NCT04239807

3-Month Home-based Training With Whole Body Vibration (WBV) Device in Patients With Heart Failure and Preserved Ejection Fraction (GALILEO-HFpEF-HOME) (GALILEOHOME)

3-Month Home-based Training With Whole Body Vibration Device in Patients With Heart Failure and Preserved Ejection Fraction (GALILEO-HFpEF-HOME)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Klinikum der Universität Köln · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

In order to evaluate Long-term effects of whole Body Vibration (wbv) in patients with HFpEF patients will get a training device to use at home for 3 months. Patients in the Intervention group will be introduced in the training program on the wbv-device in the study center 3-4 times and baseline parameters will be collected before start of the home based training. Patients randomized into the placebo arm be introduced into the training program according to the interventional arm but not performing the exercises on the wbv-device but on the floor.

Detailed description

Screening (day -21 until day -7): Subjects will be evaluated according to In- and Exclusion criteria Randomization (day -7): Subjects will be randomized to either Intervention Group (training on wbv platform) or non-Intervention Group (training without wbv). Introduction Week -1(-7d-d1): All subjects will receive introduction in their training Month 1: Day 1: From this day subjects are supposed to start their training according to protocol Day 2: Telephone Visit Day 5: Telephone Visit Day 7: Telephone Visit Day 10: Telephone Visit Day 13: Telephone Visit Day 20: Telephone Visit Day 27: Telephone Visit Week 4, Day 28: Study center Visit: 6MWD, QoL-Questionnaire, AEs, re-training Month 2: Week 5, Day 34: Week 6, Day 41: Week 7, Day 48: Week 8, Day 55: Month 3: Week 9, Day 62: Week 10, Day 69: Week 11, Day 76: Week 12, Day 83: Final Visit

Conditions

• Heart Failure With Preserved Ejection Fraction

Interventions

Type	Name	Description
DEVICE	Group 1 GALILEO WBV	3 month home based WBV training
OTHER	Group 2 Control	Training on the floor without WBV

Timeline

• Start date: 2020-03-01
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2020-01-27
• Last updated: 2020-01-27