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Pacing Activity Self-management for Patients With Multiple Sclerosis

This study is currently recruiting participants.
Verified January 2012 by Vrije Universiteit Brussel
Sponsor:
Collaborators:
University Hospital, Antwerp
Universiteit Antwerpen
Artesis University College, Antwerp
Information provided by (Responsible Party):
Jo Nijs, Vrije Universiteit Brussel
ClinicalTrials.gov Identifier:
NCT01512329
First received: January 10, 2012
Last updated: January 13, 2012
Last verified: January 2012
History of Changes
  Purpose

Given the lack of evidence in support of pacing self-management for patients with musltiple sclerosis (MS), it is examined whether physical behavior and health status of patients with MS 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 MS.


Condition Intervention Phase
Multiple Sclerosis
 Behavioral: pacing
Behavioral: relaxation
 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 Multiple Sclerosis: Randomized Controlled Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vrije Universiteit Brussel:

Primary Outcome Measures:
  • the change in scores obtained from the Canadian Occupational Performance Measure (COPM) [ Time Frame: measured at baseline (week 1) and post-treatment (week 5) ] [ Designated as safety issue: No ]
    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 once at baseline and once post-treatment ] [ 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.

  • the change in subscale scores on the Checklist Individual Strength (CIS) [ Time Frame: measured once at baseline and once post-treatment ] [ 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 autonomic activity at rest and following 3 activities of daily living [ Time Frame: measured once at baseline and once post-treatment ] [ 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: 50
Study Start Date: October 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pacing
The pacing self-management program (3 one-on-one sessions weekly for 3 consecutive weeks) focused 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), MS 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:
  • pacing
  • activity self-management
  • activity management
Active Comparator: relaxation
Relaxation therapy (3 one-on-one sessions weekly for 3 consecutive weeks) comprised of education about the role of stress in MS 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
3 one-on-one sessions weekly for 3 consecutive weeks
Other Names:
  • Schultz relaxation
  • visualisation
  • Jacobson relaxation
  • stress management

Detailed Description:

Up to 50 patients fulfilling the criteria for the diagnosis of multiple sclerosis (MS) 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult
  • age range between 18 and 65 years of age
  • willing to sign informed consent form
  • fulfilling the criteria for the diagnosis of multiple sclerosis

Exclusion Criteria:

- Not fulfilling each of the inclusion criteria listed above.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01512329

Contacts
Contact: Daphne Kos, PhD +3236418265 daphne.kos@artesis.be

Locations
Belgium
Nationaal Multiple Sclerosis Centrum Recruiting
Melsbroek, Belgium
Contact: Daphne Kos, PhD     +3236418265     daphne.kos@artesis.be    
Sponsors and Collaborators
Vrije Universiteit Brussel
University Hospital, Antwerp
Universiteit Antwerpen
Artesis University College, Antwerp
Investigators
Principal Investigator: Jo Nijs, PhD Artesis University College, Antwerp
Study Director: Daphne Kos, PhD Artesis University College, Antwerp
  More Information

Additional Information:
research group on chronic pain and chronic fatigue  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Jo Nijs, associate professor, Vrije Universiteit Brussel
ClinicalTrials.gov Identifier: NCT01512329     History of Changes
Other Study ID Numbers: PaceMS, 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:
neurology
physiotherapy
physical therapy
occupational therapy
 stress management
activity management
treatment

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013