search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Behandeling van patiŽnten met chronisch vermoeidheidssyndroom met gedoseerde oefentherapie en/of cognitieve gedragstherapie.


- candidate number10692
- NTR NumberNTR3214
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-dec-2011
- Secondary IDsNL32433.075.11 METC
- Public TitleBehandeling van patiŽnten met chronisch vermoeidheidssyndroom met gedoseerde oefentherapie en/of cognitieve gedragstherapie.
- Scientific TitleReactivation of patients with chronic fatigue syndrome with graded exercise training and cognitive behavioural therapy.
- ACRONYMCFS-ReAct
- hypothesisThe 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) studiedChronic Fatigue Syndrome (CFS)
- Inclusion criteria1. Meet CDC-94 CFS criteria;
2. Age: 18-65 yr;
3. CIS-20 score > 35 on subscale fatigue.
- Exclusion criteria1. 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-dec-2011
- planned closingdate1-mrt-2013
- Target number of participants90
- InterventionsGraded 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 outcomeCIS-20 questionnaire (fatigue severity) at 6 months.
- Secondary outcome1. 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.
- TimepointsBaseline, 3 and 6 months.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. PhD. S. Berkel, van
- CONTACT for SCIENTIFIC QUERIESMD. PhD. S. Berkel, van
- Sponsor/Initiator Isala Clinics Zwolle
- Funding
(Source(s) of Monetary or Material Support)
Isala Klinieken
- PublicationsN/A
- Brief summaryBoth 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.
- Main changes (audit trail)
- RECORD14-dec-2011 - 21-jun-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl