- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05059925
Structured Gym Activities and Aerobic Activities in People With Cardiac Conditions
Compare the Effects of Structured Gym Activities and Traditional Aerobic Activities in People With Cardiac Conditions
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan, 44000
- Fitlytics gym Rawalpindi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Individuals with cardiac conditions including post-first myocardial infarction, post valvular diseases, post-CABG patients.
- Individuals who can perform cardiorespiratory exercises with ease(who are able to complete 6 minute walk test).
- Individuals who have not performed regular physical activity in the past 6 months (PA-R)
- No regular exercise or gym activity since last 6 months
Exclusion Criteria:
- Individuals who are highly trained in gymnastic
- Already trained (any gym activity or regular exercise)
- Individuals with Diabetes, hypertension, and kidney diseases.
- Any neurological complication
- Any Musculoskeletal Disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Structured gym activities
Planned and structured activities such as Strength training for 4 weeks
|
Planned and structured activities such as Strength training
|
|
ACTIVE_COMPARATOR: Traditional aerobic activities
Activities performed such as Treadmill , Cycle ergometer , Elliptical exercises for 4 weeks
|
Activities performed such as
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life SF-36 questionnaire
Time Frame: Changes from the baseline to 4th Week
|
The Short Form 36 Health Survey Questionnaire (SF-36) questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). A final item, termed self-reported health transition, is answered by the client but is not included in the scoring process. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. |
Changes from the baseline to 4th Week
|
|
Oxygen Saturation (SpO2)
Time Frame: 4th Week
|
Changes from baseline SPO2 was measured in percentage.
Oxygen immersion is the division of oxygen-soaked hemoglobin with respect to add up to hemoglobin in the blood.
Pulse oximeter measure it.
|
4th Week
|
|
Pulse Rate
Time Frame: 4th Week
|
Changes from baseline, Pulse rate was measured per minute through pulse oximeter
|
4th Week
|
|
Modified Borg Scale of Perceived Exertion
Time Frame: 4th week
|
Changes from the Baseline, It is a subjective numeric scale ranging from 0 to 10, where 0 indicates "no dyspnea" and 10 indicates "unbearable dyspnea."
A number is chosen by the patient in order to decide the best score that matches his level of dyspnea during physical activity.
|
4th week
|
|
Systolic and diastolic blood pressure
Time Frame: 4th week
|
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
|
4th week
|
|
VO2 max
Time Frame: 4th week
|
Changes from the Baseline, Maximal oxygen consumption (VO2 max), refers to the maximum amount of oxygen that an individual can utilize during intense or maximal exercise.
|
4th week
|
|
METS
Time Frame: 4th Week
|
Changes from the Baseline, Metabolic equivalents (METS) Associated with Common Types of Endurance Exercise. METs may be calculated during Standard Bruce Protocol by dividing oxygen uptake per minute with the product of 3.5 × bodyweight (kilograms) |
4th Week
|
|
Quick Physical Activity Rating (QPAR) scale
Time Frame: 4th Week
|
10 items covering passive activities, walking, hobby and recreational activities, exercise, and housework with exemplars provided.
Hobby activities, exercise and housework were further divided into light, moderate, and strenuous activities.
Respondents were asked to consider these physical activities over the prior 4-week period.
Each activity was weighted in intensity ranging from 1 (light) to 3 (heavy) intensity.
Frequency of activity per week was collected as never (0 days), seldom (1-2 days), sometimes (3-4 days), and often (5-7 days).
Duration of activity was collected as less than one hour per day, 1-2 hours per day, and more than two hours per day.
Multiplication of the intensity (1-3), frequency (0-3) and duration (1-3) scores permitted calculation of a dose of physical activity ranging from 0-153.
The QPAR took 3-5 minutes to complete.
Changes from the baseline to 4th week
|
4th Week
|
Collaborators and Investigators
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/01084 Anam Saif
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 Cardiac Disease
-
University of British ColumbiaRecruitingSurgery | Cardiac Event | Cardiac Disease | Cardiac Complication | Cardiac Valve Disease | Surgery-ComplicationsCanada
-
Istituto Auxologico ItalianoRecruitingCardiovascular Diseases | Cardiomyopathies | Ischemic Heart Disease | Sudden Cardiac Death Due to Cardiac ArrhythmiaItaly
-
Tampere Heart HospitalTampere University; Tampere University HospitalRecruitingSudden Cardiac Death | Sudden Cardiac Death Due to Cardiac Arrhythmia | Sudden Cardiac Arrest | Coronary Arterial Disease (CAD) | Acute Coronary EventFinland
-
UMC UtrechtRadboud University Medical Center; University Medical Center Groningen; Amsterdam...RecruitingInherited Cardiac DiseaseNetherlands
-
Ostfold University CollegeNot yet recruitingCardiac Arrest | Cardiac Arrhythmia | Cardiac Disease | Cardiac Death
-
Johns Hopkins UniversityNational Human Genome Research Institute (NHGRI)Active, not recruitingGenetic Counseling | Inherited Cardiac DiseaseUnited States
-
Centro Medico TeknonRecruitingMyocardial Infarction | Ischemic Heart Disease | Ventricular Tachycardia | Magnetic Resonance Imaging | Ventricular Arrythmia | Sudden Cardiac Death | Sudden Cardiac Death Due to Cardiac ArrhythmiaSpain
-
Children's Healthcare of AtlantaTerminated
-
Corsano Health B.V.Not yet recruitingCardiac Arrythmias | Valve Heart Disease | Cardiac IschemiaNetherlands
-
University Hospital of FerraraRecruitingGenetic Disease | Cardiac Disease | Genetic Disorder | Cardiac Arrhythmias | CardiologyItaly
Clinical Trials on Structured gym activities
-
PulseSync Pte LtdSingapore Institute of TechnologyCompletedFrailty | Sarcopenia | Muscle LossSingapore
-
Aiyoudong Children and Youth Sports Health Research...Completed
-
GO fit Lab- IngesportRecruiting
-
University College DublinUnknownArthritis, RheumatoidIreland
-
University of StrathclydeCompleted
-
Egas Moniz - Cooperativa de Ensino Superior, CRLGinásio Clube Português; Faculdade de Motricidade Humana - Universidade de... and other collaboratorsCompletedVascular Stiffness | Cardiorespiratory FitnessPortugal
-
Sheba Medical CenterCompleted
-
Cairo UniversityNot yet recruitingSleep Disorder | Insomnia | Old Age; Debility | Cognitive Function Abnormal | Brain Gym Therapy
-
University of PennsylvaniaChildren's Hospital of PhiladelphiaRecruitingNeurodevelopmental Disorders | Pediatric ALL | Infant DevelopmentUnited States
-
NeuroBrave ltd.RecruitingPTSD - Post Traumatic Stress DisorderIsrael