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Combined Effects Of Diaphragm Strengthening And Accessory Muscles Stretchings In Asthma Patients

Primary Purpose

Asthma

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Diaphragm strengthening and accessory muscles stretchings
Diaphragm strengthening
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age group of 40-65 years Both male and females Phase-2 asthma patients Patients hemodynamically stable Exclusion Criteria: Patients having pulmonary tumors Patients of Having cough and sputum Patients having TB and emphysema Patients with pneumonia, pneumonectomy or other lungs surgical procedures

Sites / Locations

  • Gulab Devi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Diaphragm strengthening and accessory muscles stretchings

Diaphragm strengthening

Arm Description

Outcomes

Primary Outcome Measures

Modified Borg scale of exertion
The Modified Borg Dyspnea Scale (MBS) is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and is routinely administered during six-minute walk testing (6MWT)
6 MWT
The 6MWT was used to detect participants' functional capacity by measuring the distance they traveled during the walk test. For the 6MWT assessment, the participants were encouraged to walk as far as they could during 6 min over a flat 100-feet surface, and for consistency, the researchers used constant verbal cues and positive feedback to encourage the participants to complete the task

Secondary Outcome Measures

Quality of life questionnaire
HRQOL is one of several variables commonly studied in the field of medical outcomes research. It encompasses a wide range of human experience, including functioning and subjective responses to illness. Contemporary interpretations of HRQOL are based on the World Health Organization's definition of health as a state of complete physical, mental, and social well-being and not merely the absence of disease. contemporary HRQOL instrument domains are scored with a range of 0-100, with higher values representing better outcomes. To make useful inferences regarding absolute scores or change scores over time, it is important to determine what meaning different numerical values have. When no such thresholds have been established, one can roughly approximate the smallest difference that is important to the patient as one-third to one-half of a standard deviation

Full Information

First Posted
June 14, 2023
Last Updated
June 14, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05915793
Brief Title
Combined Effects Of Diaphragm Strengthening And Accessory Muscles Stretchings In Asthma Patients
Official Title
Combined Effects of Diaphragm Strengthening and Accessory Muscles Stretchings in Asthma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
August 29, 2023 (Anticipated)
Study Completion Date
August 29, 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

5. Study Description

Brief Summary
Asthma is a multifactorial and chronic inflammatory disease in older patients affecting many people worldwide with high cost of pharmacological treatment and physiotherapy interventions. It is characterized by a variety of symptoms including airway inflammation, bronchial hyper-responsiveness, and transient and reversible airway obstruction. Typical clinical features include wheezing, coughing, resting and/or exertional dyspnea, and chest tightness. Lung hyperinflation affects ability to inspire and increases the work of breathing. Long and short acting corticosteroids and leukotriene are considered effective pharmacological interventions while inspiratory muscle training, incentive spirometry, purse lip breathing, and diaphragm strengthening are considered effective physiotherapy interventions for asthma patients. To find the combined effects of diaphragm strengthening and accessory muscle stretching on chest expansion, pulmonary function, dyspnea and exercise capacity in asthmatic patients. A randomized controlled trial will be conducted at Gulab Davi teaching Hospital Lahore through convenient sampling technique on 40 patients which will be allocated through concealed opaque envelop into Group A and Group Pretreatment values of pulmonary function and chest expansion will be recorded. And patient's perception of exertion through Modified Borg's rating of perceived exertion (RPE) and HRQOL for quality of life will be assessed before and after treatment. Group A will be treated with diaphragm strengthening and Group B will be treated with diaphragm strengthening and accessory muscles stretching. Treatment evaluation will be done after 4 weeks. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-Wilk test, 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
Asthma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Diaphragm strengthening and accessory muscles stretchings
Arm Type
Experimental
Arm Title
Diaphragm strengthening
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Diaphragm strengthening and accessory muscles stretchings
Intervention Description
Diaphragm strengthening and accessory muscles stretchings
Intervention Type
Other
Intervention Name(s)
Diaphragm strengthening
Intervention Description
Diaphragm strengthening
Primary Outcome Measure Information:
Title
Modified Borg scale of exertion
Description
The Modified Borg Dyspnea Scale (MBS) is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and is routinely administered during six-minute walk testing (6MWT)
Time Frame
6 weeks
Title
6 MWT
Description
The 6MWT was used to detect participants' functional capacity by measuring the distance they traveled during the walk test. For the 6MWT assessment, the participants were encouraged to walk as far as they could during 6 min over a flat 100-feet surface, and for consistency, the researchers used constant verbal cues and positive feedback to encourage the participants to complete the task
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Quality of life questionnaire
Description
HRQOL is one of several variables commonly studied in the field of medical outcomes research. It encompasses a wide range of human experience, including functioning and subjective responses to illness. Contemporary interpretations of HRQOL are based on the World Health Organization's definition of health as a state of complete physical, mental, and social well-being and not merely the absence of disease. contemporary HRQOL instrument domains are scored with a range of 0-100, with higher values representing better outcomes. To make useful inferences regarding absolute scores or change scores over time, it is important to determine what meaning different numerical values have. When no such thresholds have been established, one can roughly approximate the smallest difference that is important to the patient as one-third to one-half of a standard deviation
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age group of 40-65 years Both male and females Phase-2 asthma patients Patients hemodynamically stable Exclusion Criteria: Patients having pulmonary tumors Patients of Having cough and sputum Patients having TB and emphysema Patients with pneumonia, pneumonectomy or other lungs surgical procedures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, Phd
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ameena Amjad, tDPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gulab Devi Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ameena Amjad, tDPT
Phone
03234184526
Email
ameena.uhs@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
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Combined Effects Of Diaphragm Strengthening And Accessory Muscles Stretchings In Asthma Patients

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