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

NCT06283940 | Recruiting

• 1 other identifier: 281694
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Aortic Valve Stenosis

Keywords

Aortic valve disease; Physiotherapy; Exercise; Frailty; Quality of life

Outcome Measures

Primary Outcomes (18)

• 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 Outcomes (4)

• Frailty

  Baseline, after 12 weeks

• Frailty

  12 months after the intervention completion.

• Hospital admission

  Baseline, after 12 weeks

• Hospital admission

  12 months after the intervention completion.

Study Arms (2)

Physiotherapist-led exercise based cardiac rehabilitation (PT-X)

EXPERIMENTAL

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)

Control group

NO INTERVENTION

The patient will continue with their usual activities during the control period

Interventions

Physiotherapist-led exercise based cardiac rehabilitation (PT-X) OTHER

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.

Physiotherapist-led exercise based cardiac rehabilitation (PT-X)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Aortic stenosis treated with TAVI.

You may not qualify if:

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

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

SV Hospital group Alingsås hospital

Alingsås, 41346, Sweden

RECRUITING

Related Publications (31)

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Related 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.

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Disease; Motor Activity; Frailty

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria C Borland, PhD RPT

  SV Hospital group Alingsås hospital, Alingsås, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria C Borland, Phd RPT

CONTACT

+46700816894; maria.borland@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Data collection will be conducted by a physiotherapist not involved in the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Intervention group and matched controls based on age, gender and exercise capacity in watt.

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 28, 2024
• Study Start: July 29, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)