Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-28 @ 12:10 AM
Study NCT ID:
NCT04610060
Status:
COMPLETED
Last Update Posted:
2022-10-18
First Post:
2020-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Power Walking in Cardiac Patients Who Underwent Post-coronary Angioplasty
Sponsor:
Gulf Medical University
Organization:
Study Overview
Official Title:
Effectiveness of Standardized Outpatient Cardiac Rehabilitation Program Combined With Power Walking on Quality of Life and Exercise Capacity in Patients With Post-coronary Angioplasty: A Pragmatic Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PowerWalk
Brief Summary:
The risk and prevalence of cardiovascular disease in United Arab Emirates (UAE) is high with ischemic heart disease ranks first in terms of major cause of mortality. Large number of patients undergoes coronary angioplasty but very few participate in cardiac rehabilitation because its awareness is not widespread in middle east region.
The objectives was to find the influence of standardized outpatient cardiac rehabilitation program along with power walking on Heart quality of life (Heart QoL), functional exercise capacity, Left Ventricular Ejection Fraction and metabolic equivalent task (MET's) among patients with post coronary angioplasty.
The investigators conducted a randomized clinical trail in out patient physiotherapy department at Thumbay hospitals Dubai, on patients who underwent coronary artery angioplasty. After meeting the inclusion criteria, participants were randomized into standardized outpatient cardiac rehabilitation program along with power walking (intervention group) or standardized outpatient cardiac rehabilitation program (control group).
A 4 weeks of 12 outpatient cardiac rehabilitation sessions consisting of 3 sessions per week was provided to both the groups. Intervention group received standardized outpatient cardiac rehabilitation program along with power walking based on targeted heart rate and weekly steps, whereas control group received only standardized outpatient cardiac rehabilitation program based on American College of Sports Medicine (ACSM) Guidelines.
The investigators measured Quality Of Life (HRQoL) by HeartQoL questionnaire, Exercise Capacity by 6 min walk test (6MWT), Left ventricle Ejection fraction (LVEF) using Echocardiogram, Metabolic Equivalent Task (MET'S) using Symptom-limited exercise stress test and Average number of steps walked daily using step up smartphone Pedometer App.
The objectives was to find the influence of standardized outpatient cardiac rehabilitation program along with power walking on Heart quality of life (Heart QoL), functional exercise capacity, Left Ventricular Ejection Fraction and metabolic equivalent task (MET's) among patients with post coronary angioplasty.
The investigators conducted a randomized clinical trail in out patient physiotherapy department at Thumbay hospitals Dubai, on patients who underwent coronary artery angioplasty. After meeting the inclusion criteria, participants were randomized into standardized outpatient cardiac rehabilitation program along with power walking (intervention group) or standardized outpatient cardiac rehabilitation program (control group).
A 4 weeks of 12 outpatient cardiac rehabilitation sessions consisting of 3 sessions per week was provided to both the groups. Intervention group received standardized outpatient cardiac rehabilitation program along with power walking based on targeted heart rate and weekly steps, whereas control group received only standardized outpatient cardiac rehabilitation program based on American College of Sports Medicine (ACSM) Guidelines.
The investigators measured Quality Of Life (HRQoL) by HeartQoL questionnaire, Exercise Capacity by 6 min walk test (6MWT), Left ventricle Ejection fraction (LVEF) using Echocardiogram, Metabolic Equivalent Task (MET'S) using Symptom-limited exercise stress test and Average number of steps walked daily using step up smartphone Pedometer App.
Detailed Description:
Approximately 17.8 million worldwide deaths per year are due to cardiovascular disease (CVD). Arab countries are at higher risk of CVD in which middle income countries are mostly at burden. "The threshold for cardiac arrests and cardiovascular disease (CVD) worldwide is 65 years, while people in the UAE are suffering from the CVD at the age of 45" reported by Emirates Cardiac Society. One of the most common causes of cardiovascular deaths is coronary artery disease (CAD). Coronary angioplasty one of the most common non-surgical approach for the treatment of ischemic coronary artery disease. It is widely accepted that cardiac rehabilitation can be beneficial for patients with heart diseases. Most of the patients won't achieve adequate functional improvement, if rehabilitation exercises are not done on regular basis post-coronary angioplasty.
In cardiac rehabilitation (CR) programs, psychosocial function and the assessment of quality of life (QOL) are the major objective parameters commonly used by researchers. Physical activity and emotional status influence health related quality of life (HRQOL) in patient underwent coronary angioplasty. It is important to find effectiveness of CR on health related quality of life (HRQOL). Studies has shown that tailored exercise training helped to improve Left Ventricle Ejection Fraction (LVEF) in patients post coronary angioplasty. A systematic review highlighted the effectiveness of using 6MWT to show improvement of functional capacity in patients undergoing cardiac rehabilitation.
It is well known that walking exercise reduces cardiovascular disease-related mortality and predicts longevity in patients with established CAD. One of the integral components of cardiac rehabilitation is treadmill walking. A meta-analysis demonstrated that physical activity could be enhanced in patients with the use of pedometer. Recent evidence shows that smartphone apps are effective at promoting physical activity. Studies also shows that smartphone Apps are more accurate in tracking steps as compared to fitness trackers.
Power walking is an effective part of phase II cardiac rehabilitation. Running is preferred over walking since oxygen consumption while running is less as compared to walking.
