McCarthy C J, Mills P M, Pullen R, Richardson G, Hawkins N, Roberts C R, Silman A J, Oldham J A
Centre for Rehabilitation Science, University of Manchester, Manchester Royal Infirmary, UK.
Health Technol Assess. 2004 Nov;8(46):iii-iv, 1-61. doi: 10.3310/hta8460.
To establish the relative effectiveness and cost of providing a home-based exercise programme versus home-based exercise supplemented with an 8-week class-based exercise programme.
The trial was a pragmatic, single-blind randomised clinical trial accompanied by a full economic evaluation.
Patients were randomly allocated to either home-based exercise or home exercise supplemented with class exercise programmes.
A total of 214 patients, meeting the American College of Rheumatology's classification of knee osteoarthritis, were selected from referrals from the primary and secondary care settings.
Both groups were given a home exercise programme aimed at increasing lower limb strength, and endurance, and improving balance. The supplemented group also attended 8 weeks of twice-weekly knee classes run by a physiotherapist. Classes represented typical knee class provision in the UK.
Assessments of locomotor function, using a timed score of three locomotor activities, walking pain and self-reported disability with the Western Ontario and McMaster's Universities osteoarthritis index (WOMAC) were made. General health, lower limb strength, range of movement and compliance with exercise were also measured. Patients were assessed before and after treatment, and also at 6- and 12-month follow-ups. The economic evaluation looked at health service resource use and assessed cost-effectiveness by relating differential costs to differences in quality-adjusted life-years (QALYs) based on patients' responses to the EuroQol-5 Dimensions. Data were obtained at baseline, 1 month, 6 months and 12 months through face-to-face interviews and, where appropriate, examination of hospital medical records.
Patients from the supplemented group demonstrated significantly greater improvement in locomotor function and decrease in pain while walking at all follow-ups. The supplemented group also demonstrated smaller but significant improvements in balance, strength, WOMAC score, and the physical function and pain dimensions of the Short Form-36. However, not all of these improvements were maintained over the 12-month follow-up period. There was no evidence that compliance with the home exercise programme was different or that total costs or mean QALY gains were significantly different between the groups. However, costs were slightly lower and QALY gains slightly higher in the group with the supplementary class-based programme. The economic evaluation suggests that supplemented programmes are likely to be considered cost-effective, although there is uncertainty around this estimate, with approximately 30--35% probability that the intervention would not be cost-effective.
The supplementation of a home-based exercise programme with a class-based exercise programme led to superior improvement in the supplemented group. These differential improvements were still evident at review 12 months after treatment had ceased. The additional cost of the supplemented group was offset by reductions in resource use elsewhere in the system. Compliance with the home exercise programme did not differ between the groups. Based on this evidence, the supplementation of a home-based exercise programme with an 8-week class-based exercise programme can be confidently expected to produce small improvements in locomotor function and clinically important reductions in pain. It is recommended that future research investigates methods of increasing compliance with home exercise programmes and evaluates the impact of these interventions in the primary care setting, where most patients with knee osteoarthritis are managed.
比较提供家庭锻炼计划与家庭锻炼计划辅以为期8周的课堂锻炼计划的相对有效性和成本。
该试验为实用型单盲随机临床试验，并伴有全面的经济评估。
患者被随机分配至家庭锻炼组或家庭锻炼辅以课堂锻炼计划组。
从初级和二级医疗机构的转诊患者中选取了214名符合美国风湿病学会膝关节骨关节炎分类标准的患者。
两组均接受旨在增强下肢力量、耐力和改善平衡的家庭锻炼计划。补充组还参加了由物理治疗师授课的为期8周、每周两次的膝关节课程。这些课程代表了英国典型的膝关节课程设置。
采用三项运动活动的计时评分评估运动功能，采用西安大略和麦克马斯特大学骨关节炎指数（WOMAC）评估步行疼痛和自我报告的残疾情况。还测量了总体健康状况、下肢力量、活动范围和锻炼依从性。在治疗前后以及6个月和12个月的随访时对患者进行评估。经济评估考察了卫生服务资源的使用情况，并通过将差异成本与基于患者对欧洲五维健康量表（EuroQol-5 Dimensions）的反应得出的质量调整生命年（QALY）差异相关联来评估成本效益。通过面对面访谈，并在适当情况下查阅医院病历，在基线、1个月、6个月和12个月时获取数据。
补充组患者在所有随访中运动功能改善显著，步行时疼痛减轻。补充组在平衡、力量、WOMAC评分以及简短健康调查问卷（Short Form-36）的身体功能和疼痛维度方面也有较小但显著的改善。然而，并非所有这些改善在12个月的随访期内都得以维持。没有证据表明两组在家庭锻炼计划的依从性方面存在差异，也没有证据表明两组的总成本或平均QALY增益存在显著差异。然而，辅以课堂锻炼计划的组成本略低，QALY增益略高。经济评估表明，辅以课堂锻炼计划的方案可能被认为具有成本效益，尽管该估计存在不确定性，该干预措施不具有成本效益的概率约为30%-35%。
家庭锻炼计划辅以课堂锻炼计划使补充组的改善更为显著。在治疗停止12个月后的复查中，这些差异改善仍然明显。补充组的额外成本被系统其他地方资源使用的减少所抵消。两组在家庭锻炼计划的依从性方面没有差异。基于这些证据，可以有信心地预期，家庭锻炼计划辅以为期8周的课堂锻炼计划可在运动功能方面产生小幅改善，并在临床上显著减轻疼痛。建议未来的研究调查提高家庭锻炼计划依从性的方法，并评估这些干预措施在大多数膝关节骨关节炎患者接受治疗的初级保健环境中的影响。
