Effectiveness and Cost-effectiveness of the Energetic Program

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Energetic	Energetic	Self management group program aimed at reconditioning and social participation
Control group	Control group	Usual care

Primary Outcome Measures

Name	Time	Method
Canadian Occupational Performance Measure (COPM)	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)

Secondary Outcome Measures

Name	Time	Method
Activity Card Sort (ACS)	15 months	Participation measure:% retained activities.(patient)
Hospital Anxiety and Depression Scale (HADS)	15 months	Anxiety and depression (patient)
Zarit Burden Inventory (ZBI)	15 months	Perceived caregiver burden (caregiver)
Six Minutes Walking Test (6MWT)	15 months	physical endurance, sub-max test. (patient)
Health care cost	15 months	Evaluation health care cost (patient)
Canadian Occupational Performance Measure (COPM-satisfaction)	15 months	Perceived satisfaction with performance (patient)
Canadian Occupational Performance Measure (COPM-performance)	15 months	Perceived performance in activities. Is primary outcome measure at 3 months, but data of 6 and 15 months follow up wil be used in a secondary analysis. (patient)
General Self-Efficacy Scale	15 months	Evaluation of the perceived self-efficacy (patient)
Health-related Quality of Life: Short Form 36 (SF-36)	15 months	Quality of life, used for evaluation of cost effectiveness (patient)
Checklist Individual Strength subscale fatigue (CIS-fatigue)	15 months	Impact of fatigue (patient)

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