Effects of Ground-based Walking Training in Pulmonary Hypertension
A Randomized Controlled Trial of Ground-based Walking Training for Adult Patients With Pulmonary Hypertension
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2018
CompletedFirst Posted
Study publicly available on registry
December 3, 2018
CompletedStudy Start
First participant enrolled
December 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 4, 2020
CompletedMarch 25, 2020
March 1, 2020
1.2 years
November 28, 2018
March 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Endurance exercise capacity
endurance shuttle walk test
8 weeks
Study Arms (2)
Training Group
EXPERIMENTALTraining 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.
Control Group
NO INTERVENTIONPatient education will be given and no intervention will be made.
Interventions
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
Eligibility Criteria
You may qualify if:
- years
- Diagnosed with PH
- Followed by the department of chest diseases at least six months
- Not participating in the rehabilitation program in last year
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ozge Ertan
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physiotherapist
Study Record Dates
First Submitted
November 28, 2018
First Posted
December 3, 2018
Study Start
December 10, 2018
Primary Completion
March 4, 2020
Study Completion
March 4, 2020
Last Updated
March 25, 2020
Record last verified: 2020-03