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

Stroke, Cardiovascular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05058586
• Other study ID #: 21
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: January 31, 2018

Study information

• Verified date: September 2021
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Myocardial Infarction
• Stroke
• Stroke, Cardiovascular

Intervention

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).

Locations

Country	Name	City	State
Turkey	Gaziler Physical Theraphy and Rehabilitation	Ankara
Turkey	Konya City Hospital	Meram	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Echocardiographic parameters	LV ejection fraction	Change from baseline LV ejection fraction at 4 weeks
Other	Electrocardiographic parameters	QTc	Change from baseline QTc at 4 weeks
Other	Electrocardiographic parameters	Tp-e interval	Change from baseline Tp-e interval at 4 weeks
Other	Electrocardiographic parameters	Tp-e/ QT	Change from baseline Tp-e/ QT at 4 weeks
Other	Electrocardiographic parameters	Tp-e/QTc	Change from baseline Tp-e/QTc at 4 weeks
Primary	6-minute walk test	Resting heart rate	Change from baseline resting heart rate at 4 weeks
Primary	6-minute walk test	Maximum heart rate	Change from baseline maximum heart rate at 4 weeks
Primary	6-minute walk test	Length of walking distance	Change from baseline length of walking distance at 4 weeks
Primary	Cycle ergometer training	Maximum heart rate	Change from baseline maximum heart rate at 4 weeks
Primary	Cycle ergometer training	Period of completion of test	Change from baseline period of completion of test at 4 weeks
Primary	Cycle ergometer training	METs scores	Change from baseline METs scores at 4 weeks
Primary	Cycle ergometer training	VO2 max	Change from baseline VO2 max at 4 weeks