Feasibility of a Web-based, Peer-supported Exercise Program for Patients With Hip and/or Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Feasibility: time resources used by peer-supporters
研究概览
简要总结
In this project, a web-based exercise program is developed in co-creation between specialized health care, the Norwegian Association for Rheumatic diseases (NRF) and a group of experienced patient representatives. The project emerges from the evidence that exercise is recommended as first-line treatment for patients with chronic diseases like hip- and knee-osteoarthritis (OA). However, the number of patients in need of targeted exercise will increase considerably the next decades, and their treatment needs cannot be fully handled within the health care system. Development of innovative and effective treatment trajectories and follow-up strategies is urgently required. Peer-support is recognized as an effective way to increase patients' long-term adherence to exercise. Thus, patient-organizations may be an unutilized resource in support and follow-up of patients who need long-term exercise as part of their treatment plan. After discharge from examination in hospital, patients with hip/knee OA will be recruited to follow-up in a novel web-based, peer-supported exercise program, and the feasibility of the intervention will be evaluated.
详细描述
The study will be conducted as a pre-post single-arm feasibility study comprising 50 participants.
The main objective of the study will be to evaluate the feasibility of the web-based, peer-supported exercise intervention in patients with hip and/or knee OA.
Specific research objectives are:
- to assess feasibility of intervention delivery, data collection, eligibility and inclusion/exclusion criteria and intervention fidelity
- to assess the responsiveness of relevant primary and secondary outcome measures
In the feasibility study, all participants will be allocated to an intervention group, receiving a 12-week web-based, peer-supported aerobic exercise program including weekly motivational messages. Patients between 40 and 80 years of age that are not candidates for surgery will be recruited from Diakonhjemmet Hospital, Oslo, Norway.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with hip and/or knee osteoarthritis being referred to Diakonhjemmet Hospital
排除标准
- •candidate for surgery
- •unable to understand or write Norwegian
- •unable to walk unaided and continuously for 15 minutes
- •absolute or relative contradictions to maximal exercise testing
- •have relatives with sudden death before 40 years of age
- •have first-degree relatives with hypertrophic cardiomyopathy
结局指标
主要结局
Feasibility: time resources used by peer-supporters
时间窗: baseline to 12 weeks
Time (hours/minutes) per participant-peer-support contact (frequency of contacts divided by total time used by peer-supporters).
Feasibility: time resources used on the exercise program delivery
时间窗: baseline to 12 weeks
Time (hours/minutes) per week per participant used on web-based exercise program delivery.
Feasibility: time resources used on motivational messages delivery
时间窗: baseline to 12 weeks
Time (hours/minutes) per week per participant used on motivational message delivery.
Feasibility: proportion of received exercise diaries
时间窗: baseline to 12 weeks
Proportion of received exercise diaries (0-12 per participant).
Feasibility: proportion wearing the activity monitor
时间窗: baseline
Proportion of participants providing activity monitor data (at least 4 days, including one weekend day, with minimum 10 hours recording per day) at baseline.
Feasibility: proportion completing treadmill test
时间窗: baseline
Proportion of participants completing the indirect maximal cardiorespiratory exercise test according to test-protocol at baseline.
Eligible: proportion eligible
时间窗: baseline
Proportion of potentially eligible participants approached that are invited.
Recruitment: proportion enrolled
时间窗: baseline
Proportion of eligible patients enrolled.
Retention: proportion of enrolled participants
时间窗: baseline and 12 weeks
Proportion of enrolled participants providing data at 12 week post-test.
Adverse events: number of adverse events
时间窗: 12 weeks
Total number of adverse events (by cause if possible) evaluated by answers at post-test: The four questions addressing possible adverse events: 1) Have you carried out any type of treatment during the last 3 months? (With treatment we mean medication, physical exercise, self-management course or any alternative treatments) (yes/no), 2) If yes, have you experienced any adverse event as a result of the treatment? (yes/no). 3) If yes, which adverse events as a result of treatment? 4) In your opinion, which treatment(s) do you think the adverse event was/were caused by? (medication, physical exercise, self-management course, alternative treatments, other) (Elaborate).
次要结局
- Changes in objectively measured physical activity(baseline and 12 weeks)
- Change in physical fitness (VO2 peak)(baseline and 12 weeks)
- Change in Hip disability and Osteoarthritis Outcome Score (HOOS)(baseline and 12 weeks)
- Change in Knee disability and Osteoarthritis Outcome Score (KOOS)(baseline and 12 weeks)
- Change in Patient-specific functional scale (PSFS)(baseline and 12 weeks)
- Change in self-reported physical activity (International Physical Activity Questionnaire-Short Form)(baseline and 12 weeks)
- Change in self-reported physical activity (HUNT)(baseline and 12 weeks)
- Change in self-reported pain intensity the last week(baseline and 12 weeks)
- Change in self-reported fatigue the last week(baseline and 12 weeks)
- Change in self-reported disease activity the last week(baseline and 12 weeks)
- Change in Health-related quality of life (EQ-5D-5L)(baseline and 12 weeks)
- Change in Arthritis Self-Efficacy Scale (ASES)(baseline and 12 weeks)
- Change in exercise self-efficacy(baseline and 12 weeks)
研究者
Anne Therese Tveter
Physiotherapist, PhD
Diakonhjemmet Hospital