Chronic Fatigue Syndrome - a randomized controlled pilot study to compare biofeedback therapy as cognitive behavioral intervention with graded exercise training concerning psychometric and physiological data in women with chronic fatigue syndrome

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00005445
• Date of registration: 26/11/2013
• Prospective Registration: No
• Primary sponsor: Universitätsklinikum Tübingen
• Public title: Chronic Fatigue Syndrome - a randomized controlled pilot study to compare biofeedback therapy as cognitive behavioral intervention with graded exercise training concerning psychometric and physiological data in women with chronic fatigue syndrome
• Scientific title: Chronic Fatigue Syndrome - a randomized controlled pilot study to compare biofeedback therapy as cognitive behavioral intervention with graded exercise training concerning psychometric and physiological data in women with chronic fatigue syndrome - BeNe
• Date of first enrolment: 01/11/2009
• Target sample size: 30
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00005445
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: treatment
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Petra Windthorst
• Affiliation: Universitätsklinikum Tübingen

• Name: Petra Windthorst
• Affiliation: Universitätsklinikum Tübingen

Key inclusion & exclusion criteria

Inclusion criteria: Clinically evaluated, persistent and chronic fatigue (6months or longer); four or more of the following symptoms: impaired memory or concentration, sore throat, tender cervical or axilliary lymph nodes, muscle pain, multi-joint pain, new headaches, unrefreshing sleep and post-exertion malaise.
Exclusion criteria: somatic or medical conditions explaining fatigue (e.g. can-cer), substance abuse, primary psychiatric disorder (e.g. schizophrenia), major depression or anxiety disorder, on-going psychotherapy or activation programme, a body-mass index (BMI) lower than 18.5kg/m² or higher than 35kg/m², and male sex]

Age minimum: 18 Years
Age maximum: 75 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Neurasthenia

depression, quality of life
F48.0

F48.0

Intervention(s)

Group 1: Biofeedback therapy is considered to be a specific method of cognitive behavioral therapy. It allows simultaneous feedback of physiological functions and allows patients to influence that physiological parameter in a positive way. It improves interoception and feelings of self-efficacy. In this study respiratory sinus arrhythmia (breathing, pulse frequency) was chosen as biofeedback trainings parameter. The biofeedback therapy was carried out in a manualized way by a trained clinical psychologist. Biofeedback therapy consisted of 8 individual training sessions of 50 minutes each. Patients were instructed to keep a diary to assess the intensity of fatigue, daily activities, and their individual training without device at home. The diary was discussed with patients at the beginning of each session.
Group 2: For graded exercise, the individual anaerobe threshold (IAS), collected by spirometry, was the individual training baseline. Patients were instructed in slow walking training adapted to their heart rate. The dura-tion and exercise intensity were set at a level that has been identified as achievable under spirometry testing and unlikely to exacerbate the patients´ symptoms. Graded exercise training consisted of 8 individual training sessions of 50 minutes each, carried out by a certified sports scientist. Patients were instructed to keep a diary to assess the intensity of fatigue, daily activities, and their individual training at home, that was controlled by a pulse watch. The diary was discussed with patients at the beginning of each session.

Primary Outcome(s)

Fatigue (Questionnaire); pre, post, 5month-follow-up
Fatigue was measured by the “multidimensional fatigue inventory” (MFI, Gaab & Ehlert, 2005). It measures fatigue on five subscales (general fatigue, physical fatige, reduced activity, reduced motivation, mental fatigue) and allows the accumulation of a total score. MFI was assessed pre and post intervention and in a 5 month-follow-up.

Secondary Outcome(s)

Quality of Life, depression, stress/ability to relax (questionnaires); pre, post, 5month-follow-up.

Physiological stress reaktion (orthostatic test, salivary cortisol); pre, post.

Quality of life - that is, physical and mental functioning - was assessed by the “Short Form General Health Survey” (SF36; Bullinger & Kirchberger, 1998).
Depression was assessed using the “Patient Health Questionnaire” (PHQ-9; Löwe et al., 2002).
Ability to relax was assessed by the “Symptom Checklist for Perceived Relaxation” (ASS-Sym; Krampen 2006).
Assessment of questionnaires took place before and after intervention and at a five-month follow-up.
Physiological stress reaction was measured pre and post intervention by orthostatic test and by salivary cortisol level (8 measurements a day once before and once after intervention).

Source(s) of Monetary Support

Alfred-Teufel-Stiftung, Nagold

Universitätsklinikum Tübingen Abteilung für Psychosomatische Medizin

Ethics review

Status: Approved
Approval date: 19/08/2009
Contact:

Results

• URL: http://drks.de/search/en/trial/DRKS00005445#studyResults