No registrations found.
ID
Source
Brief title
Health condition
Neuromuscular diseases
Spierziekten
Fascio Scapulo Humeral Dystrophy FSHD
Fascioscapulohumerale dystrofie FSHD
Mitochondrial Myopathy MM
Mitochondriële myopathie MM
Sponsors and support
Intervention
Outcome measures
Primary outcome
Self-perceived participation measured with the COPM (Canadian Occupational Performance Measure)
Secondary outcome
- Activity balance (Activity Calculator, AC; Activity Card Sort-NL(18-65), ACS_NL(18-65) and life balance (Occupational Balance Questionnaire, OBQ
- fatigue (Checklist Individual Strength-fatigue, CIS-fatigue);
- participation (Utrecht Scale for Evaluation of Rehabilitation-Participation, USER-P);
- health status (General Health Questionnaire, GHQ);
- quality of life (Short Form Health Survey-36, SF-36); and
- self-efficacy regarding implementation of energy conservation strategies (Self-Efficacy in Performance of Energy Conservation Strategies Assessment, SEPECSA).
Background summary
The Lifebalance study is a randomised clinical trial and evaluates the effectiveness of a personalized, individual face-to-face program ’Managing Fatigue’ to improve participation (Canadian Occupational Performance Measure / COPM) in people with FSHD and MM who experience chronic fatigue in daily life.
Study objective
A personalized, individual face-to-face program ’Managing Fatigue’ is effective to improve participation in people with FSHD or MM who experience chronic fatigue.
Study design
T0: baseline, before intervention
T1: 3 months after start of intervention
T2: 6 months after start of intervention
T3: 12 months after start of intervention
Intervention
Intervention group
Participants in the intervention group will receive a personalized individual face-to-face program ’Managing Fatigue’ (Packer, Brink et al. 1995). The Program ‘Managing Fatigue’ consists of education, practice, evaluation and implementation of energy conservation strategies in daily life. As occupational therapy is a client centred therapy, the intervention will be tailored to the clients’ individual goals and needs.
Control group
Patients in the control group will not receive any occupational therapy or other therapy treating fatigue problems until their last measurement (12 months after baseline). The control group will receive care as usual.
Inclusion criteria
- Diagnosed with FSHD or MM,
- age ≥ 18 years,
- severe fatigue, confirmed by the CIS-Fatigue ≥ 35,
- sufficient mastery of the Dutch language to participate in conversation with the therapist, and
- informed consent (written)
- able to identify, using the COPM, at least three problems in occupational performance that they wish to improve.
Exclusion criteria
- patients with co-morbidity with symptoms that include severe fatigue;
- co-morbidity that interferes with actively taking part in the intervention sessions (e.g. severe psychiatric diagnoses or people with limited life expectancy);
- current involvement in other intervention studies where improvement of fatigue is a possible outcome;
- having received occupational therapy that focused on fatigue management, in the previous twelve months.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7026 |
| NTR-old | NTR7231 |
| CCMO | NL2018-4152 |