NCT05646225

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 12, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

December 12, 2022

Status Verified

December 1, 2022

Enrollment Period

9 months

First QC Date

November 24, 2022

Last Update Submit

December 9, 2022

Conditions

Keywords

early mobilization, chest physiotherap, chronic bronchitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • pulmonary function test FEV1

    Two weeks

  • pulmonary function test

    Two weeks

  • MRC dyspnea scale

    Two weeks

Study Arms (2)

chest physiotherapy and early mobilization

EXPERIMENTAL

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 mobilizationOther: early mobilization

early mobilization

ACTIVE COMPARATOR

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

Interventions

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

chest physiotherapy and 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

chest physiotherapy and early mobilizationearly mobilization

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both gender of age 45-70 years
  • Patient diagnosed with chronic bronchitis (admitted patients)
  • Taking bronchodilators

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah hospital

Lahore, Punjab Province, 5400, Pakistan

RECRUITING

MeSH Terms

Conditions

Bronchitis, Chronic

Interventions

Early Ambulation

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesPulmonary Disease, Chronic ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Madiha younas, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2022

First Posted

December 12, 2022

Study Start

May 1, 2022

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

December 12, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations