Pacing Activity Self-management for Patients With Chronic Fatigue Syndrome

Chronic Fatigue Syndrome Clinical Trial

Official title:

Pacing Activity Self-management for Patients With Chronic Fatigue Syndrome: Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512342
• Other study ID #: PacingCFS
• Secondary ID: Artesis Universi
• Status: Completed
• Phase: Phase 2
• First received: January 10, 2012
• Last updated: December 16, 2015
• Start date: August 2011
• Est. completion date: August 2014

Study information

• Verified date: December 2015
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue
• Fatigue Syndrome, Chronic
• Syndrome

Intervention

Behavioral:
• Pacing
3 one-on-one sessions weekly for 3 consecutive weeks
• relaxation therapy
3 one-on-one sessions weekly for 3 consecutive weeks

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Antwerp

Sponsors (4)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel	Artesis University College, Antwerp, Universiteit Antwerpen, University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change in score on the Canadian Occupational Performance Measure (COPM)	well-validated, reliable and frequently used outcome measure semi-structered interview	measured at baseline (week 1) and post-treatment (week 5)	No
Secondary	the change in subscale scores on the Medical Outcomes Short Form 37 Health Status Survey (SF-36)	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.	measured at baseline (week 1) and post-treatment (week 5)	No
Secondary	the change in Ckecklist Individual Strength (CIS)	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.	measured at baseline (week 1) and post-treatment (week 5)	No
Secondary	the change in CFS Symptom List	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.	measured at baseline (week 1) and post-treatment (week 5)	No
Secondary	the change in autonomic activity at rest and following 3 activities of daily living	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.	measured at baseline (week 1) and post-treatment (week 5)	No

External Links

•   International Pain in Motion research group