Stroke, IschemicNCT07456956
HIIT vs MCIT for Stroke-Related Sarcopenia in Ischemic Stroke
A study testing High-Intensity Interval Training (HIIT) and Moderate-Intensity Continuous Training (MCIT) in people with Stroke, Ischemic and Sarcopenia, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effect of post-stroke sarcopenia on prognosis and clinical outcomes in patients with ischemic stroke and to compare the effects of High Intensity Interval Training (HIIT) and Moderate Intensity Continuous Training (MCIT) exercise programs on muscle mass, as well as on… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Ischemic, Sarcopenia
- What is being tested?
- High-Intensity Interval Training (HIIT) and Moderate-Intensity Continuous Training (MCIT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Mar 2026to 6 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First-ever stroke.
- Age 18 years or older.
- Diagnosis of ischemic stroke.
- Stroke duration between 1-6 months (subacute phase).
- Modified Rankin Scale score < 3.
- Mini-Mental State Examination (MMSE) score ≥ 24.
Show all 13Show fewer
- Brunnstrom lower extremity motor stage between Stage III-V.
- Lower extremity functional capacity sufficient to allow exercise participation (able to ambulate at least with an assistive device).
- Lower extremity spasticity ≤ 2 according to the Modified Ashworth Scale.
- Independent sitting balance (able to sit unsupported for at least 30 seconds).
- Presence of sufficient voluntary active movement in the lower extremity to permit exercise application.
- Ability to communicate.
- Willingness to participate in the study and provision of written informed consent.
Who cannot join
- Presence of hemispatial neglect.
- History of recurrent stroke.
- Presence of a psychiatric disorder.
- Presence of orthopedic, neurological, or cardiopulmonary conditions that would contraindicate the planned exercise protocols.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Fenerbahçe University
Istanbul, Ataşehir, 34758
Sümeyye Akçay, Asst. Prof., +905424002553, smyye.akcy@gmail.com
About this study
Official title: The Effect of High-Intensity Interval Training Versus Moderate-Intensity Continuous Training on Sarcopenia and Clinical Outcomes in Patients With Ischemic Stroke: A Single-Blind Randomized Controlled Trial
The aim of this study is to investigate the effect of post-stroke sarcopenia on prognosis and clinical outcomes in patients with ischemic stroke and to compare the effects of High Intensity Interval Training (HIIT) and Moderate Intensity Continuous Training (MCIT) exercise programs on muscle mass, as well as on functional capacity, quality of life, and clinical outcomes.
Read the detailed description
Sarcopenia is a skeletal muscle disease characterized by progressive and generalized loss of muscle mass, muscle strength, and physical performance, and is associated with an increased risk of falls, fractures, functional dependency, and mortality. Although aging is one of the most important causes of sarcopenia, factors such as acute and chronic diseases, physical inactivity, inflammation, and malnutrition also play a critical role in its development.
Stroke is one of the leading causes of mortality and long-term disability worldwide, and muscle loss occurring in the post-stroke period negatively affects the functional recovery process of patients. The loss of muscle mass and muscle strength that develops after stroke is not limited to the paretic extremity; significant muscle atrophy can also be observed on the non-paretic side. This condition is defined in the literature as "stroke-related sarcopenia".
Stroke-related sarcopenia arises through multifactorial mechanisms such as changes in muscle fiber type, motor unit loss, decreased neuromuscular activation, increased inflammatory response, and physical inactivity. Studies have shown that there is a marked reduction in motor unit number in the early period after stroke, and that this condition is associated with loss of muscle strength. In addition, it has been reported that post-stroke sarcopenia has negative effects on activities of daily living, walking capacity, and quality of life.
Exercise is considered one of the most effective interventions for the prevention and treatment of sarcopenia. The positive effects of aerobic and resistance exercises on muscle mass and functional performance have been demonstrated in many studies. In recent years, the effects of High Intensity Interval Training (HIIT) and Moderate Intensity Continuous Training (MCIT) approaches on the cardiovascular and musculoskeletal systems have been increasingly investigated.
HIIT is an exercise model in which short periods of high-intensity exercise are alternated with low-intensity recovery periods and is notable for providing high physiological adaptation within a limited time. MCIT, on the other hand, is an exercise approach performed at a longer duration and at a constant intensity. Although both exercise methods have been reported to be safe and feasible in stroke rehabilitation, data regarding their comparative effects on post-stroke sarcopenia are limited.
