Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Exercise, Physical activity, Quality of life
Brief summary
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.
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.
Interventions
BEHAVIORALImmediate 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.
BEHAVIORALDelayed exercise
Subjects in the delayed exercise group will begin the home exercise program 12 weeks following the initial meeting.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline in Physical Activity Behavior | 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). | Physical activity behavior will be measured with the Godin Leisure-Time Exercise Questionnaire. The Godin Leisure-Time Exercise Questionnaire calculates total weekly leisure activity by summing the products of separate intensities. Weekly leisure activity score = (9 x time/week) + (5 x times/week) + (3 x times/week) for strenuous, moderate and light activities, respectively. The scale is summed to equal the Total Units Mean. With this scale, higher numbers are considered to be the better outcome as it indicates more physical activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline in Physical Fitness | 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). | The physical assessment will include measuring the 6-minute walk test. The units reported are in meters for distance traveled by each participant during the six minutes. For this scale, the higher number is the better score as it is a direct measure of distance traveled. |
| Changes From Baseline in Quality of Life | 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). | The Multiple Sclerosis Impact Scale will be administered. The total score is a sum of individual question scores, ranging from 29 (best possible outcome) to 145 (worst possible outcome). Therefore, the lower the number, the better the outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| 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. | 16 |
| Total | 30 |
Baseline characteristics
| Characteristic | Delayed Exercise | Immediate Exercise | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 14 Participants | 30 Participants |
| Age, Continuous | 48 years STANDARD_DEVIATION 10 | 47 years STANDARD_DEVIATION 9 | 47.5 years STANDARD_DEVIATION 9.5 |
| Region of Enrollment United States | 16 participants | 14 participants | 30 participants |
| Sex: Female, Male Female | 16 Participants | 14 Participants | 30 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 16 |
| serious Total, serious adverse events | 0 / 14 | 0 / 16 |
Outcome results
Primary
Changes From Baseline in Physical Activity Behavior
Physical activity behavior will be measured with the Godin Leisure-Time Exercise Questionnaire. The Godin Leisure-Time Exercise Questionnaire calculates total weekly leisure activity by summing the products of separate intensities. Weekly leisure activity score = (9 x time/week) + (5 x times/week) + (3 x times/week) for strenuous, moderate and light activities, respectively. The scale is summed to equal the Total Units Mean. With this scale, higher numbers are considered to be the better outcome as it indicates more physical activity.
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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Immediate Exercise | Changes From Baseline in Physical Activity Behavior | Total Score (Week 1 - baseline) | 14.36 scores on a scale |
| Immediate Exercise | Changes From Baseline in Physical Activity Behavior | Total Score (Week12) | 33.07 scores on a scale |
| Immediate Exercise | Changes From Baseline in Physical Activity Behavior | Total Score (Week 24) | 26 scores on a scale |
| Delayed Exercise | Changes From Baseline in Physical Activity Behavior | Total Score (Week 1 - baseline) | 16.22 scores on a scale |
| Delayed Exercise | Changes From Baseline in Physical Activity Behavior | Total Score (Week12) | 21.00 scores on a scale |
| Delayed Exercise | Changes From Baseline in Physical Activity Behavior | Total Score (Week 24) | 23.06 scores on a scale |
Secondary
Changes From Baseline in Physical Fitness
The physical assessment will include measuring the 6-minute walk test. The units reported are in meters for distance traveled by each participant during the six minutes. For this scale, the higher number is the better score as it is a direct measure of distance traveled.
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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Immediate Exercise | Changes From Baseline in Physical Fitness | 6-minute walk (Week 1 - baseline) | 382.56 meters |
| Immediate Exercise | Changes From Baseline in Physical Fitness | 6-minute walk (Week 12) | 407.03 meters |
| Immediate Exercise | Changes From Baseline in Physical Fitness | 6-minute walk (Week 24) | 406.42 meters |
| Delayed Exercise | Changes From Baseline in Physical Fitness | 6-minute walk (Week 1 - baseline) | 324.12 meters |
| Delayed Exercise | Changes From Baseline in Physical Fitness | 6-minute walk (Week 12) | 321.23 meters |
| Delayed Exercise | Changes From Baseline in Physical Fitness | 6-minute walk (Week 24) | 333.09 meters |
Secondary
Changes From Baseline in Quality of Life
The Multiple Sclerosis Impact Scale will be administered. The total score is a sum of individual question scores, ranging from 29 (best possible outcome) to 145 (worst possible outcome). Therefore, the lower the number, the better the outcome.
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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Immediate Exercise | Changes From Baseline in Quality of Life | MS Impact score (Week 1 - baseline) | 58.57 scores on a scale |
| Immediate Exercise | Changes From Baseline in Quality of Life | MS Impact score (Week 12) | 53.57 scores on a scale |
| Immediate Exercise | Changes From Baseline in Quality of Life | MS Impact score (Week 24) | 52.29 scores on a scale |
| Delayed Exercise | Changes From Baseline in Quality of Life | MS Impact score (Week 1 - baseline) | 62.31 scores on a scale |
| Delayed Exercise | Changes From Baseline in Quality of Life | MS Impact score (Week 12) | 67.13 scores on a scale |
| Delayed Exercise | Changes From Baseline in Quality of Life | MS Impact score (Week 24) | 65.38 scores on a scale |