Multiple SclerosisAi-ChiNCT07880418
Ai-Chi in Individuals With Multiple Sclerosis
A study testing Ai-Chi exercise and Land-Based Exercise in people with Multiple Sclerosis, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The subject of this study is to examine the effects of Ai Chi-an aquatic exercise method-on balance, mobility, muscle strength, quality of life, depression, fatigue, and cognitive functions in individuals diagnosed with Multiple Sclerosis (MS), in comparison with land-based exercises. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Ai-Chi exercise and Land-Based Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jan 2026to 3 Mar 2026
- 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
- Being between 18 and 65 years of age.
- Voluntarily agreeing to participate in the study.
- Having a diagnosis of Multiple Sclerosis according to the McDonald criteria.
- Being able to read and write.
- Having an Expanded Disability Status Scale (EDSS) score between 0 and 6.5.
Who cannot join
- Having experienced an MS relapse within the previous 6 months.
- Having a severe psychological disorder that may interfere with participation in cognitive assessments.
- Having a substance dependence, including dependence on tobacco or alcohol.
- Having a fear of water (aquaphobia).
- Having a dermatological condition that may prevent participation in aquatic exercise therapy.
- Having a history of trauma within the previous 3 months.
- Being pregnant.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırşehir Ahi Evran Univercity
Kırşehir, Kırşehir, 40100
About this study
Official title: Investigation of the Effect of Ai Chi Exercises in Individuals With Multiple Sclerosis
The subject of this study is to examine the effects of Ai Chi-an aquatic exercise method-on balance, mobility, muscle strength, quality of life, depression, fatigue, and cognitive functions in individuals diagnosed with Multiple Sclerosis (MS), in comparison with land-based exercises. Developed to address the physical and cognitive symptoms associated with MS, this study aims to evaluate the effectiveness of Ai Chi exercises-performed in water-as an alternative and/or complementary rehabilitation method alongside traditional land-based exercises. In this context, the research seeks to offer an innovative approach to enhancing the quality of life and functional capacity of individuals with MS.
Read the detailed description
Multiple Sclerosis (MS) is a chronic neurological disease affecting the central nervous system and has a multidimensional negative impact on individuals' physical, cognitive, and psychosocial functioning due to its progressive and heterogeneous clinical course. The exact cause of MS remains unknown. Genetic factors, environmental factors, and the interaction between these factors are generally thought to play a role in the development of MS. Race, sex, low vitamin D levels, limited exposure to sunlight, Epstein-Barr virus infection, and smoking have been identified as major risk factors for the development of MS.
Clinical signs and symptoms of MS vary depending on the regions of the brain and spinal cord affected by the disease. Although MS is associated with a wide range of clinical signs and symptoms, motor, sensory, and autonomic dysfunctions are among the most common manifestations. The most common motor impairments observed in MS include muscle weakness, spasticity, tremor, ataxia, and visuomotor deficits. These impairments negatively affect balance and walking function and may lead to falls. Individuals with MS also demonstrate reduced muscle contraction strength, decreased endurance, reduced total muscle mass, and increased muscle atrophy.
Balance impairments are among the most common symptoms experienced by individuals with MS. Postural instability occurs as a result of impaired neural connections within the somatosensory, visual, and vestibular systems, which play important roles in maintaining balance in individuals with MS. Walking problems are another common symptom in individuals with MS. Reduced walking speed, step length, and cadence, as well as increased step width and double-support phase duration, have been reported. These walking impairments have been particularly associated with muscle weakness, spasticity, and reduced postural stability and balance. Sensory disturbances are also common in individuals with MS. Hypoesthesia, hyperesthesia, and loss of proprioception may negatively affect postural control and walking, thereby limiting individuals' activities of daily living. Fatigue is experienced by approximately 90% of individuals with MS and has a substantial negative impact on their quality of life. Cognitive dysfunction is observed in approximately 20% of individuals with MS within the first five years following disease onset, and this proportion increases as the disease progresses. Depression and anxiety are also common in MS and occur at higher rates than in the general population.
Muscle weakness, balance and mobility impairments, fatigue, cognitive problems, and depression experienced by individuals with MS restrict independence in activities of daily living and lead to a substantial reduction in quality of life. Therefore, in addition to pharmacological treatments, the development of effective, safe, and sustainable rehabilitation approaches is of great importance.
Physical activity decreases as the disease progresses in individuals with MS. Appropriate exercise programs for individuals with MS can lead to significant improvements in aerobic capacity, muscle strength and endurance, flexibility, balance, mobility, fatigue, and quality of life. In addition, systematic analyses investigating the effects of exercise have demonstrated that exercise may promote the production of neurotrophic factors, neuronal growth and proliferation, and improvements in cognitive functions such as learning and memory. Exercise has also been shown to increase the production of Brain-Derived Neurotrophic Factor (BDNF).
