Aerobic Exercise Training in Pulmonary Arterial Hypertension

February 13, 2019 updated by: Meral Boşnak Güçlü, Gazi University

Effects of Upper Extremity Aerobic Exercise Training on Functional Exercise Capacity in Patients With Pulmonary Arterial Hypertension

Decreased exercise capacity, peripheral muscle strength and quality of life and increased dyspnea and fatigue perception is prevalent in patients with pulmonary arterial hypertension. It was demonstrated exercise training has beneficial effects in patients with pulmonary arterial hypertension. However, no study investigated the effects of upper extremity aerobic exercise training, therefore effects of upper extremity aerobic exercise training on outcomes in patients with pulmonary arterial hypertension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients were diagnosed with pulmonary arterial hypertension according to the Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of f the European Society of Cardiology (ESC) and European Respiratory Society (ERS). Primary outcome measurement was exercise capacity, secondary outcomes were respiratory and peripheral muscle strength, physical activity, quality of life, fatigue, dyspnea and depression.

Study Type

Interventional

Enrollment (Actual)

30

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
      • Ankara, Turkey, 06500
        • Gazi University

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinically stable
  • Under standard medication
  • Group 1 pulmonary arterial hypertension patients
  • Having no exacerbation or infection

Exclusion Criteria:

  • Cognitive disorders
  • Orthopedic and neurological problems
  • Pneumonia or acute infection
  • Stage 4 heart failure
  • Having no comorbidity to avoid performing evaluation and training

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Training Group
Intervention:Training group will receive upper extremity aerobic exercise training using arm ergometer and breathing exercises.
Other: Upper extremity aerobic exercise training

Training group will receive upper extremity aerobic exercise training using arm ergometer at 50-80% of maximal heart rate and breathing exercises.

Training will exercise with arm ergometer 3days/week, for 6 weeks with the assistance of a physiotherapist. Training workload will be undercontrol both using target heart rate and Modified Borg dyspnea scale. Training group will also perform breathing exercises 120 times/day, 7 days/week, for 6 weeks.
Sham Comparator: Control Group
Sham: Control group will receive alternative upper extremity exercises and breathing exercises.
Other: Alternative upper extremity exercises

Control group will receive alternative upper extremity exercises and breathing exercises. Control group will perform alternative upper extremity exercises 3days/week, for 6 weeks and also breathing exercises 120 times/day, 7 days/week, for 6 weeks.

Control group will be followed-up by telephone once a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional exercise capacity (Oxygen consumption measurement during test)
Time Frame: 6 weeks
Six minute walk test (6MWT)
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripheral muscle strength
Time Frame: 6 weeks
Hand held dynamometer
6 weeks
Depression
Time Frame: 6 weeks
Montgomery Asberg Depression Rating Scale (MADRS) (Turkish versions of all scales)
6 weeks
Generic quality of life
Time Frame: 6 weeks
Short Form (SF-36) Health Survey
6 weeks
Maximum inspiratory and expiratory muscle strength (MIP, MEP)
Time Frame: 6 weeks
Mouth pressure device
6 weeks
Fatigue
Time Frame: 6 weeks
Fatigue Severity Scale (FSS)
6 weeks
Dyspnea
Time Frame: 6 weeks
Modified Borg and Modified Medical Research Council (MMRC) dyspnea scales
6 weeks
Pulmonary functions
Time Frame: 6 week
Spirometry
6 week
Physical activity
Time Frame: 6 weeks
Activity monitor
6 weeks

Collaborators and Investigators

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

Sponsor

Gazi University

Investigators

  • Study Director: Meral Boşnak Güçlü, PhD, Gazi University
  • Study Chair: Burcu Camcıoğlu, MSc, Gazi University
  • Principal Investigator: Gülten Aydoğdu Taçoy, MD, Gazi University
  • Principal Investigator: Atiye Çengel, MD, Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2015

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

February 20, 2015

First Submitted That Met QC Criteria

February 20, 2015

First Posted (Estimate)

February 26, 2015

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 13, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gazi University2

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.

Clinical Trials on Pulmonary Arterial Hypertension

Clinical Trials on Upper extremity aerobic exercise training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe