Coronary Heart DiseaseNCT06548425
Smartphone Based Tele-rehabilitation on Functional Capacity and Sleep Quality Among Coronary Heart Disease Patients.
A study testing Smart Phone Based Cardiac Telerehabilitation and Center based cardiac Rehabilitation in people with Coronary Heart Disease, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effectiveness of smartphone based tele-rehabilitation on functional capacity and sleep quality among coronary heart disease patients. Read more about this study
- Who is it for?
- Ages 20 to 69 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Smart Phone Based Cardiac Telerehabilitation and Center based cardiac Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2024to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Severe cardiovascular complications such as heart failure with reduced ejection fraction, severe arrhythmias.
- Patients with unstable conditions or cardiac episodes.
- Ejection fraction < 40%
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Yusra Rehabilitation Center
Rawalpindi, Punjab Province, 46000
About this study
Official title: 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.
- Conditions
- Coronary Heart Disease
- Being tested
- Smart Phone Based Cardiac Telerehabilitation, Center based cardiac Rehabilitation
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Phone Based Cardiac TelerehabilitationOther
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
Center based cardiac RehabilitationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Smart Phone Based Cardiac Telerehabilitation | Experimental | Not described Receives: Other: Smart Phone Based Cardiac Telerehabilitation |
| Center based cardiac Rehabilitation | Active comparator | Not described Receives: Other: Center based cardiac Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
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.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start15 Jun 2024
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Iqbal Tariq, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548425
- Sponsor's protocol ID
- REC/01890 Hassan
- Status last verified
- Mar 2025
- First submitted
- 7 Aug 2024
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Smartphone Based Tele-rehabilitation on Cardiovascular Functional Capacity and Sleep Quality Among Coronary Heart Disease Patients.
- ClinicalTrials.gov ID
- NCT06548425
- Acronym / sponsor ID
- REC/01890 Hassan
- Conditions
- Coronary Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effectiveness of smartphone based tele-rehabilitation on functional capacity and sleep quality among coronary heart disease patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smart Phone Based Cardiac Telerehabilitation | Experimental | Other: Smart Phone Based Cardiac Telerehabilitation |
| Center based cardiac Rehabilitation | Active comparator | Other: Center based cardiac Rehabilitation |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart Phone Based Cardiac TelerehabilitationSmart 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 | Other | Smart Phone Based Cardiac Telerehabilitation |
| Center based cardiac RehabilitationCenter 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 | Other | Center based cardiac Rehabilitation |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Iqbal Tariq, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Phone Based Cardiac Telerehabilitation and Center based cardiac Rehabilitation in people with Coronary Heart Disease, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (time frame: 8 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.