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

NCT ID: NCT07048678

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-17
• Study Completion Date: 2026-02-28

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.

Detailed Description

The intervention group will receive preoperative respiratory exercises including incentive spirometry, deep breathing exercises, and chest physiotherapy, one day before surgery. The control group will receive standard preoperative care without any respiratory exercises. Clinical assessments post-surgery will determine the presence of PPCs and hospital stay duration.

Conditions

Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

preoperative respiratory exercises

Group Type: EXPERIMENTAL

preoperative respiratory exercises

Intervention Type: 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:

Standard Care (Control Group)

Group Type: ACTIVE_COMPARATOR

Standard Care (Control Group)

Intervention Type: 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.

Interventions

preoperative respiratory exercises

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:

Intervention Type: COMBINATION_PRODUCT

Standard Care (Control Group)

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Superior University

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Naveed Babur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

MSAHSW/Batch-Fall23/907

Identifier Type: -

Identifier Source: org_study_id