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NCT Number: NCT01512342

Pacing Activity Self-management for Patients With Chronic Fatigue Syndrome

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Antwerp

Antwerp, B-2650, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pacing

Behavioral

3 one-on-one sessions weekly for 3 consecutive weeks

Other names: activity self-management, activity management, adaptive pacing

Relaxation therapy

Behavioral

3 one-on-one sessions weekly for 3 consecutive weeks

Other names: stress managament, Jacobson relaxation, visualisation, Schultz relaxation

Primary outcomes

  1. the change in score on the Canadian Occupational Performance Measure (COPM)

    Time frame: measured at baseline (week 1) and post-treatment (week 5)

    well-validated, reliable and frequently used outcome measure semi-structered interview

Secondary outcomes

  1. the change in subscale scores on the Medical Outcomes Short Form 37 Health Status Survey (SF-36)

    Time frame: 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.

  2. the change in Ckecklist Individual Strength (CIS)

    Time frame: 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.

  3. the change in CFS Symptom List

    Time frame: 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.

  4. the change in autonomic activity at rest and following 3 activities of daily living

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Collaborators

  • Artesis University College, Antwerp
  • Universiteit Antwerpen
  • University Hospital, Antwerp

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 19, 2012
Registry last updated
Dec 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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