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Effects of Diaphragm and Abdominal Muscle Training on PFT and Dyspnea Among COPD Obstructive Pulmonary Disease Patients.

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
• Diaphragmatic breathing technique
basic breathing technique
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring dyspnea, pulmonary function testing, diaphragmatic training, abdominal training

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age group of 35-60 years
  • Moderate COPD patients.
  • Cognitive
  • no previous surgery
  • clinically stable COPD patients with reduced inspiratory muscle strength [Pi and persistent activity-related dyspnea

Exclusion Criteria:

  • Acute attack
  • Severe copd
  • Inability to perform physiological testing
  • active cardiovascular comorbidity (i.e., severe heart failure with reduced left ventricular ejection fraction, cardiomyopathy, recent acute myocardial infarction, cardiac arrhythmias, or stroke),
  • Unstable
  • Red Flags Like: Fever, Night Sweats, Malaise

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Group A

    Group B

    Arm Description

    Group A: will be treated with basic breathing technique.

    Group B: will be treated by will be breathing technique along with diaphragm and abdominal training.

    Outcomes

    Primary Outcome Measures

    • Spirometer for pulmonary function testing FVC
    The most effective and common method for diagnosing COPD is spirometry. Its also known as a pulmonary function test or PFT. This easy, painless test measures lung function and capacity. To perform this test, you will exhale as forcefully as possible intoThe most effective and common method for diagnosing COPD is spirometry. Its also known as a pulmonary function test or PFT. This easy, painless test measures lung function and capacity. To perform this test, you will exhale as forcefully as possible into a tube connected to the spirometer, a small machine. a tube connected to the spirometer, a small machine.
    • Spirometer for pulmonary function testing FVC1
    The most effective and common method for diagnosing COPD is spirometry. Its also known as a pulmonary function test or PFT. This easy, painless test measures lung function and capacity. To perform this test, you will exhale as forcefully as possible intoThe most effective and common method for diagnosing COPD is spirometry. Its also known as a pulmonary function test or PFT. This easy, painless test measures lung function and capacity. To perform this test, you will exhale as forcefully as possible into a tube connected to the spirometer, a small machine. a tube connected to the spirometer, a small machine.

    Secondary Outcome Measures

    • Dyspnea MDP
    Use these scales to rate the intensity of the breathing sensations you feel [felt] (like the loudness of sound, regardless of whether the sensation is pleasant or unpleasant; for example a sensation could be intense without being unpleasant.)

    Full Information

    First Posted
    September 5, 2022
    Last Updated
    October 17, 2022
    Sponsor
    Riphah International University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05587829
    Brief Title
    Effects of Diaphragm and Abdominal Muscle Training on PFT and Dyspnea Among COPD Obstructive Pulmonary Disease Patients.
    Official Title
    Effects of Diaphragm and Abdominal Muscle Training on Pulmonary Function Testing and Dyspnea Among Chronic Obstructive Pulmonary Disease Patients.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2022 (Anticipated)
    Primary Completion Date
    December 30, 2022 (Anticipated)
    Study Completion Date
    January 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Riphah International University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    It will be a randomized control trial at Services Hospital Lahore through convenience sampling technique which will be allocated through simple random sampling through sealed opaque enveloped in to Group A and Group B . Group A: patients will be treated with basic breathing technique whereas Group B: will be treated by will be breathing technique along with diaphragm and abdominal training. The study will be completed within 6 months after synopsis approval from ethical Committee of RCRS & AHS . Data will be entered and analyzed by SPSS version 25. After assessing the normality of data , it will be decided either parametric or non-parametric test will be use within a group or between two groups.
    Detailed Description
    Chronic Obstructive Pulmonary Disease (COPD) is a set of diseases that cause airflow obstruction, breathing difficulties, wheezing and chest tightness. Risk factors are smoking and non-tobacco-smoking, the use of biomass fuel and open fires for domestic purposes in poorly ventilated households. Physiotherapy is an important component of multidisciplinary therapies. Airway clearing, pulmonary rehabilitation, inspiratory muscle training, and non-invasive ventilation is the prior treatment .The aim of this study will be to find the effects of diaphragm and abdominal muscle training on pulmonary function testing and dyspnea among COPD patients . It will be a randomized control trial at Services Hospital Lahore through convenience sampling technique which will be allocated through simple random sampling through sealed opaque enveloped in to Group A and Group B . Group A: patients will be treated with basic breathing technique whereas Group B: will be treated by will be breathing technique along with diaphragm and abdominal training. The study will be completed within 6 months after synopsis approval from ethical Committee of RCRS & AHS . Data will be entered and analyzed by SPSS version 25. After assessing the normality of data , it will be decided either parametric or non-parametric test will be use within a group or between two groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease
    Keywords
    dyspnea, pulmonary function testing, diaphragmatic training, abdominal training

