Cardiovascular DiseasesNCT06308276
Effects of Aerobic Versus Resistance Training in Post Percutaneous Coronary Intervention Obese Patients
A study testing Aerobic Training and Resistance Training in people with Cardiovascular Diseases, run by Riphah International University at 1 site in Pakistan.
Trial summary
The randomized clinical trial (RCT) endeavors to enroll 50 participants, divided equally into aerobic exercise and resistance exercise groups. The study employs rigorous tools such as blood pressure measurement, SF-36 questionnaire, and the Six-Minute Walk Test (6MWT) to assess VO2max. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Aerobic Training and Resistance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2024to 15 Jun 2024
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: Participants must be between 40 and 60 years old.
- Gender: Male and female both.
- Cardiovascular Status: Post Percutaneous Coronary Intervention (PCI) patients with a documented history of coronary artery disease
- Participants who are at least three months post PCI to ensure stabilization of their cardiovascular condition.
- Obesity: Participants must have a Body Mass Index (BMI) equal to or greater than 30 kg/m², indicating obesity.
- Health Status: Participants should be in stable health condition to participate in moderate physical activities.
- Willingness to Participate: Participants must provide informed consent and be willing to comply with the study protocol, including attending scheduled exercise sessions and follow-up assessments.
- Participants capable of engaging in either aerobic or resistance training, were assessed by a physical activity readiness questionnaire (PAR-Q).
Who cannot join
- Participants with severe physical limitations, disabilities, or musculoskeletal disorders that would prevent them from engaging in aerobic and resistance exercises.
- Individuals with a history of substance abuse or current substance abuse issues that might interfere with their ability to participate or adhere to the study protocol.
- Patients with Neurological diseases
- Patients with severe or unstable heart conditions, recent heart attack, or heart failure
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sialkot Medical and Physiotherapy Center
Sialkot, Punjab Province, 51310
About this study
Official title: Effects of Aerobic Versus Resistance Training on Blood Pressure, Cardiorespiratory Fitness and Quality of Life in Post Percutaneous Coronary Intervention Obese Patients
The randomized clinical trial (RCT) endeavors to enroll 50 participants, divided equally into aerobic exercise and resistance exercise groups. The study employs rigorous tools such as blood pressure measurement, SF-36 questionnaire, and the Six-Minute Walk Test (6MWT) to assess VO2max.
Read the detailed description
The randomized clinical trial (RCT) endeavors to enroll 50 participants, divided equally into aerobic exercise and resistance exercise groups. The non-probability convenient sampling technique, followed by random allocation using a lottery method, ensures a diverse yet unbiased sample. Will be conducted at the Sialkot Medical and Physiotherapy Centre, the inclusion criteria will focus on post-PCI patients aged 40-60, presenting with a BMI of 30 or higher. The study employs rigorous tools such as blood pressure measurement, SF-36 questionnaire, and the Six-Minute Walk Test (6MWT) to assess VO2max. The aerobic exercise group undergoes sessions three times a week, progressively increasing in duration and intensity, emphasizing activities like brisk walking and cycling. The resistance exercise group follows a similar schedule, engaging in full-body resistance exercises targeting major muscle groups. Both groups undergo assessments using cardiopulmonary exercise testing (CPET) to determine exercise tolerance accurately.
- Conditions
- Cardiovascular Diseases
- Being tested
- Aerobic Training, Resistance Training
- Keywords
- Aerobic Exercise, Angioplasty, Obese Patients, Percutaneous Coronary Intervention, Resistance Training
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic TrainingOther
Aerobic Training: Brisk walking, jogging, cycling, or low-impact aerobics
Resistance TrainingOther
Resistance Training: Full body resistance exercise targeting major muscle groups, including squats, lunges, chest presses, rows, and core exercises
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Brisk walking, jogging, cycling, or low-impact aerobics Receives: Other: Aerobic Training |
| Group B | Active comparator | Full body resistance exercise targeting major muscle groups, including squats, lunges, chest presses, rows, and core exercises Receives: Other: Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Blood pressure is a crucial physiological parameter often employed as a data collection tool in research, particularly in studies focused on cardiovascular health and related interventions.
Measured: 4 Weeks
Six Minute Walk Test
The 6-minute walk test (6MWT) serves as a valuable and widely used data collection tool in research, particularly in studies assessing functional capacity, exercise tolerance, and overall physical performance.
