Pacing Activity Self-management for Patients With Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: pacing
* Behavioral: relaxation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pacing<br>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<br>* 3 one-on-one sessions weekly for 3 consecutive weeks<br>* Other names: activity management;|
| Active Comparator: relaxation<br>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<br>* 3 one-on-one sessions weekly for 3 consecutive weeks<br>* Other names: stress management;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change in scores obtained from the Canadian Occupational Performance Measure (COPM) | 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) | 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) | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurology, physiotherapy, physical therapy, occupational therapy, stress management, activity management, treatment