Back to resultsPacing Activity Self-management for Patients With Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
pacing
relaxation
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring neurology, physiotherapy, physical therapy, occupational therapy, stress management, activity management, treatment
Eligibility Criteria
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.
Sites / Locations
- Nationaal Multiple Sclerosis Centrum
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
pacing
relaxation
Arm 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.
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.
Outcomes
Primary Outcome Measures
the change in scores obtained from the Canadian Occupational Performance Measure (COPM)
Semi-structered interview.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT01512329
First Posted
January 10, 2012
Last Updated
December 16, 2015
Sponsor
Vrije Universiteit Brussel
Collaborators
University Hospital, Antwerp, Universiteit Antwerpen, Artesis University College, Antwerp
1. Study Identification
Unique Protocol Identification Number
NCT01512329
Brief Title
Pacing Activity Self-management for Patients With Multiple Sclerosis
Official Title
Pacing Activity Self-management for Patients With Multiple Sclerosis: Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel
Collaborators
University Hospital, Antwerp, Universiteit Antwerpen, Artesis University College, Antwerp
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
neurology, physiotherapy, physical therapy, occupational therapy, stress management, activity management, treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pacing
Arm Type
Experimental
Arm 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.
Arm Title
relaxation
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
pacing
Other Intervention Name(s)
activity self-management, activity management
Intervention Description
3 one-on-one sessions weekly for 3 consecutive weeks
Intervention Type
Behavioral
Intervention Name(s)
relaxation
Other Intervention Name(s)
Schultz relaxation, visualisation, Jacobson relaxation, stress management
Intervention Description
3 one-on-one sessions weekly for 3 consecutive weeks
Primary Outcome Measure Information:
Title
the change in scores obtained from the Canadian Occupational Performance Measure (COPM)
Description
Semi-structered interview.
Time Frame
measured at baseline (week 1) and post-treatment (week 5)
Secondary Outcome Measure Information:
Title
the change in subscale scores on the Medical Outcomes Short Form 37 Health Status Survey (SF-36)
Description
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.
Time Frame
measured once at baseline and once post-treatment
Title
the change in subscale scores on the Checklist Individual Strength (CIS)
Description
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.
Time Frame
measured once at baseline and once post-treatment
Title
the change in autonomic activity at rest and following 3 activities of daily living
Description
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.
Time Frame
measured once at baseline and once post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jo Nijs, PhD
Organizational Affiliation
Artesis University College, Antwerp
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daphne Kos, PhD
Organizational Affiliation
Artesis University College, Antwerp
Official's Role
Study Director
Facility Information:
Facility Name
Nationaal Multiple Sclerosis Centrum
City
Melsbroek
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
17453852
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. doi: 10.1080/07420520701282364.
Results Reference
background
PubMed Identifier
16916440
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. doi: 10.1186/1471-2377-6-27.
Results Reference
background
PubMed Identifier
17623738
Citation
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.
Results Reference
background
Links:
URL
http://www.paininmotion.be
Description
International Pain in Motion research group
Learn more about this trial
Pacing Activity Self-management for Patients With Multiple Sclerosis
We'll reach out to this number within 24 hrs