Telerehabilitation in Patients With Pulmonary Hypertension
Primary Purpose
Pulmonary Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Telerehabilitation
Sponsored by
About this trial
This is an interventional supportive care trial for Pulmonary Hypertension
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
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
NCT ID
NCT04683822
First Posted
December 20, 2020
Last Updated
December 20, 2020
Sponsor
Marmara University
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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