Clinical trial NCT05058586: The Effects of Aerobic Exercise Training on Cardiorespiratory Fitness in Stroke Patients
Official title: The Effects of Aerobic Exercise Training on Cardiorespiratory Fitness, Functional Capacity, Balance and Ventricular Repolarization Indices in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Cardiovascular
Keywords: underwater walking theraphy
anti-gravity treadmill training
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: 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)

Primary outcomes:
measure: 6-minute walk test
timeFrame: Change from baseline resting heart rate at 4 weeks
measure: 6-minute walk test
timeFrame: Change from baseline maximum heart rate at 4 weeks
measure: 6-minute walk test
timeFrame: Change from baseline length of walking distance at 4 weeks
measure: Cycle ergometer training
timeFrame: Change from baseline maximum heart rate at 4 weeks
measure: Cycle ergometer training
timeFrame: Change from baseline period of completion of test at 4 weeks
measure: Cycle ergometer training
timeFrame: Change from baseline METs scores at 4 weeks
measure: Cycle ergometer training
timeFrame: Change from baseline VO2 max at 4 weeks
Secondary outcomes:
Other outcomes:
measure: Echocardiographic parameters
timeFrame: Change from baseline LV ejection fraction at 4 weeks
measure: Electrocardiographic parameters
timeFrame: Change from baseline QTc at 4 weeks
measure: Electrocardiographic parameters
timeFrame: Change from baseline Tp-e interval at 4 weeks
measure: Electrocardiographic parameters
timeFrame: Change from baseline Tp-e/ QT at 4 weeks
measure: Electrocardiographic parameters
timeFrame: Change from baseline Tp-e/QTc at 4 weeks
Locations:
city: Meram
country: Turkey
facility: Konya City Hospital
state: Konya
city: Ankara
country: Turkey
facility: Gaziler Physical Theraphy and Rehabilitation
Study officials:
References: