Exercise Training in Coronary Artery Disease Patients After Stenting

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Stent Restenosis
• Interventions: Other: Conventional Therapy; Other: Structured In-Patient and Home plan

• Registration Number: NCT05591365
• Lead Sponsor: Riphah International University

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.

Study Timeline

• Study First Submitted: 2022-03-30
• Study Start: 2022-10-18
• Study First Submitted QC: 2022-10-21
• Study First Posted: 2022-10-24
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-17
• Last Update Posted: 2023-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional therapy	Conventional Therapy	Conventional protocol as per guidelines
Structured In-patient and Home plan	Structured In-Patient and Home plan	Structured In-patient and Home plan

Primary Outcome Measures

Name	Time	Method
Mindfulness	12 weeks	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
Mean arterial pressure	3-5 days	Changes From the Baseline, measured through cardiac monitor. Normal range is between 70 and 100 mm Hg.
Rate of perceived exertion (RPE)	12 weeks	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.
Transcutaneous oxygen saturation [SpO2]	3-5 days	Changes From the Baseline, measured through Cardiac monitor/Pulse-oximeter. Normal Resting SpO2 ranges 95% or higher.
6 min walk test: Distance (meters)	12 weeks	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.
Dyspnea	12 weeks	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.
Heart Rate	3-5 days	Changes From the Baseline, measured through Cardiac monitor/Pulse-oximeter. Normal Resting Heart rate ranges from 60 to 100 beats per minute.
Respiratory rate	3-5 days	Changes From the Baseline, measured through cardiac monitor. Normal Resting Respiratory rate is12 to 20 breaths per minute

Trial Locations

Locations (1)

Armed forces institute of cardiology; 🇵🇰 Rawalpindi, Punjab, Pakistan