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

Primary Purpose

Multiple Sclerosis, Exercise Program, Telerehabilitation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Fatigue Severity Scale
Berg Balance Test
Time up and go- 25 steps walking test
Multiple Sclerosis Quality of Life
Brief International Cognitive Assessment for MS (BICAMS)
Beck Depression and Anxiety Scale
Sponsored by
Muğla Sıtkı Koçman University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring MS (Multiple Sclerosis), Exercise, Physical, Exercise Therapy, Physical Exertion

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Muğla Sıtkı Koçman University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Experimental

Arm Label

Control Group (CG)

Video Group (VG)

Brochure Group (BG)

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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. The patient starts in a seated position The patient stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated. 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.
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.
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).
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.

Secondary Outcome Measures

Beck Depression and Anxiety Scale
The Beck Depression Scale is a 21-item self-reported questionnaire in which each item consists of four statements indicating different levels of severity of a particular symptom experienced over the past week. Scores for all 21 items are summed up to yield a single depression score. Scores of 0-12 are considered in the normal range, 13-18 as mild, 19-28 as moderate, and scores of 29-63 are considered to indicate severe depression. The Beck Anxiety Scale consists of 21 symptoms that are rated on a four-point severity scale referring to the experience of symptoms over the past week. Scores for the 21 items are summed up to yield a single anxiety score. Scores between 0 and 17 are considered as normal and mild anxiety, whereas scores over 25 are considered as severe anxiety.
Mulitple Sclerosis Quality of life- 54
The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument. The developers utilized the SF-36 as the generic component to which 18 items were added to tap MS-specific issues such as fatigue, cognitive function, etc. This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The summary scores are the physical health composite summary and the mental health composite summary. The single item measures are satisfaction with sexual function and change in health.

Full Information

First Posted
July 3, 2022
Last Updated
July 16, 2022
Sponsor
Muğla Sıtkı Koçman University
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1. Study Identification

Unique Protocol Identification Number
NCT05447143
Brief Title
Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis
Official Title
Examination of the Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis: A Randomized Controlled Single-Blind Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
June 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Muğla Sıtkı Koçman University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Exercise Program, Telerehabilitation, Autoimmune Disorder
Keywords
MS (Multiple Sclerosis), Exercise, Physical, Exercise Therapy, Physical Exertion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group (CG)
Arm Type
Other
Arm Description
The control group will be queued to be included in the exercise program and participants' routine treatment will continue.
Arm Title
Video Group (VG)
Arm Type
Experimental
Arm Description
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.
Arm Title
Brochure Group (BG)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Fatigue Severity Scale
Intervention Description
Evaluation for severity of fatigue
Intervention Type
Other
Intervention Name(s)
Berg Balance Test
Intervention Description
Evaluation of balance
Intervention Type
Other
Intervention Name(s)
Time up and go- 25 steps walking test
Intervention Description
Evaluation for walking
Intervention Type
Other
Intervention Name(s)
Multiple Sclerosis Quality of Life
Intervention Description
Evaluation of quality of life
Intervention Type
Other
Intervention Name(s)
Brief International Cognitive Assessment for MS (BICAMS)
Intervention Description
Evaluation of cognitive functions
Intervention Type
Other
Intervention Name(s)
Beck Depression and Anxiety Scale
Intervention Description
Evaluation of depression and anxiety
Primary Outcome Measure Information:
Title
Timed up and go with 25 steps walking test
Description
Timed up and go: Patients wear their regular footwear and can use a walking aid, if needed. The patient starts in a seated position The patient stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated. 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.
Time Frame
Baseline- after 8 weeks (after treatment)
Title
Fatigue Severity Scale
Description
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.
Time Frame
Baseline- after 8 weeks (after treatment)
Title
Brief International Cognitive Assessment for MS (BICAMS)
Description
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).
Time Frame
Baseline- after 8 weeks (after treatment)
Title
Berg Balance Scale
Description
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.
Time Frame
Baseline- after 8 weeks (after treatment)
Secondary Outcome Measure Information:
Title
Beck Depression and Anxiety Scale
Description
The Beck Depression Scale is a 21-item self-reported questionnaire in which each item consists of four statements indicating different levels of severity of a particular symptom experienced over the past week. Scores for all 21 items are summed up to yield a single depression score. Scores of 0-12 are considered in the normal range, 13-18 as mild, 19-28 as moderate, and scores of 29-63 are considered to indicate severe depression. The Beck Anxiety Scale consists of 21 symptoms that are rated on a four-point severity scale referring to the experience of symptoms over the past week. Scores for the 21 items are summed up to yield a single anxiety score. Scores between 0 and 17 are considered as normal and mild anxiety, whereas scores over 25 are considered as severe anxiety.
Time Frame
Baseline- after 8 weeks (after treatment)
Title
Mulitple Sclerosis Quality of life- 54
Description
The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument. The developers utilized the SF-36 as the generic component to which 18 items were added to tap MS-specific issues such as fatigue, cognitive function, etc. This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The summary scores are the physical health composite summary and the mental health composite summary. The single item measures are satisfaction with sexual function and change in health.
Time Frame
Baseline- after 8 weeks (after treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: To be between the ages of 18-65 Being diagnosed with MS according to McDonald criteria Having an EDSS score between 0-5.5 Being in the Relapsing Remitting class as a clinical subtype of MS Not having any nervous system pathology other than MS Not having an MS attack in the last 1 month To ensure full cooperation and adaptation throughout the study. Exclusion Criteria: Being in an exacerbation period To have participated in a regular physical activity program in the last 6 months Having an orthopedic, cardiopulmonary or psychiatric disease that prevents exercise Continuing another exercise therapy Not volunteering to participate in the study Having problems with reading comprehension
Facility Information:
Facility Name
Muğla Sıtkı Koçman University
City
Muğla
State/Province
Merkez
ZIP/Postal Code
48000
Country
Turkey

12. IPD Sharing Statement

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

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