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
About this trial
This is an interventional treatment trial for Stent Restenosis focused on measuring Coronary artery diseases, Exercise training, Stenting
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
Sites / Locations
- Armed forces 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
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.
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
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.
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.
Mean arterial pressure
Changes From the Baseline, measured through cardiac monitor. Normal range is between 70 and 100 mm Hg.
Heart Rate
Changes From the Baseline, measured through Cardiac monitor/Pulse-oximeter. Normal Resting Heart rate ranges from 60 to 100 beats per minute.
Respiratory rate
Changes From the Baseline, measured through cardiac monitor. Normal Resting Respiratory rate is12 to 20 breaths per minute
Transcutaneous oxygen saturation [SpO2]
Changes From the Baseline, measured through Cardiac monitor/Pulse-oximeter. Normal Resting SpO2 ranges 95% or higher.
Secondary Outcome Measures
Full Information
NCT ID
NCT05591365
First Posted
March 30, 2022
Last Updated
May 17, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05591365
Brief Title
Exercise Training in Coronary Artery Disease Patients After Stenting
Official Title
Effects of Exercise Training on Cardiac Parameters 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
March 1, 2023 (Actual)
Study Completion Date
March 1, 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 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.
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
Coronary artery diseases, Exercise training, Stenting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (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
6 min walk test: Distance (meters)
Description
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.
Time Frame
12 weeks
Title
Mindfulness
Description
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
Time Frame
12 weeks
Title
Rate of perceived exertion (RPE)
Description
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.
Time Frame
12 weeks
Title
Dyspnea
Description
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.
Time Frame
12 weeks
Title
Mean arterial pressure
Description
Changes From the Baseline, measured through cardiac monitor. Normal range is between 70 and 100 mm Hg.
Time Frame
3-5 days
Title
Heart Rate
Description
Changes From the Baseline, measured through Cardiac monitor/Pulse-oximeter. Normal Resting Heart rate ranges from 60 to 100 beats per minute.
Time Frame
3-5 days
Title
Respiratory rate
Description
Changes From the Baseline, measured through cardiac monitor. Normal Resting Respiratory rate is12 to 20 breaths per minute
Time Frame
3-5 days
Title
Transcutaneous oxygen saturation [SpO2]
Description
Changes From the Baseline, measured through Cardiac monitor/Pulse-oximeter. Normal Resting SpO2 ranges 95% or higher.
Time Frame
3-5 days
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
Armed forces institute of cardiology
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
4400
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
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Exercise Training in Coronary Artery Disease Patients After Stenting
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