Effect of Exercise Training in Coronary Artery Disease Patients After Stenting

Sponsor

Riphah International University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05315193

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine the effects of exercise training on ankle-brachial index and Quality of Life 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 percutaneous intervention (PCI), and its effects on the Ankle-brachial index are not yet well known.

Condition or Disease	Intervention/Treatment	Phase
Stent Restenosis Coronary Artery Disease	Other: Structured In-patient and Home plan Other: Conventional Therapy	N/A

Detailed Description

The existence of PAD in patients with Coronary artery disease (CAD) remarkably increases the risk of cardiovascular morbidity and mortality. 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Effects of Exercise Training on Ankle-brachial Index and Quality of Life in Coronary Artery Disease Patients After Stenting.

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Structured In-patient and Home plan Structured In-patient and Home plan	Other: 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).
Placebo Comparator: Conventional therapy Conventional protocol as per guidelines	Other: Conventional Therapy In-Patient: Wound care, Bed mobility: AROMS (10 Reps3setsTD), Breathing Exercise (10 Reps3setsTD), 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)

Arm

Intervention/Treatment

Experimental: Structured In-patient and Home plan

Structured In-patient and Home plan

Other: 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).

Placebo Comparator: Conventional therapy

Conventional protocol as per guidelines

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)

Outcome Measures

Primary Outcome Measures

Ankle-brachial index [12 weeks]
Changes From the Baseline,6th week and 12 weeks, measured through the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial artery to detect Peripheral Artery Disease. Normal Ankle-brachial index ranges from 1.0 to 1.4.
Quality of life index cardiac version -IV [12 weeks]
Changes From the Baseline, 6th week and 12 weeks measured through Quality of life index cardiac version -IV. It consists of 70 items. Each item used a six-point Likert rating scale. Scores calculated for overall quality of life in four domains: health and functioning (15 items), social and economic (8 items), psychological/spiritual (7 items), and family (5 items). High scores indicated a better quality of life.

Secondary Outcome Measures

Dyspnea [3-5 days]
Changes From the Baseline, measured through Rose Dyspnea Scale. The scale consists of four items, with scores ranging from 0 to 4, where 0 indicates no dyspnea with activity, and increasing scores indicate greater limitations because of dyspnea.
Rate of perceived exertion (RPE) [12 weeks]
Changes From the Baseline,6th week and 12 weeks, measured through Borg RPE scale which measures a person's perception of their effort and exertion breathlessness, and fatigue during physical work rating between 6 and 20. The higher the number, the more intense the exercise. An RPE of 6 is often referred to as just above rest, hardly any exertion, while an RPE of 20 is a maximal effort.
Forced Expiratory Volume in 1 second (FEV1) [12 weeks]
Changes from the Baseline,6th week and 12 weeks, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
Forced vital Capacity (FVC) [12 weeks]
Changes From the Baseline,6th week and 12 weeks, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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