## Protocol Section
### Identification Module
**NCT ID:** NCT01410279

**Brief Title:** Inspiratory Muscle Training in Pulmonary Hypertension

**Official Title:** Inspiratory Muscle Training Effect on the Functional Capacity and the Quality of Life in Chronic Pulmonary Hypertension

#### Organization Study ID Info
**ID:** 09032
#### Organization
**Class:** OTHER
**Full Name:** Hospital de Clinicas de Porto Alegre
### Status Module
#### Completion Date
**Date:** 2011-12

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2011-08-05

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-08-04

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2011-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2009-12

**Status Verified Date:** 2011-08

#### Study First Post Date
**Date:** 2011-08-05
**Type:** ESTIMATED
**Study First Submit Date:** 2011-04-20
**Study First Submit QC Date:** 2011-08-04
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Associação Fundo de Incentivo à Pesquisa

**Class:** OTHER_GOV

**Name:** Conselho Nacional de Desenvolvimento Científico e Tecnológico

#### Lead Sponsor

**Class:** OTHER

**Name:** Hospital de Clinicas de Porto Alegre

#### Responsible Party

**Old Name Title:** Pedro Dal'Lago

**Old Organization:** UFCSPA

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Pulmonary Hypertension

**Keywords:**

- pulmonary hypertension

- inspiratory muscle training

- inspiratory muscle weakness

- pulmonary functional

- functional capacity

- quality of life

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 34

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

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

**Name:** Inspiratory muscle training

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**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

#### Secondary Outcomes

**Measure:** 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

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

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

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** pdallago@ufcspa.edu.br

**Name:** Pedro Dal'Lago

**Phone:** 55(51)3303-8796

**Role:** CONTACT

**Contact 2:**

**Email:** glomenz@yahoo.com.br

**Name:** Glória M Ferreira

**Phone:** 55(51)9284.0703

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Porto Alegre

**Contacts:**

***Contact 1:***

- **Email:** pdallago@ufcspa.edu.br

- **Name:** Pedro Dal'Lago

- **Phone:** +55(51)3303-8796

- **Role:** CONTACT

***Contact 2:***

- **Email:** glomenz@yahoo.com.br

- **Name:** Glória M Ferreira

- **Phone:** +55(51)9284-0703

- **Role:** CONTACT

***Contact 3:***

- **Name:** Pedro Dal'Lago

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Glória M Ferreira

- **Role:** SUB_INVESTIGATOR

***Contact 5:***

- **Name:** Sérgio M Barreto

- **Role:** SUB_INVESTIGATOR

**Country:** Brazil

**Facility:** Hospital de Clinica de Porto Alegre

**State:** Rio Grande do Sul

**Status:** RECRUITING

**Zip:** 90035003

#### Overall Officials

**Official 1:**

**Affiliation:** Hospital de Clínicas de Porto Alegre

**Name:** Pedro Dal'Lago

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** 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.

**PMID:** 16487841

**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, 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:** 16982941

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000012120

- Term: Respiration Disorders

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10024

- Name: Hypertension

- Relevance: HIGH

- As Found: Hypertension

- ID: M20944

- Name: Muscle Weakness

- Relevance: LOW

- As Found: Unknown

- ID: M13204

- Name: Paresis

- Relevance: LOW

- As Found: Unknown

- ID: M27137

- Name: Respiratory Aspiration

- Relevance: HIGH

- As Found: Inspiratory

- ID: M4554

- Name: Asthenia

- Relevance: LOW

- As Found: Unknown

- ID: M10027

- Name: Hypertension, Pulmonary

- Relevance: HIGH

- As Found: Pulmonary Hypertension

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006976

- Term: Hypertension, Pulmonary

- ID: D000053120

- Term: Respiratory Aspiration

- ID: D000006973

- Term: Hypertension

### Misc Info Module

- Version Holder: 2024-05-24
