Sedentary Behavior Modification, Cardiopulmonary Function & QOL Post Cardiac Surgery Patients.

March 16, 2026 updated by: Riphah International University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • KPK
      • Peshawar, KPK, Pakistan, 25000
        • MMC General Hospital
        • Contact:
        • Sub-Investigator:
          • Ayesha Khan, MSPT - CPPT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Those requiring invasive mechanical ventilation
  • Individuals with significant cognitive impairment affecting consent or compliance
  • Pregnant women or Lactating Mother

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sedentary Behaviour Modification
Behavioural modification through a structured protocol for reducing sitting time.
Other: Sedentary Behaviour Modification Protocol
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).
Placebo Comparator: Standard Cardiac Rehabilitation
Phase II Cardiac Rehabilitation Protocol
Other: Standard Cardiac Rehabilitation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
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.
12 weeks
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.
12 weeks
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).
12 weeks
No. of steps
Time Frame: 12 weeks
Monitoring of 24- hours number of steps on an activity track watch
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Suman Sheraz, PhD, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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. Journal of Affective Disorders. 2024 Dec 15;367:342-9.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 30, 2026

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Ayesha Khan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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