Chronic Fatigue Syndrome
Conditions
Keywords
pacing, activity management, relaxation, physiotherapy, occupational therapy, autonomic nervous system
Brief summary
Given the lack of evidence in support of pacing self-management for patients with chronic fatigue syndrome (CFS), it is examined whether physical behavior and health status of patients with CFS improve in response to a pacing self-management program. The effects of pacing will be compared with those observed when applying relaxation therapy to patients with CFS.
Detailed description
Given the lack of evidence in support of pacing self-management for patients with chronic fatigue syndrome (CFS), it is examined whether physical behavior and health status of patients with CFS improve in response to a pacing self-management program. The effects of pacing will be compared with those observed when applying relaxation therapy to patients with CFS. According to the power calculation, 36 patients fulfilling the 1994 Centre for Disease Control and Prevention criteria for the diagnosis of chronic fatigue syndrome (CFS) will be randomized to either 3 weeks of pacing activity self-management or relaxation therapy. Both treatment groups will receive 3 weekly sessions spread over 3 consecutive weeks. All treatments will be delivered by occupational therapists or physiotherapists. One treatment session lasts for about 45 minutes each. Outcome measures include the Canadian Occupational Performance Measure (COPM), Medical Outcomes Short Form 37 Health Status Survey (SF-36), Checklist Individual Strength (CIS), CFS Symptom List and autonomic activity at rest and following 3 activities of daily living (writing a standardized test on a laptop computer, ironing, and climbing 26 flights of stairs). For measuring autonomic activity, the Nexus 10 device (Mind Media, the Netherlands) will be used. Skin conductance, body temperature, heart rate, blood volume pressure and heart rate variability will be measured continuously in real time during a 2 minutes period, with the patient sitting on a chair (back supported and hands resting on legs). Electrodes will be placed on the left hand in all patients.
Interventions
BEHAVIORALPacing
3 one-on-one sessions weekly for 3 consecutive weeks
BEHAVIORALrelaxation therapy
3 one-on-one sessions weekly for 3 consecutive weeks
Sponsors
Artesis University College, Antwerp
Universiteit Antwerpen
University Hospital, Antwerp
Vrije Universiteit Brussel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* adult * age range between 18 and 65 years of age * female gender * willing to sign informed consent form * fulfilling the 1994 Centre for Disease Control and Prevention criteria for the diagnosis of chronic fatigue syndrome
Exclusion criteria
\- Not fulfilling each of the inclusion criteria listed above.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the change in score on the Canadian Occupational Performance Measure (COPM) | measured at baseline (week 1) and post-treatment (week 5) | well-validated, reliable and frequently used outcome measure semi-structered interview |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the change in subscale scores on the Medical Outcomes Short Form 37 Health Status Survey (SF-36) | measured at baseline (week 1) and post-treatment (week 5) | The SF-36 assesses functional status and well-being or quality of life. The SF-36 has been documented to have reliability and validity in a wide variety of patient populations and it is the most frequently used measure in CFS research. |
| the change in Ckecklist Individual Strength (CIS) | measured at baseline (week 1) and post-treatment (week 5) | The CIS aims at assessing the subjective fatigue experience, concentration difficulties, motivation and physical activity. Higher scores on the CIS correspond to severe fatigue, many concentration difficulties, problems with motivation and a low level of physical activity. Its psychometric properties are well established. |
| the change in CFS Symptom List | measured at baseline (week 1) and post-treatment (week 5) | The CFS Symptom List is a self-reported measure for assessing symptom severity in CFS patients. In order to assess the severity of the symptoms included in the CFS Symptom List, visual analogue scales (100 mm) are used. Psychometric work supporting the use of the CFS Symptom List has been published. |
| the change in autonomic activity at rest and following 3 activities of daily living | measured at baseline (week 1) and post-treatment (week 5) | The 3 activities of daily living entail writing a standardized test on a laptop computer, ironing, and climbing 26 flights of stairs. For measuring autonomic activity, the Nexus 10 device (Mind Media, the Netherlands) will be used. Skin conductance, body temperature, heart rate, blood volume pressure and heart rate variability will be measured continuously in real time during a 2 minutes period, with the patient sitting on a chair (back supported and hands resting on legs). Electrodes will be placed on the left hand in all patients. |
Countries
Belgium
Outcome results
None listed