Exercise Training in Coronary Artery Disease Patients After Stenting

Effects of Exercise Training on Cardiac Parameters in Coronary Artery Disease Patients After Stenting

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Stent Restenosis
• Intervention / Treatment: Other: Conventional Therapy; Other: Structured In-Patient and Home plan

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 4400
      • Armed Forces Institute of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

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
Experimental: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 min walk test: Distance (meters)	Changes from the baseline,6th week and 12th week, 6 min walk test (6 MWT) was used to measure Functional capacity. It is a sub maximal exercise test which can aid in assessing functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters which an individual covers in 6 min without any support.	12 weeks
Mindfulness	Changes from the Baseline,6th week and 12th week, measured through MAAS. The MAAS is a 15-item scale designed to assess a core characteristic of dispositional mindfulness, namely, open or receptive awareness of and attention to what is taking place in the present. The scale shows strong psychometric properties and has been validated with college, community, and cancer patient samples.Higher scores reflect higher levels of dispositional mindfulness	12 weeks
Rate of perceived exertion (RPE)	Changes from the Baseline,6th week and 12th week, 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.	12 weeks
Dyspnea	Changes From the Baseline,6th week and 12th week, 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.	12 weeks
Mean arterial pressure	Changes From the Baseline, measured through cardiac monitor. Normal range is between 70 and 100 mm Hg.	3-5 days
Heart Rate	Changes From the Baseline, measured through Cardiac monitor/Pulse-oximeter. Normal Resting Heart rate ranges from 60 to 100 beats per minute.	3-5 days
Respiratory rate	Changes From the Baseline, measured through cardiac monitor. Normal Resting Respiratory rate is12 to 20 breaths per minute	3-5 days
Transcutaneous oxygen saturation [SpO2]	Changes From the Baseline, measured through Cardiac monitor/Pulse-oximeter. Normal Resting SpO2 ranges 95% or higher.	3-5 days

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Mehwish Waseem, MSPT(CPPT), Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2022
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: October 21, 2022
• First Posted (Actual): October 24, 2022

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Exercise training; Coronary artery diseases; Stenting
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: Rec/01277 Pakiza Batool

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