Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06283940
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-02-06
Brief Title:
Exercise-based Cardiac Rehabilitation in Patients With Aortic Stenosis After Transcatheter Aortic Valve Implantation
Sponsor:
Vastra Gotaland Region
Organization:
Vastra Gotaland Region
Study Overview
Official Title:
Effect of Physiotherapist-led Exercise-based Cardiac Rehabilitation in Older Patients With Aortic Stenosis Who Have Undergone TAVI
Status:
RECRUITING
Status Verified Date:
2024-08
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:
TAVI
Brief Summary:
Aortic valve stenosis AS is the most common valve disease among older individuals In symptomatic AS mortality is high and the only treatment that improves prognosis and survival is transcatheter aortic valve implantation TAVI TAVI is a growing treatment in Sweden allowing previously inoperable older patients with AS who are often frail and have comorbidities to receive intervention This results in the need for postoperative cardiac rehabilitation for patients treated with TAVI Previous systematic reviews and meta-analyses examining the effect of physiotherapist-led exercise-based cardiac rehabilitation PT-X after TAVI have shown that participation in PT-X can improve physical fitness the highest measured oxygen uptake VO2peak walking distance walking speed and health-related quality of life HR-QoL However the included studies are limited and there is selection bias resulting in low evidence Therefore access to PT-X is currently almost non-existent in Sweden As more patients undergo TAVI it is crucial to investigate whether PT-X after TAVI can further improve physical fitness HR-QoL and reduce hospital admissions in older individuals with AS
Objective Primary to investigate whether participation in PT-X after TAVI can impact physical fitness physical activity level and health-related quality of life Secondary to study the prevalence of frailty and the number of hospital admissions during the first postoperative year after TAVI
Expected outcome If patients with AS who have undergone TAVI can improve physical fitness it could potentially strengthen the evidence and optimize the patients physical capabilities Increased access to PT-X and awareness of frailty in these patients could reduce the risk of falls and possibly the number of hospital readmissions This would decrease healthcare consumption and improve the patients quality of life
Objective Primary to investigate whether participation in PT-X after TAVI can impact physical fitness physical activity level and health-related quality of life Secondary to study the prevalence of frailty and the number of hospital admissions during the first postoperative year after TAVI
Expected outcome If patients with AS who have undergone TAVI can improve physical fitness it could potentially strengthen the evidence and optimize the patients physical capabilities Increased access to PT-X and awareness of frailty in these patients could reduce the risk of falls and possibly the number of hospital readmissions This would decrease healthcare consumption and improve the patients quality of life
Detailed Description:
Aortic valve stenosis AS is the most common valve disease with the highest prevalence in older individuals Healthcare is unequal with women receiving specialist care and interventions less frequently than men They also receive the diagnosis later and mortality rates are higher AS develops over time and in the presence of symptomatic AS such as angina pectoris syncope and heart failure the prognosis is poor and mortality is high If untreated AS is a disease with a 2-year relative mortality risk of 50 In older patients at high risk with symptomatic AS transcatheter aortic valve implantation TAVI is the only medical treatment that improves prognosis and survival
Since 2008 TAVI has been performed in Sweden as a standard treatment with priority 3 in the the recommendations given by the National Board of Health and Welfare in Sweden The number of TAVI procedures in Sweden is steadily increasing and now exceeds isolated open aortic valve surgery This development allows patients with severe symptoms and high risk who were previously inoperable to undergo valve intervention
Frailty is a condition where at least three of the following criteria should be met involuntary weight loss self-reported fatigue sarcopenia reduced physical capacity slow walking speed and low physical activity level Studies show that 50-70 of those undergoing TAVI due to AS are defined as frail elderly individuals with comorbidities such as heart failure and renal failure Furthermore studies have demonstrated an increased risk of falls and difficulty participating in daily activities due to reduced peak oxygen uptake VO2peak short walking distance lower walking speed and impaired Health Related Quality of Life HR-QoL It is well-established that a low VO2peak correlates with increased risk of premature death in both healthy individuals and those with chronic disease 19 Moreover there is a strong correlation between a short walking distance and prognosis in patients with chronic diseases
Since patients with AS already have reduced physical fitness preoperatively a prolonged recovery time is usually observed postoperatively Systematic reviews and meta-analyses examining the effect of physiotherapist-led exercise-based cardiac rehabilitation PT-X after TAVI have shown that participation in PT-X can improve VO2peak walking distance walking speed and HR-QoL However the included studies are few and exhibit varying study quality leading to selection bias Despite this the opportunity to participate in PT-X after TAVI is virtually non-existent in Sweden due to low evidence and national and international cardiac care guidelines do not mention the possibility of PT-X after TAVI
This has resulted in patients who have undergone TAVI not being recommended PT-X as part of their medical treatment unlike conditions such as heart failure and ischemic heart disease which have high priority and high evidence As more patients undergo TAVI it is of utmost importance to investigate whether PT-X after TAVI can further improve physical capacity quality of life and reduce hospital admissions
Objective Primary to investigate whether participation in PT-X after TAVI can impact physical fitness physical activity level and health-related quality of life Secondary to study the prevalence of frailty and the number of hospital admissions during the first postoperative year after TAVI
How will participation in PT-X impact exercise capacity compared to the control group that is allowed to continue with their usual life How will participation in PT-X impact the muscle function compared to the control group that is allowed to continue with their usual life How will participation in PT-X impact the patients physical activity level compared to the control group that is allowed to continue with their usual life How will participation in PT-X impact HR-QoL compared to the control group that is allowed to continue with their usual life
Secondary Research Questions
What is the prevalence of frailty in the study population that has undergone 12 weeks of PT-X compared to the control group What is the incidence of hospital admissions in patients who have undergone 12 weeks of PT-X compared to the control group
Method
Study Population Patients 65 years or older with AS who have undergone TAVI and are being followed-up at SV Alingsas Hospital will be invited to participate in an intervention study The control group consists of matched controls based on age gender and exercise capacity in watts followed up at Sahlgrenska University hospital in Gothenburg Patients in the control group will be approached for participation by a research nurse from Sahlgrenska Universityhospital All patients will be informed verbally and in writing and informed consent will be obtained The study follows the Helsinki Declaration
Data Analysis and statistical power
Ratio and interval data will be presented as mean 1 standard deviation ordinal data as median and interquartile range and nominal data in absolute and relative numbers
Depending on normal distribution Students T-test or Mann-Whitneys U-test will be used to examine differences between groups
Paired T-test or Wilcoxon signed-rank test will highlight within-group differences and Chi-square test will study differences in nominal data
Multiple regression will be used to study the relationship between group membership and the primary outcome measure work capacity in watts
Statistical power was calculated with an 80 power β to detect a statistically significant difference α at 5 For the training group to achieve a significant p005 improvement of 10 watts in work capacity compared to the control group 56 individuals must be included in each group Considering a potential dropout of approximately 20 a total of 135 individuals will be included in the study
Expected Result Clinical Significance
If patients with AS who have undergone TAVI can improve physical fitness it could potentially strengthen the evidence and optimize the patients physical fitness
Increased access to PT-X and awareness of frailty in these patients could reduce the risk of falls and possibly the number of hospital readmissions leading to reduced healthcare consumption and increased quality of life for the patient
Gender Perspective of the Project
The study will include both men and women to achieve groups as similar as possible regarding gender age and exercise capacity in watts
Since 2008 TAVI has been performed in Sweden as a standard treatment with priority 3 in the the recommendations given by the National Board of Health and Welfare in Sweden The number of TAVI procedures in Sweden is steadily increasing and now exceeds isolated open aortic valve surgery This development allows patients with severe symptoms and high risk who were previously inoperable to undergo valve intervention
