Exercise-based Cardiac Rehabilitation in Patients With Aortic Stenosis After Transcatheter Aortic Valve Implantation

Aortic Valve Stenosis Clinical Trial

— TAVI  

Official title:

Effect of Physiotherapist-led Exercise-based Cardiac Rehabilitation in Older Patients With Aortic Stenosis Who Have Undergone TAVI?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06283940
• Other study ID #: 281694
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: January 2026

Study information

• Verified date: January 2024
• Source: Vastra Gotaland Region
• Contact: Maria C Borland, Phd RPT
• Phone: +46700816894
• Email: maria.borland[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 patient's 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 patient's quality of life.

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, Student's T-test or Mann-Whitney's 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 (p=0.05) 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 patient's 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 135
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Aortic stenosis treated with TAVI.

Exclusion Criteria:

• Patients who, due to another disability, cannot perform the study protocol for physical fitness, PT-X, or complete the questionnaires included in the study.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Other:
• Physiotherapist-led exercise based cardiac rehabilitation (PT-X)
Individually prescribed centralcirculatory aerobic exercise and muscular endurance training twice a week for 60 minutes each session over 12 weeks in a hospital-based setting, and two sessions of home-based exercise recorded in an exercise diary.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise capacity in watt	Exercise capacity will be measured by a symptom-limited ergometer cycle test based on World Health Organization (WHO) protocol, monitored with electrocardiogram (ECG), bloodpressure and heartrate.	Baseline, after 12 weeks
Primary	Rating of perceived exertion Borg RPE scale 6-20	Borg's Rating of Perceived Exertion (RPE scale 6-20) are recorded. The cycle test concludes when the person reaches an exertion level of 17 on Borg's scale.	Baseline, after 12 weeks
Primary	Exercise capacity in Watt	Exercise capacity will be measured by a symptom-limited ergometer cycle test based on World Health Organization (WHO) protocol, monitored with electrocardiogram (ECG), bloodpressure and heartrate.	12 months after the intervention completion.
Primary	Rating of perceived exertion Borg RPE scale 6-20	Borg's Rating of Perceived Exertion (RPE scale 6-20) are recorded. The cycle test concludes when the person reaches an exertion level of 17 on Borg's scale.	12 months after the intervention completion.
Primary	Muscular endurance test, shoulder flexion	A unilateral isoinertial shoulder flexion test assessed with the patient sitting on a stool with their back touching the wall holding a dumbbell in their hand, 2 kg for women and 3 kg for men. The tested arm is elevated to 90º flexion and the arm not tested is placed in the patient's knee. A pace of 40 beats per min is kept by a digital metronome.	Baseline, after 12 weeks
Primary	Muscular endurance test, shoulder flexion	A unilateral isoinertial shoulder flexion test assessed with the patient sitting on a stool with their back touching the wall holding a dumbbell in their hand, 2 kg for women and 3 kg for men. The tested arm is elevated to 90º flexion and the arm not tested is placed in the patient's knee. A pace of 40 beats per min is kept by a digital metronome.	12 months after the intervention completion.
Primary	Muscle endurance test, shoulder abduction	Bilateral isometric shoulder abduction is assessed with the patient holding a 1 kg dumbbell in each hand using the same body position as above. The patient is asked to elevate both arms to 90°of shoulder abduction and to maintain this position as long as possible (measured in s).	Baseline, after 12 weeks
Primary	Muscle endurance test, shoulder abduction	Bilateral isometric shoulder abduction is assessed with the patient holding a 1 kg dumbbell in each hand using the same body position as above. The patient is asked to elevate both arms to 90°of shoulder abduction and to maintain this position as long as possible (measured in s).	12 months after the intervention completion.
Primary	Muscle endurance test, unilateral heel-lift	Unilateral isoinertial heel-lift is assessed with the patients performing as many unilateral heel-lifts as possible, with a straight knee, on a 10° tilted wedge, with shoes on. A pace of 60 beats per minutes is kept is kept by a metronome.	Baseline, after 12 weeks
Primary	Muscle endurance test, unilateral heel-lift	Unilateral isoinertial heel-lift is assessed with the patients performing as many unilateral heel-lifts as possible, with a straight knee, on a 10° tilted wedge, with shoes on. A pace of 60 beats per minutes is kept is kept by a metronome.	12 months after the intervention completion.
Primary	Lower extremity function	Swedish version of Short Physical Performance Battery (SPPB-S) is used to measure lower extremity function in older individuals. The scale consists of three domains, maximal points 12, lower scores indicates greater limitations.	Baseline, after 12 weeks
Primary	Lower extremity function	Swedish version of Short Physical Performance Battery (SPPB-S) is used to measure lower extremity function in older individuals.The scale consists of three domains, maximal points 12, lower scores indicates greater limitations.	12 months after the intervention completion.
Primary	Physical activity	Measured using an accelerometer (Actigraph® GT3x+, Actigraph, Pensacola, Florida, USA) placed on the right hip, worn continuously for seven consecutive days, excluding showering or swimming.	Baseline, after 12 weeks
Primary	Physical activity	Measured using an accelerometer with Actigraph® GT3x+ accelerometer placed on the right hip, worn continuously for seven consecutive days, excluding showering or swimming.	12 months after the intervention completion.
Primary	Self-assessed level of physical activity	Self-assessed level of physical activity is measured using the short form International Physical Activity Questionnaire (IPAQ).	Baseline, after 12 weeks
Primary	Self-assessed level of physical activity	Self-assessed level of physical activity is measured using the short form International Physical Activity Questionnaire (IPAQ).	12 months after the intervention completion.
Primary	Health Related Quality of Life	Swedish version of RAND 36 is employed to measure health-related quality of life.The scale consists of eight subscales. Subscale scores ranges from 0-100, higher value represent better health status.	Baseline, after 12 weeks
Primary	Health Related Quality of Life	Swedish version of RAND 36 is employed to measure health-related quality of life.The scale consists of eight subscales. Subscale scores ranges from 0-100, higher value represent better health status.	12 months after the intervention completion.
Secondary	Frailty	Frailty is evaluated using the Swedish version of Clinical Frailty Scale.	Baseline, after 12 weeks
Secondary	Frailty	Frailty is evaluated using the Swedish version of Clinical Frailty Scale.	12 months after the intervention completion.
Secondary	Hospital admission	Information about the number of hospital admissions after surgery will be obtained from respective hospitals.	Baseline, after 12 weeks
Secondary	Hospital admission	Information about the number of hospital admissions after surgery will be obtained from respective hospitals.	12 months after the intervention completion.

External Links

•   .The National Board of Health and Welfare. National guidelines for cardiac disease. Stockholm 2015 [December 2017]
•   Swedeheart annual report 2022 Uppsala Clinical Research Center. 2023.