Back to resultsEffects of Ground-based Walking Training in Pulmonary Hypertension
Primary Purpose
Pulmonary Hypertension
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ground-based walking training
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Hypertension focused on measuring Pulmonary Hypertension, Walking Training, Exercise, Balance, Quality of Life
Eligibility Criteria
Inclusion Criteria:
- 18-80 years
- Diagnosed with PH
- Followed by the department of chest diseases at least six months
- Not participating in the rehabilitation program in last year
Exclusion Criteria:
- Functional group four due to WHO functional classification
- PH due to left heart diseases, PH due to lung diseases and/or hypoxia
- Treatment and medication change in the last three months
- Cooperation problems
- Patients with successful pulmonary endarterectomy operation
- Smoking
- Patients with uncontrolled cardiovascular diseases
- Patients with orthopeadic and/or neurologic disorders that could limit exercise tests
- Syncope history in recent
Sites / Locations
- Ozge Ertan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Training Group
Control Group
Arm Description
Training group will attend ground-based walking training under the supervision of a physiotherapist for 2 days and 30 minutes a week. Patients will walk for 1-2 days in a week without supervision.
Patient education will be given and no intervention will be made.
Outcomes
Primary Outcome Measures
Endurance exercise capacity
endurance shuttle walk test
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03762577
Brief Title
Effects of Ground-based Walking Training in Pulmonary Hypertension
Official Title
A Randomized Controlled Trial of Ground-based Walking Training for Adult Patients With Pulmonary Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 10, 2018 (Actual)
Primary Completion Date
March 4, 2020 (Actual)
Study Completion Date
March 4, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul 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
Pulmonary Hypertension (PH) is a hemodynamic and physiopathological condition that is defined as an increase in pulmonary artery pressure ≥25 mmHg when measured at resting with symptoms such as dyspnea, fatigue, chest pain, and syncope. PH characterized by decreased exercise capacity, quality of life, peripheral muscle strength, balance, and physical inactivity. It is recommended that patients with PH should be included in cardiopulmonary rehabilitation programs in addition to medical treatment. Ground-based walking training is a safe and effective method for COPD patients. In the literature, there are no studies evaluating the effects of ground-based walking training in PH patients.
Detailed Description
The aim of this project is to determine the effect of ground-based walking training on physical activity, exercise capacity, balance, peripheral muscle strength and quality of life in patients with PH.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
Pulmonary Hypertension, Walking Training, Exercise, Balance, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Training Group
Arm Type
Experimental
Arm Description
Training group will attend ground-based walking training under the supervision of a physiotherapist for 2 days and 30 minutes a week. Patients will walk for 1-2 days in a week without supervision.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patient education will be given and no intervention will be made.
Intervention Type
Other
Intervention Name(s)
Ground-based walking training
Intervention Description
Patients will attend a 2-day 30-minute ground-based walking training under the supervision of a physiotherapist. Patients will walk for 1-2 days in a week without supervision. According to the Modified Borg Scale, the dyspnea intensity will be 3-4 (medium to slightly difficult) and the heart rate will be completed to not exceed 120 min / pulse. Heart rate of patients will be followed by finger type pulse oximeter
Primary Outcome Measure Information:
Title
Endurance exercise capacity
Description
endurance shuttle walk test
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-80 years
Diagnosed with PH
Followed by the department of chest diseases at least six months
Not participating in the rehabilitation program in last year
Exclusion Criteria:
Functional group four due to WHO functional classification
PH due to left heart diseases, PH due to lung diseases and/or hypoxia
Treatment and medication change in the last three months
Cooperation problems
Patients with successful pulmonary endarterectomy operation
Smoking
Patients with uncontrolled cardiovascular diseases
Patients with orthopeadic and/or neurologic disorders that could limit exercise tests
Syncope history in recent
Facility Information:
Facility Name
Ozge Ertan
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
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Effects of Ground-based Walking Training in Pulmonary Hypertension
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