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

NCT05058586 | Completed DMC

• 1 other identifier: 21
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke, Cardiovascular

Keywords

underwater walking theraphy; anti-gravity treadmill training

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• Echocardiographic parameters

  Change from baseline LV ejection fraction at 4 weeks

• Electrocardiographic parameters

  Change from baseline QTc at 4 weeks

• Electrocardiographic parameters

  Change from baseline Tp-e interval at 4 weeks

Study Arms (3)

Conventional theraphy group

ACTIVE COMPARATOR

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

Anti gravity treadmill training

ACTIVE COMPARATOR

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

Underwater walking therapy group

ACTIVE COMPARATOR

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

Interventions

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).

Anti gravity treadmill training; Conventional theraphy group; Underwater walking therapy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (2)

Konya City Hospital

Meram, Konya, Turkey (Türkiye)

Location

Gaziler Physical Theraphy and Rehabilitation

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 27, 2021
• Study Start: July 1, 2017
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)