. Secondarily, we will evaluate the preliminary efficacy of the SBU + ITM model on infant motor and neurobehavioral outcomes, as well as maternal stress and sense of competence. Finally, we will explore the ITM's potential influence on two important drivers of health care costs in the NICU as compared to UCT: (1) time to infant achievement of independent oral feeds and (2) length of hospitalization.</p><p><strong>Discussion: </strong>Findings may inform neonatal physical and occupational therapy practices by evaluating a novel care model aimed at improving outcomes for both infants and parents. Given its practical implementation and potential for significant impact, the ITM could represent a paradigm shift in NICU-based therapy care.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT06927037, Registered 16 April 2025, https://clinicaltrials.gov/study/NCT06927037?intr=Immersive%20Physical%20Therapy&term=preterm%20infant&rank=1 .</p><p><strong>Protocol number: </strong>Version 5, 2/16/2026.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13599279/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148382630","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}