Early Mobilization With and Without Chest Physiotherapy in Chronic Bronchitis Patients.

Effects of Early Mobilization With and Without Chest Physiotherapy on Dyspnea, Pulmonary Function Test and Quality of Life in Elderly Patients With Chronic Bronchitis.

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Bronchitis
• Intervention / Treatment: Other: chest physiotherapy and early mobilization; Other: early mobilization

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 5400
      • Recruiting
      • Jinnah Hospital
      • Contact: Madiha younas, MS; Phone Number: 03338148025; Email: madihha.younas@riphah.edu.pk
      • Sub-Investigator: Mishal tanveer, MSCPPT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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; Other: 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
Active Comparator: 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.	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Madiha younas, MS, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: November 24, 2022
• First Submitted That Met QC Criteria: December 9, 2022
• First Posted (Estimate): December 12, 2022

Study Record Updates

• Last Update Posted (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 9, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: early mobilization, chest physiotherap, chronic bronchitis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Acute Disease; Bronchitis; Bronchitis, Chronic
• Other Study ID Numbers: REC/0315 Mishal Tanveer

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No