Exercise Training in Coronary Artery Disease Patients After Stenting

NCT ID: NCT05591365

Last Updated: 2023-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-18
• Study Completion Date: 2023-03-01

Brief Summary

To determine the effect of exercise training on cardiac outcomes in coronary artery disease patients after Stenting. There is a need to develop strategies, not only to prevent restenosis but also to improve patients' functional status and perception of well-being. In particular, it is not well defined whether exercise training can reduce the restenosis rate and improve the outcome after PCI.

Detailed Description

Based on an analysis of literature reviews, psychological symptoms (such as depression and anxiety), angina, vital exhaustion, and dyspnea have been observed to have the most significant influence on the quality of life in people with CAD. Almost half of the patients, after an initial encouraging improvement in functional capacity and quality of life (QOL) after the PCI, deal with recurrent chest pain that requires medical attention, reduces functional capacity, and creates a status of psychological distress.

Conditions

Stent Restenosis; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Structured In-patient and Home plan

Structured In-patient and Home plan

Group Type: EXPERIMENTAL

Structured In-Patient and Home plan

Intervention Type: OTHER

A patient education session and a protocol comprise of 3 days. It consists of three different levels having progressive activities. The in-patient protocol will start from the day of the procedure. Each level contains 2 to 6 tasks, performed in sets of 5-10 repetitions 3 times a day. Home plan: Walking 3 days a week starting from normal pace ((RPE: 8-9) for10 minutes and progressively increased intensity and duration over the period of 12 weeks (RPE: 13-14).

Conventional therapy

Conventional protocol as per guidelines

Group Type: PLACEBO_COMPARATOR

Conventional Therapy

Intervention Type: OTHER

In-Patient: Wound care, Bed mobility:

AROMS (10 Reps*3sets*TD), Breathing Exercise (10 Reps*3sets*TD), Mobilization (Walk as per patient tolerance) Patient Education: To keep the heart healthy Diet Avoid strenuous exercise and lifting heavy objects Avoid valsalva manure, Quit smoking Lower cholesterol levels, Maintain a healthy weight Control other conditions, such as diabetes and high blood pressure Take medications as prescribed by your doctor Get regular exercise: Walking at a normal pace as per tolerance (RPE up to 10)

Interventions

Structured In-Patient and Home plan

A patient education session and a protocol comprise of 3 days. It consists of three different levels having progressive activities. The in-patient protocol will start from the day of the procedure. Each level contains 2 to 6 tasks, performed in sets of 5-10 repetitions 3 times a day. Home plan: Walking 3 days a week starting from normal pace ((RPE: 8-9) for10 minutes and progressively increased intensity and duration over the period of 12 weeks (RPE: 13-14).

Intervention Type: OTHER

Conventional Therapy

In-Patient: Wound care, Bed mobility:

AROMS (10 Reps*3sets*TD), Breathing Exercise (10 Reps*3sets*TD), Mobilization (Walk as per patient tolerance) Patient Education: To keep the heart healthy Diet Avoid strenuous exercise and lifting heavy objects Avoid valsalva manure, Quit smoking Lower cholesterol levels, Maintain a healthy weight Control other conditions, such as diabetes and high blood pressure Take medications as prescribed by your doctor Get regular exercise: Walking at a normal pace as per tolerance (RPE up to 10)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• GCS = 15
• Disease chronicity: 1-3 years
• Elective / stenting procedure
• Single or Double vessel stunting
• EF: 35 above

Exclusion Criteria

• Unwilling to participate in research
• Known cases of Uncontrolled DM or HTN
• Known cases of Cognitive/memory/neurological disorders
• Known cases of any Systemic disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mehwish Waseem, MSPT(CPPT)

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Armed forces institute of cardiology

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

Rec/01277 Pakiza Batool

Identifier Type: -

Identifier Source: org_study_id