Muğla Sıtkı Koçman University
Muğla, Merkez, 48000, Turkey (Türkiye)
NCT Number: NCT05447143
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Muğla, Merkez, 48000, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Evaluation for severity of fatigue
Evaluation of balance
Evaluation for walking
Evaluation of quality of life
Evaluation of cognitive functions
Evaluation of depression and anxiety
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.
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)
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)
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)
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)
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)
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.
Muğla Sıtkı Koçman University
Other
Examination of the Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis: A Randomized Controlled Single-Blind Trial
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