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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02882724
Other study ID # 201527921IR
Secondary ID
Status Completed
Phase Phase 1
First received August 15, 2016
Last updated August 29, 2016
Start date January 2016

Study information

Verified date August 2016
Source University of Isfahan
Contact n/a
Is FDA regulated No
Health authority Iran: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 50 Years
Eligibility 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).

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise
8-week aquatic exercise training program
Control
Control group did not do the exercise training.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Isfahan

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of exercise on balance was surveyed with using of Berg analyze up to 8 weeks No
Secondary Effect of exercise on speed was measured by walking test Up to 8 weeks No
Secondary Effect of exercise on endurance was measured by walking test Up to 8 weeks No
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