|- candidate number||10692|
|- NTR Number||NTR3214|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-dec-2011|
|- Secondary IDs||NL32433.075.11 METC|
|- Public Title||Behandeling van patiŽnten met chronisch vermoeidheidssyndroom met gedoseerde oefentherapie en/of cognitieve gedragstherapie.|
|- Scientific Title||Reactivation of patients with chronic fatigue syndrome with graded exercise training and cognitive behavioural therapy.|
|- hypothesis||The hypothesis is that a combination of graded exercise training and cognitive behavioural therapy is more effective than each of these therapies alone.|
|- Healt Condition(s) or Problem(s) studied||Chronic Fatigue Syndrome (CFS)|
|- 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-dec-2011|
|- planned closingdate||1-mrt-2013|
|- Target number of participants||90|
|- Interventions||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.
|- 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.
|- Timepoints||Baseline, 3 and 6 months.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MD. PhD. S. Berkel, van|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. S. Berkel, van|
|- Sponsor/Initiator ||Isala Clinics Zwolle|
(Source(s) of Monetary or Material Support)
|- Brief 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.
Prospective intervention study.
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.
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.
|- Main changes (audit trail)|
|- RECORD||14-dec-2011 - 21-jun-2017|