The hypothesis is that a combination of graded exercise training and cognitive behavioural therapy is more effective than each of these therapies alone.
ID
Bron
Verkorte titel
Aandoening
Chronic fatigue syndrome
Chronisch vermoeidheidssyndroom
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
CIS-20 questionnaire (fatigue severity) at 6 months.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
The hypothesis is that a combination of graded exercise training and cognitive behavioural therapy is more effective than each of these therapies alone.
Onderzoeksopzet
Baseline, 3 and 6 months.
Onderzoeksproduct en/of interventie
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.
Publiek
Isala klinieken Zwolle<br>
Postbus 10500
S. Berkel, van
Zwolle 8000 GM
The Netherlands
+31 (0)38 4245689
sportgeneeskunde@isala.nl
Wetenschappelijk
Isala klinieken Zwolle<br>
Postbus 10500
S. Berkel, van
Zwolle 8000 GM
The Netherlands
+31 (0)38 4245689
sportgeneeskunde@isala.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Meet CDC-94 CFS criteria;
2. Age: 18-65 yr;
3. CIS-20 score > 35 on subscale fatigue.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL3066 |
NTR-old | NTR3214 |
CCMO | NL32433.075.11 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |