Pacing Activity Self-management for Patients With Multiple Sclerosis

NCT ID: NCT01512329

Last Updated: 2015-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-10-31

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.

Conditions

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Multiple Sclerosis

Keywords

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neurology physiotherapy physical therapy occupational therapy stress management activity management treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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pacing

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.

Group Type EXPERIMENTAL

pacing

Intervention Type BEHAVIORAL

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

relaxation

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.

Group Type ACTIVE_COMPARATOR

relaxation

Intervention Type BEHAVIORAL

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

Interventions

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pacing

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

Intervention Type BEHAVIORAL

relaxation

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

Intervention Type BEHAVIORAL

Other Intervention Names

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activity self-management activity management Schultz relaxation visualisation Jacobson relaxation stress management

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Antwerp

OTHER

Sponsor Role collaborator

Universiteit Antwerpen

OTHER

Sponsor Role collaborator

Artesis University College, Antwerp

OTHER

Sponsor Role collaborator

Vrije Universiteit Brussel

OTHER

Sponsor Role lead

Responsible Party

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Jo Nijs

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jo Nijs, PhD

Role: PRINCIPAL_INVESTIGATOR

Artesis University College, Antwerp

Daphne Kos, PhD

Role: STUDY_DIRECTOR

Artesis University College, Antwerp

Locations

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Nationaal Multiple Sclerosis Centrum

Melsbroek, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND
PMID: 17453852 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16916440 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17623738 (View on PubMed)

Related Links

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http://www.paininmotion.be

International Pain in Motion research group

Other Identifiers

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Artesis University College

Identifier Type: OTHER

Identifier Source: secondary_id

PaceMS

Identifier Type: -

Identifier Source: org_study_id