Pacing Activity Self-management for Patients With Multiple Sclerosis

NCT01512329 | Completed Phase 2

• 2 other identifiers: PaceMSArtesis University College
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

neurology; physiotherapy; physical therapy; occupational therapy; stress management; activity management; treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• the change in subscale scores on the Medical Outcomes Short Form 37 Health Status Survey (SF-36)

  measured once at baseline and once post-treatment

• the change in subscale scores on the Checklist Individual Strength (CIS)

  measured once at baseline and once post-treatment

• the change in autonomic activity at rest and following 3 activities of daily living

  measured once at baseline and once post-treatment

Study Arms (2)

pacing

EXPERIMENTAL

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

relaxation

ACTIVE COMPARATOR

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

Interventions

pacing BEHAVIORAL

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

Also known as: activity self-management, activity management

pacing

relaxation BEHAVIORAL

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

Also known as: Schultz relaxation, visualisation, Jacobson relaxation, stress management

relaxation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• University Hospital, Antwerp: collaborator
• Universiteit Antwerpen: collaborator
• Artesis University College, Antwerp: collaborator

Study Sites (1)

Nationaal Multiple Sclerosis Centrum

Melsbroek, Belgium

Location

Related Publications (3)

• 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.

  PMID: 17453852 BACKGROUND

• 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.

  PMID: 16916440 BACKGROUND

• 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.

  PMID: 17623738 BACKGROUND

Related Links

• International Pain in Motion research group

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jo Nijs, PhD

  Artesis University College, Antwerp

  PRINCIPAL INVESTIGATOR

• Daphne Kos, PhD

  Artesis University College, Antwerp

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: January 10, 2012
• First Posted: January 19, 2012
• Study Start: October 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 17, 2015

Record last verified: 2015-12

Locations

BE (1)