Pacing Activity Self-management for Patients With Chronic Fatigue Syndrome

NCT01512342 | Completed Phase 2

• 2 other identifiers: PacingCFSArtesis University College
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Fatigue Syndrome

Keywords

pacing; activity management; relaxation; physiotherapy; occupational therapy; autonomic nervous system

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

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

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

• the change in Ckecklist Individual Strength (CIS)

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

• the change in CFS Symptom List

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

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

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

Study Arms (2)

Pacing

EXPERIMENTAL

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

relaxation therapy

ACTIVE COMPARATOR

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

Interventions

Pacing BEHAVIORAL

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

Also known as: activity self-management, activity management, adaptive pacing

Pacing

relaxation therapy BEHAVIORAL

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

Also known as: stress managament, Jacobson relaxation, visualisation, Schultz relaxation

relaxation therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• Artesis University College, Antwerp: collaborator
• Universiteit Antwerpen: collaborator
• University Hospital, Antwerp: collaborator

Study Sites (1)

University Hospital Antwerp

Antwerp, B-2650, Belgium

Location

Related Publications (4)

• 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.

  PMID: 20104421 BACKGROUND

• 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.

  PMID: 18382818 BACKGROUND

• 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.

  PMID: 22032215 BACKGROUND

• 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.

  PMID: 39697147 DERIVED

Related Links

• International Pain in Motion research group

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Daphne Kos, PhD

  Artesis University College Antwerp, Belgium

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 10, 2012
• First Posted: January 19, 2012
• Study Start: August 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 17, 2015

Record last verified: 2015-12

Locations

BE (1)