Pulmonary HypertensionNCT01410279
Inspiratory Muscle Training in Pulmonary Hypertension
A study testing Inspiratory muscle training in people with Pulmonary Hypertension, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The purpose of this study is evaluate the effect the inspiratory muscle training on the functional capacity of patients with pulmonary hypertension. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Inspiratory muscle training
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2009to Dec 2011
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis pulmonary hypertension
- World Health Organization (WHO) functional class II to IV
- inspiratory muscle weakness
Who cannot join
- obesity
- chronic obstructive pulmonary disease
- orthopedic and neurological disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clinica de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035003
Pedro Dal'Lago, +55(51)3303-8796, pdallago@ufcspa.edu.br
Glória M Ferreira, +55(51)9284-0703, glomenz@yahoo.com.br
About this study
Official title: Inspiratory Muscle Training Effect on the Functional Capacity and the Quality of Life in Chronic Pulmonary Hypertension
The purpose of this study is evaluate the effect the inspiratory muscle training on the functional capacity of patients with pulmonary hypertension.
Read the detailed description
Pulmonary hypertension (PH) is a syndrome, in the case of hemodynamic alteration of a number of diseases and processes, such as the progressive increase in pulmonary vascular resistance, right heart failure and early death. Frequently patients with PH have reduced functional capacity, quality of life and survival. It was demonstrated recently that patients with HP also have inspiratory muscle weakness, possibly further increase the fatigue and dyspnea during exercise. To meet this need, inspiratory muscle training can lead to significant improvement in respiratory muscle strength, exercise tolerance and dyspnea, thus resulting in reduction of discomfort during activities of daily living, increase in exercise capacity and improved quality of life in different situations.
- Conditions
- Pulmonary Hypertension
- Being tested
- Inspiratory muscle training
- Keywords
- pulmonary hypertension, inspiratory muscle training, inspiratory muscle weakness, pulmonary functional, functional capacity, quality of life
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingOther
The load is adjusted weekly in thirty percent of maximal inspiratory pressure of the subject.
What is being measured
The primary outcome is the main question the study is designed to answer.
The distance traveled in meters in the six minutes walk test after 8 weeks the inspiratory muscle training
Measured: patients will be monitored throughout the training protocol for 8 weeks
Secondary outcomes (1)
Increase in score of quality of life questionnaire after 8 weeks the inspiratory muscle training
Measured: patients will be monitored throughout the training protocol for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startDec 2009
- Primary completionSep 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Associação Fundo de Incentivo à Pesquisa, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Investigators
- Pedro Dal'Lago, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410279
- Sponsor's protocol ID
- 09032
- Status last verified
- Aug 2011
- First submitted
- 20 Apr 2011
- Last updated
- 5 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Dall'Ago P, Chiappa GR, Guths H, Stein R, Ribeiro JP. Inspiratory muscle training in patients with heart failure and inspiratory muscle weakness: a randomized trial. J Am Coll Cardiol. 2006 Feb 21;47(4):757-63. doi: 10.1016/j.jacc.2005.09.052. Epub 2006 Jan 26.
PubMed 16487841Mereles 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 16982941
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Muscle Training Effect on the Functional Capacity and the Quality of Life in Chronic Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT01410279
- Acronym / sponsor ID
- 09032
- Conditions
- Pulmonary Hypertension
- Keywords
- pulmonary hypertension, inspiratory muscle training, inspiratory muscle weakness, pulmonary functional, functional capacity, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Associação Fundo de Incentivo à Pesquisa, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Dec 2009
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 5 Aug 2011 (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.
The purpose of this study is evaluate the effect the inspiratory muscle training on the functional capacity of patients with pulmonary hypertension.
Detailed description
Pulmonary hypertension (PH) is a syndrome, in the case of hemodynamic alteration of a number of diseases and processes, such as the progressive increase in pulmonary vascular resistance, right heart failure and early death. Frequently patients with PH have reduced functional capacity, quality of life and survival. It was demonstrated recently that patients with HP also have inspiratory muscle weakness, possibly further increase the fatigue and dyspnea during exercise. To meet this need, inspiratory muscle training can lead to significant improvement in respiratory muscle strength, exercise tolerance and dyspnea, thus resulting in reduction of discomfort during activities of daily living, increase in exercise capacity and improved quality of life in different situations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis pulmonary hypertension
- World Health Organization (WHO) functional class II to IV
- inspiratory muscle weakness
Key exclusion criteria (3 listed)
- obesity
- chronic obstructive pulmonary disease
- orthopedic and neurological disease
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 |
|---|---|---|
| Inspiratory muscle trainingThe load is adjusted weekly in thirty percent of maximal inspiratory pressure of the subject. | Other | – |
Primary outcome
The distance traveled in meters in the six minutes walk test after 8 weeks the inspiratory muscle training
Time frame: patients will be monitored throughout the training protocol for 8 weeks
1 secondary outcome
Increase in score of quality of life questionnaire after 8 weeks the inspiratory muscle training
Time frame: patients will be monitored throughout the training protocol for 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2011.
- Results publication: PubMed 16487841Dall'Ago P, Chiappa GR, Guths H, Stein R, Ribeiro JP. Inspiratory muscle training in patients with heart failure and inspiratory muscle weakness: a randomized trial. J Am Coll Cardiol. 2006 Feb 21;47(4):757-63. doi: 10.1016/j.jacc.2005.09.052. Epub 2006 Jan 26.
- 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.
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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.
Pedro Dal'Lago principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training in people with Pulmonary Hypertension, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Aug 2011. 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 Brazil. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pedro Dal'Lago (55(51)3303-8796, pdallago@ufcspa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The distance traveled in meters in the six minutes walk test after 8 weeks the inspiratory muscle training (time frame: patients will be monitored throughout the training protocol for 8 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 NCT01410279, which also lists 2 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 5 Aug 2011.