Effect of Exercise Training in Coronary Artery Disease Patients After Stenting

NCT05315193 | Completed DMC

• 1 other identifier: Rec/01279 Umair Ahmad
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Stent Restenosis; Coronary Artery Disease

Keywords

Ankle-Brachial Index; Coronary artery diseases; Exercise training; Quality of life; Stenting

Outcome Measures

Primary Outcomes (2)

• Ankle-brachial index

  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.

  12 weeks

• Quality of life index cardiac version -IV

  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.

  12 weeks

Secondary Outcomes (4)

• Dyspnea

  3-5 days

• Rate of perceived exertion (RPE)

  12 weeks

• Forced Expiratory Volume in 1 second (FEV1)

  12 weeks

• Forced vital Capacity (FVC)

  12 weeks

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)

Peshawar Institute of cardiology

Peshawar, KPK, 25000, 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: April 7, 2022
• Study Start: October 18, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)