Comparison of Two Physical Activity Interventions in Individuals With Multiple Sclerosis

NCT02496416 | Unknown

• 1 other identifier: R-876-15
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Cognition measured by results of standardized neuropsychological tests

  standardized measures of processing speed, executive functioning, working memory and long-term memory

  8 weeks

Secondary Outcomes (2)

• Fatigue measured by self-report questionnaires

  8 weeks

• Quality of Life measured by self report questionnaires

  8 weeks

Study Arms (2)

Treatment

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 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

Control

ACTIVE COMPARATOR

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

Interventions

Aquatic Exercise Program 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.

Treatment

Stretching Program 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.

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of MS.
• between the ages of 18-65.
• read and speak English fluently.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kessler Foundation: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

Kessler Foundation

East Hanover, New Jersey, 07936, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Helen Genova, PhD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Smith, MA

CONTACT

973-324-8448; asmith@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: July 7, 2015
• First Posted: July 14, 2015
• Study Start: August 1, 2016
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 5, 2022

Record last verified: 2022-12

Locations

US (1)