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

NCT07484477 | Recruiting DMC

• 1 other identifier: Ayesha Khan
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Post-cardiac Surgery Patients

Keywords

Sedentary Behaviour; Quality of Life; Cardiopulmonary Function

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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).

  12 weeks

• No. of steps

  Monitoring of 24- hours number of steps on an activity track watch

  12 weeks

Study Arms (2)

Sedentary Behaviour Modification

EXPERIMENTAL

Behavioural modification through a structured protocol for reducing sitting time.

Other: Sedentary Behaviour Modification Protocol

Standard Cardiac Rehabilitation

PLACEBO COMPARATOR

Phase II Cardiac Rehabilitation Protocol

Other: Standard Cardiac Rehabilitation

Interventions

Sedentary Behaviour Modification Protocol OTHER

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).

Sedentary Behaviour Modification

Standard Cardiac Rehabilitation OTHER

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

Standard Cardiac Rehabilitation

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

MMC General Hospital

Peshawar, KPK, 25000, Pakistan

RECRUITING

Related Publications (1)

• 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.

  PMID: 39236885 BACKGROUND

Study Officials

• Suman Sheraz, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suman Sheraz, PhD

CONTACT

03335646361; suman.sheraz@riphah.edu.pk

Imran Amjad, PhD

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 20, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)