Pacing Activity Self-management for Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512329
• Other study ID #: PaceMS
• Secondary ID: Artesis Universi
• Status: Completed
• Phase: Phase 2
• First received: January 10, 2012
• Last updated: December 16, 2015
• Start date: October 2011
• Est. completion date: October 2014

Study information

• Verified date: December 2015
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• pacing
3 one-on-one sessions weekly for 3 consecutive weeks
• relaxation
3 one-on-one sessions weekly for 3 consecutive weeks

Locations

Country	Name	City	State
Belgium	Nationaal Multiple Sclerosis Centrum	Melsbroek

Sponsors (4)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel	Artesis University College, Antwerp, Universiteit Antwerpen, University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

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. Epub 2007 Jul 10. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   International Pain in Motion research group