Pacing Activity Self-management for Patients With Multiple Sclerosis

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01512329

Enrollment

Registered

2012-01-19

Start date

2011-10-31

Completion date

2014-10-31

Last updated

2015-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

neurology, physiotherapy, physical therapy, occupational therapy, stress management, activity management, 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.

Interventions

BEHAVIORALpacing

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

BEHAVIORALrelaxation

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
the change in scores obtained from the Canadian Occupational Performance Measure (COPM)	measured at baseline (week 1) and post-treatment (week 5)	Semi-structered interview.

Secondary

Measure	Time frame	Description
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 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.
the change in subscale scores on the Checklist Individual Strength (CIS)	measured once at baseline and once post-treatment	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.
the change in autonomic activity at rest and following 3 activities of daily living	measured once at baseline and once post-treatment	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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026