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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02371733
Other study ID # Gazi University2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2015
Est. completion date April 2018

Study information

Verified date February 2019
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 2018
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Turkey Gazi University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View Citation

Deboeck G, Niset G, Lamotte M, Vachiéry JL, Naeije R. Exercise testing in pulmonary arterial hypertension and in chronic heart failure. Eur Respir J. 2004 May;23(5):747-51. — View 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. — View 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, Grünig E. Exercise and respiratory training improve exercise capacity a — View 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. — View Citation

Riley MS, Pórszász 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Functional exercise capacity (Oxygen consumption measurement during test) Six minute walk test (6MWT) 6 weeks
Secondary Maximum inspiratory and expiratory muscle strength (MIP, MEP) Mouth pressure device 6 weeks
Secondary Peripheral muscle strength Hand held dynamometer 6 weeks
Secondary Pulmonary functions Spirometry 6 week
Secondary Physical activity Activity monitor 6 weeks
Secondary Dyspnea Modified Borg and Modified Medical Research Council (MMRC) dyspnea scales 6 weeks
Secondary Fatigue Fatigue Severity Scale (FSS) 6 weeks
Secondary Generic quality of life Short Form (SF-36) Health Survey 6 weeks
Secondary Depression Montgomery Asberg Depression Rating Scale (MADRS) (Turkish versions of all scales) 6 weeks
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