HIIT vs MCIT for Stroke-Related Sarcopenia in Ischemic Stroke

NCT07456956 | Recruiting

• 1 other identifier: FenerbahceUni
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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 functional capacity, quality of life, and clinical outcomes.

Conditions

Stroke, Ischemic; Sarcopenia

Keywords

Ischemic Stroke; Stroke-Related Sarcopenia; HIIT; MCIT; Exercise Training; Muscle Thickness

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 6 weeks

Secondary Outcomes (7)

• Handgrip strength

  Baseline and 6 weeks

• Six-Minute Walk Test distance

  Baseline and 6 weeks

• Fugl-Meyer Assessment Lower Extremity score

  Baseline and 6 weeks

• Functional Independence Measure (FIM) score

  Baseline and 6 weeks

• SF-36 quality of life score

  Baseline and 6 weeks

Study Arms (2)

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.

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.

Behavioral: Moderate-Intensity Continuous Training (MCIT)

Interventions

High-Intensity Interval Training (HIIT) BEHAVIORAL

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.

Also known as: HIIT

High-Intensity Interval Training (HIIT)

Moderate-Intensity Continuous Training (MCIT) BEHAVIORAL

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.

Also known as: MCIT

Moderate-Intensity Continuous Training (MCIT)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fenerbahce University: lead

Study Sites (1)

Fenerbahçe University

Istanbul, Ataşehir, 34758, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Sarcopenia

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sümeyye Akçay, Asst. Prof.

  Fenerbahçe University

  PRINCIPAL INVESTIGATOR

• Arzu Dinç Yavaş, MD

  Istanbul Aydın University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sümeyye Akçay, Asst. Prof.

CONTACT

+905424002553; smyye.akcy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and care providers will not be blinded due to the nature of the exercise interventions. However, the outcomes assessor conducting the evaluations will be blinded to group allocation. Participants will be instructed not to disclose their assigned intervention to the assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: 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.

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 9, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): April 6, 2027
• Study Completion (Estimated): June 6, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)