Effectiveness and Cost-effectiveness of the Energetic Program
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 50
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 able to formulate at least 3 individual participation goals during the interview with the occupational therapist.
- ...
- formal diagnosis of muscular disease, either FascioScapuloHumeral Dystrophy (FSHD), Inclusion Body Myositis (IBM), Mitochondrial Myopathy (MM) or any other;
- being severely fatigued
- being able to formulate at least 3 individual participation goals during the interview with the occupational therapist.
- 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)
Exclusion Criteria
- active depression or other psychiatric disorder as indicated by a consultant psychologist or by the medical history,
- pregnancy,
- having participated in the Energetic program before
- ...
- active depression or other psychiatric disorder as indicated by a consultant psychologist or by the medical history,
- pregnancy,
- having participated in the Energetic program before
- severe co-morbid condition,
- a travel distance perceived as too burdensome
Summary
- Conditions
- Neuromuscular Diseases
- Type
- Interventional
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 85 years
- Gender
- Both males and females
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 able to formulate at least 3 individual participation goals during the interview with the occupational therapist.
- ...
- formal diagnosis of muscular disease, either FascioScapuloHumeral Dystrophy (FSHD), Inclusion Body Myositis (IBM), Mitochondrial Myopathy (MM) or any other;
- being severely fatigued
- being able to formulate at least 3 individual participation goals during the interview with the occupational therapist.
- 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)
Exclusion Criteria
- active depression or other psychiatric disorder as indicated by a consultant psychologist or by the medical history,
- pregnancy,
- having participated in the Energetic program before
- ...
- active depression or other psychiatric disorder as indicated by a consultant psychologist or by the medical history,
- pregnancy,
- having participated in the Energetic program before
- severe co-morbid condition,
- a travel distance perceived as too burdensome
Tracking Information
- NCT #
- NCT02208687
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Revalidatiefonds Nederland
- Center of expertise Sneller herstel
- Investigators
- Principal Investigator: Edith Cup, dr. Radboudumc, department Rehabilitation
- Edith Cup, dr. Radboudumc, department Rehabilitation
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