NCT01410279

Brief Summary

The purpose of this study is evaluate the effect the inspiratory muscle training on the functional capacity of patients with pulmonary hypertension.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

December 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 5, 2011

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 5, 2011

Status Verified

August 1, 2011

Enrollment Period

1.8 years

First QC Date

April 20, 2011

Last Update Submit

August 4, 2011

Conditions

Keywords

pulmonary hypertensioninspiratory muscle traininginspiratory muscle weaknesspulmonary functionalfunctional capacityquality of life

Outcome Measures

Primary Outcomes (1)

  • The distance traveled in meters in the six minutes walk test after 8 weeks the inspiratory muscle training

    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

    patients will be monitored throughout the training protocol for 8 weeks

Interventions

The load is adjusted weekly in thirty percent of maximal inspiratory pressure of the subject.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis pulmonary hypertension
  • World Health Organization (WHO) functional class II to IV
  • inspiratory muscle weakness

You may not qualify if:

  • obesity
  • chronic obstructive pulmonary disease
  • orthopedic and neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clinica de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035003, Brazil

RECRUITING

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Pedro Dal'Lago

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 20, 2011

First Posted

August 5, 2011

Study Start

December 1, 2009

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

August 5, 2011

Record last verified: 2011-08

Locations