Effects of Aerobic Versus Resistance Training in Post Percutaneous Coronary Intervention Obese Patients

Cardiovascular Diseases Clinical Trial

Official title:

Effects of Aerobic Versus Resistance Training on Blood Pressure, Cardiorespiratory Fitness and Quality of Life in Post Percutaneous Coronary Intervention Obese Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06308276
• Other study ID #: REC/RCR&AHS/23/0363
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: June 15, 2024

Study information

• Verified date: March 2024
• Source: Riphah International University
• Contact: Imran Amjad, PHD
• Phone: 03324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 15, 2024
• Est. primary completion date: June 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Other:
• Aerobic Training
Aerobic Training: Brisk walking, jogging, cycling, or low-impact aerobics
• Resistance Training
Resistance Training: Full body resistance exercise targeting major muscle groups, including squats, lunges, chest presses, rows, and core exercises

Locations

Country	Name	City	State
Pakistan	Sialkot Medical and Physiotherapy Center	Sialkot	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 Weeks
Primary	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.	4 Weeks
Primary	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.	4 Weeks