Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis

NCT ID: NCT05447143

Last Updated: 2022-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-30

Study Completion Date

2022-06-15

Brief Summary

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Multiple Sclerosis (MS) is a chronic, inflammatory, neurodegenerative, and autoimmune disease that progresses with progressive neurological dysfunction and affects the central nervous system. A multidisciplinary rehabilitation approach is crucial in the systematic and supportive treatment of MS. Exercise training is a therapeutic approach that minimizes functional capacity loss and slows progression in MS. Randomized controlled studies have shown that exercise training improves physical fitness, reduces motor fatigue, and improves the quality of life and psychological state in individuals with MS.

When the literature is examined, it is seen that popular exercises such as pilates, yoga, and Tai-Chi are used in addition to aerobics, strengthening, endurance, and stretching exercises in the treatment of individuals with MS. In order to eliminate the economic burden, which is one of the exercise barriers of individuals, and to gain exercise habits, home exercise programs should be expanded. When the literature is examined, it is emphasized that the importance of home exercise programs is emphasized, and it is very important in the treatment of patients who cannot attend an exercise program, especially by going to any center for various reasons. However, there is little information on the effectiveness and content of home exercise programs in patients with MS. From this point of view, this study is capable of supporting the missing part of the literature.

Detailed Description

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Conditions

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Multiple Sclerosis Exercise Program Telerehabilitation Autoimmune Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control Group (CG)

The control group will be queued to be included in the exercise program and participants' routine treatment will continue.

Group Type OTHER

Fatigue Severity Scale

Intervention Type OTHER

Evaluation for severity of fatigue

Berg Balance Test

Intervention Type OTHER

Evaluation of balance

Time up and go- 25 steps walking test

Intervention Type OTHER

Evaluation for walking

Multiple Sclerosis Quality of Life

Intervention Type OTHER

Evaluation of quality of life

Brief International Cognitive Assessment for MS (BICAMS)

Intervention Type OTHER

Evaluation of cognitive functions

Beck Depression and Anxiety Scale

Intervention Type OTHER

Evaluation of depression and anxiety

Video Group (VG)

The exercise will be given as a video and participants will be asked to continue the exercises for 8 weeks, 3 days a week. Patients will be contacted by phone every week to ask if participants have any problems with the exercise program and their compliance.

Group Type EXPERIMENTAL

Fatigue Severity Scale

Intervention Type OTHER

Evaluation for severity of fatigue

Berg Balance Test

Intervention Type OTHER

Evaluation of balance

Time up and go- 25 steps walking test

Intervention Type OTHER

Evaluation for walking

Multiple Sclerosis Quality of Life

Intervention Type OTHER

Evaluation of quality of life

Brief International Cognitive Assessment for MS (BICAMS)

Intervention Type OTHER

Evaluation of cognitive functions

Beck Depression and Anxiety Scale

Intervention Type OTHER

Evaluation of depression and anxiety

Brochure Group (BG)

Exercise will be given as a brochure and participants will be asked to continue the exercises given for 8 weeks, 3 days a week. Visual feedback will be provided by asking participants to mark the exercise tracking chart on the exercise brochures.

Group Type EXPERIMENTAL

Fatigue Severity Scale

Intervention Type OTHER

Evaluation for severity of fatigue

Berg Balance Test

Intervention Type OTHER

Evaluation of balance

Time up and go- 25 steps walking test

Intervention Type OTHER

Evaluation for walking

Multiple Sclerosis Quality of Life

Intervention Type OTHER

Evaluation of quality of life

Brief International Cognitive Assessment for MS (BICAMS)

Intervention Type OTHER

Evaluation of cognitive functions

Beck Depression and Anxiety Scale

Intervention Type OTHER

Evaluation of depression and anxiety

Interventions

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Fatigue Severity Scale

Evaluation for severity of fatigue

Intervention Type OTHER

Berg Balance Test

Evaluation of balance

Intervention Type OTHER

Time up and go- 25 steps walking test

Evaluation for walking

Intervention Type OTHER

Multiple Sclerosis Quality of Life

Evaluation of quality of life

Intervention Type OTHER

Brief International Cognitive Assessment for MS (BICAMS)

Evaluation of cognitive functions

Intervention Type OTHER

Beck Depression and Anxiety Scale

Evaluation of depression and anxiety

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. To be between the ages of 18-65
2. Being diagnosed with MS according to McDonald criteria
3. Having an EDSS score between 0-5.5
4. Being in the Relapsing Remitting class as a clinical subtype of MS
5. Not having any nervous system pathology other than MS
6. Not having an MS attack in the last 1 month
7. To ensure full cooperation and adaptation throughout the study.

Exclusion Criteria

1. Being in an exacerbation period
2. To have participated in a regular physical activity program in the last 6 months
3. Having an orthopedic, cardiopulmonary or psychiatric disease that prevents exercise
4. Continuing another exercise therapy
5. Not volunteering to participate in the study
6. Having problems with reading comprehension
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Muğla Sıtkı Koçman University

OTHER

Sponsor Role lead

Responsible Party

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Banu BAYAR

Principal investigator, Head of Physiotherapy and Rehabilitation Department, Pt. PhD. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Muğla Sıtkı Koçman University

Muğla, Merkez, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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200301

Identifier Type: -

Identifier Source: org_study_id

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