Promoting Physical Activity Behavior in Persons With Multiple Sclerosis
This study is currently recruiting participants.
Verified April 2012 by The Cleveland Clinic
Sponsor:
The Cleveland Clinic
Collaborator:
Information provided by (Responsible Party):
Matthew Plow, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01572207
First received: March 28, 2012
Last updated: April 4, 2012
Last verified: April 2012
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Purpose
The purpose of this research study is to evaluate whether tailored print material can promote physical activity and exercise, and subsequently improve quality of life and fitness levels among people with multiple sclerosis (MS). Research suggests that routine physical activity is beneficial in people with mild to moderate MS. However, people with MS may face many barriers for engaging in regular physical activity. Prescribing a home exercise program and receiving tailored motivational print material may help people engage in physical activity. Thus, the investigators hope to figure out whether tailored print material can be used as strategy to promote physical activity and improve physical function in people with MS.
| Condition | Intervention |
|---|---|
|
Multiple Sclerosis |
Behavioral: Immediate exercise Behavioral: Delayed exercise |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Using Targeted Print-material to Promote Physical Activity Behavior in Adults With Multiple Sclerosis |
Resource links provided by NLM:
Further study details as provided by The Cleveland Clinic:
Primary Outcome Measures:
- Changes from baseline in physical activity behavior [ Time Frame: Each subject will be given the questionnaire at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline). ] [ Designated as safety issue: No ]Physical activity behavior will be measured with the Physical Activity and Disability Survey, the Godin Leisure-Time Exercise Questionnaire, and an exercise log.
Secondary Outcome Measures:
- Changes from baseline in physical fitness [ Time Frame: Each patient will be given the assessment at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline). ] [ Designated as safety issue: No ]The physical assessment will include measuring body morphology (height and weight), cardiovascular endurance, physical function, endurance strength, flexibility, agility, and manual dexterity.
- Changes from baseline in quality of life [ Time Frame: Each patient will be given the assessment at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline). ] [ Designated as safety issue: No ]The SF-12 and the Multiple Sclerosis Impact Scale will be administered.
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Immediate Exercise
Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
|
Behavioral: Immediate exercise
Subjects in the immediate exercise group will be prescribed a home exercise program during the first meeting and will begin the 12 week training period immediately following the first meeting.
Other Name: Treatment arm
|
|
Experimental: Delayed exercise
Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
|
Behavioral: Delayed exercise
Subjects in the delayed exercise group will begin the home exercise program 12 weeks following the initial meeting.
Other Name: control arm
|
Detailed Description:
The objective of the proposed study is to further our understanding of methods to promote physical activity (PA) in people with multiple sclerosis (MS). The investigators will evaluate the efficacy of a print-based multifaceted intervention that consists of prescribing an exercise program and teaching self-management strategies.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- A physician-confirmed diagnosis of relapsing-remitting MS
Exclusion Criteria:
- Exercise more than 150 minutes per week
- Pregnant
- Metabolic or cardiopulmonary disease that puts patient at high risk for engaging in a home exercise program (patients with controlled diabetes and high blood pressure will still be considered eligible)
- Four or more falls in the past 6 months
- Be able to walk 25 feet with or without a cane
- Severe cognitive deficits
- Unable to read at a 6th grade level
- A condition besides MS that had lead to hospitalization in the past year
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572207
Contacts
| Contact: Corey McDaniel | (216) 445-9674 | mcdanic3@ccf.org |
Locations
| United States, Ohio | |
| The Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Corey McDaniel, BA 216-445-9674 mcdanic3@ccf.org | |
| Contact: Matthew Plow, PhD (216) 445-3288 plowm@ccf.org | |
Sponsors and Collaborators
The Cleveland Clinic
Investigators
| Principal Investigator: | Matthew Plow, PhD | The Cleveland Clinic |
More Information
No publications provided
| Responsible Party: | Matthew Plow, Project Scientist, The Cleveland Clinic |
| ClinicalTrials.gov Identifier: | NCT01572207 History of Changes |
| Other Study ID Numbers: | 10-531, 1R03HD060073-01A1 |
| Study First Received: | March 28, 2012 |
| Last Updated: | April 4, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The Cleveland Clinic:
|
Multiple Sclerosis Exercise Physical activity Quality of life |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases |
Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013