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Active, Not Recruiting

NCT Number: NCT07048678

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pulmonary Disease Lung Diseases Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Lahore, Punjab Province, 54770, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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:

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.

Primary outcomes

  1. Postoperative Pulmonary Complication (PPC) assessment

    Time frame: 12 Months

    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

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Official study title

Evaluating the Impact of Preoperative Respiratory Exercises on Post-Surgical Pulmonary Outcomes: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 2, 2025
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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