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Completed

NCT Number: NCT05058586

The Effects of Aerobic Exercise Training on Cardiorespiratory Fitness in Stroke Patients

Background:

Aerobic exercise training has favorable effects on quality of life, motor recovery, and aerobic endurance after stroke.

Objectives: In this study, the investigators aimed to explore the effects of anti-gravity treadmill gait training and underwater walking therapy on cardiorespiratory fitness in stroke survivors.

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Key information

Conditions

Stroke, Cardiovascular Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Konya City Hospital, Meram, Konya, Turkey (Türkiye)

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About this study

Methods: Seventy patients with a history of stroke were admitted to our center between July 2017 and January 2018. Subjects who participated in the study were randomly assigned to anti-gravity treadmill training, underwater walking therapy, and control group. Investigators examined the aerobic capacity of participants by using the 6-minute walk test and cycle ergometer testing before starting the treatment along with a one-month follow-up. The patient's balance was examined by using the Berg Balance Scale (BBS).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients between the ages of 18 and 80 and diagnosed with stroke and time from stroke onset to admission were longer than three months
  • Independent walking ability more than 10 meters with or without assistance
  • Patients whose cognitive and functional status were suitable for the training program

Exclusion criteria

  • Had a previous history of stroke
  • Bilateral hemiplegia
  • Leg-length difference >2.0 cm
  • Fixed flexion contracture or severe joint deformity
  • Bladder or bowel incontinence
  • Open wound
  • Cardiovascular complaints and can not tolerate exercise training
  • Other neurological comorbidities including, multiple sclerosis (MS), spinal cord injury (SCI), traumatic brain injury (TBI), Parkinson's disease, and intracranial tumors
  • Congestive heart failure
  • Atrial fibrillation (AF), use of antiarrhythmic drugs affecting QT duration, any type of bundle branch block on electrocardiogram (ECG)

Treatment and study plan

The Effects of Aerobic Exercise Training on Cardiorespiratory Fitness, Functional Capacity, Balance and Ventricular Repolarization Indices in Stroke Patients

Other

Seventy patients with history of stroke admitted to our center between July 2017 and January 2018. Subjects participated in the study were randomly assigned to anti-gravity treadmill training, underwater walking therapy and control group. We examined aerobic capacity of participants by using 6-minute walk test and cycle ergometer testing before starting the treatment along with one month follow up. Patient's balance examined by using the Berg Balance Scale (BBS).

Primary outcomes

  1. 6-minute walk test

    Time frame: Change from baseline resting heart rate at 4 weeks

    Resting heart rate

  2. 6-minute walk test

    Time frame: Change from baseline maximum heart rate at 4 weeks

    Maximum heart rate

  3. 6-minute walk test

    Time frame: Change from baseline length of walking distance at 4 weeks

    Length of walking distance

  4. Cycle ergometer training

    Time frame: Change from baseline maximum heart rate at 4 weeks

    Maximum heart rate

  5. Cycle ergometer training

    Time frame: Change from baseline period of completion of test at 4 weeks

    Period of completion of test

  6. Cycle ergometer training

    Time frame: Change from baseline METs scores at 4 weeks

    METs scores

  7. Cycle ergometer training

    Time frame: Change from baseline VO2 max at 4 weeks

    VO2 max

Other outcomes

  1. Echocardiographic parameters

    Time frame: Change from baseline LV ejection fraction at 4 weeks

    LV ejection fraction

  2. Electrocardiographic parameters

    Time frame: Change from baseline QTc at 4 weeks

    QTc

  3. Electrocardiographic parameters

    Time frame: Change from baseline Tp-e interval at 4 weeks

    Tp-e interval

  4. Electrocardiographic parameters

    Time frame: Change from baseline Tp-e/ QT at 4 weeks

    Tp-e/ QT

  5. Electrocardiographic parameters

    Time frame: Change from baseline Tp-e/QTc at 4 weeks

    Tp-e/QTc

Sponsors and collaborators

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Other

Registry information

Official study title

The Effects of Aerobic Exercise Training on Cardiorespiratory Fitness, Functional Capacity, Balance and Ventricular Repolarization Indices in Stroke Patients

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 27, 2021
Registry last updated
Sep 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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