Measured: 4 Weeks
SF 36 Questionnaire
The Short Form 36 (SF-36) is a widely used health-related quality of life (HRQoL) questionnaire that serves as a comprehensive data collection tool in research studies across various disciplines.
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start1 Mar 2024
- Primary completion5 Jun 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Faizan Hamid, MS-CPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308276
- Sponsor's protocol ID
- REC/RCR&AHS/23/0363
- Status last verified
- Jul 2024
- First submitted
- 4 Mar 2024
- Last updated
- 23 Jul 2024
- 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 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Versus Resistance Training on Blood Pressure, Cardiorespiratory Fitness and Quality of Life in Post Percutaneous Coronary Intervention Obese Patients
- ClinicalTrials.gov ID
- NCT06308276
- Acronym / sponsor ID
- REC/RCR&AHS/23/0363
- Conditions
- Cardiovascular Diseases
- Keywords
- Aerobic Exercise, Angioplasty, Obese Patients, Percutaneous Coronary Intervention, Resistance Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 13 Mar 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.
The randomized clinical trial (RCT) endeavors to enroll 50 participants, divided equally into aerobic exercise and resistance exercise groups. The study employs rigorous tools such as blood pressure measurement, SF-36 questionnaire, and the Six-Minute Walk Test (6MWT) to assess VO2max.
Detailed description
The randomized clinical trial (RCT) endeavors to enroll 50 participants, divided equally into aerobic exercise and resistance exercise groups. The non-probability convenient sampling technique, followed by random allocation using a lottery method, ensures a diverse yet unbiased sample. Will be conducted at the Sialkot Medical and Physiotherapy Centre, the inclusion criteria will focus on post-PCI patients aged 40-60, presenting with a BMI of 30 or higher. The study employs rigorous tools such as blood pressure measurement, SF-36 questionnaire, and the Six-Minute Walk Test (6MWT) to assess VO2max. The aerobic exercise group undergoes sessions three times a week, progressively increasing in duration and intensity, emphasizing activities like brisk walking and cycling. The resistance exercise group follows a similar schedule, engaging in full-body resistance exercises targeting major muscle groups. Both groups undergo assessments using cardiopulmonary exercise testing (CPET) to determine exercise tolerance accurately.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Aerobic TrainingBrisk walking, jogging, cycling, or low-impact aerobics |
| Group B | Active comparator | Other: Resistance TrainingFull body resistance exercise targeting major muscle groups, including squats, lunges, chest presses, rows, and core exercises |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age: Participants must be between 40 and 60 years old.
- Gender: Male and female both.
- Cardiovascular Status: Post Percutaneous Coronary Intervention (PCI) patients with a documented history of coronary artery disease
- Participants who are at least three months post PCI to ensure stabilization of their cardiovascular condition.
- Obesity: Participants must have a Body Mass Index (BMI) equal to or greater than 30 kg/m², indicating obesity.
Key exclusion criteria (4 listed)
- Participants with severe physical limitations, disabilities, or musculoskeletal disorders that would prevent them from engaging in aerobic and resistance exercises.
- Individuals with a history of substance abuse or current substance abuse issues that might interfere with their ability to participate or adhere to the study protocol.
- Patients with Neurological diseases
- Patients with severe or unstable heart conditions, recent heart attack, or heart failure
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 |
|---|---|---|
| Aerobic TrainingAerobic Training: Brisk walking, jogging, cycling, or low-impact aerobics | Other | Group A |
| Resistance TrainingResistance Training: Full body resistance exercise targeting major muscle groups, including squats, lunges, chest presses, rows, and core exercises | Other | Group B |
Primary outcome
Blood Pressure
Time frame: 4 Weeks
Blood pressure is a crucial physiological parameter often employed as a data collection tool in research, particularly in studies focused on cardiovascular health and related interventions.
Six Minute Walk Test
Time frame: 4 Weeks
The 6-minute walk test (6MWT) serves as a valuable and widely used data collection tool in research, particularly in studies assessing functional capacity, exercise tolerance, and overall physical performance.
SF 36 Questionnaire
Time frame: 4 Weeks
The Short Form 36 (SF-36) is a widely used health-related quality of life (HRQoL) questionnaire that serves as a comprehensive data collection tool in research studies across various disciplines.
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 23 Jul 2024.
- 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 Faizan Hamid, MS-CPPT 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 Aerobic Training and Resistance Training in people with Cardiovascular Diseases, 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 8 inclusion and 4 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 23 Jul 2024. 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?
Blood Pressure (time frame: 4 Weeks). 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 23 Jul 2024.