Frailty is a condition where at least three of the following criteria should be met involuntary weight loss self-reported fatigue sarcopenia reduced physical capacity slow walking speed and low physical activity level Studies show that 50-70 of those undergoing TAVI due to AS are defined as frail elderly individuals with comorbidities such as heart failure and renal failure Furthermore studies have demonstrated an increased risk of falls and difficulty participating in daily activities due to reduced peak oxygen uptake VO2peak short walking distance lower walking speed and impaired Health Related Quality of Life HR-QoL It is well-established that a low VO2peak correlates with increased risk of premature death in both healthy individuals and those with chronic disease 19 Moreover there is a strong correlation between a short walking distance and prognosis in patients with chronic diseases
Since patients with AS already have reduced physical fitness preoperatively a prolonged recovery time is usually observed postoperatively Systematic reviews and meta-analyses examining the effect of physiotherapist-led exercise-based cardiac rehabilitation PT-X after TAVI have shown that participation in PT-X can improve VO2peak walking distance walking speed and HR-QoL However the included studies are few and exhibit varying study quality leading to selection bias Despite this the opportunity to participate in PT-X after TAVI is virtually non-existent in Sweden due to low evidence and national and international cardiac care guidelines do not mention the possibility of PT-X after TAVI
This has resulted in patients who have undergone TAVI not being recommended PT-X as part of their medical treatment unlike conditions such as heart failure and ischemic heart disease which have high priority and high evidence As more patients undergo TAVI it is of utmost importance to investigate whether PT-X after TAVI can further improve physical capacity quality of life and reduce hospital admissions
Objective Primary to investigate whether participation in PT-X after TAVI can impact physical fitness physical activity level and health-related quality of life Secondary to study the prevalence of frailty and the number of hospital admissions during the first postoperative year after TAVI
How will participation in PT-X impact exercise capacity compared to the control group that is allowed to continue with their usual life How will participation in PT-X impact the muscle function compared to the control group that is allowed to continue with their usual life How will participation in PT-X impact the patients physical activity level compared to the control group that is allowed to continue with their usual life How will participation in PT-X impact HR-QoL compared to the control group that is allowed to continue with their usual life
Secondary Research Questions
What is the prevalence of frailty in the study population that has undergone 12 weeks of PT-X compared to the control group What is the incidence of hospital admissions in patients who have undergone 12 weeks of PT-X compared to the control group
Method
Study Population Patients 65 years or older with AS who have undergone TAVI and are being followed-up at SV Alingsas Hospital will be invited to participate in an intervention study The control group consists of matched controls based on age gender and exercise capacity in watts followed up at Sahlgrenska University hospital in Gothenburg Patients in the control group will be approached for participation by a research nurse from Sahlgrenska Universityhospital All patients will be informed verbally and in writing and informed consent will be obtained The study follows the Helsinki Declaration
Data Analysis and statistical power
Ratio and interval data will be presented as mean 1 standard deviation ordinal data as median and interquartile range and nominal data in absolute and relative numbers
Depending on normal distribution Students T-test or Mann-Whitneys U-test will be used to examine differences between groups
Paired T-test or Wilcoxon signed-rank test will highlight within-group differences and Chi-square test will study differences in nominal data
Multiple regression will be used to study the relationship between group membership and the primary outcome measure work capacity in watts
Statistical power was calculated with an 80 power β to detect a statistically significant difference α at 5 For the training group to achieve a significant p005 improvement of 10 watts in work capacity compared to the control group 56 individuals must be included in each group Considering a potential dropout of approximately 20 a total of 135 individuals will be included in the study
Expected Result Clinical Significance
If patients with AS who have undergone TAVI can improve physical fitness it could potentially strengthen the evidence and optimize the patients physical fitness
Increased access to PT-X and awareness of frailty in these patients could reduce the risk of falls and possibly the number of hospital readmissions leading to reduced healthcare consumption and increased quality of life for the patient
Gender Perspective of the Project
The study will include both men and women to achieve groups as similar as possible regarding gender age and exercise capacity in watts
Study Oversight
Has Oversight DMC:
None
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?:
None