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Recruiting NCT07484477

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

No phase Interventional Post-cardiac Surgery Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sedentary Behaviour Modification Protocol, Standard Cardiac Rehabilitation.
Who it may be relevant to
Registry conditions: Post-cardiac Surgery Patients. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Sedentary Behaviour Modification on Cardiopulmonary Function and Quality of Life in Post-Cardiac Surgery Patients

Overview

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).

Interventions

  • 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).
  • 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

Primary outcome measures

  • Peak Expiratory Flow Rate (PEFR) [Time frame: 12 weeks]
  • Forced Vital Capacity (FVC) [Time frame: 12 weeks]
  • Forced Expiratory volume in 1sec (FEV1) [Time frame: 12 weeks]
  • 36-Item Short Form Health Survey [Time frame: 12 weeks]
  • No. of steps [Time frame: 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Pakistan · 1 center
  • MMC General Hospital — Peshawar

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. PMID 39236885

Identifiers

NCT: NCT07484477 · Ayesha Khan

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