Pulmonary DiseaseNCT07048678
Evaluating the Impact of Preoperative Respiratory Exercises on Post-Surgical Pulmonary Outcomes RCT
A study testing preoperative respiratory exercises in people with Pulmonary Disease, run by Superior University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease
- What is being tested?
- preoperative respiratory exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Mar 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Horizon hospital, 03, 404, 436 Block D-II, M.A Block D 2, Phase 1, Johar Town
Lahore, Punjab Province, 54770
About this study
Official title: Evaluating the Impact of Preoperative Respiratory Exercises on Post-Surgical Pulmonary Outcomes: A Randomized Controlled Trial
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.
Read the 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
- Being tested
- preoperative respiratory exercises, Standard Care (Control Group)
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative respiratory exercisesCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| preoperative respiratory exercises | Experimental | Not described Receives: Combination Product: preoperative respiratory exercises |
| Standard Care (Control Group) | Active comparator | Not described Receives: Combination Product: Standard Care (Control Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start17 Mar 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048678
- Sponsor's protocol ID
- MSAHSW/Batch-Fall23/907
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Preoperative Respiratory Exercises on Post-Surgical Pulmonary Outcomes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07048678
- Acronym / sponsor ID
- MSAHSW/Batch-Fall23/907
- Conditions
- Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preoperative respiratory exercises | Experimental | Combination Product: preoperative respiratory exercises |
| Standard Care (Control Group) | Active comparator | Combination Product: Standard Care (Control Group) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preoperative respiratory exercisesParticipants 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: | Combination product | preoperative respiratory exercises |
| 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. | Combination product | Standard Care (Control Group) |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preoperative respiratory exercises in people with Pulmonary Disease, run by Superior University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pulmonary Complication (PPC) assessment (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.