Post-cardiac Surgery PatientsNCT07484477
Sedentary Behavior Modification, Cardiopulmonary Function & QOL Post Cardiac Surgery Patients.
A study testing Sedentary Behaviour Modification Protocol and Standard Cardiac Rehabilitation in people with Post-cardiac Surgery Patients, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study aims to investigate randomized controlled trial to evaluate whether reducing sedentary behavior improves recovery in post-cardiac surgery patients. Participants are assigned to either a behavioral intervention that substitutes sitting with light activity or to usual care. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Post-cardiac Surgery Patients
- What is being tested?
- Sedentary Behaviour Modification Protocol and Standard Cardiac Rehabilitation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Apr 2026to 30 Sep 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient Aged 50-80 years (represents the majority cases)
- Natural decline in physical capacity, making them an ideal population for studying these outcomes)
- Underwent elective or emergency cardiac surgery (once patient is in ward)/1
Who cannot join
- Those requiring invasive mechanical ventilation
- Individuals with significant cognitive impairment affecting consent or compliance
- Pregnant women or Lactating Mother
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
MMC General Hospital
Peshawar, KPK, 25000
Suman Sheraz, PhD, 03335646361, suman.sheraz@riphah.edu.pk
Ayesha Khan, MSPT - CPPT
About this study
Official title: Effects of Sedentary Behaviour Modification on Cardiopulmonary Function and Quality of Life in Post-Cardiac Surgery Patients
This study aims to investigate randomized controlled trial to evaluate whether reducing sedentary behavior improves recovery in post-cardiac surgery patients. Participants are assigned to either a behavioral intervention that substitutes sitting with light activity or to usual care. Changes in exercise capacity and quality of life are the primary measured outcomes. It is hypothesized that the intervention group will demonstrate superior gains in both physical function and well-being. The results could inform a valuable adjunct to existing cardiac rehabilitation programs.
Read the detailed description
This randomized controlled trial (RCT) aims to determine the efficacy of a targeted sedentary behavior (SB) modification program as a component of early recovery following cardiac surgery. Participants are randomly allocated to either an intervention group, receiving structured counseling and feedback to replace prolonged sitting with frequent bouts of light-intensity physical activity, or a control group receiving standard postoperative care alone. subjective enhancements in health-related quality of life, assessed via validated questionnaires.The randomized control trial involving 24 patients.The study duration will be 3 months with assesment conducted at baseline,mid and end of intervention.Group A(interventional group recieving Sedantary Behavior protocol+Cardiac Rehab),Group B(Control group recieving only Cardiac Rehab).
- Conditions
- Post-cardiac Surgery Patients
- Being tested
- Sedentary Behaviour Modification Protocol, Standard Cardiac Rehabilitation
- Keywords
- Sedentary Behaviour, Quality of Life, Cardiopulmonary Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedentary Behaviour Modification ProtocolOther
structured intervention designed to reduce the total time spent sitting or lying down (excluding sleeping) and to break up long, uninterrupted periods of inactivity. Effective protocols, often guided by the COM-B model (Capability, Opportunity, Motivation, Behaviour), aim to replace sedentary time with light-intensity physical activity (e.g., walking, standing).
Standard Cardiac RehabilitationOther
A 3-12 week outpatient, medically supervised program starting shortly after surgery, focusing on monitored exercise (Treadmill), risk factor modification, and education to safely improve heart function. It involves 1-hour sessions 2-3 times a week, combining aerobic training, light strength training, and lifestyle counseling
| Study group | Role | What they receive |
|---|---|---|
| Sedentary Behaviour Modification | Experimental | Behavioural modification through a structured protocol for reducing sitting time. Receives: Other: Sedentary Behaviour Modification Protocol |
| Standard Cardiac Rehabilitation | Placebo comparator | Phase II Cardiac Rehabilitation Protocol Receives: Other: Standard Cardiac Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Expiratory Flow Rate (PEFR)
peak expiratory flow rates measured through digital spirometer.3 zones of measurements are commonly used to interpret peak flow rates. Normal value of PEFR is 80 to 100%.Green zone indicates 80 to 100% normal peak flow reading, yellow zone indicates 50 to 79 %of normal peak flow readings, and red zone indicates less than 50% of normal peak flow reading.
Measured: 12 weeks
Forced Vital Capacity (FVC)
Forced Vital Capacity (FVC) Forced vital capacity (FVC) measured through digital spirometer. If the value of FVC is within 80% of the reference value, the results are considered normal. Changes in FVC from baseline to 3rd week and after 6 weeks day of intervention will be assessed.
Measured: 12 weeks
Forced Expiratory volume in 1sec (FEV1)
Forced expiratory volume in 1sec (FEV1) measured through digital spirometer. If the value of FEV1 is within 80% of the reference value, the results are considered normal.
Measured: 12 weeks
36-Item Short Form Health Survey
The SF-36 Health Survey is a widely used tool that measures eight scales related to functional and well-being health-related quality of life (HRQOL).
Measured: 12 weeks
No. of steps
Monitoring of 24- hours number of steps on an activity track watch
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start15 Apr 2026
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-cardiac Surgery PatientsStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suman Sheraz, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484477
- Sponsor's protocol ID
- Ayesha Khan
- Status last verified
- Jul 2026
- First submitted
- 16 Mar 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang Y, Wang Y, Yang L. Association between physical activity and sedentary behavior and depression in US adults with cardiovascular disease: NHANES 2007-2016. J Affect Disord. 2024 Dec 15;367:342-349. doi: 10.1016/j.jad.2024.09.012. Epub 2024 Sep 3.
