- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06548425
Smartphone Based Tele-rehabilitation on Functional Capacity and Sleep Quality Among Coronary Heart Disease Patients.
Effectiveness of Smartphone Based Tele-rehabilitation on Cardiovascular Functional Capacity and Sleep Quality Among Coronary Heart Disease Patients.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan, 46000
- Yusra Rehabilitation Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Principal Investigator: Muhammad Iqbal Tariq, PhD*, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/01890 Hassan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Coronary Heart Disease
-
Shenyang Northern HospitalRecruitingCoronary Heart Disease (CHD)China
-
Peking University Third HospitalCompletedCoronary Microvascular Dysfunction | Obstructive Coronary Heart DiseaseChina
-
Chang Gung University of Science and TechnologyChang Gung Memorial Hospital; Chang Gung University; National Science and Technology...Enrolling by invitationCoronary Heart Disease (CHD) | Coronary Arterial Disease (CAD)Taiwan
-
Centro de estudios en Cardiologia IntervencionistaCompletedCoronary Heart Disease | Coronary RestenosisArgentina
-
Tung Wah CollegeRecruitingCoronary Heart Disease (CHD)Hong Kong
-
China National Center for Cardiovascular DiseasesChinese Academy of Medical Sciences, Fuwai HospitalNot yet recruiting
-
Tsinghua UniversityNot yet recruitingCoronary Heart Disease (CHD)
-
MedImmune LLCCompletedStable Coronary Heart DiseaseUnited States
-
Medical University of LodzBaxter Healthcare CorporationUnknownCHD - Coronary Heart DiseasePoland
-
University of ZurichCompletedStable Coronary Heart DiseaseSwitzerland
Clinical Trials on Smart Phone Based Cardiac Telerehabilitation
-
University of Eastern FinlandOulu University Hospital; Kuopio University HospitalRecruiting
-
Hacettepe UniversityBozok UniversityCompletedHypertension | Arterial Hypertension | Systemic HypertensionTurkey (Türkiye)
-
Mansoura UniversityRecruitingCoronary Artery Disease | Cardiac RehabilitationEgypt
-
Kaohsiung Veterans General Hospital.Completed
-
National Cancer Center, KoreaCompletedStage I Gastric CancerKorea, Republic of
-
Florida State UniversityCompleted
-
Charles University, Czech RepublicInstitute for Clinical and Experimental MedicineCompletedMyocardial InfarctionCzechia
-
The First Hospital of Hebei Medical UniversityCompletedPsychological Distress After Coronary Artery Bypass Grafting (CABG)China
-
University of Texas Southwestern Medical CenterCompletedHigh-Risk Cancer
-
Massachusetts General HospitalKing's College London; University of California, San Francisco; Rwanda Palliative... and other collaboratorsWithdrawn