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Comparison of Two Physical Activity Interventions in Individuals With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aquatic Exercise Program
Stretching Program
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kessler FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Fatigue measured by self-report questionnaires
Modified Fatigue Impact Scale (MFIS) and Fatigue Severity Scale (FSS_
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).

Full Information

First Posted
July 7, 2015
Last Updated
December 1, 2022
Sponsor
Kessler Foundation
Collaborators
National Multiple Sclerosis Society
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1. Study Identification

Unique Protocol Identification Number
NCT02496416
Brief Title
Comparison of Two Physical Activity Interventions in Individuals With Multiple Sclerosis
Official Title
Comparison of Two Physical Activity Interventions in Individuals With Multiple Sclerosis: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 2016 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation
Collaborators
National Multiple Sclerosis Society

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Aquatic Exercise Program
Intervention Description
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
Intervention Name(s)
Stretching Program
Intervention Description
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 Measure Information:
Title
Cognition measured by results of standardized neuropsychological tests
Description
standardized measures of processing speed, executive functioning, working memory and long-term memory
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Fatigue measured by self-report questionnaires
Description
Modified Fatigue Impact Scale (MFIS) and Fatigue Severity Scale (FSS_
Time Frame
8 weeks
Title
Quality of Life measured by self report questionnaires
Description
General QOL measured with Satisfaction with Life Scale (SWLS) and HRQOL measured with Health Status Questionnaire (HSQ).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Smith, MA
Phone
973-324-8448
Email
asmith@kesslerfoundation.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Genova, PhD
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Foundation
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy B Moore, MA
Phone
973-324-8450
Email
nbmoore@kesslerfoundation.org
First Name & Middle Initial & Last Name & Degree
Angela A Smith, MA
Phone
973-324-8448
Email
asmith@kesslerfoundation.org

12. IPD Sharing Statement

Learn more about this trial

Comparison of Two Physical Activity Interventions in Individuals With Multiple Sclerosis

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