No registrations found.
ID
Source
Brief title
Health condition
Chronic fatigue syndrome
Chronisch vermoeidheidssyndroom
Sponsors and support
Intervention
Outcome measures
Primary outcome
CIS-20 questionnaire (fatigue severity) at 6 months.
Secondary outcome
1. CIS-20 questionnaire (fatigue severity) at baseline and 3 months;
2. SCL-90-R questionnaire (psychiatric symptom) at baseline, 3 and 6 months;
3. RAND-36 questionnaire (functional impairment) at baseline, 3 and 6 months;
4. Maximal oxygen uptake capacity at baseline, 3 and 6 months;
5. EuroQol 5D (health outcome) at baseline, 3 and 6 months;
6. Healthcare consumption and economic costs questions at baseline, 3 and 6 months.
Background summary
Both cognitive behaviour therapy and graded exercise therapy are proven effective therapies that can improve outcome, however both therapies are only moderately effective. The hypothesis is that a combination of graded exercise training and cognitive behavioural therapy is more effective than each of these therapies alone.
Study design:
Prospective intervention study.
Study population:
Patients with chronic fatigue syndrome, 18-65 yr old. An internal physician will refer patients eligable for this study to the investigator. All patients will be recruted in the Netherlands.
Intervention:
Group one receives graded exercise training by a sports physician, group two receives cognitive behavioural therapy by a clinical physchologist and group three receives both cognitive behaviour therapy and graded exercise therapy by both a sports physician and a clinical psychologist.
Main study parameters/endpoints:
The main study parameter will be fatigue, the main symptom in chronic fatigue syndrome, measured by a validated questionnaire (CIS-20) at 6 months treatment. Secondary endpoints will be fatigue at 3 months treatment, psychiatric symptoms, functional impairment, physical condition, work participation and medical consumption at 3 and 6 months treatment.
Study objective
The hypothesis is that a combination of graded exercise training and cognitive behavioural therapy is more effective than each of these therapies alone.
Study design
Baseline, 3 and 6 months.
Intervention
Graded exercise therapy:
The duration is gradually increased to 3 times 30 minutes in 6 months. The treatment starts with an intake interview followed by 3 individual sessions of 1 hours in 6 months.
Cognitive behaviour therapy:
The treatment starts with an intake interview followed by 14 individual sessions of 2 hours in 6 months and 2 follow-up sessions.
Combined Graded exercise therapy and Cognitive behaviour therapy:
The treatment starts with an intake interview followed by 10 to 12 individual sessions of 2 hours and 2 follow-up sessions with the psychologist and 3 sessions with the sports physician of 1 hour in 6 months.
Isala klinieken Zwolle<br>
Postbus 10500
S. Berkel, van
Zwolle 8000 GM
The Netherlands
+31 (0)38 4245689
sportgeneeskunde@isala.nl
Isala klinieken Zwolle<br>
Postbus 10500
S. Berkel, van
Zwolle 8000 GM
The Netherlands
+31 (0)38 4245689
sportgeneeskunde@isala.nl
Inclusion criteria
1. Meet CDC-94 CFS criteria;
2. Age: 18-65 yr;
3. CIS-20 score > 35 on subscale fatigue.
Exclusion criteria
1. Not able to understand, speak, read or write Dutch sufficiently;
2. Severe mental disorder or severe physical co-morbidity, impeding physical exercise;
3. Patient is currently engaged in a legal procedure concerning disability-related financial benefits;
4. Previously treated with GET or CBT for CFS.
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 | NL3066 |
| NTR-old | NTR3214 |
| CCMO | NL32433.075.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |