Pacing Activity Self-management for Patients With Chronic Fatigue Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Vrije Universiteit Brussel.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Artesis University College, Antwerp
Universiteit Antwerpen
University Hospital, Antwerp
Information provided by (Responsible Party):
Jo Nijs, Vrije Universiteit Brussel
ClinicalTrials.gov Identifier:
NCT01512342
First received: January 10, 2012
Last updated: January 13, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Chronic Fatigue Syndrome
Behavioral: Pacing
Behavioral: relaxation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pacing Activity Self-management for Patients With Chronic Fatigue Syndrome: Randomized Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Vrije Universiteit Brussel:

Primary Outcome Measures:
  • the change in score on the Canadian Occupational Performance Measure (COPM) [ Time Frame: measured at baseline (week 1) and post-treatment (week 5) ] [ Designated as safety issue: No ]
    well-validated, reliable and frequently used outcome measure semi-structered interview


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) [ Time Frame: measured at baseline (week 1) and post-treatment (week 5) ] [ Designated as safety issue: No ]
    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 [ Time Frame: measured at baseline (week 1) and post-treatment (week 5) ] [ Designated as safety issue: No ]
    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 [ Time Frame: measured at baseline (week 1) and post-treatment (week 5) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 36
Study Start Date: August 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: Pacing
3 one-on-one sessions weekly for 3 consecutive weeks
Other Names:
  • activity self-management
  • activity management
  • adaptive pacing
Active Comparator: 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.
Behavioral: relaxation therapy
3 one-on-one sessions weekly for 3 consecutive weeks
Other Names:
  • stress managament
  • Jacobson relaxation
  • visualisation
  • Schultz relaxation

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512342

Contacts
Contact: Jo Nijs, PhD +3226292222 Jo.Nijs@vub.ac.be
Contact: Daphne Kos, PhD +3236418265 daphne.kos@artesis.be

Locations
Belgium
University Hospital Antwerp Recruiting
Antwerp, Belgium, B-2650
Contact: Daphne Kos, PhD    +3236418265      
Principal Investigator: Jo Nijs, PhD         
Sponsors and Collaborators
Vrije Universiteit Brussel
Artesis University College, Antwerp
Universiteit Antwerpen
University Hospital, Antwerp
Investigators
Study Director: Daphne Kos, PhD Artesis University College Antwerp, Belgium
  More Information

Publications:
Responsible Party: Jo Nijs, Associate professor, Vrije Universiteit Brussel
ClinicalTrials.gov Identifier: NCT01512342     History of Changes
Other Study ID Numbers: PacingCFS, Artesis University College
Study First Received: January 10, 2012
Last Updated: January 13, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by Vrije Universiteit Brussel:
pacing
activity management
relaxation
physiotherapy
occupational therapy
autonomic nervous system

Additional relevant MeSH terms:
Fatigue
Fatigue Syndrome, Chronic
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on July 20, 2014