Cardiac DiseaseNCT05059925
Structured Gym Activities and Aerobic Activities in People With Cardiac Conditions
A study testing Structured gym activities and Traditional aerobic activities in people with Cardiac Disease, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effect of structured gym activities and traditional aerobic activities on cardiorespiratory endurance in people with cardiac conditions To compare the effect of structured gym activities and traditional aerobic activities on quality of life in people with cardiac conditions Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Structured gym activities and Traditional aerobic activities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Oct 2021to 30 Aug 2022
- 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 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compare the Effects of Structured Gym Activities and Traditional Aerobic Activities in People With Cardiac Conditions
To compare the effect of structured gym activities and traditional aerobic activities on cardiorespiratory endurance in people with cardiac conditions To compare the effect of structured gym activities and traditional aerobic activities on quality of life in people with cardiac conditions
- Conditions
- Cardiac Disease
- Being tested
- Structured gym activities, Traditional aerobic activities
- Keywords
- Gym Activities, Aerobic Exercises
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured gym activitiesOther
Planned and structured activities such as Strength training
- Dumbbell Exercises (1kg with 2 sets of 10 repetitions)
- Sit-ups (2 sets of 10 repetitions)
- Stair climbing, (2 sets of 10 stairs up and down)
- Squat (2 sets of 10 repetitions) Flexibility training • Tai chi (Peng. Lu, chi, an Tsai, lieh, chou, Kao (Hold each posture for 20 seconds)) • Pilates (Breathing., Shoulder bridge, Leg lifts (Hold each pose for 20 seconds)) • Stretching techniques (Neck stretch, Shoulder stretch, Side stretch Hold each stretch for 20 seconds)).
Traditional aerobic activitiesOther
Activities performed such as
- Treadmill Time: 10 minutes Intensity: 60 to 80% of target heart rate
- Cycle ergometer Time: 10 minutes Intensity: 60 to 80% of target heart rate
- Elliptical exercises Time: 10 minutes Intensity: 60 to 80% of target heart rate
| Study group | Role | What they receive |
|---|---|---|
| Structured gym activities | Experimental | Planned and structured activities such as Strength training for 4 weeks Receives: Other: Structured gym activities |
| Traditional aerobic activities | Active comparator | Activities performed such as Treadmill , Cycle ergometer , Elliptical exercises for 4 weeks Receives: Other: Traditional aerobic activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life SF-36 questionnaire
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.
Measured: Changes from the baseline to 4th Week
Oxygen Saturation (SpO2)
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.
Measured: 4th Week
Pulse Rate
Changes from baseline, Pulse rate was measured per minute through pulse oximeter
Measured: 4th Week
Modified Borg Scale of Perceived Exertion
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.
Measured: 4th week
Systolic and diastolic blood pressure
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
Measured: 4th week
VO2 max
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.
Measured: 4th week
METS
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)
Measured: 4th Week
Quick Physical Activity Rating (QPAR) scale
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
Measured: 4th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start25 Oct 2021
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Iqbal Tariq, MSCPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059925
- Sponsor's protocol ID
- REC/01084 Anam Saif
- Status last verified
- Oct 2022
- First submitted
- 18 Sep 2021
- Last updated
- 24 Oct 2022
- 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 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Effects of Structured Gym Activities and Traditional Aerobic Activities in People With Cardiac Conditions
- ClinicalTrials.gov ID
- NCT05059925
- Acronym / sponsor ID
- REC/01084 Anam Saif
- Conditions
- Cardiac Disease
- Keywords
- Gym Activities, Aerobic Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 28 Sep 2021 (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 compare the effect of structured gym activities and traditional aerobic activities on cardiorespiratory endurance in people with cardiac conditions To compare the effect of structured gym activities and traditional aerobic activities on quality of life in people with cardiac conditions
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured gym activities | Experimental | Other: Structured gym activitiesPlanned and structured activities such as Strength training for 4 weeks |
| Traditional aerobic activities | Active comparator | Other: Traditional aerobic activitiesActivities performed such as Treadmill , Cycle ergometer , Elliptical exercises for 4 weeks |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Structured gym activitiesPlanned and structured activities such as Strength training * Dumbbell Exercises (1kg with 2 sets of 10 repetitions) * Sit-ups (2 sets of 10 repetitions) * Stair climbing, (2 sets of 10 stairs up and down) * Squat (2 sets of 10 repetitions) Flexibility training • Tai chi (Peng. Lu, chi, an Tsai, lieh, chou, Kao (Hold each posture for 20 seconds)) • Pilates (Breathing., Shoulder bridge, Leg lifts (Hold each pose for 20 seconds)) • Stretching techniques (Neck stretch, Shoulder stretch, Side stretch Hold each stretch for 20 seconds)). | Other | Structured gym activities |
| Traditional aerobic activitiesActivities performed such as * Treadmill Time: 10 minutes Intensity: 60 to 80% of target heart rate * Cycle ergometer Time: 10 minutes Intensity: 60 to 80% of target heart rate * Elliptical exercises Time: 10 minutes Intensity: 60 to 80% of target heart rate | Other | Traditional aerobic activities |
Primary outcome
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.
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.
Pulse Rate
Time frame: 4th Week
Changes from baseline, Pulse rate was measured per minute through pulse oximeter
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.
Systolic and diastolic blood pressure
Time frame: 4th week
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
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.
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)
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
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 24 Oct 2022.
- 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, MSCPPT 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 Structured gym activities and Traditional aerobic activities in people with Cardiac 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 4 inclusion and 5 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 24 Oct 2022. 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?
Quality of Life SF-36 questionnaire (time frame: Changes from the baseline to 4th Week). The study lists 8 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 24 Oct 2022.