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

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

Study Overview

• Status: Completed
• Conditions: Stroke, Cardiovascular
• Intervention / Treatment: Other: The Effects of Aerobic Exercise Training on Cardiorespiratory Fitness, Functional Capacity, Balance and Ventricular Repolarization Indices in Stroke Patients

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Gaziler Physical Theraphy and Rehabilitation
  • Konya
    • Meram, Konya, Turkey
      • Konya City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional theraphy group; 13 patients received twenty sessions of conventional therapy for four weeks	Other: The Effects of Aerobic Exercise Training on Cardiorespiratory Fitness, Functional Capacity, Balance and Ventricular Repolarization Indices in Stroke Patients; 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).
Active Comparator: Anti gravity treadmill training; 13 patients received twenty sessions of conventional therapy for four weeks and Alter-G training was performed 3 days/week for 4 weeks, with up to 30 min. of training per session.	Other: The Effects of Aerobic Exercise Training on Cardiorespiratory Fitness, Functional Capacity, Balance and Ventricular Repolarization Indices in Stroke Patients; 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).
Active Comparator: Underwater walking therapy group; 13 patients received twenty sessions of conventional therapy for four weeks and three sessions of aerobic exercise treatment of 45 minutes per week underwater	Other: The Effects of Aerobic Exercise Training on Cardiorespiratory Fitness, Functional Capacity, Balance and Ventricular Repolarization Indices in Stroke Patients; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-minute walk test	Resting heart rate	Change from baseline resting heart rate at 4 weeks
6-minute walk test	Maximum heart rate	Change from baseline maximum heart rate at 4 weeks
6-minute walk test	Length of walking distance	Change from baseline length of walking distance at 4 weeks
Cycle ergometer training	Maximum heart rate	Change from baseline maximum heart rate at 4 weeks
Cycle ergometer training	Period of completion of test	Change from baseline period of completion of test at 4 weeks
Cycle ergometer training	METs scores	Change from baseline METs scores at 4 weeks
Cycle ergometer training	VO2 max	Change from baseline VO2 max at 4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Echocardiographic parameters	LV ejection fraction	Change from baseline LV ejection fraction at 4 weeks
Electrocardiographic parameters	QTc	Change from baseline QTc at 4 weeks
Electrocardiographic parameters	Tp-e interval	Change from baseline Tp-e interval at 4 weeks
Electrocardiographic parameters	Tp-e/ QT	Change from baseline Tp-e/ QT at 4 weeks
Electrocardiographic parameters	Tp-e/QTc	Change from baseline Tp-e/QTc at 4 weeks

Collaborators and Investigators

• Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): January 31, 2018
• Study Completion (Actual): January 31, 2018

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Actual): September 27, 2021
• Last Update Submitted That Met QC Criteria: September 16, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: underwater walking theraphy; anti-gravity treadmill training
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infarction; Myocardial Infarction; Stroke
• Other Study ID Numbers: 21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No