It was reported that up to 1 year, cardiac rehabilitation improves QOL in patients with acute myocardial infarction (AMI) or revascularization procedures. Four weeks of short CR course provides better attendance, improvement in quality of life and exercise capacity.
Accordingly, the current study was conducted for 4 weeks, a shorter period of rehabilitation and documented the effectiveness on cardiac fitness including health related quality of life, functional exercise capacity, ejection fraction and metabolic equivalent task (MET's) of patients with post angioplasty.
Although the advantages of CR are well known to most of the physicians, still one third of the patients do not receive CR post coronary angioplasty due to poor referral trends. Higher rates of quality-of-care measures were found among patients who were referred for CR compared to those who were not referred. Post coronary angioplasty patients need to continue with cardiac rehabilitation in a progressive manner to attain the overall improvement. In a comparative study where 5 and 39 CR programs participated from Arab countries and Canada respectively showed that in Arab countries CR programs are very limited. Recent statistics in UAE has shown that 30% deaths are due to cardiovascular diseases, 30-70% population has cardiovascular diseases or are at risk and 37% population do not exercise and are physical inactive.
The concept is very clear that significant number of eligible patients with cardiac conditions is not referred for outpatient CR. Although most patients post coronary angioplasty are encouraged by cardiologist to gradually increase their activity levels, limited data are available on the amount of physical and walking activity and regular aerobic exercises done by patients with post coronary angioplasty at phase II CR.
Power walking has an advantage that it consumes 55% more energy in comparison to just walking alone or running at a speed of 6 to 8 km/h, while being at a lower intensity. Despite the advantages of power walking, the exercise effects have not been reported in cardiac rehabilitation programs.
This study will help to fulfill great need for referral and awareness of out patient cardiac rehabilitation by proving outcomes of standardized outpatient cardiac rehabilitation program. The investigators utilized power walking along with standardized cardiac rehabilitation to find effectiveness on health related quality of life, functional exercise capacity, ejection fraction and metabolic equivalent task (MET's) of patients with post coronary angioplasty. Henceforth, the need for research is to prove the effectiveness of cardiac rehabilitation in UAE population.
In cardiac rehabilitation (CR) programs, psychosocial function and the assessment of quality of life (QOL) are the major objective parameters commonly used by researchers. Physical activity and emotional status influence health related quality of life (HRQOL) in patient underwent coronary angioplasty. It is important to find effectiveness of CR on health related quality of life (HRQOL). Studies has shown that tailored exercise training helped to improve Left Ventricle Ejection Fraction (LVEF) in patients post coronary angioplasty. A systematic review highlighted the effectiveness of using 6MWT to show improvement of functional capacity in patients undergoing cardiac rehabilitation.
It is well known that walking exercise reduces cardiovascular disease-related mortality and predicts longevity in patients with established CAD. One of the integral components of cardiac rehabilitation is treadmill walking. A meta-analysis demonstrated that physical activity could be enhanced in patients with the use of pedometer. Recent evidence shows that smartphone apps are effective at promoting physical activity. Studies also shows that smartphone Apps are more accurate in tracking steps as compared to fitness trackers.
Power walking is an effective part of phase II cardiac rehabilitation. Running is preferred over walking since oxygen consumption while running is less as compared to walking.
It was reported that up to 1 year, cardiac rehabilitation improves QOL in patients with acute myocardial infarction (AMI) or revascularization procedures. Four weeks of short CR course provides better attendance, improvement in quality of life and exercise capacity.
Accordingly, the current study was conducted for 4 weeks, a shorter period of rehabilitation and documented the effectiveness on cardiac fitness including health related quality of life, functional exercise capacity, ejection fraction and metabolic equivalent task (MET's) of patients with post angioplasty.
Although the advantages of CR are well known to most of the physicians, still one third of the patients do not receive CR post coronary angioplasty due to poor referral trends. Higher rates of quality-of-care measures were found among patients who were referred for CR compared to those who were not referred. Post coronary angioplasty patients need to continue with cardiac rehabilitation in a progressive manner to attain the overall improvement. In a comparative study where 5 and 39 CR programs participated from Arab countries and Canada respectively showed that in Arab countries CR programs are very limited. Recent statistics in UAE has shown that 30% deaths are due to cardiovascular diseases, 30-70% population has cardiovascular diseases or are at risk and 37% population do not exercise and are physical inactive.
The concept is very clear that significant number of eligible patients with cardiac conditions is not referred for outpatient CR. Although most patients post coronary angioplasty are encouraged by cardiologist to gradually increase their activity levels, limited data are available on the amount of physical and walking activity and regular aerobic exercises done by patients with post coronary angioplasty at phase II CR.
Power walking has an advantage that it consumes 55% more energy in comparison to just walking alone or running at a speed of 6 to 8 km/h, while being at a lower intensity. Despite the advantages of power walking, the exercise effects have not been reported in cardiac rehabilitation programs.
This study will help to fulfill great need for referral and awareness of out patient cardiac rehabilitation by proving outcomes of standardized outpatient cardiac rehabilitation program. The investigators utilized power walking along with standardized cardiac rehabilitation to find effectiveness on health related quality of life, functional exercise capacity, ejection fraction and metabolic equivalent task (MET's) of patients with post coronary angioplasty. Henceforth, the need for research is to prove the effectiveness of cardiac rehabilitation in UAE population.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: