Comparison of Two Physical Activity Interventions in Individuals With Multiple Sclerosis

Not Applicable

Recruiting

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: Aquatic Exercise Program; Behavioral: Stretching Program

• Registration Number: NCT02496416
• Lead Sponsor: Kessler Foundation

Brief 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).

Detailed 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.

Study Timeline

• Study First Submitted: 2015-07-07
• Study First Submitted QC: 2015-07-09
• Study First Posted: 2015-07-14
• Study Start: 2016-08
• Status Verified: 2022-12
• Primary Completion: 2022-12
• Study Completion: 2022-12
• Last Update Submitted: 2022-12-01
• Last Update Posted: 2022-12-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment	Aquatic Exercise Program	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.
Control	Stretching Program	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.

Primary Outcome Measures

Name	Time	Method
Cognition measured by results of standardized neuropsychological tests	8 weeks	standardized measures of processing speed, executive functioning, working memory and long-term memory

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kessler Foundation; 🇺🇸 East Hanover, New Jersey, United States