Status:
COMPLETED
Effectiveness and Cost-effectiveness of the Energetic Program
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Revalidatiefonds Nederland
Conditions:
Neuromuscular Diseases
Eligibility:
All Genders
18-85 years
Phase:
NA
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 acti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2017
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT02208687
Start Date
August 1 2014
End Date
May 1 2017
Last Update
November 7 2017
Active Locations (1)
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1
Radboudumc
Nijmegen, Gelderland, Netherlands