Overview

This trial is active, not recruiting.

Condition multiple sclerosis
Treatment aquatic exercise program
Sponsor Kessler Foundation
Collaborator National Multiple Sclerosis Society
Start date August 2016
End date August 2016
Trial size 15 participants
Trial identifier NCT02496416, R-876-15

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
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 Scotch Plains-Fanwood, 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.
aquatic exercise program
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.
(Active Comparator)
The wait-list control group will participate in an eight week aquatic exercise program during weeks 11-19 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 Scotch Plains-Fanwood, 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.
aquatic exercise program
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.

Primary Outcomes

Measure
Cognition measured by results of standardized neuropsychological tests
time frame: 8 weeks

Secondary Outcomes

Measure
Fatigue measured by self-report questionnaires
time frame: 8 weeks
Quality of Life measured by self report questionnaires
time frame: 8 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - diagnosis of MS. - between the ages of 18-65. - read and speak English fluently. - no history of significant substance abuse. - no history of neurological disease other than MS (for example, stroke, epilepsy, or brain injury). - no history of significant psychiatric illness (for example, bipolar disorder or schizophrenia). - completed at least 30 minutes of moderate to strenuous exercise at least one day per week for at least the past 6 months. Exclusion Criteria: - no diagnosis of MS - younger than 18 - older than 65 - do not read and speak English fluently. - 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). - have not completed at least 30 minutes of moderate to strenuous exercise at least one day per week for at least the past 6 months.

Additional Information

Official title Aquatic Exercise Intervention in Multiple Sclerosis: A Randomized Clinical Trial
Principal investigator Helen Genova, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Kessler Foundation.