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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
31
3 one-on-one sessions weekly for 3 consecutive weeks
3 one-on-one sessions weekly for 3 consecutive weeks
Nationaal Multiple Sclerosis Centrum
Melsbroek, Belgium
the change in scores obtained from the Canadian Occupational Performance Measure (COPM)
Semi-structered interview.
Time frame: measured at baseline (week 1) and post-treatment (week 5)
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.
Time frame: 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.
Time frame: 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.
Time frame: measured once at baseline and once post-treatment
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