NCT02882724

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 multiple-sclerosis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

3 months

First QC Date

August 15, 2016

Last Update Submit

August 29, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Effect of exercise on balance was surveyed with using of Berg analyze

    up to 8 weeks

Secondary Outcomes (2)

  • Effect of exercise on speed was measured by walking test

    Up to 8 weeks

  • Effect of exercise on endurance was measured by walking test

    Up to 8 weeks

Study Arms (2)

Exercise training

EXPERIMENTAL
Behavioral: Exercise

Control

EXPERIMENTAL

Control group did not do any exercise training.

Behavioral: Control

Interventions

ExerciseBEHAVIORAL

8-week aquatic exercise training program

Exercise training
ControlBEHAVIORAL

Control group did not do the exercise training.

Control

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Multiple SclerosisMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 15, 2016

First Posted

August 30, 2016

Study Start

January 1, 2016

Primary Completion

April 1, 2016

Last Updated

August 30, 2016

Record last verified: 2016-08