Trial Outcomes & Findings for Promoting Physical Activity Behavior in Persons With Multiple Sclerosis (NCT NCT01572207)
NCT ID: NCT01572207
Last Updated: 2022-01-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
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).
Results posted on
2022-01-05
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
16
|
|
Overall Study
COMPLETED
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Promoting Physical Activity Behavior in Persons With Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Immediate Exercise
n=14 Participants
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.
|
Delayed Exercise
n=16 Participants
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.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 9 • n=5 Participants
|
48 years
STANDARD_DEVIATION 10 • n=7 Participants
|
47.5 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Immediate Exercise
n=14 Participants
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.
|
Delayed Exercise
n=16 Participants
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.
|
|---|---|---|
|
Changes From Baseline in Physical Activity Behavior
Total Score (Week 1 - baseline)
|
14.36 scores on a scale
Interval 0.0 to 36.0
|
16.22 scores on a scale
Interval 0.0 to 64.0
|
|
Changes From Baseline in Physical Activity Behavior
Total Score (Week12)
|
33.07 scores on a scale
Interval 0.0 to 85.0
|
21.00 scores on a scale
Interval 0.0 to 45.0
|
|
Changes From Baseline in Physical Activity Behavior
Total Score (Week 24)
|
26 scores on a scale
Interval 0.0 to 58.0
|
23.06 scores on a scale
Interval 3.0 to 43.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Immediate Exercise
n=14 Participants
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.
|
Delayed Exercise
n=16 Participants
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.
|
|---|---|---|
|
Changes From Baseline in Physical Fitness
6-minute walk (Week 24)
|
406.42 meters
Interval 207.9 to 558.55
|
333.09 meters
Interval 139.02 to 479.15
|
|
Changes From Baseline in Physical Fitness
6-minute walk (Week 12)
|
407.03 meters
Interval 207.9 to 507.64
|
321.23 meters
Interval 91.44 to 464.82
|
|
Changes From Baseline in Physical Fitness
6-minute walk (Week 1 - baseline)
|
382.56 meters
Interval 213.36 to 489.66
|
324.12 meters
Interval 144.17 to 483.72
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Immediate Exercise
n=14 Participants
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.
|
Delayed Exercise
n=16 Participants
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.
|
|---|---|---|
|
Changes From Baseline in Quality of Life
MS Impact score (Week 1 - baseline)
|
58.57 scores on a scale
Interval 31.0 to 98.0
|
62.31 scores on a scale
Interval 30.0 to 106.0
|
|
Changes From Baseline in Quality of Life
MS Impact score (Week 12)
|
53.57 scores on a scale
Interval 30.0 to 85.0
|
67.13 scores on a scale
Interval 33.0 to 119.0
|
|
Changes From Baseline in Quality of Life
MS Impact score (Week 24)
|
52.29 scores on a scale
Interval 29.0 to 114.0
|
65.38 scores on a scale
Interval 31.0 to 122.0
|
Adverse Events
Immediate Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Delayed Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place