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Effect of Exercise Training in Coronary Artery Disease Patients After Stenting

Primary Purpose

Stent Restenosis, Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Structured In-patient and Home plan
Conventional Therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stent Restenosis focused on measuring Ankle-Brachial Index, Coronary artery diseases, Exercise training, Quality of life, Stenting

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Peshawar Institute of cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Structured In-patient and Home plan

Conventional therapy

Arm Description

Structured In-patient and Home plan

Conventional protocol as per guidelines

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Dyspnea
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)
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)
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)
Changes From the Baseline,6th week and 12 weeks, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters

Full Information

First Posted
March 30, 2022
Last Updated
May 17, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05315193
Brief Title
Effect of Exercise Training in Coronary Artery Disease Patients After Stenting
Official Title
Effects of Exercise Training on Ankle-brachial Index and Quality of Life in Coronary Artery Disease Patients After Stenting.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 18, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stent Restenosis, Coronary Artery Disease
Keywords
Ankle-Brachial Index, Coronary artery diseases, Exercise training, Quality of life, Stenting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Structured In-patient and Home plan
Arm Type
Experimental
Arm Description
Structured In-patient and Home plan
Arm Title
Conventional therapy
Arm Type
Placebo Comparator
Arm Description
Conventional protocol as per guidelines
Intervention Type
Other
Intervention Name(s)
Structured In-patient and Home plan
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Conventional Therapy
Intervention Description
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)
Primary Outcome Measure Information:
Title
Ankle-brachial index
Description
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.
Time Frame
12 weeks
Title
Quality of life index cardiac version -IV
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Dyspnea
Description
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.
Time Frame
3-5 days
Title
Rate of perceived exertion (RPE)
Description
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.
Time Frame
12 weeks
Title
Forced Expiratory Volume in 1 second (FEV1)
Description
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
Time Frame
12 weeks
Title
Forced vital Capacity (FVC)
Description
Changes From the Baseline,6th week and 12 weeks, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehwish Waseem, MSPT(CPPT)
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peshawar Institute of cardiology
City
Peshawar
State/Province
KPK
ZIP/Postal Code
25000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Exercise Training in Coronary Artery Disease Patients After Stenting

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