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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02383277
Other study ID # UFPEFT2015
Secondary ID
Status Active, not recruiting
Phase N/A
First received February 13, 2015
Last updated August 7, 2015
Start date November 2014
Est. completion date November 2015

Study information

Verified date August 2015
Source Universidade Federal de Pernambuco
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

Investigate the effects of stretching the muscles of the rib cage in individuals with COPD during exercise.


Description:

To investigate the effects of a stretching program for the muscles of the rib cage or control in patients with COPD during exercise and / or the immediate post-exercise, using the following parameters:

- Tidal volume (VT), respiratory rate (RR), minute volume (MV), inspiratory time (Tins) and expiratory (T exp).

- Change in volumes of total and regional chest magazines (pulmonary rib cage, abdominal rib cage and abdomen).

- Diaphragmatic mobility.

- electrical muscle activity

- endurance time.

- Dyspnea sensation.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date November 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria:

- Smoking history, occupational or environmental exposure to pollutants and / or symptoms of cough, dyspnea or hypersecretion;

- FEV1 <80% predicted and post-bronchodilator FEV1 / FVC <70% to confirm the diagnosis of airway obstruction not fully reversible bronchodilator therapy;

- Absence of co-morbidities that does not allow the realization of stress (hypertension, severe pulmonary hypertension, myocardial infarction, congestive heart failure, severe dyspnoea);

- Preserved cognitive functioning;

- Sedentary

- Clinically stable during the study period.

Exclusion Criteria:

- Patients with cognitive, hearing or visual deficit;

- Changes in the neuro-musculo-skeletal system which endangers or impairs the assessment;

- Obese

- Not be able to achieve at least three stages of the incremental test.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Stretching
Stretching of the rib cage muscles
Control
Rest without stretching (sham)
Exercise
Constant load exercise on a bike

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal de Pernambuco

Outcome

Type Measure Description Time frame Safety issue
Primary Endurance tolerance as measured by the duration of the exercise Participants will be followed for the duration of the exercise, an expected average of 10 minutes No
Primary Dyspnea as measured by Borg Escale Participants will be followed for the duration of the exercise, an expected average of 10 minutes No
Secondary Diaphragm mobility measured by ultrasound Participants will be followed for the duration of the stretching and the exercise, an expected average of 60 minutes No
Secondary Volumes of the chest wall measured by pletismography optoelectronic Participants will be followed for the duration of the stretching and the exercise, an expected average of 60 minutes No
Secondary Muscle electrical activity measured by surface electromyography Participants will be followed for the duration of the stretching and the exercise, an expected average of 60 minutes No
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