3-Month Home-based Training With Whole Body Vibration Device in Patients With PAH (GALILEO-PAH-HOME)

Not Applicable

• Conditions: Changes in Six Minute Walking Distance, Peak Oxygen Uptake, Quality of Life
• Interventions: Device: Body Vibration platform GALILEO; Other: exercises at home on the floor

• Registration Number: NCT02997683
• Lead Sponsor: Klinikum der Universität Köln

Brief Summary

In order to evaluate Long term effects of whole Body Vibration (wbv) in patients with PAH and CTEPH 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 perfoming 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 critera

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 accoridng 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

Study Timeline

• Study First Submitted: 2016-12-16
• Study First Submitted QC: 2016-12-19
• Study First Posted: 2016-12-20
• Study Start: 2018-01-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-25
• Last Update Posted: 2019-04-26
• Primary Completion: 2019-11
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Men and women age 18-90 years
• Signed informed consent
• Symptomatic PAH (idiopathic, hereditary or associated with systemic scleroderma)
• Persistend or inoperable CTEPH
• Invasively confirmed PAH
• 6MWT ≥ 50 - 450 m
• Stable specific therapy for at least 6 weeks
• Ability to perform bike test
• Ability to perform wbv training
• NYHA/WHO-FC II-III

Exclusion Criteria

any other PAH/PH than idiopathic, hereditary, associated with systemic scleroderma or CTEPH

• Rehabilitation or other training concept performed within 6 weeks before inclusion
• pregnancy
• acute thrombosis
• newly implanted Hip or Knee
• recent bone fracture
• Disability to confirm consent
• NYHA/WHO-FC IV
• 6MWD below 50 or above 450 m

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
3-month home based training on whole body vibration platform	Body Vibration platform GALILEO	This Group will receive a training device to perform their given exercises on
3-month home based training on floor	exercises at home on the floor	This Group will perform their given exercises at home on the floor

Primary Outcome Measures

Name	Time	Method
Changes in 6 Minute Walking distance	4 weeks interm analysis

Secondary Outcome Measures

Name	Time	Method
Changes in Quality of Life	4 weeks
Changes in Peak Oxygen uptake in cardiopulmonary exercise testing (CPET)	4 weeks

Trial Locations

Locations (1)

Spezialambulanz für pulmonale Hypertonie Uniklinik Köln; 🇩🇪 Köln, NRW, Germany