NCT03762577

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

December 10, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2020

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

1.2 years

First QC Date

November 28, 2018

Last Update Submit

March 24, 2020

Conditions

Keywords

Pulmonary HypertensionWalking TrainingExerciseBalanceQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Endurance exercise capacity

    endurance shuttle walk test

    8 weeks

Study Arms (2)

Training Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Patient 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

Training Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

MeSH Terms

Conditions

Hypertension, PulmonaryMotor Activity

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesBehavior

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

Locations