Comparison of Two Physical Activity Interventions in Individuals With Multiple Sclerosis

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

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).

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Aquatic Exercise Program; Behavioral: Stretching Program

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angela Smith, MA; Phone Number: 973-324-8448; Email: asmith@kesslerfoundation.org

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Recruiting
      • Kessler Foundation
      • Contact: Nancy B Moore, MA; Phone Number: 973-324-8450; Email: nbmoore@kesslerfoundation.org
      • Contact: Angela A Smith, MA; Phone Number: 973-324-8448; Email: asmith@kesslerfoundation.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognition measured by results of standardized neuropsychological tests	standardized measures of processing speed, executive functioning, working memory and long-term memory	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue measured by self-report questionnaires	Modified Fatigue Impact Scale (MFIS) and Fatigue Severity Scale (FSS_	8 weeks
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

Collaborators and Investigators

• Sponsor: Kessler Foundation
• Collaborators: National Multiple Sclerosis Society
• Investigators: Principal Investigator: Helen Genova, PhD, Kessler Foundation

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: July 7, 2015
• First Submitted That Met QC Criteria: July 9, 2015
• First Posted (Estimate): July 14, 2015

Study Record Updates

• Last Update Posted (Actual): December 5, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: R-876-15