Changes in Speed, Endurance and Balance in Women Patients With Multiple Sclerosis After 4 & 8 Weeks of Aquatic Exercise Training
Primary Purpose
Multiple Sclerosis, Aquatic, Exercise
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Exercise
Control
Sponsored by

About this trial
This is an interventional treatment trial for Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria:
- All women diagnosis of clinically or laboratory supported MS, a minimum time of two years since the diagnosis was made, no relapse within the 4 weeks preceding baseline, ability to participate in regular exercise sessions.
Exclusion Criteria:
- Patients were excluded from the study if they had a relapse during the intervention period, and had a disease preventing their participation (e.g. cardiovascular, respiratory or skeletal diseases).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Exercise training
Control
Arm Description
Control group did not do any exercise training.
Outcomes
Primary Outcome Measures
Effect of exercise on balance was surveyed with using of Berg analyze
Secondary Outcome Measures
Effect of exercise on speed was measured by walking test
Effect of exercise on endurance was measured by walking test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02882724
Brief Title
Changes in Speed, Endurance and Balance in Women Patients With Multiple Sclerosis After 4 & 8 Weeks of Aquatic Exercise Training
Official Title
Effect Aquatic Exercise Training on Patients With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Isfahan
4. Oversight
5. Study Description
Brief Summary
Background: It has been shown that adults with Multiple sclerosis (MS) have less leg strength than their peers, as well as impaired balance, which has led to an increased prevalence of falls in this population.The purpose of this study was to assess the effects of 8-weeks aquatic exercise training in balance, endurance and speed in women with MS.
Methods: In this semi-experimental study, 32 women with clinically-definite relapsing-remittent MS who were registered through the Isfahan MS association volunteered for this study. They randomly selected an aquatic exercise (n = 17) and control (n = 15) groups. Aquatic exercise group completed a 8-week aquatic exercise training program consisted of three sessions per week, each session lasting 45 to 60 minutes 50 to 75 percent of their maximum heart rate reserve on 20-25 degree centigrade's, whereas the control group was instructed to maintain their current lifestyle. The balance of angry was surveyed with using of Berg analyze, speed and endurance 6 minutes walking test before starting of exercise program and after 4 weeks and at the end of 8 weeks was analyzed. The obtained data's were analyzed using analysis of variance with repeated measures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Aquatic, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise training
Arm Type
Experimental
Arm Title
Control
Arm Type
Experimental
Arm Description
Control group did not do any exercise training.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
8-week aquatic exercise training program
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Control group did not do the exercise training.
Primary Outcome Measure Information:
Title
Effect of exercise on balance was surveyed with using of Berg analyze
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Effect of exercise on speed was measured by walking test
Time Frame
Up to 8 weeks
Title
Effect of exercise on endurance was measured by walking test
Time Frame
Up to 8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All women diagnosis of clinically or laboratory supported MS, a minimum time of two years since the diagnosis was made, no relapse within the 4 weeks preceding baseline, ability to participate in regular exercise sessions.
Exclusion Criteria:
Patients were excluded from the study if they had a relapse during the intervention period, and had a disease preventing their participation (e.g. cardiovascular, respiratory or skeletal diseases).
12. IPD Sharing Statement
Citations:
PubMed Identifier
28735720
Citation
Kargarfard M, Shariat A, Ingle L, Cleland JA, Kargarfard M. Randomized Controlled Trial to Examine the Impact of Aquatic Exercise Training on Functional Capacity, Balance, and Perceptions of Fatigue in Female Patients With Multiple Sclerosis. Arch Phys Med Rehabil. 2018 Feb;99(2):234-241. doi: 10.1016/j.apmr.2017.06.015. Epub 2017 Jul 20.
Results Reference
derived
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Changes in Speed, Endurance and Balance in Women Patients With Multiple Sclerosis After 4 & 8 Weeks of Aquatic Exercise Training
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