In the literature, the number of randomized controlled trials evaluating changes in muscle structure during the stroke rehabilitation process using objective measurement methods such as muscle ultrasonography is quite limited. Therefore, investigating the effects of different exercise approaches applied in the post-stroke period on sarcopenia, functional capacity, and clinical outcomes is important for both clinical practice and the planning of rehabilitation programs.
This study aims to investigate the effect of sarcopenia on prognosis and clinical outcomes in patients with ischemic stroke and to compare the effects of HIIT and MCIT exercise programs on muscle mass, as well as on functional and clinical parameters.
- Conditions
- Stroke, Ischemic, Sarcopenia
- Being tested
- High-Intensity Interval Training (HIIT), Moderate-Intensity Continuous Training (MCIT)
- Keywords
- Ischemic Stroke, Stroke-Related Sarcopenia, HIIT, MCIT, Exercise Training, Muscle Thickness
- Medical subject headings
- Ischemic Stroke, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Interval Training (HIIT)Behavioural
Also called HIIT
High-Intensity Interval Training (HIIT) will be delivered on a cycle ergometer under physiotherapist supervision. Each session includes a 5-minute warm-up at 50% of maximum heart rate (HRmax), followed by five cycles of 1 minute at 80% HRmax and 2 minutes of active recovery at 60% HRmax, and a 5-minute cool-down at 50% HRmax. Sessions will be performed 3 times per week for 6 weeks, with intensity progressed by 5% every two weeks as tolerated.
Moderate-Intensity Continuous Training (MCIT)Behavioural
Also called MCIT
Moderate-Intensity Continuous Training (MCIT) will be delivered on a cycle ergometer under physiotherapist supervision. Each session includes a 5-minute warm-up at 50% of maximum heart rate (HRmax), followed by 20 minutes of continuous exercise at 80% HRmax, and a 5-minute cool-down at 50% HRmax. Sessions will be performed 3 times per week for 6 weeks, with intensity progressed by 5% every two weeks as tolerated.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Interval Training (HIIT) | Experimental | Participants assigned to the HIIT group will perform High-Intensity Interval Training on a cycle ergometer. The protocol consists of a 5-minute warm-up at 50% of maximum heart rate (HRmax), followed by five cycles of 1 minute at 80% HRmax and 2 minutes of active recovery at 60% HRmax, and a 5-minute cool-down at 50% HRmax. Sessions will be conducted three times per week for 6 weeks. Exercise intensity will be progressively increased by 5% every two weeks. All sessions will be supervised by a physiotherapist. Receives: Behavioral: High-Intensity Interval Training (HIIT) |
| Moderate-Intensity Continuous Training (MCIT) | Active comparator | Participants assigned to the MCIT group will perform Moderate-Intensity Continuous Training on a cycle ergometer. The protocol consists of a 5-minute warm-up at 50% of maximum heart rate (HRmax), followed by 20 minutes of continuous exercise at 80% HRmax, and a 5-minute cool-down at 50% HRmax. Sessions will be conducted three times per week for 6 weeks. Exercise intensity will be progressively increased by 5% every two weeks. All sessions will be supervised by a physiotherapist. Receives: Behavioral: Moderate-Intensity Continuous Training (MCIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quadriceps muscle thickness measured by ultrasonography
Quadriceps muscle thickness (rectus femoris and vastus intermedius) will be measured bilaterally using ultrasound imaging. The primary endpoint will be the change from baseline to post-intervention.
Measured: Baseline and 6 weeks
Secondary outcomes (7)
Handgrip strength
Handgrip strength will be measured using a Jamar dynamometer. The outcome will be the change from baseline to post-intervention (highest value of three trials will be used).
Measured: Baseline and 6 weeks
Six-Minute Walk Test distance
Functional capacity will be assessed using the Six-Minute Walk Test. The outcome will be the change in walking distance (meters) from baseline to post-intervention.
Measured: Baseline and 6 weeks
Fugl-Meyer Assessment Lower Extremity score
Lower extremity motor function will be assessed using the Fugl-Meyer Assessment (Lower Extremity), which ranges from 0 to 34, with higher scores indicating better motor function.
Measured: Baseline and 6 weeks
Functional Independence Measure (FIM) score
Functional status and independence in activities of daily living will be assessed using the Functional Independence Measure (FIM), which ranges from 18 to 126, with higher scores indicating greater independence (better functional outcome).
Measured: Baseline and 6 weeks
SF-36 quality of life score
Health-related quality of life will be assessed using the Short Form-36 (SF-36), with domain and/or summary scores transformed to a 0 to 100 scale, where higher scores indicate better health-related quality of life.
