Aerobic Exercise Training in Pulmonary Arterial Hypertension

NCT ID: NCT02371733

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2018-04-30

Brief Summary

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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

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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.

Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Training Group

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

Group Type ACTIVE_COMPARATOR

Upper extremity aerobic exercise training

Intervention Type OTHER

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.

Control Group

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

Group Type SHAM_COMPARATOR

Alternative upper extremity exercises

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Meral Boşnak Güçlü

Assoc. Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Burcu Camcıoğlu, MSc

Role: STUDY_CHAIR

Gazi University

Meral Boşnak Güçlü, PhD

Role: STUDY_DIRECTOR

Gazi University

Müşerrefe N Karadallı, MSc

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Gülten Aydoğdu Taçoy, MD

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Atiye Çengel, MD

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Locations

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Gazi University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 3109813 (View on PubMed)

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.

Reference Type RESULT
PMID: 10933371 (View on PubMed)

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.

Reference Type RESULT
PMID: 15176691 (View on PubMed)

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.

Reference Type RESULT
PMID: 16982941 (View on PubMed)

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.

Reference Type RESULT
PMID: 22452973 (View on PubMed)

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.

Reference Type RESULT
PMID: 17474643 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32457004 (View on PubMed)

Other Identifiers

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Gazi University2

Identifier Type: -

Identifier Source: org_study_id

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