Pacing Activity Self-management for Patients With Multiple Sclerosis

December 16, 2015 updated by: Jo Nijs, Vrije Universiteit Brussel

Pacing Activity Self-management for Patients With Multiple Sclerosis: Randomized Controlled Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Melsbroek, Belgium
        • Nationaal Multiple Sclerosis Centrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • 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:
  • Jacobson relaxation
  • visualisation
  • Schultz relaxation
  • stress management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change in scores obtained from the Canadian Occupational Performance Measure (COPM)
Time Frame: measured at baseline (week 1) and post-treatment (week 5)
Semi-structered interview.
measured at baseline (week 1) and post-treatment (week 5)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
measured once at baseline and once post-treatment
the change in subscale scores on the Checklist Individual Strength (CIS)
Time Frame: measured once at baseline and once post-treatment
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 once at baseline and once post-treatment
the change in autonomic activity at rest and following 3 activities of daily living
Time Frame: measured once at baseline and once post-treatment
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 once at baseline and once post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vrije Universiteit Brussel

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

January 10, 2012

First Submitted That Met QC Criteria

January 13, 2012

First Posted (Estimate)

January 19, 2012

Study Record Updates

Last Update Posted (Estimate)

December 17, 2015

Last Update Submitted That Met QC Criteria

December 16, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PaceMS
  • Artesis University College (Other Identifier: Artesis University College Antwerp PWO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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