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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03762577
Other study ID # 30146
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 10, 2018
Est. completion date March 4, 2020

Study information

Verified date March 2020
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date March 4, 2020
Est. primary completion date March 4, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Turkey Ozge Ertan Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Endurance exercise capacity endurance shuttle walk test 8 weeks
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