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NCT Number: NCT01512329

Pacing Activity Self-management for Patients With Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nationaal Multiple Sclerosis Centrum

Melsbroek, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pacing

Behavioral

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

Other names: activity self-management, activity management

Relaxation

Behavioral

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

Other names: Schultz relaxation, visualisation, Jacobson relaxation, stress management

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Collaborators

  • Artesis University College, Antwerp
  • Universiteit Antwerpen
  • University Hospital, Antwerp

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 19, 2012
Registry last updated
Dec 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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