Pulmonary Arterial HypertensionNCT02371733
Aerobic Exercise Training in Pulmonary Arterial Hypertension
A study testing Upper extremity aerobic exercise training and Alternative upper extremity exercises in people with Pulmonary Arterial Hypertension, run by Gazi University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Upper extremity aerobic exercise training and Alternative upper extremity exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2015to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically stable
- Under standard medication
- Group 1 pulmonary arterial hypertension patients
- Having no exacerbation or infection
Who cannot join
- Cognitive disorders
- Orthopedic and neurological problems
- Pneumonia or acute infection
- Stage 4 heart failure
- Having no comorbidity to avoid performing evaluation and training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Upper extremity aerobic exercise training, Alternative upper extremity exercises
- Keywords
- pulmonary arterial hypertension, aerobic exercise training, upper extremity, exercise capacity
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Active comparator | Intervention:Training group will receive upper extremity aerobic exercise training using arm ergometer and breathing exercises. Receives: Other: Upper extremity aerobic exercise training |
| Control Group | Sham comparator | Sham: Control group will receive alternative upper extremity exercises and breathing exercises. Receives: Other: Alternative upper extremity exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional exercise capacity (Oxygen consumption measurement during test)
Six minute walk test (6MWT)
Measured: 6 weeks
Secondary outcomes (8)
Maximum inspiratory and expiratory muscle strength (MIP, MEP)
Mouth pressure device
Measured: 6 weeks
Peripheral muscle strength
Hand held dynamometer
Measured: 6 weeks
Pulmonary functions
Spirometry
Measured: 6 week
Physical activity
Activity monitor
Measured: 6 weeks
Dyspnea
Modified Borg and Modified Medical Research Council (MMRC) dyspnea scales
Measured: 6 weeks
Fatigue
Fatigue Severity Scale (FSS)
Measured: 6 weeks
Generic quality of life
Short Form (SF-36) Health Survey
Measured: 6 weeks
Depression
Montgomery Asberg Depression Rating Scale (MADRS) (Turkish versions of all scales)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral Boşnak Güçlü, Gazi University
- Investigators
- Burcu Camcıoğlu, MSc, Study chair, Gazi UniversityMeral Boşnak Güçlü, PhD, Study director, Gazi UniversityMüşerrefe N Karadallı, MSc, Principal investigator, Gazi UniversityGülten Aydoğdu Taçoy, MD, Principal investigator, Gazi UniversityAtiye Çengel, MD, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371733
- Sponsor's protocol ID
- Gazi University2
- Status last verified
- Feb 2019
- First submitted
- 20 Feb 2015
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 3109813Riley 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.
PubMed 10933371Deboeck 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.
PubMed 15176691Mereles 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.
PubMed 16982941McKeough 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.
PubMed 22452973Nyquist-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.
PubMed 17474643Yilmaz 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.
PubMed 32457004
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Upper Extremity Aerobic Exercise Training on Functional Exercise Capacity in Patients With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT02371733
- Acronym / sponsor ID
- Gazi University2
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- pulmonary arterial hypertension, aerobic exercise training, upper extremity, exercise capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jan 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Group | Active comparator | Other: Upper extremity aerobic exercise trainingIntervention:Training group will receive upper extremity aerobic exercise training using arm ergometer and breathing exercises. |
| Control Group | Sham comparator | Other: Alternative upper extremity exercisesSham: Control group will receive alternative upper extremity exercises and breathing exercises. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinically stable
- Under standard medication
- Group 1 pulmonary arterial hypertension patients
- Having no exacerbation or infection
Key exclusion criteria (5 listed)
- Cognitive disorders
- Orthopedic and neurological problems
- Pneumonia or acute infection
- Stage 4 heart failure
- Having no comorbidity to avoid performing evaluation and training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper extremity aerobic exercise trainingTraining 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. | Other | Training Group |
| Alternative upper extremity exercisesControl 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. | Other | Control Group |
Primary outcome
Functional exercise capacity (Oxygen consumption measurement during test)
Time frame: 6 weeks
Six minute walk test (6MWT)
8 secondary outcomes
Maximum inspiratory and expiratory muscle strength (MIP, MEP)
Time frame: 6 weeks
Peripheral muscle strength
Time frame: 6 weeks
Pulmonary functions
Time frame: 6 week
Physical activity
Time frame: 6 weeks
Dyspnea
Time frame: 6 weeks
Fatigue
Time frame: 6 weeks
Generic quality of life
Time frame: 6 weeks
Depression
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Results publication: PubMed 3109813D'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 publication: PubMed 10933371Riley 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 publication: PubMed 15176691Deboeck 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 publication: PubMed 16982941Mereles 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 publication: PubMed 22452973McKeough 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 publication: PubMed 17474643Nyquist-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.
- Derived from this study: PubMed 32457004Yilmaz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Burcu Camcıoğlu, MSc study chair
Gazi University
Meral Boşnak Güçlü, PhD study director
Gazi University
Müşerrefe N Karadallı, MSc principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper extremity aerobic exercise training and Alternative upper extremity exercises in people with Pulmonary Arterial Hypertension, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional exercise capacity (Oxygen consumption measurement during test) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02371733, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.