Smartphone Based Tele-rehabilitation on Functional Capacity and Sleep Quality Among Coronary Heart Disease Patients.

March 19, 2025 updated by: Riphah International University

Effectiveness of Smartphone Based Tele-rehabilitation on Cardiovascular Functional Capacity and Sleep Quality Among Coronary Heart Disease Patients.

To determine the effectiveness of smartphone based tele-rehabilitation on functional capacity and sleep quality among coronary heart disease patients.

Study Overview

Study Type

Interventional

Enrollment (Actual)

38

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 Locations

    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46000
        • Yusra Rehabilitation Center

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:

  • Both Male & Female
  • Age 20-69 years
  • Participants should have a documented diagnosis of CAD, confirmed by a medical professional.
  • Individuals with a history of myocardial infarction (heart attack), angina, or evidence of significant coronary artery stenosis.
  • Stable CAD who are not experiencing acute coronary events, such as recent heart attacks or unstable angina.

Exclusion Criteria:

  • Acute illness
  • Uncontrolled hypertension
  • Uncontrolled metabolic disease
  • Bone fracture in the last 6 months
  • Neurological diseases that limit the ability to ambulate or stand from a chair
  • MSK disease
  • Severe cardiovascular complications such as heart failure with reduced ejection fraction, severe arrhythmias.
  • Patients with unstable conditions or cardiac episodes.
  • Ejection fraction < 40%

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Smart Phone Based Cardiac Telerehabilitation

Smart Phone Based Cardiac Telerehabilitation

Frequency:3 sessions per week for 8 weeks Intensity: 40-60 % THR and modified borg scale 9 (very light- 13 (somewhat hard) Time: Approx. 30 Min Type: Aerobic & strength Exercises

Active Comparator: Center based cardiac Rehabilitation

Center based cardiac Rehabilitation

Frequency:3 sessions per week for 8 weeks Intensity: 40-60% THR and modified borg scale 9 (very light- 13 (somewhat hard)

Time: Approx. 30 Min Type: Aerobic & strength Exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality Index
Time Frame: 8 week
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Only self-rated questions are included in the scoring. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The PSQI has a high test-retest reliability and a good validity for patients with cardiac patients. Changes from the baseline will be measured.
8 week
Duke Activity Status Index
Time Frame: 8 week
The Duke Activity Status Index (DASI) is an assessment tool used to evaluate the functional capacity of patients with cardiovascular disease (CVD), such as coronary artery disease, myocardial infarction, and heart failure. In clinical practice, DASI can be used to assess the effects of medical treatments and cardiac rehabilitation as well. Positive responses are summed up to get a total score, which ranges from 0 to 58.2. Higher scores would indicate a higher functional capacity. Changes from the baseline will be measured.
8 week
6 Minute walk test
Time Frame: 8 week
six-minute walk test as a measure of functional status or fitness Before you begin to walk, the researchers will take a participant's blood pressure, pulse, and oxygen saturation using a pulse oximeter. Participants will get the instructions below. For six minutes, the contestants will walk as far as they can. to a chair or cone at your usual speed, then turn around. and will keep going back and forth for another six minutes. Distance will be measured in meters. Changes from the baseline will be measured.
8 week

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Muhammad Iqbal Tariq, PhD*, Riphah International University

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 (Actual)

June 15, 2024

Primary Completion (Actual)

January 15, 2025

Study Completion (Actual)

January 15, 2025

Study Registration Dates

First Submitted

August 7, 2024

First Submitted That Met QC Criteria

August 7, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 19, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

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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