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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05646225
Other study ID # REC/0315 Mishal Tanveer
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date February 2023

Study information

Verified date December 2022
Source Riphah International University
Contact Imran amjad, PHD
Phone 03324390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

It will be a randomized control trial study in which data are collected from hospital. A sample of 26 patients will divided into two group. One group of 13 patients will receive early mobilization and other group of 13 patients will receive early mobilization and chest physiotherapy only. All subject will receive 30 minute two session per day till two weeks. Outcome will be measured with MRC dyspnea scale and Pulmonary function test with spirometry to measure FEV1 and FEV1/FVC and quality of life will be checked by using ST. GEORGE'S respiratory questionnaire. Data will be analyzed by using SPSS version 21.


Description:

It will be a randomized control trial study in which data are collected from Jinnah hospital Lahore. A sample of 26 patients will be included and divided into two group. One group of 13 patients will receive early mobilization with chest physiotherapy and other group of 13 patients will receive early mobilization only. All subject will receive 30 minute two session per day till two weeks. Outcome will be measured with MRC dyspnea scale and Pulmonary function test with spirometry to measure FEV1 and FEV1/FVC and quality of life will be checked by using ST. GEORGE'S respiratory questionnaire. Data will be analyzed by using SPSS version 21.


Recruitment information / eligibility

Status Recruiting
Enrollment 26
Est. completion date February 2023
Est. primary completion date February 2023
Accepts healthy volunteers No
Gender All
Age group 45 Years to 70 Years
Eligibility Inclusion Criteria: - Both gender of age 45-70 years - Patient diagnosed with chronic bronchitis (admitted patients) - Taking bronchodilators Exclusion Criteria: - • Patient having any other condition cardiovascular, diabetes mellitus and neurological conditions - Patient history of radiotherapy - Unconscious ICU patients - Patient received any pre-admitted Physiotherapy protocol

Study Design


Intervention

Other:
chest physiotherapy and early mobilization
Chest Physiotherapy: Each session included a series of exercises, lasting a total of 15 minutes and including positioning self-conscious breathing control, diaphragmatic breathing control, and exercises for the chest wall and abdominal muscle walls. Early mobilization: Each session included abdominal and upper and lower limb exercises, shoulder and full arm circling, lying to sit, sit to stand, walk and other exercises. This training has been described previously and used in other clinical trials. Each exercise was repeated 8-10 times over 30 minutes
early mobilization
Each session included abdominal and upper and lower limb exercises, shoulder and full arm circling, lying to sit, sit to stand, walk and other exercises. This training has been described previously and used in other clinical trials. Each exercise was repeated 8-10 times over 30 minutes

Locations

Country Name City State
Pakistan Jinnah hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Other pulmonary function test FEV1 spirometery is portable, and handheld device used to measure capacities and volumes of lungs. predicted percentage(%) value of FEV1. The patient stands up straight, then takes a deep breath, and holds it till the mouthpiece is placed in between the teeth. Instruct the patient not to put the tongue against or inside the hole of the mouthpiece. The patient was asked to blow in the hole as fast and hard in a single blow. The first burst of air is the most important. The number was noted down, and the same procedure was repeated three times. The best of the three readings was the value used for the analysis. evaluation will be done before and after 2 week treatment plan Two weeks
Other pulmonary function test spirometery is portable, and handheld device used to measure capacities and volumes of lungs. predicted percentage(%) value of FEV1/FVC will be recorded through spirometery. The patient stands up straight, then takes a deep breath, and holds it till the mouthpiece is placed in between the teeth. Instruct the patient not to put the tongue against or inside the hole of the mouthpiece. The patient was asked to blow in the hole as fast and hard in a single blow. The first burst of air is the most important. The number was noted down, and the same procedure was repeated three times. The best of the three readings was the value used for the analysis. evaluation will be done before and after 2 week treatment plan Two weeks
Other MRC dyspnea scale Using the MRC dyspnea scale, self-perceived dyspnea in connection to physical impairment has been evaluated. Patients is required to rate their self-perceived dyspnea on a scale of (0-4) using pre-defined sentences. There will be pre- and post-treatment evaluations. Two weeks
Primary St. George Respiratory Questionnaire Using the SGRQ-C, the QOL of the study participants is evaluated. There are 14 questions in this questionnaire. The questionnaire would be given to the patients, who will instructed to answer it truthfully. The response is whatever they believe to be true for them. The minimum and maximum values are 0 and 100, respectively. Better QOL is indicated by a lower score. The formula was used to determine the total of the three component scores (symptoms, activity, and effects). Two weeks
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