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

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05646225
Collaborator
(none)
26
1
2
9.1
2.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: chest physiotherapy and early mobilization
  • Other: early mobilization
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. St. George Respiratory Questionnaire [Two weeks]

    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).

Other Outcome Measures

  1. pulmonary function test FEV1 [Two weeks]

    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

  2. pulmonary function test [Two weeks]

    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

  3. MRC dyspnea scale [Two weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jinnah hospital Lahore Punjab Pakistan 5400

Sponsors and Collaborators

  • Riphah International University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05646225
Other Study ID Numbers:
  • REC/0315 Mishal Tanveer
First Posted:
Dec 12, 2022
Last Update Posted:
Dec 12, 2022
Last Verified:
Dec 1, 2022
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
Keywords provided by Riphah International University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 12, 2022