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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Other: Physiotherapist-led exercise based cardiac rehabilitation (PT-X)

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, 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.

• Study Type: Interventional
• Enrollment (Estimated): 135
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria C Borland, Phd RPT; Phone Number: +46700816894; Email: maria.borland@vgregion.se

Study Locations

• Sweden
  • Alingsås, Sweden, 41346
    • Recruiting
    • SV Hospital group Alingsås hospital
    • Contact: Maria Borland, PhD; Phone Number: +46322226285; Email: maria.borland@vgregion.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physiotherapist-led exercise based cardiac rehabilitation (PT-X); PT-X consists of centralcirculatory aerobic exercise and muscular endurance training in an existing PT-X group at Alingsas Hospital in Sweden. The patients will follow an individually tailored exercise program, twice a week for 60 minutes each session over 12 weeks. The physiotherapist guides and progresses the program based on the patient's exercise capacity throughout the intervention. Additionally, two sessions of home-based exercise will be added and recorded in an exercise diary. The exercise programs are prescribed after the patient's individual exercise capacity, with perceived exertion graded 13-17 on Borg's 6-20 scale.	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.
No Intervention: Control group; The patient will continue with their usual activities during the control period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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.
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frailty	Frailty is evaluated using the Swedish version of Clinical Frailty Scale.	Baseline, after 12 weeks
Frailty	Frailty is evaluated using the Swedish version of Clinical Frailty Scale.	12 months after the intervention completion.
Hospital admission	Information about the number of hospital admissions after surgery will be obtained from respective hospitals.	Baseline, after 12 weeks
Hospital admission	Information about the number of hospital admissions after surgery will be obtained from respective hospitals.	12 months after the intervention completion.

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Investigators: Principal Investigator: Maria C Borland, PhD RPT, SV Hospital group Alingsås hospital, Alingsås, Sweden

Publications and helpful links

General Publications

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• Orwelius L, Nilsson M, Nilsson E, Wenemark M, Walfridsson U, Lundstrom M, Taft C, Palaszewski B, Kristenson M. The Swedish RAND-36 Health Survey - reliability and responsiveness assessed in patient populations using Svensson's method for paired ordinal data. J Patient Rep Outcomes. 2017;2(1):4. doi: 10.1186/s41687-018-0030-0. Epub 2018 Feb 7.
• Otto CM, Prendergast B. Aortic-valve stenosis--from patients at risk to severe valve obstruction. N Engl J Med. 2014 Aug 21;371(8):744-56. doi: 10.1056/NEJMra1313875. No abstract available.
• Mack MJ, Leon MB, Smith CR, Miller DC, Moses JW, Tuzcu EM, Webb JG, Douglas PS, Anderson WN, Blackstone EH, Kodali SK, Makkar RR, Fontana GP, Kapadia S, Bavaria J, Hahn RT, Thourani VH, Babaliaros V, Pichard A, Herrmann HC, Brown DL, Williams M, Akin J, Davidson MJ, Svensson LG; PARTNER 1 trial investigators. 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet. 2015 Jun 20;385(9986):2477-84. doi: 10.1016/S0140-6736(15)60308-7. Epub 2015 Mar 15.
• Exercise tests in relation to cardiovascular function. Report of a WHO meeting. World Health Organ Tech Rep Ser. 1968;388:1-30. No abstract available.
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• Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease: Developed by the Task Force for the management of valvular heart disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Rev Esp Cardiol (Engl Ed). 2022 Jun;75(6):524. doi: 10.1016/j.rec.2022.05.006. No abstract available. English, Spanish.
• Carabello BA, Paulus WJ. Aortic stenosis. Lancet. 2009 Mar 14;373(9667):956-66. doi: 10.1016/S0140-6736(09)60211-7. Epub 2009 Feb 21.
• Coffey S, Roberts-Thomson R, Brown A, Carapetis J, Chen M, Enriquez-Sarano M, Zuhlke L, Prendergast BD. Global epidemiology of valvular heart disease. Nat Rev Cardiol. 2021 Dec;18(12):853-864. doi: 10.1038/s41569-021-00570-z. Epub 2021 Jun 25.
• Lindman BR, Sukul D, Dweck MR, Madhavan MV, Arsenault BJ, Coylewright M, Merryman WD, Newby DE, Lewis J, Harrell FE Jr, Mack MJ, Leon MB, Otto CM, Pibarot P. Evaluating Medical Therapy for Calcific Aortic Stenosis: JACC State-of-the-Art Review. J Am Coll Cardiol. 2021 Dec 7;78(23):2354-2376. doi: 10.1016/j.jacc.2021.09.1367.
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• Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021 Feb 2;143(5):e35-e71. doi: 10.1161/CIR.0000000000000932. Epub 2020 Dec 17. Erratum In: Circulation. 2021 Feb 2;143(5):e228. doi: 10.1161/CIR.0000000000000960. Circulation. 2021 Mar 9;143(10):e784. doi: 10.1161/CIR.0000000000000966.

Helpful 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Quality of life; Physiotherapy; Frailty; Aortic valve disease
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: 281694

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No