Multiple SclerosisNCT05447143
Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis
A study testing Fatigue Severity Scale, Berg Balance Test and Time up and go- 25 steps walking test in people with Multiple Sclerosis and Exercise Program, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Exercise Program, Telerehabilitation
- What is being tested?
- Fatigue Severity Scale, Berg Balance Test and Time up and go- 25 steps walking test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2021to 15 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Muğla Sıtkı Koçman University
Muğla, Merkez, 48000
About this study
Official title: Examination of the Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis: A Randomized Controlled Single-Blind Trial
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.
- Being tested
- 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)
- Keywords
- MS (Multiple Sclerosis), Exercise, Physical, Exercise Therapy, Physical Exertion
- Medical subject headings
- Multiple Sclerosis, Autoimmune Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatigue Severity ScaleOther
Evaluation for severity of fatigue
Berg Balance TestOther
Evaluation of balance
Time up and go- 25 steps walking testOther
Evaluation for walking
Multiple Sclerosis Quality of LifeOther
Evaluation of quality of life
Brief International Cognitive Assessment for MS (BICAMS)Other
Evaluation of cognitive functions
Beck Depression and Anxiety ScaleOther
Evaluation of depression and anxiety
| Study group | Role | What they receive |
|---|---|---|
| Control Group (CG) | Other | The control group will be queued to be included in the exercise program and participants' routine treatment will continue. Receives: Other: Fatigue Severity Scale; Other: Berg Balance Test; Other: Time up and go- 25 steps walking test; Other: Multiple Sclerosis Quality of Life; Other: 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. Receives: Other: Fatigue Severity Scale; Other: Berg Balance Test; Other: Time up and go- 25 steps walking test; Other: Multiple Sclerosis Quality of Life; Other: Brief International Cognitive Assessment for MS (BICAMS); Other: Beck Depression and Anxiety Scale |
| 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. Receives: Other: Fatigue Severity Scale; Other: Berg Balance Test; Other: Time up and go- 25 steps walking test; Other: Multiple Sclerosis Quality of Life; Other: Brief International Cognitive Assessment for MS (BICAMS); Other: Beck Depression and Anxiety Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline- after 8 weeks (after treatment)
Secondary outcomes (2)
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.
Measured: Baseline- after 8 weeks (after treatment)
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.
Measured: Baseline- after 8 weeks (after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start30 Sep 2021
- Primary completion30 Nov 2021
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Banu BAYAR, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447143
- Sponsor's protocol ID
- 200301
- Status last verified
- Jul 2022
- First submitted
- 3 Jul 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis: A Randomized Controlled Single-Blind Trial
- ClinicalTrials.gov ID
- NCT05447143
- Acronym / sponsor ID
- 200301
- Keywords
- MS (Multiple Sclerosis), Exercise, Physical, Exercise Therapy, Physical Exertion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group (CG) | Other | Other: Fatigue Severity Scale, Other: Berg Balance Test, Other: Time up and go- 25 steps walking test, Other: Multiple Sclerosis Quality of Life, Other: Brief International Cognitive Assessment for MS (BICAMS), Other: Beck Depression and Anxiety ScaleThe control group will be queued to be included in the exercise program and participants' routine treatment will continue. |
| Video Group (VG) | Experimental | Other: Fatigue Severity Scale, Other: Berg Balance Test, Other: Time up and go- 25 steps walking test, Other: Multiple Sclerosis Quality of Life, Other: Brief International Cognitive Assessment for MS (BICAMS), Other: Beck Depression and Anxiety ScaleThe 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 | Other: Fatigue Severity Scale, Other: Berg Balance Test, Other: Time up and go- 25 steps walking test, Other: Multiple Sclerosis Quality of Life, Other: Brief International Cognitive Assessment for MS (BICAMS), Other: Beck Depression and Anxiety ScaleExercise 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fatigue Severity ScaleEvaluation for severity of fatigue | Other | Brochure Group (BG), Control Group (CG), Video Group (VG) |
| Berg Balance TestEvaluation of balance | Other | Brochure Group (BG), Control Group (CG), Video Group (VG) |
| Time up and go- 25 steps walking testEvaluation for walking | Other | Brochure Group (BG), Control Group (CG), Video Group (VG) |
| Multiple Sclerosis Quality of LifeEvaluation of quality of life | Other | Brochure Group (BG), Control Group (CG), Video Group (VG) |
| Brief International Cognitive Assessment for MS (BICAMS)Evaluation of cognitive functions | Other | Brochure Group (BG), Control Group (CG), Video Group (VG) |
| Beck Depression and Anxiety ScaleEvaluation of depression and anxiety | Other | Brochure Group (BG), Control Group (CG), Video Group (VG) |
Primary outcome
Timed up and go with 25 steps walking test
Time frame: Baseline- after 8 weeks (after treatment)
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.
Fatigue Severity Scale
Time frame: Baseline- after 8 weeks (after treatment)
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)
Time frame: Baseline- after 8 weeks (after treatment)
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
Time frame: Baseline- after 8 weeks (after treatment)
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.
2 secondary outcomes
Beck Depression and Anxiety Scale
Time frame: Baseline- after 8 weeks (after treatment)
Mulitple Sclerosis Quality of life- 54
Time frame: Baseline- after 8 weeks (after treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fatigue Severity Scale, Berg Balance Test and Time up and go- 25 steps walking test in people with Multiple Sclerosis and Exercise Program, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed up and go with 25 steps walking test (time frame: Baseline- after 8 weeks (after treatment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.