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

Primary Purpose

Chronic Bronchitis

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
chest physiotherapy and early mobilization
early mobilization
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Bronchitis focused on measuring early mobilization, chest physiotherap, chronic bronchitis

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jinnah hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

chest physiotherapy and early mobilization

early mobilization

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
November 24, 2022
Last Updated
December 9, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05646225
Brief Title
Early Mobilization With and Without Chest Physiotherapy in Chronic Bronchitis Patients.
Official Title
Effects of Early Mobilization With and Without Chest Physiotherapy on Dyspnea, Pulmonary Function Test and Quality of Life in Elderly Patients With Chronic Bronchitis.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Bronchitis
Keywords
early mobilization, chest physiotherap, chronic bronchitis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
chest physiotherapy and early mobilization
Arm Type
Experimental
Arm Description
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
Arm Title
early mobilization
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
chest physiotherapy and early mobilization
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
early mobilization
Intervention Description
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
Primary Outcome Measure Information:
Title
St. George Respiratory Questionnaire
Description
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).
Time Frame
Two weeks
Other Pre-specified Outcome Measures:
Title
pulmonary function test FEV1
Description
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
Time Frame
Two weeks
Title
pulmonary function test
Description
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
Time Frame
Two weeks
Title
MRC dyspnea scale
Description
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.
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Madiha younas, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinnah hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
5400
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madiha younas, MS
Phone
03338148025
Email
madihha.younas@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Mishal tanveer, MSCPPT

12. IPD Sharing Statement

Plan to Share IPD
No

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

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