Neuromuscular Diseases
Conditions
Keywords
Social Participation, Fatigue, Self-Management, Rehabilitation, Physical therapy, Occupational therapy, Group intervention, Exercise
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.
Interventions
BEHAVIORALEnergetic
Physiotherapy and occupational therapy aimed at reconditioning and social participation.
OTHERControl group
Usual care
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Revalidatiefonds Nederland
Center of expertise Sneller herstel
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Canadian Occupational Performance Measure (COPM-performance) | 6 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) |
| Activity Card Sort (ACS) | 3 months | Participation measure:% retained activities.(patient) |
| Six Minutes Walking Test (6MWT) | 3 months | physical endurance, sub-max test. (patient) |
| Health care cost | 3 months | Evaluation health care cost (patient) |
| Canadian Occupational Performance Measure (COPM-satisfaction) | 3 months | Perceived satisfaction with performance (patient) |
| Health-related Quality of Life: Short Form 36 (SF-36) | 3 months | Quality of life, used for evaluation of cost effectiveness (patient) |
| General Self-Efficacy Scale | 3 months | Evaluation of the perceived self-efficacy (patient) |
| Hospital Anxiety and Depression Scale (HADS) | 3 months | Anxiety and depression (patient) |
| Zarit Burden Inventory (ZBI) | 3 months | Perceived caregiver burden (caregiver) |
| Checklist Individual Strength subscale fatigue (CIS-fatigue) | 3 months | Impact of fatigue (patient) |
Countries
Netherlands
Outcome results
None listed