Clinical trial NCT06308276: Effects of Aerobic Versus Resistance Training in Post Percutaneous Coronary Intervention Obese Patients
Official title: Effects of Aerobic Versus Resistance Training on Blood Pressure, Cardiorespiratory Fitness and Quality of Life in Post Percutaneous Coronary Intervention Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Aerobic Exercise
Angioplasty
Obese Patients
Percutaneous Coronary Intervention
Resistance Training
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: Blood Pressure
timeFrame: 4 Weeks
measure: Six Minute Walk Test
timeFrame: 4 Weeks
measure: SF 36 Questionnaire
timeFrame: 4 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sialkot
country: Pakistan
facility: Sialkot Medical and Physiotherapy Center
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Faizan Hamid, MS-CPPT
role: PRINCIPAL_INVESTIGATOR
References: