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Acute Effects of a Stretching Program of the Rib Cage Muscles on Patients With COPD During Exercise

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stretching
Control
Exercise
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Stretching and Exercise

    Control and Exercise

    Arm Description

    This group undergo a session of stretching aiming flexibility of the rib cage and later at an exercise test with constant load up to the limit of tolerance for exercise bike

    This group will carry out the exercise test with constant load up to the limit of tolerance for exercise bike after a period of rest under the same environmental conditions and the experimental group time. During this time the therapist will place their hands but not performing the stretch.

    Outcomes

    Primary Outcome Measures

    Endurance tolerance as measured by the duration of the exercise
    Dyspnea as measured by Borg Escale

    Secondary Outcome Measures

    Diaphragm mobility measured by ultrasound
    Volumes of the chest wall measured by pletismography optoelectronic
    Muscle electrical activity measured by surface electromyography

    Full Information

    First Posted
    February 13, 2015
    Last Updated
    August 7, 2015
    Sponsor
    Universidade Federal de Pernambuco
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02383277
    Brief Title
    Acute Effects of a Stretching Program of the Rib Cage Muscles on Patients With COPD During Exercise
    Official Title
    Acute Effects of a Stretching Program of the Rib Cage Muscles on the Regional Distribution of Ventilation and the Diaphragmatic Mobility of Patients With COPD During Exercise: a Randomized Crossover Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    October 2015 (Anticipated)
    Study Completion Date
    November 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal de Pernambuco

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Stretching and Exercise
    Arm Type
    Experimental
    Arm Description
    This group undergo a session of stretching aiming flexibility of the rib cage and later at an exercise test with constant load up to the limit of tolerance for exercise bike
    Arm Title
    Control and Exercise
    Arm Type
    Sham Comparator
    Arm Description
    This group will carry out the exercise test with constant load up to the limit of tolerance for exercise bike after a period of rest under the same environmental conditions and the experimental group time. During this time the therapist will place their hands but not performing the stretch.
    Intervention Type
    Other
    Intervention Name(s)
    Stretching
    Intervention Description
    Stretching of the rib cage muscles
    Intervention Type
    Other
    Intervention Name(s)
    Control
    Intervention Description
    Rest without stretching (sham)
    Intervention Type
    Other
    Intervention Name(s)
    Exercise
    Intervention Description
    Constant load exercise on a bike
    Primary Outcome Measure Information:
    Title
    Endurance tolerance as measured by the duration of the exercise
    Time Frame
    Participants will be followed for the duration of the exercise, an expected average of 10 minutes
    Title
    Dyspnea as measured by Borg Escale
    Time Frame
    Participants will be followed for the duration of the exercise, an expected average of 10 minutes
    Secondary Outcome Measure Information:
    Title
    Diaphragm mobility measured by ultrasound
    Time Frame
    Participants will be followed for the duration of the stretching and the exercise, an expected average of 60 minutes
    Title
    Volumes of the chest wall measured by pletismography optoelectronic
    Time Frame
    Participants will be followed for the duration of the stretching and the exercise, an expected average of 60 minutes
    Title
    Muscle electrical activity measured by surface electromyography
    Time Frame
    Participants will be followed for the duration of the stretching and the exercise, an expected average of 60 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Adriane Cardim, Graduated
    Organizational Affiliation
    Universidade Federal de Pernambuco
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Acute Effects of a Stretching Program of the Rib Cage Muscles on Patients With COPD During Exercise

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