PubMed 39236885
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sedentary Behaviour Modification on Cardiopulmonary Function and Quality of Life in Post-Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT07484477
- Acronym / sponsor ID
- Ayesha Khan
- Conditions
- Post-cardiac Surgery Patients
- Keywords
- Sedentary Behaviour, Quality of Life, Cardiopulmonary Function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 20 Mar 2026 (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 study aims to investigate randomized controlled trial to evaluate whether reducing sedentary behavior improves recovery in post-cardiac surgery patients. Participants are assigned to either a behavioral intervention that substitutes sitting with light activity or to usual care. Changes in exercise capacity and quality of life are the primary measured outcomes. It is hypothesized that the intervention group will demonstrate superior gains in both physical function and well-being. The results could inform a valuable adjunct to existing cardiac rehabilitation programs.
Detailed description
This randomized controlled trial (RCT) aims to determine the efficacy of a targeted sedentary behavior (SB) modification program as a component of early recovery following cardiac surgery. Participants are randomly allocated to either an intervention group, receiving structured counseling and feedback to replace prolonged sitting with frequent bouts of light-intensity physical activity, or a control group receiving standard postoperative care alone. subjective enhancements in health-related quality of life, assessed via validated questionnaires.The randomized control trial involving 24 patients.The study duration will be 3 months with assesment conducted at baseline,mid and end of intervention.Group A(interventional group recieving Sedantary Behavior protocol+Cardiac Rehab),Group B(Control group recieving only Cardiac Rehab).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedentary Behaviour Modification | Experimental | Other: Sedentary Behaviour Modification ProtocolBehavioural modification through a structured protocol for reducing sitting time. |
| Standard Cardiac Rehabilitation | Placebo comparator | Other: Standard Cardiac RehabilitationPhase II Cardiac Rehabilitation Protocol |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient Aged 50-80 years (represents the majority cases)
- Natural decline in physical capacity, making them an ideal population for studying these outcomes)
- Underwent elective or emergency cardiac surgery (once patient is in ward)/1
Key exclusion criteria (3 listed)
- Those requiring invasive mechanical ventilation
- Individuals with significant cognitive impairment affecting consent or compliance
- Pregnant women or Lactating Mother
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 |
|---|---|---|
| Sedentary Behaviour Modification Protocolstructured intervention designed to reduce the total time spent sitting or lying down (excluding sleeping) and to break up long, uninterrupted periods of inactivity. Effective protocols, often guided by the COM-B model (Capability, Opportunity, Motivation, Behaviour), aim to replace sedentary time with light-intensity physical activity (e.g., walking, standing). | Other | Sedentary Behaviour Modification |
| Standard Cardiac RehabilitationA 3-12 week outpatient, medically supervised program starting shortly after surgery, focusing on monitored exercise (Treadmill), risk factor modification, and education to safely improve heart function. It involves 1-hour sessions 2-3 times a week, combining aerobic training, light strength training, and lifestyle counseling | Other | Standard Cardiac Rehabilitation |
Primary outcome
Peak Expiratory Flow Rate (PEFR)
Time frame: 12 weeks
peak expiratory flow rates measured through digital spirometer.3 zones of measurements are commonly used to interpret peak flow rates. Normal value of PEFR is 80 to 100%.Green zone indicates 80 to 100% normal peak flow reading, yellow zone indicates 50 to 79 %of normal peak flow readings, and red zone indicates less than 50% of normal peak flow reading.
Forced Vital Capacity (FVC)
Time frame: 12 weeks
Forced Vital Capacity (FVC) Forced vital capacity (FVC) measured through digital spirometer. If the value of FVC is within 80% of the reference value, the results are considered normal. Changes in FVC from baseline to 3rd week and after 6 weeks day of intervention will be assessed.
Forced Expiratory volume in 1sec (FEV1)
Time frame: 12 weeks
Forced expiratory volume in 1sec (FEV1) measured through digital spirometer. If the value of FEV1 is within 80% of the reference value, the results are considered normal.
36-Item Short Form Health Survey
Time frame: 12 weeks
The SF-36 Health Survey is a widely used tool that measures eight scales related to functional and well-being health-related quality of life (HRQOL).
No. of steps
Time frame: 12 weeks
Monitoring of 24- hours number of steps on an activity track watch
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 29 Jul 2026.
- Background: PubMed 39236885Yang Y, Wang Y, Yang L. Association between physical activity and sedentary behavior and depression in US adults with cardiovascular disease: NHANES 2007-2016. J Affect Disord. 2024 Dec 15;367:342-349. doi: 10.1016/j.jad.2024.09.012. Epub 2024 Sep 3.
- 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.
Suman Sheraz, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedentary Behaviour Modification Protocol and Standard Cardiac Rehabilitation in people with Post-cardiac Surgery Patients, run by Riphah International 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 29 Jul 2026. 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. Some participants in this study may receive a placebo. 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?
Contact Suman Sheraz, PhD (03335646361, suman.sheraz@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Expiratory Flow Rate (PEFR) (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07484477, which also lists 1 linked publication.
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 29 Jul 2026.