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The efficacy of cognitive behavior therapy and aerobic exercise training for decreasing experienced fatigue in patients with facioscapulohumeral dystrophy.


- candidate number3990
- NTR NumberNTR1447
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-sep-2008
- Secondary IDs89000003  ZonMW
- Public TitleThe efficacy of cognitive behavior therapy and aerobic exercise training for decreasing experienced fatigue in patients with facioscapulohumeral dystrophy.
- Scientific TitleThe efficacy of cognitive behavior therapy and aerobic exercise training for decreasing experienced fatigue in patients with facioscapulohumeral dystrophy.
- ACRONYMFACTS-2-NMD
- hypothesisAerobic exercise therapy (AET) and cognitive behavioral therapy (CBT) are hypothesized to be both more effective in improving activity level and, with that, decreasing experienced fatigue of FSHD patients compared to the usual care. The maintenance of the beneficial effects of CBT may be longer than those of AET, because the changes in activity level are achieved more intrinsically.
- Healt Condition(s) or Problem(s) studiedCognitive behavior therapy, Exercise therapy, Fatigue, Neuromuscular diseases, Facioscapulohumeral dystrophy, Muscular dystrophy
- Inclusion criteria1. Age between 18 and 70 years
2. A life-expectancy longer than one year
3. Suffering from severe experienced fatigue (i.e. a score on the CIS-fatigue >= 35)
4. Ability to walk independently (ankle-foot orthoses and canes are accepted)
5. Being able to exercise on a bicycle ergometer
6. Being able to complete the intervention
- Exclusion criteria1. Cognitive impairment
2. Insufficient mastery of the Dutch language
3. Disabling co-morbidity interfering with the intervention programs or influencing outcome parameters
4. Pregnancy
5. Use of psychotropic drugs (except simple sleeping medication)
6. Severe cardiopulmonary disease (chest pain, arrhythmia, pacemaker, cardiac surgery, severe dyspnoea dí effort, emphysema)
7. Epileptic seizures
8. Poorly regulated diabetes mellitus or hypertension
9. Clinical depression, as diagnosed with Beck Depression Inventory for primary care (BDI-PC) (Arnau et al. 2001) (Beck et al. 1997)
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2009
- planned closingdate31-jan-2011
- Target number of participants75
- InterventionsCognitive behavioral therapy, 1-hour session, once a week in the expert centre of chronic fatigue, during 16 weeks.
OR aerobic exercise therapy, 1-hour session, three times a week, one session at a rehabilitation centre, two sessions at home during 16 weeks.
- Primary outcomeExperienced fatigue
- Secondary outcome- aerobic exercise tolerance
- muscle strength
- fall incidence
- quality of life
- pain
- psychological well-being and sleeping pattern
- physical activity in daily life
- self perceived functional status
- limitations in participation and autonomy
- coping
- illness cognitions
- motivation
- concentration
- caregiver strain
- experienced fatigue partner
- experienced fatigue partner over patient
- social support
- coping of partner
- metabolic profiel of muscles, blood and urine
- Timepoints- at baseline t=0
- after the treatment period t = 4 months
- after three motnhs follow-up t = 7 months
- aftre 6 months follow-up t = 10 months
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDrs. N.B.M. Voet
- CONTACT for SCIENTIFIC QUERIESProf Dr. A.C.H. Geurts
- Sponsor/Initiator Radboud University Nijmegen Medical Centre, Department of Rehabilitation
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Prinses Beatrix Fonds
- PublicationsN/A
- Brief summaryIn facioscapulohumeral dystrophy (FSHD) muscle function is impaired and declines over time. Currently there is no effective therapeutic treatment available for FSHD. Loss of muscle strength contributes to experienced fatigue through a lower level of physical activity. Fatigue and physical inactivity determine social dependency and loss of participation. Therefore, to decrease experienced fatigue and improve quality of life, two distinctly different therapeutic approaches can be followed: aerobic exercise training (AET) to maintain functional capacity or a cognitive-behavioral approach (CBT) to stimulate an active life-style yet avoiding excessive physical strain. There is preliminary evidence for the effectiveness of aerobic exercise in FSHD. CBT has been proven effective in chronic fatigue syndrome and post-cancer fatigue. AET and CBT are hypothesized to be both more effective in improving activity level and, with that, decreasing experienced fatigue of FSHD patients compared to the usual care. The maintenance of the beneficial effects of CBT may be longer than those of AET, because the changes in activity level are achieved more intrinsically.
- Main changes (audit trail)
- RECORD16-sep-2008 - 2-dec-2013


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