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

Primary Purpose

Stroke, Cardiovascular

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
The Effects of Aerobic Exercise Training on Cardiorespiratory Fitness, Functional Capacity, Balance and Ventricular Repolarization Indices in Stroke Patients
Sponsored by
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Cardiovascular focused on measuring underwater walking theraphy, anti-gravity treadmill training

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Konya City Hospital
  • Gaziler Physical Theraphy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Conventional theraphy group

Anti gravity treadmill training

Underwater walking therapy group

Arm Description

13 patients received twenty sessions of conventional therapy for four weeks

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.

13 patients received twenty sessions of conventional therapy for four weeks and three sessions of aerobic exercise treatment of 45 minutes per week underwater

Outcomes

Primary Outcome Measures

6-minute walk test
Resting heart rate
6-minute walk test
Maximum heart rate
6-minute walk test
Length of walking distance
Cycle ergometer training
Maximum heart rate
Cycle ergometer training
Period of completion of test
Cycle ergometer training
METs scores
Cycle ergometer training
VO2 max

Secondary Outcome Measures

Full Information

First Posted
August 25, 2021
Last Updated
September 16, 2021
Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05058586
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
January 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cardiovascular
Keywords
underwater walking theraphy, anti-gravity treadmill training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional theraphy group
Arm Type
Active Comparator
Arm Description
13 patients received twenty sessions of conventional therapy for four weeks
Arm Title
Anti gravity treadmill training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Underwater walking therapy group
Arm Type
Active Comparator
Arm Description
13 patients received twenty sessions of conventional therapy for four weeks and three sessions of aerobic exercise treatment of 45 minutes per week underwater
Intervention Type
Other
Intervention Name(s)
The Effects of Aerobic Exercise Training on Cardiorespiratory Fitness, Functional Capacity, Balance and Ventricular Repolarization Indices in Stroke Patients
Intervention Description
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 Outcome Measure Information:
Title
6-minute walk test
Description
Resting heart rate
Time Frame
Change from baseline resting heart rate at 4 weeks
Title
6-minute walk test
Description
Maximum heart rate
Time Frame
Change from baseline maximum heart rate at 4 weeks
Title
6-minute walk test
Description
Length of walking distance
Time Frame
Change from baseline length of walking distance at 4 weeks
Title
Cycle ergometer training
Description
Maximum heart rate
Time Frame
Change from baseline maximum heart rate at 4 weeks
Title
Cycle ergometer training
Description
Period of completion of test
Time Frame
Change from baseline period of completion of test at 4 weeks
Title
Cycle ergometer training
Description
METs scores
Time Frame
Change from baseline METs scores at 4 weeks
Title
Cycle ergometer training
Description
VO2 max
Time Frame
Change from baseline VO2 max at 4 weeks
Other Pre-specified Outcome Measures:
Title
Echocardiographic parameters
Description
LV ejection fraction
Time Frame
Change from baseline LV ejection fraction at 4 weeks
Title
Electrocardiographic parameters
Description
QTc
Time Frame
Change from baseline QTc at 4 weeks
Title
Electrocardiographic parameters
Description
Tp-e interval
Time Frame
Change from baseline Tp-e interval at 4 weeks
Title
Electrocardiographic parameters
Description
Tp-e/ QT
Time Frame
Change from baseline Tp-e/ QT at 4 weeks
Title
Electrocardiographic parameters
Description
Tp-e/QTc
Time Frame
Change from baseline Tp-e/QTc at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Konya City Hospital
City
Meram
State/Province
Konya
Country
Turkey
Facility Name
Gaziler Physical Theraphy and Rehabilitation
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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