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

IF 2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary clinical trials Pub Date : 2024-09-11 DOI:10.1016/j.cct.2024.107686
I. Kaur , S.L. Baynton , S. Teo , A. White-Kiely , L. Paul , B.A. Wall , F. van Rens , T.J. Fairchild , Y.C. Learmonth
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Abstract

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.

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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
背景许多多发性硬化症患者没有达到建议的运动量,因此无法获得健康益处。本研究旨在确定向多发性硬化症患者在线提供符合当前运动建议和行为改变原则的运动干预的可行性、安全性、可接受性和适当性。方法72名轻度至中度多发性硬化症患者(年龄:43.3 ± 13.3岁)根据以往的运动行为进行分层,并随机分为三组:对照组(CON;n = 24)、一般运动组(GE;n = 24)(筛查时不符合当前运动建议)和高级运动组(AE;n = 24)(筛查时符合当前运动建议)。普通运动组和高级运动组接受为期四个月的在线监督、基于行为改变理论的运动计划,并在基线、四个月、五个月和十一个月时对参与体育锻炼的情况进行评估。结果 在 198 名潜在参与者中,143 人符合资格标准(72%),72 人被随机分配。53 名参与者完成了干预(74% 即时保留),44 名参与者在 6 个月的随访中保留(61%)。干预时间为 369 小时,每位参与者的总费用为 1036.20 澳元。运动次数≥70%的坚持率为73%(GE)和38%(AE)。结论针对GE或AE的嵌入行为干预的在线锻炼计划似乎是可行的、可接受的、适当的和安全的,并且可能对轻度至中度多发性硬化症患者增加锻炼行为有长期疗效:试验注册:ANZCRT 编号 ACTRN12619000228189p。
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来源期刊
CiteScore
3.70
自引率
4.50%
发文量
281
审稿时长
44 days
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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