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Respiratory Muscle Stretching in Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

respiratory muscle stretching

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, diaphragm, muscle, stretching, exercises, dyspnea, respiratory muscle stretching, pulmonary rehabilitation, exercise training, improved exercise capacity, dyspnea, quality of life

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects between 40 and 75 years of age referred by a physician to the Pulmonary Rehabilitation Program
With a clinical and spirometric diagnosis of moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD), in a stable condition (without exacerbations or infections for at least a month)
Former smokers

Exclusion Criteria:

Patients with a known history of asthma, or severe and/or unstable heart disease
Any other pathological condition that could impair their physical activities

Sites / Locations

Faculdade Evangelica do Paraná

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

exercise training program

Arm Description

The exercise training program consisted of three 90-minute sessions per week for eight weeks. Each session consisted of a stretching exercise, resistance that patients started at 70% of the initial one-repetition maximum (1RM: the maximum load which can be moved only once over the full range of motion without compensatory movements) in the first week (3x8 repetitions). Every week the load was increased by 5% of the 1RM, and endurance training (treadmill walking speed was set at 60% of the average speed obtained from the 6MWT (6MWTpeak) for 10 mins in the first week and was increased to 20 mins in week 8

Outcomes

Primary Outcome Measures

Inspiratory muscle strength

Secondary Outcome Measures

Exercise capacity

Full Information

NCT ID

NCT00935181

First Posted

June 29, 2009

Last Updated

July 7, 2009

Sponsor

Faculdade Evangelica do Parana

1. Study Identification

Unique Protocol Identification Number

NCT00935181

Brief Title

Respiratory Muscle Stretching in Chronic Obstructive Pulmonary Disease (COPD)

Official Title

Respiratory Muscle Stretching in Patients With Chronic Obstructive Pulmonary Disease Submitted a Pulmonary Rehabilitation Program

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

December 2006 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Faculdade Evangelica do Parana

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Objective: The investigators studied the effects of respiratory muscle stretching in an 8-week pulmonary rehabilitation program. Methods: This was a simple-blind parallel controlled trial, conducted an out-patient clinic. Twenty six patients with COPD (mean age 68 ± 6 y, percent of predicted FEV1 47 ± 16) were randomized to either respiratory muscle stretching group plus exercise training (RMS), and exercise training group (Sham), in an 8-week exercise program that had 3 sessions per week. The investigators measured inspiratory and expiratory muscle strength (by maximal inspiratory and expiratory pressure - PIM and PEM), exercise capacity (by 6-minute walk distance), dyspnea and quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

COPD, diaphragm, muscle, stretching, exercises, dyspnea, respiratory muscle stretching, pulmonary rehabilitation, exercise training, improved exercise capacity, dyspnea, quality of life

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

exercise training program

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

respiratory muscle stretching

Other Intervention Name(s)

pulmonary rehabilitation

Intervention Description

stretching exercises for respiratory muscles like diaphragm, pectoral, dorsalis etc

Primary Outcome Measure Information:

Title

Inspiratory muscle strength

Time Frame

2 hours

Secondary Outcome Measure Information:

Title

Exercise capacity

Time Frame

2 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects between 40 and 75 years of age referred by a physician to the Pulmonary Rehabilitation Program With a clinical and spirometric diagnosis of moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD), in a stable condition (without exacerbations or infections for at least a month) Former smokers Exclusion Criteria: Patients with a known history of asthma, or severe and/or unstable heart disease Any other pathological condition that could impair their physical activities

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Silvia R. Valderramas, Ph.D

Organizational Affiliation

Faculdade Evangelica do Paraná

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculdade Evangelica do Paraná

City

Curitiba

State/Province

Paraná

ZIP/Postal Code

80730-000

Country

Brazil

12. IPD Sharing Statement

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Respiratory Muscle Stretching in Chronic Obstructive Pulmonary Disease (COPD)

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