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Aerobic Exercise Training in Pulmonary Arterial Hypertension

Primary Purpose

Pulmonary Arterial Hypertension

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Upper extremity aerobic exercise training
Alternative upper extremity exercises
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pulmonary Arterial Hypertension focused on measuring pulmonary arterial hypertension, aerobic exercise training, upper extremity, exercise capacity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gazi University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Training Group

Control Group

Arm Description

Intervention:Training group will receive upper extremity aerobic exercise training using arm ergometer and breathing exercises.

Sham: Control group will receive alternative upper extremity exercises and breathing exercises.

Outcomes

Primary Outcome Measures

Functional exercise capacity (Oxygen consumption measurement during test)
Six minute walk test (6MWT)

Secondary Outcome Measures

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

Full Information

First Posted
February 20, 2015
Last Updated
February 13, 2019
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT02371733
Brief Title
Aerobic Exercise Training in Pulmonary Arterial Hypertension
Official Title
Effects of Upper Extremity Aerobic Exercise Training on Functional Exercise Capacity in Patients With Pulmonary Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
pulmonary arterial hypertension, aerobic exercise training, upper extremity, exercise capacity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training Group
Arm Type
Active Comparator
Arm Description
Intervention:Training group will receive upper extremity aerobic exercise training using arm ergometer and breathing exercises.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Sham: Control group will receive alternative upper extremity exercises and breathing exercises.
Intervention Type
Other
Intervention Name(s)
Upper extremity aerobic exercise training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Alternative upper extremity exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional exercise capacity (Oxygen consumption measurement during test)
Description
Six minute walk test (6MWT)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Maximum inspiratory and expiratory muscle strength (MIP, MEP)
Description
Mouth pressure device
Time Frame
6 weeks
Title
Peripheral muscle strength
Description
Hand held dynamometer
Time Frame
6 weeks
Title
Pulmonary functions
Description
Spirometry
Time Frame
6 week
Title
Physical activity
Description
Activity monitor
Time Frame
6 weeks
Title
Dyspnea
Description
Modified Borg and Modified Medical Research Council (MMRC) dyspnea scales
Time Frame
6 weeks
Title
Fatigue
Description
Fatigue Severity Scale (FSS)
Time Frame
6 weeks
Title
Generic quality of life
Description
Short Form (SF-36) Health Survey
Time Frame
6 weeks
Title
Depression
Description
Montgomery Asberg Depression Rating Scale (MADRS) (Turkish versions of all scales)
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burcu Camcıoğlu, MSc
Organizational Affiliation
Gazi University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Meral Boşnak Güçlü, PhD
Organizational Affiliation
Gazi University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Müşerrefe N Karadallı, MSc
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gülten Aydoğdu Taçoy, MD
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Atiye Çengel, MD
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gazi University
City
Ankara
ZIP/Postal Code
06500
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
3109813
Citation
D'Alonzo GE, Gianotti LA, Pohil RL, Reagle RR, DuRee SL, Fuentes F, Dantzker DR. Comparison of progressive exercise performance of normal subjects and patients with primary pulmonary hypertension. Chest. 1987 Jul;92(1):57-62. doi: 10.1378/chest.92.1.57.
Results Reference
result
PubMed Identifier
10933371
Citation
Riley MS, Porszasz J, Engelen MP, Shapiro SM, Brundage BH, Wasserman K. Responses to constant work rate bicycle ergometry exercise in primary pulmonary hypertension: the effect of inhaled nitric oxide. J Am Coll Cardiol. 2000 Aug;36(2):547-56. doi: 10.1016/s0735-1097(00)00727-0.
Results Reference
result
PubMed Identifier
15176691
Citation
Deboeck G, Niset G, Lamotte M, Vachiery JL, Naeije R. Exercise testing in pulmonary arterial hypertension and in chronic heart failure. Eur Respir J. 2004 May;23(5):747-51. doi: 10.1183/09031936.04.00111904.
Results Reference
result
PubMed Identifier
16982941
Citation
Mereles D, Ehlken N, Kreuscher S, Ghofrani S, Hoeper MM, Halank M, Meyer FJ, Karger G, Buss J, Juenger J, Holzapfel N, Opitz C, Winkler J, Herth FF, Wilkens H, Katus HA, Olschewski H, Grunig E. Exercise and respiratory training improve exercise capacity and quality of life in patients with severe chronic pulmonary hypertension. Circulation. 2006 Oct 3;114(14):1482-9. doi: 10.1161/CIRCULATIONAHA.106.618397. Epub 2006 Sep 18.
Results Reference
result
PubMed Identifier
22452973
Citation
McKeough ZJ, Bye PT, Alison JA. Arm exercise training in chronic obstructive pulmonary disease: a randomised controlled trial. Chron Respir Dis. 2012 Aug;9(3):153-62. doi: 10.1177/1479972312440814. Epub 2012 Mar 27.
Results Reference
result
PubMed Identifier
17474643
Citation
Nyquist-Battie C, Fletcher GF, Fletcher B, Carlson JM, Castello R, Oken K. Upper-extremity exercise training in heart failure. J Cardiopulm Rehabil Prev. 2007 Jan-Feb;27(1):42-5. doi: 10.1097/01.hcr.0000265019.18661.82.
Results Reference
result
PubMed Identifier
32457004
Citation
Yilmaz BC, Guclu MB, Keles MN, Tacoy GA, Cengel A. Effects of upper extremity aerobic exercise training on oxygen consumption, exercise capacity, dyspnea and quality of life in patients with pulmonary arterial hypertension. Heart Lung. 2020 Sep-Oct;49(5):564-571. doi: 10.1016/j.hrtlng.2020.04.006. Epub 2020 May 24.
Results Reference
derived

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Aerobic Exercise Training in Pulmonary Arterial Hypertension

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