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Telerehabilitation in Patients With Pulmonary Hypertension

Primary Purpose

Pulmonary Hypertension

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

About this trial

This is an interventional supportive care trial for Pulmonary Hypertension

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with pulmonary hypertension

Exclusion Criteria:

  • Patients with severe exercise intolerance
  • Patients with musculoskeletal problems that hinder exercise
  • Patients who refuse to join the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Exercise group

    Control

    Arm Description

    Patients who receive telerehabilitaton

    Patients with routine care

    Outcomes

    Primary Outcome Measures

    Muscle strength
    Muscle strength measured with hand held dynamometer

    Secondary Outcome Measures

    Full Information

    First Posted
    December 20, 2020
    Last Updated
    December 20, 2020
    Sponsor
    Marmara University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04683822
    Brief Title
    Telerehabilitation in Patients With Pulmonary Hypertension
    Official Title
    Investigation of the Effectiveness of a Home Exercise Program Combined With Telerehabilitation in Pulmonary Hypertension Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2021 (Anticipated)
    Primary Completion Date
    May 2021 (Anticipated)
    Study Completion Date
    June 2021 (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
    Patients with pulmonary hypertension will be randomized into two groups. One group will receive telerehabilitation sessions including upper and lower extremity strengthening exercises and breathing exercises. The other will me monitored routinely. Patients will be assessed by 6 minute walk test, emphasis-10 questionnaire for quality of life and muscle strength with hand-held dynamometer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Hypertension

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise group
    Arm Type
    Experimental
    Arm Description
    Patients who receive telerehabilitaton
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Patients with routine care
    Intervention Type
    Other
    Intervention Name(s)
    Telerehabilitation
    Intervention Description
    Patients will attend telerehabilitation sessions
    Primary Outcome Measure Information:
    Title
    Muscle strength
    Description
    Muscle strength measured with hand held dynamometer
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with pulmonary hypertension Exclusion Criteria: Patients with severe exercise intolerance Patients with musculoskeletal problems that hinder exercise Patients who refuse to join the study

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Telerehabilitation in Patients With Pulmonary Hypertension

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