Evaluating the Impact of Preoperative Respiratory Exercises on Post-Surgical Pulmonary Outcomes RCT

NCT07048678 | Active Not Recruiting DMC

• 1 other identifier: MSAHSW/Batch-Fall23/907
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to evaluate the role of preoperative respiratory exercises in reducing postoperative pulmonary complications (PPCs) such as atelectasis, pneumonia, and hypoxia, and in shortening the hospital stay in surgical patients. A total of 126 adult patients (\>40 years), scheduled for total knee or hip replacement surgeries at Horizon Hospital Lahore, will be randomly assigned into two groups: the intervention group and the control group.

Conditions

Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Postoperative Pulmonary Complication (PPC) assessment

  Postoperative Pulmonary Complication (PPC) assessment involves evaluating various risk factors to predict the likelihood of respiratory complications after surgery. The ARISCAT score is a widely used tool for this purpose, assigning points based on factors like age, preoperative oxygen saturation, respiratory infection history, anemia, surgical incision type, surgery duration, and whether it was an emergency procedure. Other assessment methods include the PPC Risk Prediction Score (focused on lung function, weight loss, and incision type) and indices like the Shapiro index and PI score

  12 Months

Study Arms (2)

preoperative respiratory exercises

EXPERIMENTAL

Combination Product: preoperative respiratory exercises

Standard Care (Control Group)

ACTIVE COMPARATOR

Combination Product: Standard Care (Control Group)

Interventions

preoperative respiratory exercises COMBINATION_PRODUCT

Participants in Group 1 will receive a combination of preoperative respiratory exercises designed to improve lung function and reduce the risk of postoperative pulmonary complications. The intervention includes:

preoperative respiratory exercises

Standard Care (Control Group) COMBINATION_PRODUCT

Participants in Group 2 will receive standard preoperative care provided by the hospital, which includes routine instructions related to surgery such as fasting guidelines, medication administration, and anesthesia protocols. No preoperative respiratory exercises (incentive spirometry, chest physiotherapy, or deep breathing exercises) will be provided to this group. This group serves as a control to compare the outcomes with the intervention group.

Standard Care (Control Group)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged over 40 years.
• Scheduled for total knee replacement (TKR) or total hip replacement (THR) surgery.
• Able to understand and follow instructions (cognitively intact).
• Provide informed consent to participate.

You may not qualify if:

• Patients will be excluded from the study if they meet any of the following conditions:
• Age below 40 years.
• Pregnancy.
• Edentulous patients (patients with no teeth).
• Patients with spinal or backbone injuries.
• Patients with contraindications to incentive spirometry or chest physiotherapy (e.g., recent eye surgery, rib fractures).
• Patients with impaired cognitive function who are unable to perform respiratory exercises correctly.

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Horizon hospital, 03, 404, 436 Block D-II, M.A Block D 2, Phase 1, Johar Town

Lahore, Punjab Province, 54770, Pakistan

Location

MeSH Terms

Conditions

Lung Diseases

Interventions

Standard of Care; Control Groups

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: March 17, 2025
• Primary Completion: September 1, 2025
• Study Completion: February 28, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)