NCT02208687已完成不适用
Energetic, a Self Management Group Program Aimed at Reconditioning and Social Participation in Persons With a Muscle Disease; a Multicentre Randomized Controlled Trial.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Canadian Occupational Performance Measure (COPM)
研究概览
简要总结
Fatigue is present in at least 60% of the patients with a muscle disease and can be the most disabling symptom. In combination with other impairments, this often results in low levels of physical activity and decreased social participation, leading to large societal costs. Energetic is a self-management group program aimed at improving participation and physical endurance in these patients. Our hypothesis is that Energetic results in improved participation and improved physical endurance, less experienced fatigue and better quality of life compared to usual care, without increasing health care costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •formal diagnosis of muscular disease, either FascioScapuloHumeral Dystrophy (FSHD), Inclusion Body Myositis (IBM), Mitochondrial Myopathy (MM) or any other;
- •being severely fatigued
- •being cardiopulmonary stable and capable of aerobic training (as determined using a submaximal cycling exercise test with ECG (electrocardiography) and advice from a consultant cardiologist and pulmonologist);
- •being motivated, committed to the program, and 'ready to change' which is discussed with the patient during the screening by a rehabilitation physician and an occupational therapist; to this end, motivational interviewing will be used (including a advantages/disadvantages matrix; a visual analogue scale (VAS) to rate the importance of participation in de program; and a VAS to rate the confidence a patient has that participation in the program is feasible)
- •being able to formulate at least 3 individual participation goals during the interview with the occupational therapist.
排除标准
- •active depression or other psychiatric disorder as indicated by a consultant psychologist or by the medical history,
- •pregnancy,
- •severe co-morbid condition,
- •having participated in the Energetic program before
- •a travel distance perceived as too burdensome
研究组 & 干预措施
Energetic
Experimental
Self management group program aimed at reconditioning and social participation
干预措施: Energetic (Behavioral)
Control group
Other
Usual care
干预措施: Control group (Other)
结局指标
主要结局
Canadian Occupational Performance Measure (COPM)
时间窗: 3 months
Perceived activity performance. Three months will be the primary analysis. Effects at follow up will be measured at 6 and 12 months (see secondary outcome measures) (patient)
次要结局
- Activity Card Sort (ACS)(15 months)
- Hospital Anxiety and Depression Scale (HADS)(15 months)
- Zarit Burden Inventory (ZBI)(15 months)
- Six Minutes Walking Test (6MWT)(15 months)
- Health care cost(15 months)
- Canadian Occupational Performance Measure (COPM-satisfaction)(15 months)
- Canadian Occupational Performance Measure (COPM-performance)(15 months)
- General Self-Efficacy Scale(15 months)
- Health-related Quality of Life: Short Form 36 (SF-36)(15 months)
- Checklist Individual Strength subscale fatigue (CIS-fatigue)(15 months)
- Canadian Occupational Performance Measure (COPM-satisfaction)(3 months)
- Canadian Occupational Performance Measure (COPM-satisfaction)(6 months)
- Canadian Occupational Performance Measure (COPM-performance)(6 months)
- Activity Card Sort (ACS)(3 months)
- Activity Card Sort (ACS)(6 months)
- Six Minutes Walking Test (6MWT)(3 months)
- Six Minutes Walking Test (6MWT)(6 months)
- Health care cost(3 months)
- Health care cost(6 months)
- Checklist Individual Strength subscale fatigue (CIS-fatigue)(3 months)
- Checklist Individual Strength subscale fatigue (CIS-fatigue)(6 months)
- Health-related Quality of Life: Short Form 36 (SF-36)(3 months)
- Health-related Quality of Life: Short Form 36 (SF-36)(6 months)
- General Self-Efficacy Scale(3 months)
- General Self-Efficacy Scale(6 months)
- Hospital Anxiety and Depression Scale (HADS)(3 months)
- Hospital Anxiety and Depression Scale (HADS)(6 months)
- Zarit Burden Inventory (ZBI)(3 months)
- Zarit Burden Inventory (ZBI)(6 months)
研究者
研究点 (1)
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