AzTrials
AzTrials

Chronic Fatigue SyndromePhase 2NCT01512342

Pacing Activity Self-management for Patients With Chronic Fatigue Syndrome

A Phase 2 study testing Pacing and relaxation therapy in people with Chronic Fatigue Syndrome, run by Vrije Universiteit Brussel at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Chronic Fatigue Syndrome
What is being tested?
Pacing and relaxation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteBelgium
Study dates
Aug 2011to Aug 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Not fulfilling each of the inclusion criteria listed above.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • University Hospital Antwerp

    Antwerp, B-2650

Other trials in Belgium

About this study

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

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.

Read the 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.

Being tested
Pacing, relaxation therapy
Keywords
pacing, activity management, relaxation, physiotherapy, occupational therapy, autonomic nervous system
Medical subject headings
Fatigue Syndrome, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PacingBehavioural

    Also called activity self-management, activity management, adaptive pacing

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

  • relaxation therapyBehavioural

    Also called stress managament, Jacobson relaxation, visualisation, Schultz relaxation

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

Study groups in NCT01512342
Study groupRoleWhat they receive
PacingExperimentalThe 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.
Receives: Behavioral: Pacing
relaxation therapyActive comparatorRelaxation 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.
Receives: Behavioral: relaxation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

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

Secondary outcomes (4)

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

  2. 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: measured at baseline (week 1) and post-treatment (week 5)

  3. 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: measured at baseline (week 1) and post-treatment (week 5)

  4. 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: measured at baseline (week 1) and post-treatment (week 5)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2012 (estimated)
  2. Study startAug 2011
  3. Primary completionJun 2014
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01512342
Sponsor's protocol ID
PacingCFS
Other IDs
Artesis University College
Status last verified
Dec 2015
First submitted
10 Jan 2012
Last updated
17 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20104421

  • 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.

    PubMed 18382818

  • 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.

    PubMed 22032215

  • 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.

    PubMed 39697147

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pacing and relaxation therapy in people with Chronic Fatigue Syndrome, run by Vrije Universiteit Brussel at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the change in score on the Canadian Occupational Performance Measure (COPM) (time frame: measured at baseline (week 1) and post-treatment (week 5)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01512342, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in