Effects of Chest Physiotherapy Exercise in Prevention of Pre and Post Operative Complications By Cardiac Surgery

April 17, 2024 updated by: Muhammad Naveed Babur, Superior University

Effects of Chest Physiotherapy Exercise in Prevention of Pre-Operative and Post-Operative Complications Followed By Cardiac Surgery

"A randomized control trial will be conducted among 189 patients who have undergone cardiac surgery in past. The participants for this research will be patients of Pakistan Institute of Cardiology, University of Lahore Teaching Hospital, Azra Naheed Medical College and Bahria International Hospital. The chest physiotherapy technique will be applied on 2 controlled groups.

In 94 patients the effects of chest physiotherapy will be checked post - operatively and the effects will be checked on other half pre - operatively. The data will be gathered on practical performance and treatment based along with questionnaire. The data collected will then be analyzed using SPSS"

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

189

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Lahore, Pakistan
        • Punjab Institute of Cardiology Hospital
    • Punjab
      • Lahore, Punjab, Pakistan
        • The University of Lahore Teaching Hospital
      • Lahore, Punjab, Pakistan
        • Azra Naheed Medical College, Superior University
      • Lahore, Punjab, Pakistan
        • Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University
      • Lahore, Punjab, Pakistan
        • Bahria Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing in Cardiac Surgery like, CABG, univalve, bivalve and trivalve.

Exclusion Criteria:

  • Valve and CABG surgery combined with other cardiac surgery like percutaneous valve replacement.
  • Cognitive disorder of the heart.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Incentive Spirometer
Diagnostic test: Incentive Spirometer

Specificity and sensitivity: Incentive spirometry is a specific type of spirometry that aims to encourage people to breathe deeply intentionally but does not provide a measurement or inform management of chronic lung diseases. Less than 5 repetitions per day (sensitivity 93%, specificity 77%) and less than 2 balls per repetition (sensitivity 93%, specificity 77%) were predictive of postoperative pulmonary complications. (1) Validity and reliability: Incentive spirometry can be used as a simple mean to follow lung function, especially VC, in the postoperative period in spontaneously breathing patients. Incentive spirometry is noninvasive and can be performed repeatedly at the bedside in the intensive care setting. (2)

Interpretation:

There are only three numeric values that are required to interpret spirometry:

  • Forced Vital Capacity (FVC)
  • Forced Expiratory Volume (FEV1)
  • FEV1/FVC ratio.
Other: Numeric Pain Rating Scale
Diagnostic test: Numeric Pain Rating Scale

Sensitivity: The area under the receiver operator characteristic curve for the NRS as a test for pain that interferes with functioning was 0.76, indicating fair accuracy. A pain screening NRS score of 1 was 69% sensitive for pain that interferes with functioning. (4) he diagnostic value of different NRS cut-off values for administering analgesics is determined by an ROC curve. Sensitivity of NRS > 3 for 'unbearable' pain in older patients was 72% with a specificity of 97·2%. With a cut-off point NRS > 4, sensitivity increased to 83%, while specificity was 96·7%. (5) Validity and reliability: The numerical rating scale is a reliable and valid tool for pain assessment in patients with musculoskeletal impairments. (3)

Measurement (circle): Categorical /Numerical /Both:

Numerical:

The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incentive Spirometer
Time Frame: 6 Month
A pain screening NRS score of 1 was 69% sensitive for pain that interferes with functioning. (4) Specificity: The diagnostic value of different NRS cut-off values for administering analgesics is determined by an ROC curve. Sensitivity of NRS > 3 for 'unbearable' pain in older patients was 72% with a specificity of 97·2%. With a cut-off point NRS > 4, sensitivity increased to 83%, while specificity was 96·7%. (5) Validity and reliability: The numerical rating scale is a reliable and valid tool for pain assessment in patients with musculoskeletal impairments.
6 Month
Incentive Spirometer
Time Frame: 6 Months
Specificity and sensitivity: Incentive spirometry is a specific type of spirometry that aims to encourage people to breathe deeply intentionally but does not provide a measurement or inform management of chronic lung diseases. Less than 5 repetitions per day (sensitivity 93%, specificity 77%) and less than 2 balls per repetition (sensitivity 93%, specificity 77%) were predictive of postoperative pulmonary complications.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Superior University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

April 17, 2024

First Submitted That Met QC Criteria

April 17, 2024

First Posted (Actual)

April 22, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPT/Batch-Fall19/557

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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