Brief Summary

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.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline

Completed

Started Sep 2021

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach

1 country

1 active site

Status

completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9 months study duration

Study Start

First participant enrolled

September 30, 2021

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed

18 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2022

Completed

4 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed

Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

July 3, 2022

Last Update Submit

July 16, 2022

Conditions

Multiple Sclerosis Exercise Program Telerehabilitation Autoimmune Disorder

Keywords

MS (Multiple Sclerosis)Exercise, PhysicalExercise TherapyPhysical Exertion

Outcome Measures

Primary Outcomes (4)

Timed up and go with 25 steps walking test
Timed up and go: Patients wear their regular footwear and can use a walking aid, if needed. 1. The patient starts in a seated position 2. The patient stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down. 3. The time stops when the patient is seated. 4. Be sure to document the assistive device used. Note: A practice trial should be completed before the timed trial. High falling risk\>13.5 seconds. The 25 steps walking test is a quantitative mobility and leg function performance test based on a timed 25-walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is recorded.
Baseline- after 8 weeks (after treatment)
Fatigue Severity Scale
The Fatigue Severity Scale questionnaire contains nine statements that rate the severity of fatigue symptoms. A total score of less than 36 suggests that patient may not be suffering from fatigue. A higher score is indicated high level of fatigue.
Baseline- after 8 weeks (after treatment)
Brief International Cognitive Assessment for MS (BICAMS)
The Brief International Cognitive Assessment for MS (BICAMS) initiative was undertaken to recommend a brief, cognitive assessment for MS that is optimized for small centers. BICAMS was particularly focused on international use, to facilitate comparison across settings. An expert committee of twelve neurologists and neuropsychologists representing the main cultural groups that have so far contributed extensive data about cognitive dysfunction in MS was convened. The opinions generated from the meeting are published elsewhere. Consensus was also achieved on optimal measures for learning and memory in MS patients, time permitting: the initial learning trials of the second edition of the California Verbal Learning Test (CVLT2) and the revised Brief Visuospatial Memory Test (BVMTR).
Baseline- after 8 weeks (after treatment)
Berg Balance Scale
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. A score of 56 indicates functional balance. A score of \< 45 indicates individuals may be at greater risk of falling.
Baseline- after 8 weeks (after treatment)

Secondary Outcomes (2)

Beck Depression and Anxiety Scale
Baseline- after 8 weeks (after treatment)
Mulitple Sclerosis Quality of life- 54
Baseline- after 8 weeks (after treatment)

Study Arms (3)

Control Group (CG)

OTHER

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

Other: Fatigue Severity ScaleOther: Berg Balance TestOther: Time up and go- 25 steps walking testOther: Multiple Sclerosis Quality of LifeOther: Brief International Cognitive Assessment for MS (BICAMS)Other: Beck Depression and Anxiety Scale

Video Group (VG)

EXPERIMENTAL

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.

Brochure Group (BG)

EXPERIMENTAL

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.