Treatment approaches for MS are generally classified into pharmacological and non-pharmacological interventions. Although there is currently no definitive cure for MS, pharmacological agents used in its management modify or suppress the immune system and thereby alter the course of the disease. These agents are generally used to reduce the frequency of relapses, slow physical deterioration, and alleviate MS-related symptoms. In addition to pharmacological treatment, physiotherapy and rehabilitation are among the most important approaches for improving quality of life and maintaining independent mobility in individuals with MS.
Exercise-based rehabilitation approaches are known to have positive effects on functional capacity, balance, walking, and quality of life in individuals with MS. However, land-based exercises may be limiting for some individuals due to MS-specific factors such as heat sensitivity, rapid fatigue, and changes in muscle tone. In this context, the buoyancy of water reduces body weight and increases the range of motion, while the greater density of water compared with air provides natural resistance. Hydrostatic pressure contributes to reducing edema and provides proprioceptive feedback, while the thermal properties of water may reduce muscle spasms at an appropriate temperature and promote circulation. Aquatic exercises offer several advantages for individuals with MS, including facilitating thermoregulation, providing a pain-free and supported movement environment, improving balance and coordination, increasing muscle strength and endurance, reducing spasticity and muscle tension, promoting psychological well-being, and improving functional ability and quality of life.
Aquatic exercises have been used for many years in the treatment of various diseases. The aquatic environment possesses several properties, including buoyancy, turbulence, hydrostatic pressure, and resistance, which facilitate various therapeutic exercise benefits. Buoyancy reduces body weight and helps individuals who have difficulty moving on land to move more easily. Turbulent water provides a suitable environment for static and dynamic balance training with minimal risk of injury. Resistance is also important for strength training in water. Aquatic exercises are widely used in various therapeutic settings. Individuals with MS are frequently referred to physical therapy to benefit from aquatic exercises. However, the literature indicates that research in this field remains limited. Studies in the literature suggest that aquatic exercise approaches are effective, safe, and feasible methods for improving balance, fatigue, pain, functional mobility, and quality of life in individuals with MS. In particular, mind-body-based aquatic approaches such as Ai-Chi and WATSU appear to be effective in improving fatigue and psychosocial symptoms. Ai-Chi is a holistic exercise approach performed in water that combines Tai Chi- and Qigong-based slow and controlled movements with breathing awareness. Ai-Chi focuses on balance, strength, relaxation, flexibility, and breathing. Through these characteristics, Ai-Chi has the potential to simultaneously target physical, cognitive, and emotional components in individuals with MS. However, studies systematically and multidimensionally investigating the effects of Ai-Chi exercises in individuals with MS remain limited. This highlights the need to scientifically clarify the role of Ai-Chi in MS rehabilitation.
Research Question
In individuals diagnosed with Multiple Sclerosis, are Ai-Chi exercises, as an aquatic exercise method, more effective than land-based exercises in improving balance, mobility, muscle strength, quality of life, depression, fatigue, and cognitive functions?
Research Hypotheses
H1: Individuals with MS who participate in Ai-Chi exercises demonstrate significantly greater improvements in balance and mobility compared with individuals who participate in land-based exercise programs.
H2: Ai-Chi exercises are more effective than land-based exercises in reducing fatigue and improving quality of life in individuals with MS.
H3: Ai-Chi exercises have more positive effects on depression levels and cognitive functions in individuals with MS compared with land-based exercises.
H4: Ai-Chi exercises result in a significant increase in muscle strength in individuals with MS.
- Conditions
- Multiple Sclerosis
- Being tested
- Ai-Chi exercise, Land-Based Exercise
- Keywords
- Multiple Sclerosis, Balance, Exercise, Aquatic exercises, Ai-Chi
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ai-Chi exerciseOther
Participants in the aquatic exercise group will participate in an Ai Chi exercise program. The exercises will be performed in a group setting for 45 minutes per session, five days per week for five weeks, resulting in a total of 25 sessions. Ai Chi utilizes the properties of water to facilitate movements that primarily focus on balance, muscle strength, flexibility, and breathing control. The sessions will be conducted in a pool with a water depth of 1.2 m and a temperature maintained between 28 and 30°C. Appropriate environmental conditions and safety measures will be ensured throughout the intervention. Before each session, participants will be informed about the aquatic exercise program and the precautions to be taken during the sessions. All sessions will be supervised by a physiotherapist experienced in neurological rehabilitation and Ai Chi.
