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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06308276
Other study ID # REC/RCR&AHS/23/0363
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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