Measured: Baseline and 6 weeks
30-Second Sit-to-Stand Test repetitions
Lower extremity muscle endurance will be assessed using the 30-Second Sit-to-Stand Test. The outcome will be the change in the number of completed repetitions from baseline to post-intervention.
Measured: Baseline and 6 weeks
International Physical Activity Questionnaire (IPAQ) score
Physical activity level will be assessed using the International Physical Activity Questionnaire (IPAQ), reported as MET-minutes/week (range: 0 to no fixed upper limit), with higher values indicating greater levels of physical activity (better outcome).
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start2 Mar 2026
- Primary completion6 Apr 2027 (estimated)
- Study completion6 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Fenerbahce UniversityThe sponsor's other registered studies.
- 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
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the HIIT group or the MCIT group. Both groups will receive their respective exercise interventions in parallel over a 6-week period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sümeyye Akçay, Fenerbahce University
- Investigators
- Sümeyye Akçay, Asst. Prof., Principal investigator, Fenerbahçe UniversityArzu Dinç Yavaş, MD, Principal investigator, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456956
- Sponsor's protocol ID
- FenerbahceUni
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High-Intensity Interval Training Versus Moderate-Intensity Continuous Training on Sarcopenia and Clinical Outcomes in Patients With Ischemic Stroke: A Single-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07456956
- Acronym / sponsor ID
- FenerbahceUni
- Conditions
- Stroke, Ischemic, Sarcopenia
- Keywords
- Ischemic Stroke, Stroke-Related Sarcopenia, HIIT, MCIT, Exercise Training, Muscle Thickness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 6 Apr 2027 (estimated)
- Study completion
- 6 Jun 2027 (estimated)
- First posted
- 9 Mar 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 aim of this study is to investigate the effect of post-stroke sarcopenia on prognosis and clinical outcomes in patients with ischemic stroke and to compare the effects of High Intensity Interval Training (HIIT) and Moderate Intensity Continuous Training (MCIT) exercise programs on muscle mass, as well as on functional capacity, quality of life, and clinical outcomes.
Detailed description
Sarcopenia is a skeletal muscle disease characterized by progressive and generalized loss of muscle mass, muscle strength, and physical performance, and is associated with an increased risk of falls, fractures, functional dependency, and mortality. Although aging is one of the most important causes of sarcopenia, factors such as acute and chronic diseases, physical inactivity, inflammation, and malnutrition also play a critical role in its development.
Stroke is one of the leading causes of mortality and long-term disability worldwide, and muscle loss occurring in the post-stroke period negatively affects the functional recovery process of patients. The loss of muscle mass and muscle strength that develops after stroke is not limited to the paretic extremity; significant muscle atrophy can also be observed on the non-paretic side. This condition is defined in the literature as "stroke-related sarcopenia".
Stroke-related sarcopenia arises through multifactorial mechanisms such as changes in muscle fiber type, motor unit loss, decreased neuromuscular activation, increased inflammatory response, and physical inactivity. Studies have shown that there is a marked reduction in motor unit number in the early period after stroke, and that this condition is associated with loss of muscle strength. In addition, it has been reported that post-stroke sarcopenia has negative effects on activities of daily living, walking capacity, and quality of life.
Exercise is considered one of the most effective interventions for the prevention and treatment of sarcopenia. The positive effects of aerobic and resistance exercises on muscle mass and functional performance have been demonstrated in many studies. In recent years, the effects of High Intensity Interval Training (HIIT) and Moderate Intensity Continuous Training (MCIT) approaches on the cardiovascular and musculoskeletal systems have been increasingly investigated.
HIIT is an exercise model in which short periods of high-intensity exercise are alternated with low-intensity recovery periods and is notable for providing high physiological adaptation within a limited time. MCIT, on the other hand, is an exercise approach performed at a longer duration and at a constant intensity. Although both exercise methods have been reported to be safe and feasible in stroke rehabilitation, data regarding their comparative effects on post-stroke sarcopenia are limited.
In the literature, the number of randomized controlled trials evaluating changes in muscle structure during the stroke rehabilitation process using objective measurement methods such as muscle ultrasonography is quite limited. Therefore, investigating the effects of different exercise approaches applied in the post-stroke period on sarcopenia, functional capacity, and clinical outcomes is important for both clinical practice and the planning of rehabilitation programs.