Land-Based ExerciseOther
Participants in the land-based exercise group will participate in 45-minute exercise sessions, five days per week for five weeks. During the first five minutes of each session, participants will perform warm-up exercises consisting of light aerobic activities, including upper and lower extremity swings, low-intensity walking, and stretching.
The subsequent 35 minutes will be devoted to balance, mobility, and strengthening exercises. Balance exercises will include single-leg standing, forward-reaching exercises, and standing on a balance board. Mobility exercises will include sit-to-stand transfers from a chair, lateral walking, heel-to-toe walking, and walking over obstacles. Strengthening exercises will include upper and lower extremity exercises using a yellow resistance band, mini-squats, and elbow flexion and extension exercises using light weights.
| Study group | Role | What they receive |
|---|---|---|
| Ai-Chi Group | Experimental | Participants in the aquatic exercise group will participate in an Ai Chi exercise program. The exercises will be performed in a group setting for 45 minutes per session, five days per week for five weeks, resulting in a total of 25 sessions. Ai Chi utilizes the properties of water to facilitate movements that primarily focus on balance, muscle strength, flexibility, and breathing control. The sessions will be conducted in a pool with a water depth of 1.2 m and a temperature maintained between 28 and 30°C. Appropriate environmental conditions and safety measures will be ensured throughout the intervention. Before each session, participants will be informed about the aquatic exercise program and the precautions to be taken during the sessions. All sessions will be supervised by a physiotherapist experienced in neurological rehabilitation and Ai Chi. Receives: Other: Ai-Chi exercise |
| Land-Based Exercise Group | Active comparator | Participants in the land-based exercise group will participate in 45-minute exercise sessions, five days per week for five weeks. During the first five minutes of each session, participants will perform warm-up exercises consisting of light aerobic activities, including upper and lower extremity swings, low-intensity walking, and stretching.
The subsequent 35 minutes will be devoted to balance, mobility, and strengthening exercises. Balance exercises will include single-leg standing, forward-reaching exercises, and standing on a balance board. Mobility exercises will include sit-to-stand transfers from a chair, lateral walking, heel-to-toe walking, and walking over obstacles. Strengthening exercises will include upper and lower extremity exercises using a yellow resistance band, mini-squats, and elbow flexion and extension exercises using light weights. Receives: Other: Land-Based Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Extremity Strength Assessment
A handheld dynamometer will be used to assess lower extremity muscle strength. Participants will be informed about the test procedure before testing. Each test will be performed three times with maximal effort, and the mean value will be recorded in Newtons. The quadriceps femoris, hamstrings, hip flexors, hip extensors, hip adductors, and hip abductors will be evaluated.
Each test will be repeated three times, with a 30-second rest period between measurements. When necessary, the therapist will stabilize the relevant extremity during testing. For the assessment of the quadriceps femoris, the participant will sit at the edge of a treatment table with the hip and knee flexed at 90°. The dynamometer will be placed approximately 1-2 cm proximal to the malleoli on the distal tibia. The participant will then be instructed to perform knee extension with maximal force, and the results of the three maximal trials will be recorded.
Measured: Baseline and immediately after the 5-week intervention
Upper Extremity Strength Assessment
The Jamar hand dynamometer will be used to assess upper extremity muscle strength. Participants will be seated in a chair with their back supported. The tested shoulder will be positioned in adduction, with the elbow flexed at 90°, while the forearm and wrist will be maintained in a neutral position. Prior to testing, participants will be informed about the procedure. The test will be performed three times with maximal effort, and the mean value will be recorded in kilograms.
Measured: Baseline and immediately after the 5-week intervention
Balance Assessment
The Berg Balance Scale (BBS) will be used to assess balance. The scale consists of 14 items, each scored from 0 (unable to perform) to 4 (normal performance). The test includes tasks such as forward reaching, standing with the eyes open and closed, and standing on one leg. A total score of 0-20 indicates a high level of balance impairment, 21-40 indicates a moderate level of balance impairment, and 41-56 indicates a low level of balance impairment.
Measured: Baseline and immediately after the 5-week intervention
Fatigue Assessment
The Fatigue Impact Scale (FIS) will be used to assess fatigue severity. The FIS is a self-report scale consisting of 40 items covering physical, psychosocial, and cognitive domains. Each item is scored from 0 (never) to 4 (almost always). The total score ranges from 0 to 160, with higher scores indicating a greater impact of fatigue on the individual.
