Effects of Ground-based Walking Training in Pulmonary Hypertension

March 24, 2020 updated by: Ozge Ertan, Istanbul University

A Randomized Controlled Trial of Ground-based Walking Training for Adult Patients With Pulmonary Hypertension

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Ozge Ertan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endurance exercise capacity
Time Frame: 8 weeks
endurance shuttle walk test
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 10, 2018

Primary Completion (ACTUAL)

March 4, 2020

Study Completion (ACTUAL)

March 4, 2020

Study Registration Dates

First Submitted

November 28, 2018

First Submitted That Met QC Criteria

November 30, 2018

First Posted (ACTUAL)

December 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30146

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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