Clinical trial NCT01512329: Pacing Activity Self-management for Patients With Multiple Sclerosis
Official title: Pacing Activity Self-management for Patients With Multiple Sclerosis: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: neurology
physiotherapy
physical therapy
occupational therapy
stress management
activity management
treatment
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
name: Universiteit Antwerpen
name: Artesis University College, Antwerp
First posted: 2012-01-19
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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 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.

Primary outcomes:
measure: the change in scores obtained from the Canadian Occupational Performance Measure (COPM)
timeFrame: measured at baseline (week 1) and post-treatment (week 5)
Secondary outcomes:
measure: the change in subscale scores on the Medical Outcomes Short Form 37 Health Status Survey (SF-36)
timeFrame: measured once at baseline and once post-treatment
measure: the change in subscale scores on the Checklist Individual Strength (CIS)
timeFrame: measured once at baseline and once post-treatment
measure: the change in autonomic activity at rest and following 3 activities of daily living
timeFrame: measured once at baseline and once post-treatment
Other outcomes:
Locations:
city: Melsbroek
country: Belgium
facility: Nationaal Multiple Sclerosis Centrum
Study officials:
affiliation: Artesis University College, Antwerp
name: Jo Nijs, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Artesis University College, Antwerp
name: Daphne Kos, PhD
role: STUDY_DIRECTOR
References:
citation: Kos D, Nagels G, D'Hooghe MB, Duquet W, Ilsbroukx S, Delbeke S, Kerckhofs E. Measuring activity patterns using actigraphy in multiple sclerosis. Chronobiol Int. 2007;24(2):345-56. doi: 10.1080/07420520701282364.
citation: Kos D, Nagels G, D'Hooghe MB, Duportail M, Kerckhofs E. A rapid screening tool for fatigue impact in multiple sclerosis. BMC Neurol. 2006 Aug 17;6:27. doi: 10.1186/1471-2377-6-27.
citation: Kos D, Duportail M, D'hooghe M, Nagels G, Kerckhofs E. Multidisciplinary fatigue management programme in multiple sclerosis: a randomized clinical trial. Mult Scler. 2007 Sep;13(8):996-1003. doi: 10.1177/1352458507078392. Epub 2007 Jul 10.