Measured: Baseline and immediately after the 5-week intervention
Secondary outcomes (7)
Quality of Life Assessment
The Multiple Sclerosis Quality of Life-54 (MSQOL-54) questionnaire, which is specifically designed for individuals with MS, will be used to assess quality of life. The questionnaire was developed based on the SF-36 Health Survey. In addition to the SF-36 items, 18 additional items assessing domains such as pain, cognitive function, and physical function were incorporated. The questionnaire consists of 54 items, and each domain is scored separately according to its specific scoring system. Scores range from 0 to 100, with higher scores indicating better quality of life.
Measured: Baseline and immediately after the 5-week intervention
Mobility Assessment
The Multiple Sclerosis Walking Scale-12 (MSWS-12), specifically developed for individuals with multiple sclerosis (MS), will be used to assess walking ability and its limitations. The scale consists of 12 items rated on a 5-point Likert scale, ranging from 1 (not at all) to 5 (extremely). The items assess the impact of MS on walking ability, including walking distance, speed, balance, and the need for support. The raw total score ranges from 12 to 60, with higher scores indicating greater walking limitations. The raw score can be transformed to a 0-100 scale according to the instrument's scoring guidelines, with higher transformed scores also indicating greater walking impairment.
Measured: Baseline and immediately after the 5-week intervention
Mobility Assessment
Another method that will be used to assess mobility is the Timed Up and Go (TUG) Test. Participants will be informed about the test procedure before testing. A distance of 3 meters will be marked between the chair and a designated turning point. The participant will sit in a chair with a backrest and armrests. Following the command "Go," the participant will stand up from the chair, walk 3 meters at their normal walking speed, turn around at the designated point, walk back 3 meters, and sit down in the chair again. The time required to complete the task will be recorded in seconds. A shorter completion time indicates better mobility.
Measured: Baseline and immediately after the 5-week intervention
Cognitive Function Assessment
The Brief International Cognitive Assessment for MS (BICAMS) is a brief assessment battery specifically developed for individuals with MS to evaluate cognitive function. It consists of three subtests: the Symbol Digit Modalities Test (SDMT), the California Verbal Learning Test-Second Edition (CVLT-II), and the Brief Visuospatial Memory Test-Revised (BVMT-R). Participants will be informed about the procedures for each subtest before the assessment.
Measured: Baseline and immediately after the 5-week intervention
Cognitive Function Assessment
The Symbol Digit Modalities Test (SDMT) is used to assess information-processing speed and consists of nine digits and nine corresponding symbols. Participants are required to write the digits corresponding to the presented symbols as quickly and accurately as possible within 90 seconds. Following one practice trial, the test will be administered. The numbers of correct and incorrect responses will be recorded.
Measured: Baseline and immediately after the 5-week intervention
Cognitive Function Assessment
The California Verbal Learning Test-Second Edition (CVLT-II) is used to assess verbal-auditory learning and memory. The test consists of 16 words representing categories such as vegetables, household items, animals, and vehicles. The examiner will read the 16 words aloud in a clear and audible voice five consecutive times. After each presentation, participants will be asked to recall as many words as possible, and the recalled words will be recorded. A maximum of 80 words can be recalled across the five trials. The test will be administered without a time limit, and the numbers of correct and incorrect responses will be recorded.
Measured: Baseline and immediately after the 5-week intervention
Cognitive Function Assessment
The Brief Visuospatial Memory Test-Revised (BVMT-R) requires participants to examine six geometric figures for 10 seconds and subsequently reproduce the figures from memory on a separate sheet of paper. Each figure will be scored according to both its accuracy and spatial location: 2 points will be awarded if the figure and its location are reproduced correctly, 1 point if the location is correct but the figure is only approximately reproduced, and 0 points if the figure cannot be reproduced. A maximum of 12 points can be obtained per trial. The test will be repeated three times, and the total score will be calculated.
Measured: Baseline and immediately after the 5-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start25 Jan 2026
- Primary completion25 Jan 2026
- Study completion3 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buket Büyükturan, Kirsehir Ahi Evran Universitesi
- Investigators
- Buket Büyükturan, Principal investigator, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880418
- Sponsor's protocol ID
- 01429813
- Acronym
- Ai-Chi
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient-level data will not be publicly shared because they contain sensitive health-related information and may compromise participant privacy and confidentiality. Anonymized data may be made available upon reasonable request, subject to ethical and institutional approval.
