HIIT vs MCIT for Stroke-Related Sarcopenia in Ischemic Stroke

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFenerbahce University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

First-ever stroke.

Age 18 years or older.

Diagnosis of ischemic stroke.

Stroke duration between 1-6 months (subacute phase).

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: High-Intensity Interval Training (HIIT)Experimental treatment 1 intervention
Group B: Moderate-Intensity Continuous Training (MCIT)Active comparator 1 intervention

Trial outcomes

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.

Time frame
Baseline and 6 weeks

Secondary outcomes

1

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).

Time frame
Baseline and 6 weeks
2

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.

Time frame
Baseline and 6 weeks
3

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.

Time frame
Baseline and 6 weeks
4

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).

Time frame
Baseline and 6 weeks

Other outcomes

Sponsors and contacts

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