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| ID | Type | Description | Link |
|---|---|---|---|
| 1R03HD060073-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Exercise | Experimental | 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. |
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| Delayed exercise | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate exercise | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Plow, PhD | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Full Range | scores on a scale | 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). |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Plow | Case Western Reserve University | 216-368-8969 | map208@case.edu |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Delayed exercise | Behavioral | Subjects in the delayed exercise group will begin the home exercise program 12 weeks following the initial meeting. |
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| 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. | 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). |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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. |
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| 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. | Posted | Mean | Full Range | meters | 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). |
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| 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. | Posted | Mean | Full Range | scores on a scale | 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). |
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| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | 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. | 0 | 16 | 0 | 16 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
| 6-minute walk (Week 24) |
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| MS Impact score (Week 24) |
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