Exercise Training in Coronary Artery Disease Patients After Stenting

NCT05591365 | Completed DMC

• 1 other identifier: Rec/01277 Pakiza Batool
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stent Restenosis; Coronary Artery Disease

Keywords

Coronary artery diseases; Exercise training; Stenting

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Structured In-patient and Home plan

EXPERIMENTAL

Structured In-patient and Home plan

Other: Structured In-Patient and Home plan

Conventional therapy

PLACEBO COMPARATOR

Conventional protocol as per guidelines

Other: Conventional Therapy

Interventions

Structured In-Patient and Home plan 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).

Structured In-patient and Home plan

Conventional Therapy 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)

Conventional therapy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Armed forces institute of cardiology

Rawalpindi, Punjab Province, 4400, Pakistan

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Mehwish Waseem, MSPT(CPPT)

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: October 24, 2022
• Study Start: October 18, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)