NCT02371733

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

2.8 years

First QC Date

February 20, 2015

Last Update Submit

February 13, 2019

Conditions

Pulmonary Arterial Hypertension

Keywords

pulmonary arterial hypertensionaerobic exercise trainingupper extremityexercise capacity

Outcome Measures

Primary Outcomes (1)

  • Functional exercise capacity (Oxygen consumption measurement during test)

    Six minute walk test (6MWT)

    6 weeks

Secondary Outcomes (8)

  • Maximum inspiratory and expiratory muscle strength (MIP, MEP)

    6 weeks

  • Peripheral muscle strength

    6 weeks

  • Pulmonary functions

    6 week

  • Physical activity

    6 weeks

  • Dyspnea

    6 weeks

  • +3 more secondary outcomes

Study Arms (2)

Training Group

ACTIVE COMPARATOR

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

Other: Upper extremity aerobic exercise training

Control Group

SHAM COMPARATOR

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

Other: Alternative upper extremity exercises

Interventions

Upper extremity aerobic exercise trainingOTHER

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.

Training Group
Alternative upper extremity exercisesOTHER

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.

Control Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, 06500, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    PMID: 3109813RESULT

  • 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.

    PMID: 10933371RESULT

  • 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.

    PMID: 15176691RESULT

  • 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.

    PMID: 16982941RESULT

  • 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.

    PMID: 22452973RESULT

  • 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.

    PMID: 17474643RESULT

  • 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.

    PMID: 32457004DERIVED

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Burcu Camcıoğlu, MSc

    Gazi University

    STUDY CHAIR

  • Meral Boşnak Güçlü, PhD

    Gazi University

    STUDY DIRECTOR

  • Müşerrefe N Karadallı, MSc

    Gazi University

    PRINCIPAL INVESTIGATOR

  • Gülten Aydoğdu Taçoy, MD

    Gazi University

    PRINCIPAL INVESTIGATOR

  • Atiye Çengel, MD

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof

Study Record Dates

First Submitted

February 20, 2015

First Posted

February 26, 2015

Study Start

April 1, 2015

Primary Completion

January 1, 2018

Study Completion

April 1, 2018

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

TU(1)