Publications
Beghi, E., Gervasoni, E., Pupillo, E., Bianchi, E., Montesano, A., Aprile, I., Agostini, M., Rovaris, M., Cattaneo, D., and NEUROFALL Group (2018). Prediction of Falls in Subjects Suffering From Parkinson Disease, Multiple Sclerosis, and Stroke. Archives of physical medicine and rehabilitation, 99(4), 641-651. Berg, K. (1992). Measuring balance in the elderly: Development and validation of an instrument. Boeschoten, R. E., Braamse, A. M. J., Beekman, A. T. F., Cuijpers, P., van Oppen, P., Dekker, J., and Uitdehaag, B. M. J. (2017). Prevalence of depression and anxiety in Multiple Sclerosis: A systematic review and meta-analysis. Journal of the neurological sciences, 372, 331-341. Cameron, M. H., and Nilsagard, Y. (2018). Balance, gait, and falls in multiple sclerosis. Handbook of clinical neurology, 159, 237-250. Castro-Sánchez, A. M., Matarán-Peñarrocha, G. A., Lara-Palomo, I., Saavedra-Hernández, M., Arroyo-Morales, M., & Moreno-Lorenzo, C. (2012). Hydrotherapy for the treatment of pain in people with multiple sclerosis: a randomized controlled trial. Evidence-Based Complementary and Alternative Medicine, 2012(1), 473963.
Becker BE. Aquatic therapy: scientific foundations and clinical rehabilitation applications. PM R. 2009 Sep;1(9):859-72. doi: 10.1016/j.pmrj.2009.05.017.
PubMed 19769921Bayraktar D, Guclu-Gunduz A, Yazici G, Lambeck J, Batur-Caglayan HZ, Irkec C, Nazliel B. Effects of Ai-Chi on balance, functional mobility, strength and fatigue in patients with multiple sclerosis: a pilot study. NeuroRehabilitation. 2013;33(3):431-7. doi: 10.3233/NRE-130974.
PubMed 23949074Nazary Soltan Ahmad S, Shojaedin SS, Tazji MK. Comparative effects of dual-task training versus combined exercise training in water and on land on patients with multiple sclerosis: a study protocol of a randomised factorial trial. BMJ Open. 2025 Jan 15;15(1):e086941. doi: 10.1136/bmjopen-2024-086941.
PubMed 39819920
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Ai Chi Exercises in Individuals With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07880418
- Acronym / sponsor ID
- Ai-Chi / 01429813
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Balance, Exercise, Aquatic exercises, Ai-Chi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 25 Jan 2026 (actual)
- Primary completion
- 25 Jan 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 19 Oct 2026 (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.
The subject of this study is to examine the effects of Ai Chi-an aquatic exercise method-on balance, mobility, muscle strength, quality of life, depression, fatigue, and cognitive functions in individuals diagnosed with Multiple Sclerosis (MS), in comparison with land-based exercises. Developed to address the physical and cognitive symptoms associated with MS, this study aims to evaluate the effectiveness of Ai Chi exercises-performed in water-as an alternative and/or complementary rehabilitation method alongside traditional land-based exercises. In this context, the research seeks to offer an innovative approach to enhancing the quality of life and functional capacity of individuals with MS.
Detailed description
Multiple Sclerosis (MS) is a chronic neurological disease affecting the central nervous system and has a multidimensional negative impact on individuals' physical, cognitive, and psychosocial functioning due to its progressive and heterogeneous clinical course. The exact cause of MS remains unknown. Genetic factors, environmental factors, and the interaction between these factors are generally thought to play a role in the development of MS. Race, sex, low vitamin D levels, limited exposure to sunlight, Epstein-Barr virus infection, and smoking have been identified as major risk factors for the development of MS.
Clinical signs and symptoms of MS vary depending on the regions of the brain and spinal cord affected by the disease. Although MS is associated with a wide range of clinical signs and symptoms, motor, sensory, and autonomic dysfunctions are among the most common manifestations. The most common motor impairments observed in MS include muscle weakness, spasticity, tremor, ataxia, and visuomotor deficits. These impairments negatively affect balance and walking function and may lead to falls. Individuals with MS also demonstrate reduced muscle contraction strength, decreased endurance, reduced total muscle mass, and increased muscle atrophy.
Balance impairments are among the most common symptoms experienced by individuals with MS. Postural instability occurs as a result of impaired neural connections within the somatosensory, visual, and vestibular systems, which play important roles in maintaining balance in individuals with MS. Walking problems are another common symptom in individuals with MS. Reduced walking speed, step length, and cadence, as well as increased step width and double-support phase duration, have been reported. These walking impairments have been particularly associated with muscle weakness, spasticity, and reduced postural stability and balance. Sensory disturbances are also common in individuals with MS. Hypoesthesia, hyperesthesia, and loss of proprioception may negatively affect postural control and walking, thereby limiting individuals' activities of daily living. Fatigue is experienced by approximately 90% of individuals with MS and has a substantial negative impact on their quality of life. Cognitive dysfunction is observed in approximately 20% of individuals with MS within the first five years following disease onset, and this proportion increases as the disease progresses. Depression and anxiety are also common in MS and occur at higher rates than in the general population.
