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Effects of Ground-based Walking Training in Pulmonary Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03762577
Recruitment Status : Completed
First Posted : December 3, 2018
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Ozge Ertan, Istanbul University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Other: Ground-based walking training Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Ground-based Walking Training for Adult Patients With Pulmonary Hypertension
Actual Study Start Date : December 10, 2018
Actual Primary Completion Date : March 4, 2020
Actual Study Completion Date : March 4, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Training Group
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.
 Other: Ground-based walking training
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
No Intervention: Control Group
Patient education will be given and no intervention will be made.


Outcome Measures
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Primary Outcome Measures :
  1. Endurance exercise capacity [ Time Frame: 8 weeks ]
    endurance shuttle walk test


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03762577


Locations
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Turkey
Ozge Ertan
Istanbul, Turkey
Sponsors and Collaborators
Istanbul University
More Information
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Responsible Party: Ozge Ertan, Physiotherapist, Istanbul University
ClinicalTrials.gov Identifier: NCT03762577    
Other Study ID Numbers: 30146
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ozge Ertan, Istanbul University:
Pulmonary Hypertension
Walking Training
Exercise
Balance
Quality of Life
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases