Clinical trial NCT01512342: Pacing Activity Self-management for Patients With Chronic Fatigue Syndrome
Official title: Pacing Activity Self-management for Patients With Chronic Fatigue Syndrome: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Fatigue Syndrome
Keywords: pacing
activity management
relaxation
physiotherapy
occupational therapy
autonomic nervous system
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
Collaborators: name: Artesis University College, Antwerp
name: Universiteit Antwerpen
name: University Hospital, Antwerp
First posted: 2012-01-19
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the change in score on the Canadian Occupational Performance Measure (COPM)
timeFrame: measured at baseline (week 1) and post-treatment (week 5)
Secondary outcomes:
measure: the change in subscale scores on the Medical Outcomes Short Form 37 Health Status Survey (SF-36)
timeFrame: measured at baseline (week 1) and post-treatment (week 5)
measure: the change in Ckecklist Individual Strength (CIS)
timeFrame: measured at baseline (week 1) and post-treatment (week 5)
measure: the change in CFS Symptom List
timeFrame: measured at baseline (week 1) and post-treatment (week 5)
measure: the change in autonomic activity at rest and following 3 activities of daily living
timeFrame: measured at baseline (week 1) and post-treatment (week 5)
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: University Hospital Antwerp
Study officials:
affiliation: Artesis University College Antwerp, Belgium
name: Daphne Kos, PhD
role: STUDY_DIRECTOR
References:
citation: Nijs J, van Eupen I, Vandecauter J, Augustinus E, Bleyen G, Moorkens G, Meeus M. Can pacing self-management alter physical behavior and symptom severity in chronic fatigue syndrome? A case series. J Rehabil Res Dev. 2009;46(7):985-96. doi: 10.1682/jrrd.2009.01.0007.
citation: Nijs J, Paul L, Wallman K. Chronic fatigue syndrome: an approach combining self-management with graded exercise to avoid exacerbations. J Rehabil Med. 2008 Apr;40(4):241-7. doi: 10.2340/16501977-0185.
citation: Meeus M, van Eupen I, van Baarle E, De Boeck V, Luyckx A, Kos D, Nijs J. Symptom fluctuations and daily physical activity in patients with chronic fatigue syndrome: a case-control study. Arch Phys Med Rehabil. 2011 Nov;92(11):1820-6. doi: 10.1016/j.apmr.2011.06.023.