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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
University of Isfahan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    August 15, 2016
    Last Updated
    August 29, 2016
    Sponsor
    University of Isfahan
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    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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