Grant E Norte, Neal R Glaviano, David A Sherman, Justin L Rush, Amanda M Murray
{"title":"对通过腘绳肌腱自体移植进行前交叉韧带重建的患者进行为期四周的北欧式腘绳肌锻炼干预：随机对照试验的可行性。","authors":"Grant E Norte, Neal R Glaviano, David A Sherman, Justin L Rush, Amanda M Murray","doi":"10.1186/s40814-025-01624-6","DOIUrl":null,"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":1.6000,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11969947/pdf/","citationCount":"0","resultStr":"{\"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\":null,\"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\":1.6000,\"publicationDate\":\"2025-04-03\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11969947/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pilot and Feasibility Studies\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1186/s40814-025-01624-6\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pilot and Feasibility Studies","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1186/s40814-025-01624-6","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
Four-week Nordic hamstring exercise intervention for individuals with ACL reconstruction via hamstrings tendon autograft: feasibility of a pilot randomized controlled trial.
Background: 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.
Methods: 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.
Results: 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.
Conclusions: 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.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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