Muscle weakness, balance and mobility impairments, fatigue, cognitive problems, and depression experienced by individuals with MS restrict independence in activities of daily living and lead to a substantial reduction in quality of life. Therefore, in addition to pharmacological treatments, the development of effective, safe, and sustainable rehabilitation approaches is of great importance.
Physical activity decreases as the disease progresses in individuals with MS. Appropriate exercise programs for individuals with MS can lead to significant improvements in aerobic capacity, muscle strength and endurance, flexibility, balance, mobility, fatigue, and quality of life. In addition, systematic analyses investigating the effects of exercise have demonstrated that exercise may promote the production of neurotrophic factors, neuronal growth and proliferation, and improvements in cognitive functions such as learning and memory. Exercise has also been shown to increase the production of Brain-Derived Neurotrophic Factor (BDNF).
Treatment approaches for MS are generally classified into pharmacological and non-pharmacological interventions. Although there is currently no definitive cure for MS, pharmacological agents used in its management modify or suppress the immune system and thereby alter the course of the disease. These agents are generally used to reduce the frequency of relapses, slow physical deterioration, and alleviate MS-related symptoms. In addition to pharmacological treatment, physiotherapy and rehabilitation are among the most important approaches for improving quality of life and maintaining independent mobility in individuals with MS.
Exercise-based rehabilitation approaches are known to have positive effects on functional capacity, balance, walking, and quality of life in individuals with MS. However, land-based exercises may be limiting for some individuals due to MS-specific factors such as heat sensitivity, rapid fatigue, and changes in muscle tone. In this context, the buoyancy of water reduces body weight and increases the range of motion, while the greater density of water compared with air provides natural resistance. Hydrostatic pressure contributes to reducing edema and provides proprioceptive feedback, while the thermal properties of water may reduce muscle spasms at an appropriate temperature and promote circulation. Aquatic exercises offer several advantages for individuals with MS, including facilitating thermoregulation, providing a pain-free and supported movement environment, improving balance and coordination, increasing muscle strength and endurance, reducing spasticity and muscle tension, promoting psychological well-being, and improving functional ability and quality of life.
Aquatic exercises have been used for many years in the treatment of various diseases. The aquatic environment possesses several properties, including buoyancy, turbulence, hydrostatic pressure, and resistance, which facilitate various therapeutic exercise benefits. Buoyancy reduces body weight and helps individuals who have difficulty moving on land to move more easily. Turbulent water provides a suitable environment for static and dynamic balance training with minimal risk of injury. Resistance is also important for strength training in water. Aquatic exercises are widely used in various therapeutic settings. Individuals with MS are frequently referred to physical therapy to benefit from aquatic exercises. However, the literature indicates that research in this field remains limited. Studies in the literature suggest that aquatic exercise approaches are effective, safe, and feasible methods for improving balance, fatigue, pain, functional mobility, and quality of life in individuals with MS. In particular, mind-body-based aquatic approaches such as Ai-Chi and WATSU appear to be effective in improving fatigue and psychosocial symptoms. Ai-Chi is a holistic exercise approach performed in water that combines Tai Chi- and Qigong-based slow and controlled movements with breathing awareness. Ai-Chi focuses on balance, strength, relaxation, flexibility, and breathing. Through these characteristics, Ai-Chi has the potential to simultaneously target physical, cognitive, and emotional components in individuals with MS. However, studies systematically and multidimensionally investigating the effects of Ai-Chi exercises in individuals with MS remain limited. This highlights the need to scientifically clarify the role of Ai-Chi in MS rehabilitation.
Research Question
In individuals diagnosed with Multiple Sclerosis, are Ai-Chi exercises, as an aquatic exercise method, more effective than land-based exercises in improving balance, mobility, muscle strength, quality of life, depression, fatigue, and cognitive functions?
Research Hypotheses
H1: Individuals with MS who participate in Ai-Chi exercises demonstrate significantly greater improvements in balance and mobility compared with individuals who participate in land-based exercise programs.
H2: Ai-Chi exercises are more effective than land-based exercises in reducing fatigue and improving quality of life in individuals with MS.
H3: Ai-Chi exercises have more positive effects on depression levels and cognitive functions in individuals with MS compared with land-based exercises.