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Experimental
    Arm Description
    Group A: will be treated with basic breathing technique.
    Arm Title
    Group B
    Arm Type
    Experimental
    Arm Description
    Group B: will be treated by will be breathing technique along with diaphragm and abdominal training.
    Intervention Type
    Other
    Intervention Name(s)
    • Diaphragmatic breathing technique
    Other Intervention Name(s)
    • Abdominal breathing technique
    Intervention Description
    In supine position, the participant inhales through the mouth for 5 s to expand the abdomen to the maximal level, minimizing movement of the thorax, and performs a long exhalation to maintain a lower abdominal contraction and retroversion of the pelvis
    Intervention Type
    Other
    Intervention Name(s)
    basic breathing technique
    Intervention Description
    Deep Breathing for 15 minutes
    Primary Outcome Measure Information:
    Title
    • Spirometer for pulmonary function testing FVC
    Description
    The most effective and common method for diagnosing COPD is spirometry. Its also known as a pulmonary function test or PFT. This easy, painless test measures lung function and capacity. To perform this test, you will exhale as forcefully as possible intoThe most effective and common method for diagnosing COPD is spirometry. Its also known as a pulmonary function test or PFT. This easy, painless test measures lung function and capacity. To perform this test, you will exhale as forcefully as possible into a tube connected to the spirometer, a small machine. a tube connected to the spirometer, a small machine.
    Time Frame
    4 months
    Title
    • Spirometer for pulmonary function testing FVC1
    Description
    The most effective and common method for diagnosing COPD is spirometry. Its also known as a pulmonary function test or PFT. This easy, painless test measures lung function and capacity. To perform this test, you will exhale as forcefully as possible intoThe most effective and common method for diagnosing COPD is spirometry. Its also known as a pulmonary function test or PFT. This easy, painless test measures lung function and capacity. To perform this test, you will exhale as forcefully as possible into a tube connected to the spirometer, a small machine. a tube connected to the spirometer, a small machine.
    Time Frame
    4 months
    Secondary Outcome Measure Information:
    Title
    • Dyspnea MDP
    Description
    Use these scales to rate the intensity of the breathing sensations you feel [felt] (like the loudness of sound, regardless of whether the sensation is pleasant or unpleasant; for example a sensation could be intense without being unpleasant.)
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age group of 35-60 years Moderate COPD patients. Cognitive no previous surgery clinically stable COPD patients with reduced inspiratory muscle strength [Pi and persistent activity-related dyspnea Exclusion Criteria: Acute attack Severe copd Inability to perform physiological testing active cardiovascular comorbidity (i.e., severe heart failure with reduced left ventricular ejection fraction, cardiomyopathy, recent acute myocardial infarction, cardiac arrhythmias, or stroke), Unstable Red Flags Like: Fever, Night Sweats, Malaise
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wajeeha Zia, PP-DPT
    Phone
    0323 4500788
    Email
    wajeeha.zia@riphah.edu.pk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wajeeha Zia, PP-DPT
    Organizational Affiliation
    Riphah International University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Effects of Diaphragm and Abdominal Muscle Training on PFT and Dyspnea Among COPD Obstructive Pulmonary Disease Patients.

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