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临床试验/CTRI/2025/10/096416
CTRI/2025/10/096416尚未招募2/3 期

Effect of High Intensity Interval Training on Resting Heart Rate, Heart Rate Recovery, Functional Capacity, Body Composition and Quality of Life in Stroke Survivors.

Sharda University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年11月15日最近更新:
适应症
相关药物

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
32
试验地点
1
主要终点
Resting heart rate

研究概览

简要总结

Stroke often leads to reduced cardiovascular fitness, slower recovery after activity, poor physical capacity, and decline in quality of life. Exercise is known to support recovery after stroke, but the role of high intensity interval training has not been studied widely in Indian stroke survivors.

This randomized controlled trial aims to examine the effects of a four week program of treadmill based high intensity interval training on cardiovascular and functional outcomes in stroke survivors. A total of 32 participants aged 40 to 75 years will be randomly assigned into two groups. The intervention group will undergo supervised high intensity interval training three times per week for four weeks, while the control group will receive standard care without additional structured exercise.

The primary outcomes are resting heart rate, heart rate recovery after exercise, and functional capacity measured using the six minute walk test. The secondary outcomes are body composition measured by standard anthropometric methods and health related quality of life assessed.

Assessments will be done at baseline and after four weeks. This trial is expected to provide evidence on the safety and effectiveness of high intensity interval training for improving cardiovascular health, functional recovery, and overall well being in people recovering from stroke.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
40.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Stroke survivors aged 40 to 75 years.
  • Medically stable with vital signs within acceptable range and cleared by a physician for participation in exercise.
  • In the subacute or chronic phase of stroke recovery (at least three months post stroke).
  • Able to walk independently or with a walking aid for at least ten meters Not enrolled in any structured exercise program during the past twelve months.
  • Able to understand and follow simple instructions (Mini Mental State Examination score more than 24 if applicable).
  • Provided written informed consent.
  • Passed pre exercise cardiovascular screening (resting heart rate less than 100 beats per minute and resting blood pressure less than 160 over 100 millimetres of mercury).

排除标准

  • Cognitive impairment or inability to provide informed consent.
  • Clinically unstable patients such as those with fluctuating blood pressure, active infection, or unstable neurological status.
  • History of fainting or loss of consciousness during exertion in the past twelve months.
  • Recent myocardial infarction, unstable angina, or cardiac surgery within the past three months.
  • Uncontrolled high blood pressure at rest defined as systolic blood pressure 160 millimetres of mercury or more and or diastolic blood pressure 100 millimetres of mercury or more.
  • Severe heart or lung disease such as decompensated heart failure, severe chronic obstructive pulmonary disease, or unstable arrhythmias.
  • Severe orthopedic or neurological problems that prevent safe exercise, such as non weight bearing fractures or severe spasticity.
  • Any other condition considered unsafe for high intensity exercise by the physiotherapist or physician.

结局指标

主要结局

Resting heart rate

时间窗: Baseline (before intervention) | After four weeks of intervention

Heart rate recovery after exercise

时间窗: Baseline (before intervention) | After four weeks of intervention

Functional capacity measured using six-minute walk test

时间窗: Baseline (before intervention) | After four weeks of intervention

次要结局

  • Body composition measured by standard methods

研究者

申办方类型
Other [academics]
责任方
Principal Investigator
主要研究者

Dr Saima Zaki

Sharda University

研究点 (1)

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