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Pacing Activity Self-management for Patients With Multiple Sclerosis

V

Vrije Universiteit Brussel

Status and phase

Completed
Phase 2

Conditions

Multiple Sclerosis

Treatments

Behavioral: pacing
Behavioral: relaxation

Study type

Interventional

Funder types

Other

Identifiers

NCT01512329
PaceMS
Artesis University College (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

31 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

31 participants in 2 patient groups

pacing
Experimental group
Description:
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.
Treatment:
Behavioral: pacing
relaxation
Active Comparator group
Description:
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.
Treatment:
Behavioral: relaxation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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