To evaluate the effectiveness and cost-effectiveness of Energetic. Secondary objectives include evaluation of barriers and facilitators for implementation of Energetic in other settings.
ID
Source
Brief title
Condition
- Muscle disorders
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Social participation is evaluated with the Canadian Occupational Performance
Measure (COPM) as primary outcome measure.
Secondary outcome
The Activity Card Sort (ACS), 6 minute walking test (6MWT) and Checklist
Individual Strength subscale fatigue (CIS-Fatigue) and General Self- Efficacy
Scale (GSE) are secondary measures Also a health diary (health care costs and
sick leave) is kept by all participants in the study.
Efficiency is studied from a societal perspective calculating costs and quality
adjusted life years.
Background 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 social participation and physical endurance.
Our hypothesis is that Energetic results in , improved participation and
physical endurance and quality of life without increasing health care costs
compared to usual care.
Study objective
To evaluate the effectiveness and cost-effectiveness of Energetic. Secondary
objectives include evaluation of barriers and facilitators for implementation
of Energetic in other settings.
Study design
Randomized controlled multicenter trial comparing persons participating in
Energetic with a control group receiving usual care. Eligible persons are
allocated at random to the intervention or control group (waiting list).
Outcome measures are recorded before randomisation, at the end of the program
(after 16 weeks), at 3 and 12 months follow-up.
Intervention
The Energetic program lasts 16 weeks: the first 9 weeks sessions twice a week
and the last 7 weeks once a week. The program includes four modules: 1)
tailored aerobic exercise training; 2) education about aerobic exercise; 3)
self-management training in applying energy conservation strategies; and 4)
implementation and relapse prevention in daily life. In this program, next of
kin will also be involved. At three months follow-up a recall session is
organized.
During the first year 5 groups (5 persons each) will follow Energetic, 2 at the
Radboud University Medical Centre and (after education) 2 groups at
rehabilitation centre Groot Klimmendaal and one group in a community health
centre. In the second year follow-up measurements will take place and results
will be analyzed and presented.
Study burden and risks
The burden includes the frequent visits for the intervention (twice a week for
9 weeks and once a week for another seven weeks). By then persons are
encouraged to continue training in their own environment. Participants are also
expected to do home exercises. As their cardiopulmonary condition is stable
there are no risks associated with participation in Energetic.
Reinier Postlaan 2
Nijmegen 6584 CG
NL
Reinier Postlaan 2
Nijmegen 6584 CG
NL
Listed location countries
Age
Inclusion criteria
-Adults between 18 and 65 years of age
- Having one of the following muscle diseases: FascioScapuloHumeral Dystrophy (FSHD), Inclusion Body Myositis (IBM), or Mitochondrial Myopathy (MM) (n=30) or other neuromuscular diseases (n=20)
- Being severely fatigued (CIS-fatigue > 35);
-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; using motivational interviewing tools (advantages /disadvantages matrix; a visual analogue scale, VAS, to rate the importance of participation in de program and a VAS to rate the confidence the
patient has that participation in the program is feasible for them)
- Being able to formulate at least 2 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,
- Limited life expectancy (< 5 years) due to known co-morbidity.
Design
Recruitment
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 |
|---|---|
| CCMO | NL47624.091.14 |