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

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05915793
Collaborator
(none)
42
1
2
6.9
6.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Diaphragm strengthening and accessory muscles stretchings
  • Other: Diaphragm strengthening
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Combined Effects of Diaphragm Strengthening and Accessory Muscles Stretchings in Asthma Patients
Actual Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Aug 29, 2023
Anticipated Study Completion Date :
Aug 29, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Diaphragm strengthening and accessory muscles stretchings

Other: Diaphragm strengthening and accessory muscles stretchings
Diaphragm strengthening and accessory muscles stretchings

Active Comparator: Diaphragm strengthening

Other: Diaphragm strengthening
Diaphragm strengthening

Outcome Measures

Primary Outcome Measures

  1. Modified Borg scale of exertion [6 weeks]

    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)

  2. 6 MWT [6 weeks]

    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

  1. Quality of life questionnaire [6 weeks]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gulab Devi Hospital Lahore Punjab Pakistan 54000

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Ameena Amjad, tDPT, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05915793
Other Study ID Numbers:
  • REC/RCR&AHS/23/0315
First Posted:
Jun 23, 2023
Last Update Posted:
Jun 23, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 23, 2023