I. Kaur , S.L. Baynton , S. Teo , A. White-Kiely , L. Paul , B.A. Wall , F. van Rens , T.J. Fairchild , Y.C. Learmonth
{"title":"改变有氧运动和力量锻炼的行为：确定多发性硬化症患者在线锻炼计划的安全性、可行性和消费者评估的 I 期随机研究结果","authors":"I. Kaur , S.L. Baynton , S. Teo , A. White-Kiely , L. Paul , B.A. Wall , F. van Rens , T.J. Fairchild , Y.C. Learmonth","doi":"10.1016/j.cct.2024.107686","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>Many people with MS do not meet the recommended exercise regime to elicit health benefits. This study aimed to determine the feasibility, safety, acceptability, and appropriateness of an exercise intervention delivered online to persons with MS that meets current exercise recommendations and behaviour change principles.</p></div><div><h3>Methods</h3><p>Seventy-two participants (age: 43.3 ± 13.3 years) with mild to moderate MS were stratified according to previous exercise behaviour and block-randomised into one of three groups: Control (CON; <em>n</em> = 24), General Exercise (GE; <em>n</em> = 24) who at screening did not meet current exercise recommendations, and Advanced Exercise, (AE; <em>n</em> = 24) who at screening met the current exercise recommendations. GE and AE groups received a four-month online-supervised, behaviour change theory-based exercise program and were assessed at baseline, four-months, five-months, and eleven-months for physical activity participation. The feasibility of process, resources, management, and scientific outcomes was assessed.</p></div><div><h3>Results</h3><p>Of 198 potential participants, 143 met the eligibility criteria (72 %), and 72 were randomised. Fifty-three participants completed the intervention (74 % immediate retention), and 44 were retained at the six-month follow-up (61 %). Personnel time was 369 h, and total per-participant cost was Au$1036.20. Adherence rate to ≥70 % of exercise sessions was 73 % (GE) and 38 % (AE). The GE group observed a small magnitude of improvement in physical activity (d = −0.23).</p></div><div><h3>Conclusions</h3><p>An online exercise program embedded with behaviour interventions for either GE or AE appears feasible, acceptable, appropriate and safe and may show long-term efficacy in increased exercise behaviours for persons with mild to moderate MS.</p><p>Trial registration: ANZCRT number ACTRN12619000228189p.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107686"},"PeriodicalIF":2.0000,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1551714424002696/pdfft?md5=d72ef8636af836e613e91db480b61922&pid=1-s2.0-S1551714424002696-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Implementing changing behaviour towards aerobic and strength exercise: Results of a randomised, phase I study determining the safety, feasibility, and consumer-evaluation of an online exercise program in persons with multiple sclerosis\",\"authors\":\"I. Kaur , S.L. Baynton , S. Teo , A. White-Kiely , L. Paul , B.A. Wall , F. van Rens , T.J. Fairchild , Y.C. Learmonth\",\"doi\":\"10.1016/j.cct.2024.107686\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>Many people with MS do not meet the recommended exercise regime to elicit health benefits. This study aimed to determine the feasibility, safety, acceptability, and appropriateness of an exercise intervention delivered online to persons with MS that meets current exercise recommendations and behaviour change principles.</p></div><div><h3>Methods</h3><p>Seventy-two participants (age: 43.3 ± 13.3 years) with mild to moderate MS were stratified according to previous exercise behaviour and block-randomised into one of three groups: Control (CON; <em>n</em> = 24), General Exercise (GE; <em>n</em> = 24) who at screening did not meet current exercise recommendations, and Advanced Exercise, (AE; <em>n</em> = 24) who at screening met the current exercise recommendations. GE and AE groups received a four-month online-supervised, behaviour change theory-based exercise program and were assessed at baseline, four-months, five-months, and eleven-months for physical activity participation. The feasibility of process, resources, management, and scientific outcomes was assessed.</p></div><div><h3>Results</h3><p>Of 198 potential participants, 143 met the eligibility criteria (72 %), and 72 were randomised. Fifty-three participants completed the intervention (74 % immediate retention), and 44 were retained at the six-month follow-up (61 %). Personnel time was 369 h, and total per-participant cost was Au$1036.20. Adherence rate to ≥70 % of exercise sessions was 73 % (GE) and 38 % (AE). The GE group observed a small magnitude of improvement in physical activity (d = −0.23).</p></div><div><h3>Conclusions</h3><p>An online exercise program embedded with behaviour interventions for either GE or AE appears feasible, acceptable, appropriate and safe and may show long-term efficacy in increased exercise behaviours for persons with mild to moderate MS.</p><p>Trial registration: ANZCRT number ACTRN12619000228189p.</p></div>\",\"PeriodicalId\":10636,\"journal\":{\"name\":\"Contemporary clinical trials\",\"volume\":\"146 \",\"pages\":\"Article 107686\"},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2024-09-11\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S1551714424002696/pdfft?md5=d72ef8636af836e613e91db480b61922&pid=1-s2.0-S1551714424002696-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contemporary clinical trials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1551714424002696\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714424002696","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
Implementing changing behaviour towards aerobic and strength exercise: Results of a randomised, phase I study determining the safety, feasibility, and consumer-evaluation of an online exercise program in persons with multiple sclerosis
Background
Many people with MS do not meet the recommended exercise regime to elicit health benefits. This study aimed to determine the feasibility, safety, acceptability, and appropriateness of an exercise intervention delivered online to persons with MS that meets current exercise recommendations and behaviour change principles.
Methods
Seventy-two participants (age: 43.3 ± 13.3 years) with mild to moderate MS were stratified according to previous exercise behaviour and block-randomised into one of three groups: Control (CON; n = 24), General Exercise (GE; n = 24) who at screening did not meet current exercise recommendations, and Advanced Exercise, (AE; n = 24) who at screening met the current exercise recommendations. GE and AE groups received a four-month online-supervised, behaviour change theory-based exercise program and were assessed at baseline, four-months, five-months, and eleven-months for physical activity participation. The feasibility of process, resources, management, and scientific outcomes was assessed.
Results
Of 198 potential participants, 143 met the eligibility criteria (72 %), and 72 were randomised. Fifty-three participants completed the intervention (74 % immediate retention), and 44 were retained at the six-month follow-up (61 %). Personnel time was 369 h, and total per-participant cost was Au$1036.20. Adherence rate to ≥70 % of exercise sessions was 73 % (GE) and 38 % (AE). The GE group observed a small magnitude of improvement in physical activity (d = −0.23).
Conclusions
An online exercise program embedded with behaviour interventions for either GE or AE appears feasible, acceptable, appropriate and safe and may show long-term efficacy in increased exercise behaviours for persons with mild to moderate MS.
Trial registration: ANZCRT number ACTRN12619000228189p.
期刊介绍：
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
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