Comparison of Two Physical Activity Interventions in Individuals With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02496416
• Other study ID #: R-876-15
• Status: Recruiting
• Phase: N/A
• Start date: August 2016
• Est. completion date: December 2022

Study information

• Verified date: December 2022
• Source: Kessler Foundation
• Contact: Angela Smith, MA
• Phone: 973-324-8448
• Email: asmith[@]kesslerfoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• 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.
• Stretching Program
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.

Locations

Country	Name	City	State
United States	Kessler Foundation	East Hanover	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Kessler Foundation	National Multiple Sclerosis Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognition measured by results of standardized neuropsychological tests	standardized measures of processing speed, executive functioning, working memory and long-term memory	8 weeks
Secondary	Fatigue measured by self-report questionnaires	Modified Fatigue Impact Scale (MFIS) and Fatigue Severity Scale (FSS_	8 weeks
Secondary	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