StrokeNCT03558542
Cardiopulmonary Rehabilitation in Chronic Stroke
A study testing cardiopulmonary rehabilitation plus neurorehabilitation in people with Stroke and Hemiplegia, run by Marmara University.
Trial summary
This study is aimed to determine the effects of an accompanying structured cardiopulmonary rehabilitation program along with a neurorehabilitation program on the quality of life, care-giver burden and overall well-being of the patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Hemiplegia
- What is being tested?
- cardiopulmonary rehabilitation plus neurorehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2018to Jun 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A history of ischemic stroke at least 6 months ago
Who cannot join
- any cardiac or pulmonary problem that renders the patient unavailable for the program
- mental impairment
- not being able to perform exercise testing
- not being able to walk independently
About this study
Official title: Cardiopulmonary Rehabilitation in Chronic Stroke Patients
This study is aimed to determine the effects of an accompanying structured cardiopulmonary rehabilitation program along with a neurorehabilitation program on the quality of life, care-giver burden and overall well-being of the patients.
- Conditions
- Stroke, Hemiplegia
- Being tested
- cardiopulmonary rehabilitation plus neurorehabilitation
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiopulmonary rehabilitation plus neurorehabilitationOther
Patients with stroke will undergo an accompanying structured cardiopulmonary rehabilitation program along with a neurorehabilitation program
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | cardiopulmonary rehabilitation plus neurorehabilitation Receives: Other: cardiopulmonary rehabilitation plus neurorehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2max
Maximum oxygen consumption
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study startJun 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558542
- Sponsor's protocol ID
- 09.2018.229
- Status last verified
- Jun 2018
- First submitted
- 14 May 2018
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Rehabilitation in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT03558542
- Acronym / sponsor ID
- 09.2018.229
- Conditions
- Stroke, Hemiplegia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Jun 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 15 Jun 2018 (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.
This study is aimed to determine the effects of an accompanying structured cardiopulmonary rehabilitation program along with a neurorehabilitation program on the quality of life, care-giver burden and overall well-being of the patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: cardiopulmonary rehabilitation plus neurorehabilitationcardiopulmonary rehabilitation plus neurorehabilitation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A history of ischemic stroke at least 6 months ago
Key exclusion criteria (4 listed)
- any cardiac or pulmonary problem that renders the patient unavailable for the program
- mental impairment
- not being able to perform exercise testing
- not being able to walk independently
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 |
|---|---|---|
| cardiopulmonary rehabilitation plus neurorehabilitationPatients with stroke will undergo an accompanying structured cardiopulmonary rehabilitation program along with a neurorehabilitation program | Other | Study Group |
Primary outcome
VO2max
Time frame: 2 months
Maximum oxygen consumption
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Questions about this trial
What is this clinical trial studying?
A study testing cardiopulmonary rehabilitation plus neurorehabilitation in people with Stroke and Hemiplegia, run by Marmara University.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
VO2max (time frame: 2 months). 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 15 Jun 2018.