H4: Ai-Chi exercises result in a significant increase in muscle strength in individuals with MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ai-Chi Group | Experimental | Other: Ai-Chi exerciseParticipants in the aquatic exercise group will participate in an Ai Chi exercise program. The exercises will be performed in a group setting for 45 minutes per session, five days per week for five weeks, resulting in a total of 25 sessions. Ai Chi utilizes the properties of water to facilitate movements that primarily focus on balance, muscle strength, flexibility, and breathing control. The sessions will be conducted in a pool with a water depth of 1.2 m and a temperature maintained between 28 and 30°C. Appropriate environmental conditions and safety measures will be ensured throughout the intervention. Before each session, participants will be informed about the aquatic exercise program and the precautions to be taken during the sessions. All sessions will be supervised by a physiotherapist experienced in neurological rehabilitation and Ai Chi. |
| Land-Based Exercise Group | Active comparator | Other: Land-Based ExerciseParticipants in the land-based exercise group will participate in 45-minute exercise sessions, five days per week for five weeks. During the first five minutes of each session, participants will perform warm-up exercises consisting of light aerobic activities, including upper and lower extremity swings, low-intensity walking, and stretching. The subsequent 35 minutes will be devoted to balance, mobility, and strengthening exercises. Balance exercises will include single-leg standing, forward-reaching exercises, and standing on a balance board. Mobility exercises will include sit-to-stand transfers from a chair, lateral walking, heel-to-toe walking, and walking over obstacles. Strengthening exercises will include upper and lower extremity exercises using a yellow resistance band, mini-squats, and elbow flexion and extension exercises using light weights. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being between 18 and 65 years of age.
- Voluntarily agreeing to participate in the study.
- Having a diagnosis of Multiple Sclerosis according to the McDonald criteria.
- Being able to read and write.
- Having an Expanded Disability Status Scale (EDSS) score between 0 and 6.5.
Key exclusion criteria (7 listed)
- Having experienced an MS relapse within the previous 6 months.
- Having a severe psychological disorder that may interfere with participation in cognitive assessments.
- Having a substance dependence, including dependence on tobacco or alcohol.
- Having a fear of water (aquaphobia).
- Having a dermatological condition that may prevent participation in aquatic exercise therapy.
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 |
|---|---|---|
| Ai-Chi exerciseParticipants in the aquatic exercise group will participate in an Ai Chi exercise program. The exercises will be performed in a group setting for 45 minutes per session, five days per week for five weeks, resulting in a total of 25 sessions. Ai Chi utilizes the properties of water to facilitate movements that primarily focus on balance, muscle strength, flexibility, and breathing control. The sessions will be conducted in a pool with a water depth of 1.2 m and a temperature maintained between 28 and 30°C. Appropriate environmental conditions and safety measures will be ensured throughout the intervention. Before each session, participants will be informed about the aquatic exercise program and the precautions to be taken during the sessions. All sessions will be supervised by a physiotherapist experienced in neurological rehabilitation and Ai Chi. | Other | Ai-Chi Group |
| Land-Based ExerciseParticipants in the land-based exercise group will participate in 45-minute exercise sessions, five days per week for five weeks. During the first five minutes of each session, participants will perform warm-up exercises consisting of light aerobic activities, including upper and lower extremity swings, low-intensity walking, and stretching. The subsequent 35 minutes will be devoted to balance, mobility, and strengthening exercises. Balance exercises will include single-leg standing, forward-reaching exercises, and standing on a balance board. Mobility exercises will include sit-to-stand transfers from a chair, lateral walking, heel-to-toe walking, and walking over obstacles. Strengthening exercises will include upper and lower extremity exercises using a yellow resistance band, mini-squats, and elbow flexion and extension exercises using light weights. | Other | Land-Based Exercise Group |
Primary outcome
Lower Extremity Strength Assessment
Time frame: Baseline and immediately after the 5-week intervention
A handheld dynamometer will be used to assess lower extremity muscle strength. Participants will be informed about the test procedure before testing. Each test will be performed three times with maximal effort, and the mean value will be recorded in Newtons. The quadriceps femoris, hamstrings, hip flexors, hip extensors, hip adductors, and hip abductors will be evaluated. Each test will be repeated three times, with a 30-second rest period between measurements. When necessary, the therapist will stabilize the relevant extremity during testing. For the assessment of the quadriceps femoris, the participant will sit at the edge of a treatment table with the hip and knee flexed at 90°. The dynamometer will be placed approximately 1-2 cm proximal to the malleoli on the distal tibia. The participant will then be instructed to perform knee extension with maximal force, and the results of the three maximal trials will be recorded.
Upper Extremity Strength Assessment
Time frame: Baseline and immediately after the 5-week intervention
The Jamar hand dynamometer will be used to assess upper extremity muscle strength. Participants will be seated in a chair with their back supported. The tested shoulder will be positioned in adduction, with the elbow flexed at 90°, while the forearm and wrist will be maintained in a neutral position. Prior to testing, participants will be informed about the procedure. The test will be performed three times with maximal effort, and the mean value will be recorded in kilograms.
