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

Completed

Conditions: facioscapulohumeral muscular dystrophy
Landouzy Dejerine
10028302

Registration Number: NL-OMON32128

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 75

Inclusion Criteria

(1) aged 18 years and older
(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 Criteria

(1) 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 d* 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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>At baseline, after conclusion of the intervention and after 3 and 6 months<br /><br>follow-up experienced fatigue will be assessed by the subscale fatigue of the<br /><br>Checklist Individual Strength</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>aerobic exercise tolerance<br /><br>muscle strength<br /><br>cardiovascular risk factors<br /><br>limitations in autonomy and participation<br /><br>objective and subejctive phyiscal activity in daily life<br /><br>pain<br /><br>fall incidence<br /><br>psychological well being and sleeping pattern<br /><br>self perceived functional status<br /><br>coping style<br /><br>illness cognitions<br /><br>perceived control or self efficacy<br /><br>motivation<br /><br>concentration<br /><br>social support<br /><br>experienced fatigue of first relative<br /><br>caregiver strain<br /><br><br /><br>optional:<br /><br>metabolic profile of muscles, blood and urine</p><br>