Pacing Activity Self-management for Patients With Chronic Fatigue Syndrome
NCT ID: NCT01512342
Last Updated: 2015-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
33 participants
INTERVENTIONAL
2011-08-31
2014-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Pacing
The pacing self-management program focussed on teaching the patient to estimate their current physical capabilities prior to commencing an activity. In order to appropriately pace activities (daily activities and exercise bouts), CFS patients were learned to estimate their current physical capabilities prior to commencing an activity, keeping in mind the regular fluctuating nature of their symptoms. The activity duration used within the program was less than that reported by the patient so to account for typical overestimations made by the patient. Each activity block was interspersed with breaks, with the length of this break equating to the duration of the activity.
Pacing
3 one-on-one sessions weekly for 3 consecutive weeks
relaxation therapy
Relaxation therapy comprised of education about the role of stress in CFS biology, and the opportunities stress management provides to handle this issue. Patients were then taught how to apply stress management techniques like Jacobson relaxation skills, Schultz relaxation skills, visualization, etc.
relaxation therapy
3 one-on-one sessions weekly for 3 consecutive weeks
Interventions
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Pacing
3 one-on-one sessions weekly for 3 consecutive weeks
relaxation therapy
3 one-on-one sessions weekly for 3 consecutive weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
65 Years
FEMALE
No
Sponsors
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Artesis University College, Antwerp
OTHER
Universiteit Antwerpen
OTHER
University Hospital, Antwerp
OTHER
Vrije Universiteit Brussel
OTHER
Responsible Party
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Jo Nijs
Associate professor
Principal Investigators
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Daphne Kos, PhD
Role: STUDY_DIRECTOR
Artesis University College Antwerp, Belgium
Locations
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University Hospital Antwerp
Antwerp, , Belgium
Countries
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References
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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.
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.
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.
Larun L, Brurberg KG, Odgaard-Jensen J, Price JR. Exercise therapy for chronic fatigue syndrome. Cochrane Database Syst Rev. 2024 Dec 19;12(12):CD003200. doi: 10.1002/14651858.CD003200.pub9.
Related Links
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International Pain in Motion research group
Other Identifiers
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Artesis University College
Identifier Type: OTHER
Identifier Source: secondary_id
PacingCFS
Identifier Type: -
Identifier Source: org_study_id