Balance Assessment
Time frame: Baseline and immediately after the 5-week intervention
The Berg Balance Scale (BBS) will be used to assess balance. The scale consists of 14 items, each scored from 0 (unable to perform) to 4 (normal performance). The test includes tasks such as forward reaching, standing with the eyes open and closed, and standing on one leg. A total score of 0-20 indicates a high level of balance impairment, 21-40 indicates a moderate level of balance impairment, and 41-56 indicates a low level of balance impairment.
Fatigue Assessment
Time frame: Baseline and immediately after the 5-week intervention
The Fatigue Impact Scale (FIS) will be used to assess fatigue severity. The FIS is a self-report scale consisting of 40 items covering physical, psychosocial, and cognitive domains. Each item is scored from 0 (never) to 4 (almost always). The total score ranges from 0 to 160, with higher scores indicating a greater impact of fatigue on the individual.
7 secondary outcomes
Quality of Life Assessment
Time frame: Baseline and immediately after the 5-week intervention
Mobility Assessment
Time frame: Baseline and immediately after the 5-week intervention
Mobility Assessment
Time frame: Baseline and immediately after the 5-week intervention
Cognitive Function Assessment
Time frame: Baseline and immediately after the 5-week intervention
Cognitive Function Assessment
Time frame: Baseline and immediately after the 5-week intervention
Cognitive Function Assessment
Time frame: Baseline and immediately after the 5-week intervention
Cognitive Function Assessment
Time frame: Baseline and immediately after the 5-week intervention
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 19 Oct 2026.
- BackgroundBeghi, E., Gervasoni, E., Pupillo, E., Bianchi, E., Montesano, A., Aprile, I., Agostini, M., Rovaris, M., Cattaneo, D., and NEUROFALL Group (2018). Prediction of Falls in Subjects Suffering From Parkinson Disease, Multiple Sclerosis, and Stroke. Archives of physical medicine and rehabilitation, 99(4), 641-651. Berg, K. (1992). Measuring balance in the elderly: Development and validation of an instrument. Boeschoten, R. E., Braamse, A. M. J., Beekman, A. T. F., Cuijpers, P., van Oppen, P., Dekker, J., and Uitdehaag, B. M. J. (2017). Prevalence of depression and anxiety in Multiple Sclerosis: A systematic review and meta-analysis. Journal of the neurological sciences, 372, 331-341. Cameron, M. H., and Nilsagard, Y. (2018). Balance, gait, and falls in multiple sclerosis. Handbook of clinical neurology, 159, 237-250. Castro-Sánchez, A. M., Matarán-Peñarrocha, G. A., Lara-Palomo, I., Saavedra-Hernández, M., Arroyo-Morales, M., & Moreno-Lorenzo, C. (2012). Hydrotherapy for the treatment of pain in people with multiple sclerosis: a randomized controlled trial. Evidence-Based Complementary and Alternative Medicine, 2012(1), 473963.
- Background: PubMed 19769921Becker BE. Aquatic therapy: scientific foundations and clinical rehabilitation applications. PM R. 2009 Sep;1(9):859-72. doi: 10.1016/j.pmrj.2009.05.017.
- Background: PubMed 23949074Bayraktar D, Guclu-Gunduz A, Yazici G, Lambeck J, Batur-Caglayan HZ, Irkec C, Nazliel B. Effects of Ai-Chi on balance, functional mobility, strength and fatigue in patients with multiple sclerosis: a pilot study. NeuroRehabilitation. 2013;33(3):431-7. doi: 10.3233/NRE-130974.
- Background: PubMed 39819920Nazary Soltan Ahmad S, Shojaedin SS, Tazji MK. Comparative effects of dual-task training versus combined exercise training in water and on land on patients with multiple sclerosis: a study protocol of a randomised factorial trial. BMJ Open. 2025 Jan 15;15(1):e086941. doi: 10.1136/bmjopen-2024-086941.
- Individual participant dataSharing planned: No. Individual patient-level data will not be publicly shared because they contain sensitive health-related information and may compromise participant privacy and confidentiality. Anonymized data may be made available upon reasonable request, subject to ethical and institutional approval.
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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.
Buket Büyükturan principal investigator
Kirsehir Ahi Evran Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ai-Chi exercise and Land-Based Exercise in people with Multiple Sclerosis, run by Kirsehir Ahi Evran Universitesi 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 5 inclusion and 7 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 19 Oct 2026. 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?
Lower Extremity Strength Assessment (time frame: Baseline and immediately after the 5-week intervention). 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?
On the ClinicalTrials.gov record for NCT07880418, which also lists 4 linked publications.
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 19 Oct 2026.