Comparison of Two Physical Activity Interventions in Individuals With Multiple Sclerosis

NCT ID: NCT02496416

Last Updated: 2022-12-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2022-12-31

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment

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.

Group Type: EXPERIMENTAL

Aquatic Exercise Program

Intervention Type: BEHAVIORAL

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.

Control

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.

Group Type: ACTIVE_COMPARATOR

Stretching Program

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Multiple Sclerosis Society

OTHER

Sponsor Role: collaborator

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Helen Genova

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helen Genova, PhD

Role: PRINCIPAL_INVESTIGATOR

Kessler Foundation

Locations

Kessler Foundation

East Hanover, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Angela Smith, MA

Role: CONTACT

asmith@kesslerfoundation.org

973-324-8448

Facility Contacts

Nancy B Moore, MA

Role: primary

nbmoore@kesslerfoundation.org

973-324-8450

Angela A Smith, MA

Role: backup

asmith@kesslerfoundation.org

973-324-8448

Other Identifiers

R-876-15

Identifier Type: -

Identifier Source: org_study_id