search
Back to results

Pacing Activity Self-management for Patients With Chronic Fatigue Syndrome

Primary Purpose

Chronic Fatigue Syndrome

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Pacing
relaxation therapy
Sponsored by
Vrije Universiteit Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Fatigue Syndrome focused on measuring pacing, activity management, relaxation, physiotherapy, occupational therapy, autonomic nervous system

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital Antwerp

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pacing

relaxation therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
January 10, 2012
Last Updated
December 16, 2015
Sponsor
Vrije Universiteit Brussel
Collaborators
Artesis University College, Antwerp, Universiteit Antwerpen, University Hospital, Antwerp
search

1. Study Identification

Unique Protocol Identification Number
NCT01512342
Brief Title
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

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel
Collaborators
Artesis University College, Antwerp, Universiteit Antwerpen, University Hospital, Antwerp

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome
Keywords
pacing, activity management, relaxation, physiotherapy, occupational therapy, autonomic nervous system

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pacing
Arm Type
Experimental
Arm Description
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.
Arm Title
relaxation therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pacing
Other Intervention Name(s)
activity self-management, activity management, adaptive pacing
Intervention Description
3 one-on-one sessions weekly for 3 consecutive weeks
Intervention Type
Behavioral
Intervention Name(s)
relaxation therapy
Other Intervention Name(s)
stress managament, Jacobson relaxation, visualisation, Schultz relaxation
Intervention Description
3 one-on-one sessions weekly for 3 consecutive weeks
Primary Outcome Measure Information:
Title
the change in score on the Canadian Occupational Performance Measure (COPM)
Description
well-validated, reliable and frequently used outcome measure semi-structered interview
Time Frame
measured at baseline (week 1) and post-treatment (week 5)
Secondary Outcome Measure Information:
Title
the change in subscale scores on the Medical Outcomes Short Form 37 Health Status Survey (SF-36)
Description
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.
Time Frame
measured at baseline (week 1) and post-treatment (week 5)
Title
the change in Ckecklist Individual Strength (CIS)
Description
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.
Time Frame
measured at baseline (week 1) and post-treatment (week 5)
Title
the change in CFS Symptom List
Description
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.
Time Frame
measured at baseline (week 1) and post-treatment (week 5)
Title
the change in autonomic activity at rest and following 3 activities of daily living
Description
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.
Time Frame
measured at baseline (week 1) and post-treatment (week 5)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daphne Kos, PhD
Organizational Affiliation
Artesis University College Antwerp, Belgium
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Antwerp
City
Antwerp
ZIP/Postal Code
B-2650
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
20104421
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.
Results Reference
background
PubMed Identifier
18382818
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.
Results Reference
background
PubMed Identifier
22032215
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.
Results Reference
background
Links:
URL
http://www.paininmotion.be
Description
International Pain in Motion research group

Learn more about this trial

Pacing Activity Self-management for Patients With Chronic Fatigue Syndrome

We'll reach out to this number within 24 hrs