Stroke, CardiovascularNCT05058586
The Effects of Aerobic Exercise Training on Cardiorespiratory Fitness in Stroke Patients
A study testing The Effects of Aerobic Exercise Training on Cardiorespiratory Fitness, Functional Capacity, Balance and Ventricular Repolarization Indices in Stroke Patients in people with Stroke, Cardiovascular, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 2 sites in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Cardiovascular
- What is being tested?
- The Effects of Aerobic Exercise Training on Cardiorespiratory Fitness, Functional Capacity, Balance and Ventricular Repolarization Indices in Stroke Patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jul 2017to 31 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Gaziler Physical Theraphy and Rehabilitation
Ankara
Konya City Hospital
Meram, Konya
About this study
Official title: 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.
Read the 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).
- Conditions
- Stroke, Cardiovascular
- Being tested
- The Effects of Aerobic Exercise Training on Cardiorespiratory Fitness, Functional Capacity, Balance and Ventricular Repolarization Indices in Stroke Patients
- Keywords
- underwater walking theraphy, anti-gravity treadmill training
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Effects of Aerobic Exercise Training on Cardiorespiratory Fitness, Functional Capacity, Balance and Ventricular Repolarization Indices in Stroke PatientsOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Conventional theraphy group | Active comparator | 13 patients received twenty sessions of conventional therapy for four weeks Receives: 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. Receives: 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 Receives: Other: The Effects of Aerobic Exercise Training on Cardiorespiratory Fitness, Functional Capacity, Balance and Ventricular Repolarization Indices in Stroke Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test
Resting heart rate
Measured: Change from baseline resting heart rate at 4 weeks
6-minute walk test
Maximum heart rate
Measured: Change from baseline maximum heart rate at 4 weeks
6-minute walk test
Length of walking distance
Measured: Change from baseline length of walking distance at 4 weeks
Cycle ergometer training
Maximum heart rate
Measured: Change from baseline maximum heart rate at 4 weeks
Cycle ergometer training
Period of completion of test
Measured: Change from baseline period of completion of test at 4 weeks
Cycle ergometer training
METs scores
Measured: Change from baseline METs scores at 4 weeks
Cycle ergometer training
VO2 max
Measured: Change from baseline VO2 max at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start1 Jul 2017
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, CardiovascularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058586
- Sponsor's protocol ID
- 21
- Status last verified
- Sep 2021
- First submitted
- 25 Aug 2021
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Aerobic Exercise Training on Cardiorespiratory Fitness, Functional Capacity, Balance and Ventricular Repolarization Indices in Stroke Patients
- ClinicalTrials.gov ID
- NCT05058586
- Acronym / sponsor ID
- 21
- Conditions
- Stroke, Cardiovascular
- Keywords
- underwater walking theraphy, anti-gravity treadmill training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional theraphy group | Active comparator | Other: The Effects of Aerobic Exercise Training on Cardiorespiratory Fitness, Functional Capacity, Balance and Ventricular Repolarization Indices in Stroke Patients13 patients received twenty sessions of conventional therapy for four weeks |
| Anti gravity treadmill training | Active comparator | Other: The Effects of Aerobic Exercise Training on Cardiorespiratory Fitness, Functional Capacity, Balance and Ventricular Repolarization Indices in Stroke Patients13 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. |
| Underwater walking therapy group | Active comparator | Other: The Effects of Aerobic Exercise Training on Cardiorespiratory Fitness, Functional Capacity, Balance and Ventricular Repolarization Indices in Stroke Patients13 patients received twenty sessions of conventional therapy for four weeks and three sessions of aerobic exercise treatment of 45 minutes per week underwater |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Effects of Aerobic Exercise Training on Cardiorespiratory Fitness, Functional Capacity, Balance and Ventricular Repolarization Indices in Stroke PatientsSeventy 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). | Other | Anti gravity treadmill training, Conventional theraphy group, Underwater walking therapy group |
Primary outcome
6-minute walk test
Time frame: Change from baseline resting heart rate at 4 weeks
Resting heart rate
6-minute walk test
Time frame: Change from baseline maximum heart rate at 4 weeks
Maximum heart rate
6-minute walk test
Time frame: Change from baseline length of walking distance at 4 weeks
Length of walking distance
Cycle ergometer training
Time frame: Change from baseline maximum heart rate at 4 weeks
Maximum heart rate
Cycle ergometer training
Time frame: Change from baseline period of completion of test at 4 weeks
Period of completion of test
Cycle ergometer training
Time frame: Change from baseline METs scores at 4 weeks
METs scores
Cycle ergometer training
Time frame: Change from baseline VO2 max at 4 weeks
VO2 max
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Individual participant dataSharing planned: No
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Effects of Aerobic Exercise Training on Cardiorespiratory Fitness, Functional Capacity, Balance and Ventricular Repolarization Indices in Stroke Patients in people with Stroke, Cardiovascular, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk test (time frame: Change from baseline resting heart rate at 4 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.