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Cardiopulmonary Rehabilitation in Chronic Stroke

Primary Purpose

Stroke, Hemiplegia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cardiopulmonary rehabilitation plus neurorehabilitation
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A history of ischemic stroke at least 6 months ago

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Study Group

    Arm Description

    cardiopulmonary rehabilitation plus neurorehabilitation

    Outcomes

    Primary Outcome Measures

    VO2max
    Maximum oxygen consumption

    Secondary Outcome Measures

    Full Information

    First Posted
    May 14, 2018
    Last Updated
    June 14, 2018
    Sponsor
    Marmara University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03558542
    Brief Title
    Cardiopulmonary Rehabilitation in Chronic Stroke
    Official Title
    Cardiopulmonary Rehabilitation in Chronic Stroke Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2018 (Anticipated)
    Primary Completion Date
    December 2018 (Anticipated)
    Study Completion Date
    June 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Marmara University

    4. Oversight

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

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Hemiplegia

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Study Group
    Arm Type
    Experimental
    Arm Description
    cardiopulmonary rehabilitation plus neurorehabilitation
    Intervention Type
    Other
    Intervention Name(s)
    cardiopulmonary rehabilitation plus neurorehabilitation
    Intervention Description
    Patients with stroke will undergo an accompanying structured cardiopulmonary rehabilitation program along with a neurorehabilitation program
    Primary Outcome Measure Information:
    Title
    VO2max
    Description
    Maximum oxygen consumption
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: A history of ischemic stroke at least 6 months ago Exclusion Criteria: 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Cardiopulmonary Rehabilitation in Chronic Stroke

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