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

NCT06548425 | Completed DMC

• 1 other identifier: REC/01890 Hassan
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (3)

• Pittsburgh Sleep Quality Index

  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

  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

  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

Study Arms (2)

Smart Phone Based Cardiac Telerehabilitation

EXPERIMENTAL

Other: Smart Phone Based Cardiac Telerehabilitation

Center based cardiac Rehabilitation

ACTIVE COMPARATOR

Other: Center based cardiac Rehabilitation

Interventions

Smart Phone Based Cardiac Telerehabilitation OTHER

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

Smart Phone Based Cardiac Telerehabilitation

Center based cardiac Rehabilitation OTHER

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

Center based cardiac Rehabilitation

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Yusra Rehabilitation Center

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Muhammad Iqbal Tariq, PhD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 12, 2024
• Study Start: June 15, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)