This study aims to investigate the effect of sarcopenia on prognosis and clinical outcomes in patients with ischemic stroke and to compare the effects of HIIT and MCIT exercise programs on muscle mass, as well as on functional and clinical parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the HIIT group or the MCIT group. Both groups will receive their respective exercise interventions in parallel over a 6-week period.
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Interval Training (HIIT) | Experimental | Behavioral: High-Intensity Interval Training (HIIT)Participants assigned to the HIIT group will perform High-Intensity Interval Training on a cycle ergometer. The protocol consists of a 5-minute warm-up at 50% of maximum heart rate (HRmax), followed by five cycles of 1 minute at 80% HRmax and 2 minutes of active recovery at 60% HRmax, and a 5-minute cool-down at 50% HRmax. Sessions will be conducted three times per week for 6 weeks. Exercise intensity will be progressively increased by 5% every two weeks. All sessions will be supervised by a physiotherapist. |
| Moderate-Intensity Continuous Training (MCIT) | Active comparator | Behavioral: Moderate-Intensity Continuous Training (MCIT)Participants assigned to the MCIT group will perform Moderate-Intensity Continuous Training on a cycle ergometer. The protocol consists of a 5-minute warm-up at 50% of maximum heart rate (HRmax), followed by 20 minutes of continuous exercise at 80% HRmax, and a 5-minute cool-down at 50% HRmax. Sessions will be conducted three times per week for 6 weeks. Exercise intensity will be progressively increased by 5% every two weeks. All sessions will be supervised by a physiotherapist. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- First-ever stroke.
- Age 18 years or older.
- Diagnosis of ischemic stroke.
- Stroke duration between 1-6 months (subacute phase).
- Modified Rankin Scale score < 3.
Key exclusion criteria (4 listed)
- Presence of hemispatial neglect.
- History of recurrent stroke.
- Presence of a psychiatric disorder.
- Presence of orthopedic, neurological, or cardiopulmonary conditions that would contraindicate the planned exercise protocols.
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 |
|---|---|---|
| High-Intensity Interval Training (HIIT)Also: HIITHigh-Intensity Interval Training (HIIT) will be delivered on a cycle ergometer under physiotherapist supervision. Each session includes a 5-minute warm-up at 50% of maximum heart rate (HRmax), followed by five cycles of 1 minute at 80% HRmax and 2 minutes of active recovery at 60% HRmax, and a 5-minute cool-down at 50% HRmax. Sessions will be performed 3 times per week for 6 weeks, with intensity progressed by 5% every two weeks as tolerated. | Behavioural | High-Intensity Interval Training (HIIT) |
| Moderate-Intensity Continuous Training (MCIT)Also: MCITModerate-Intensity Continuous Training (MCIT) will be delivered on a cycle ergometer under physiotherapist supervision. Each session includes a 5-minute warm-up at 50% of maximum heart rate (HRmax), followed by 20 minutes of continuous exercise at 80% HRmax, and a 5-minute cool-down at 50% HRmax. Sessions will be performed 3 times per week for 6 weeks, with intensity progressed by 5% every two weeks as tolerated. | Behavioural | Moderate-Intensity Continuous Training (MCIT) |
Primary outcome
Change in quadriceps muscle thickness measured by ultrasonography
Time frame: Baseline and 6 weeks
Quadriceps muscle thickness (rectus femoris and vastus intermedius) will be measured bilaterally using ultrasound imaging. The primary endpoint will be the change from baseline to post-intervention.
7 secondary outcomes
Handgrip strength
Time frame: Baseline and 6 weeks
Six-Minute Walk Test distance
Time frame: Baseline and 6 weeks
Fugl-Meyer Assessment Lower Extremity score
Time frame: Baseline and 6 weeks
Functional Independence Measure (FIM) score
Time frame: Baseline and 6 weeks
SF-36 quality of life score
Time frame: Baseline and 6 weeks
30-Second Sit-to-Stand Test repetitions
Time frame: Baseline and 6 weeks
International Physical Activity Questionnaire (IPAQ) score
Time frame: Baseline and 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Sümeyye Akçay, Asst. Prof. principal investigator
Fenerbahçe University
Arzu Dinç Yavaş, MD principal investigator
Istanbul Aydın University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Interval Training (HIIT) and Moderate-Intensity Continuous Training (MCIT) in people with Stroke, Ischemic and Sarcopenia, run by Fenerbahce 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 13 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 25 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sümeyye Akçay, Asst. Prof. (+905424002553, smyye.akcy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quadriceps muscle thickness measured by ultrasonography (time frame: Baseline and 6 weeks). 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 25 Mar 2026.