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

Influence of Training With Whole Body Vibration Device on Quality of Life (QoL), Exercise Capacity, as Well as on the Effects of Muscle Power and Muscle Function in Patients With Pulmonal Arterial Hypertension (PAH) in an Extended 3-month Home Based Training. Background and Rationale for the Proposal: Capacity and the Ability to Exercise, in Patients With PAH is Limited. Primary Scientific Question Addressed:Changes in Muscle Power, Changes in 6-Minute Walk Distance (6MWD) and Changes in QoL Are to be Evaluated.

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.

Study Overview

• Status: Unknown
• Conditions: Changes in Six Minute Walking Distance, Peak Oxygen Uptake, Quality of Life
• Intervention / Treatment: Device: Body Vibration platform GALILEO; Other: exercises at home 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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Köln, NRW, Germany, 50937
      • Recruiting
      • Spezialambulanz für pulmonale Hypertonie Uniklinik Köln
      • Contact: Felix Gerhardt, PhD; Phone Number: 89413 +49221478; Email: felix.gerhardt@uk-koeln.de
      • Principal Investigator: Felix Gerhardt, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 3-month home based training on whole body vibration platform; This Group will receive a training device to perform their given exercises on	Device: Body Vibration platform GALILEO; 3 month home based training on whole Body Vibration platform GALILEO
PLACEBO_COMPARATOR: 3-month home based training on floor; This Group will perform their given exercises at home on the floor	Other: exercises at home on the floor; exercises at home on the floor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in 6 Minute Walking distance	3 months
Changes in 6 Minute Walking distance	4 weeks interm analysis

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in Peak Oxygen uptake in cardiopulmonary exercise testing (CPET)	3 months
Changes in Peak Oxygen uptake in cardiopulmonary exercise testing (CPET)	4 weeks
Changes in Quality of Life	3 months
Changes in Quality of Life	4 weeks

Collaborators and Investigators

• Sponsor: Klinikum der Universität Köln

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ANTICIPATED): November 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: December 16, 2016
• First Submitted That Met QC Criteria: December 19, 2016
• First Posted (ESTIMATE): December 20, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 26, 2019
• Last Update Submitted That Met QC Criteria: April 25, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 002 (University of CT Health Center)

Drug and device information, study documents

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