NCT05015712

Effects of MICT on Cardiopulmonary Function in Patients After TAVI

Effects of Moderate Intensity Continuous Training (MICT) on Cardiopulmonary Function in Patients After Transcatheter Aortic Valve Implantation (TAVI): A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Han Yaling, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Cardiac rehabilitation (CR), particularly regular exercise, can improve the cardiopulmonary function, exercise capacity, and quality of life for patients undergoing transcatheter aortic valve implantation (TAVI). Consequently, the patients after TAVI will be enrolled in our randomized controlled trial to demonstrate if the moderate-intensity continuous training (MICT) can improve the cardiopulmonary function compared with the control group after receiving treatment for 12 weeks. Moreover, we will provide new insights regarding whether cardiac systolic function or cardiac diastolic function is mainly improved after regular exercise for TAVI patients. As a result, the principal hypothesis of our study is that MICT will improve the cardiopulmonary function and can extremely affect the cardiac diastolic function of patients with TAVI after the implementation of exercise for 12 weeks.

Conditions

• Valve Disease, Aortic
• Cardiac Rehabilitation

Interventions

Type	Name	Description
BEHAVIORAL	moderate intensity continuous training	Moderate intensity continuous training was scheduled 3 times per week for 3 months. Every sessions included warm-up (\<50% target intensity for 2 min then gradually increasing load 1-10 W/min up to 100% target intensity for 5-10 min), exercise phase (100% target intensity (heart rate at anaerobic threshold±5) starting with 20 min and gradually lengthening up to 45 min in the 1 month as well as 45 min in another 2 months), cool down with gradual reduction of load within 3 min. The target intensity will be determined by the heart rate at anaerobic threshold measured by cardiopulmonary exercise test (CPET). The intensity will be adjusted after implementation of CPET and will keep at a minimum intensity, gradually increasing to the maximum intensity every month. Moreover, patients will be instructed to complete 2 supervised sessions and 1 home-based session during the 1 month and then to continue 3 home-based session for a further 2 months.

Timeline

• Start date: 2021-08-20
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2021-08-20
• Last updated: 2022-07-14

Locations

1 site across 1 country: China