Comparison of Two Physical Activity Interventions in Individuals With Multiple Sclerosis

Study Overview
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Brief Summary
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This study will examine the effectiveness of aquatic therapy on a range of MS-related symptoms such as cognition, mood, fatigue and quality of life (QOL).

Detailed Description
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Aim 1. Examine the impact of aquatic exercise on cognitive abilities. The proposed study will test the hypotheses that, compared to the wait-list control group, the treatment group will demonstrate significantly greater improvements in cognitive outcomes, specifically: processing speed, executive functioning, working memory and long-term memory. Aim 2. The current study will examine the impact of an aquatic exercise on fatigue, mood, wellness, QOL and physical functioning. Specifically the investigators predict that aquatic exercise will lead to improvements in: 1.Fatigue 2. Health related QOL 3. Depression/anxiety 4. Self-efficacy 5. Physical Functioning (i.e. gait and walking). Aim 3: Examine the long-term effects of aquatic exercise on all outcome measures.

Official Title
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Comparison of Two Physical Activity Interventions in Individuals With Multiple Sclerosis: A Randomized Clinical Trial

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Aquatic Exercise Program
* Behavioral: Stretching Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of MS. between the ages of 18-65. read and speak English fluently. Exclusion Criteria: history of significant substance abuse. history of neurological disease other than MS (for example, stroke, epilepsy, or brain injury). history of significant psychiatric illness (for example, bipolar disorder or schizophrenia). has engaged in more than 30 minutes of moderate to strenuous exercise per week during the past six months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>The treatment group will participate in an eight week aquatic exercise program during weeks 2-9 of the study. The aquatic exercise program will consist of 45 minute classes held 3 days/week for 8 weeks (18 hours total). The program is based on guidelines provided by the National Multiple Sclerosis Society (NMSS) and will be led by an aquatic fitness instructor certified to teach individuals with MS at the YMCA in Randolph, NJ.. The exercises will focus on improving flexibility, balance and strength. Equipment such as water mitts, paddles, noodles and bands will be used to increase the level of difficulty as needed. | Behavioral: Aquatic Exercise Program<br>* The aquatic exercise program will consist of 45 minute classes held 3 days/week for 8 weeks (18 hours total). The program is based on guidelines provided by the National Multiple Sclerosis Society (NMSS) and will be led by an aquatic fitness instructor certified to teach individuals with MS at the YMCA in Scotch Plains-Fanwood. The exercises will focus on improving flexibility, balance and strength. Equipment such as water mitts, paddles, noodles and bands will be used to increase the level of difficulty as needed.<br>|
| Active Comparator: Control<br>The control group will participate in an eight week stretching program during weeks 2-9 of the study. The stretching program will consist of 45 minute classes held 3 days/week for 8 weeks (18 hours total). The program is based on guidelines provided by the National Multiple Sclerosis Society (NMSS) and will be conducted online via a secure video-conferencing website. | Behavioral: Stretching Program<br>* The stretching program will consist of 45 minute classes held 3 days/week for 8 weeks (18 hours total). The program is based on guidelines provided by the National Multiple Sclerosis Society (NMSS) and will be conducted online via a secure video-conferencing website.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognition measured by results of standardized neuropsychological tests | standardized measures of processing speed, executive functioning, working memory and long-term memory | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue measured by self-report questionnaires | Modified Fatigue Impact Scale (MFIS) and Fatigue Severity Scale (FSS_ | 8 weeks | 
| Quality of Life measured by self report questionnaires | General QOL measured with Satisfaction with Life Scale (SWLS) and HRQOL measured with Health Status Questionnaire (HSQ). | 8 weeks |