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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Other: Aerobic Training; Other: Resistance Training

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Imran Amjad, Phd; Phone Number: 03324390125; Email: imran.amjad@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab
    • Sialkot, Punjab, Pakistan, 51310
      • Recruiting
      • Sialkot Medical and Physiotherapy Center
      • Contact: Fasih Ahmed Rehmani, MS-OMPT; Phone Number: 03348005240; Email: Fasih12190@gmail.com
      • Sub-Investigator: Teenat Fatima, DPT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Brisk walking, jogging, cycling, or low-impact aerobics	Other: Aerobic Training; Aerobic Training: Brisk walking, jogging, cycling, or low-impact aerobics
Active Comparator: Group B; Full body resistance exercise targeting major muscle groups, including squats, lunges, chest presses, rows, and core exercises	Other: Resistance Training; Resistance Training: Full body resistance exercise targeting major muscle groups, including squats, lunges, chest presses, rows, and core exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Muhammad Faizan Hamid, Ms-CPPT, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): June 5, 2024
• Study Completion (Estimated): June 15, 2024

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Obese Patients; Aerobic Exercise; Angioplasty; Resistance Training
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: REC/RCR&AHS/23/0363

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No