NCT02997683

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2016

Completed
1 year until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 26, 2019

Status Verified

April 1, 2019

Enrollment Period

1.8 years

First QC Date

December 16, 2016

Last Update Submit

April 25, 2019

Conditions

Changes in Six Minute Walking Distance, Peak Oxygen Uptake, Quality of Life

Outcome Measures

Primary Outcomes (2)

  • Changes in 6 Minute Walking distance

    3 months

  • Changes in 6 Minute Walking distance

    4 weeks interm analysis

Secondary Outcomes (4)

  • 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

Study Arms (2)

3-month home based training on whole body vibration platform

EXPERIMENTAL

This Group will receive a training device to perform their given exercises on

Device: Body Vibration platform GALILEO

3-month home based training on floor

PLACEBO COMPARATOR

This Group will perform their given exercises at home on the floor

Other: exercises at home on the floor

Interventions

Body Vibration platform GALILEODEVICE

3 month home based training on whole Body Vibration platform GALILEO

3-month home based training on whole body vibration platform
exercises at home on the floorOTHER

exercises at home on the floor

3-month home based training on floor

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • MWT ≥ 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

You may not qualify if:

  • any other PAH/PH than idiopathic, hereditary, associated with systemic scleroderma or CTEPH
  • pregnancy
  • acute thrombosis
  • newly implanted Hip or Knee
  • recent bone fracture
  • Disability to confirm consent
  • NYHA/WHO-FC IV
  • MWD below 50 or above 450 m

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spezialambulanz für pulmonale Hypertonie Uniklinik Köln

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

Central Study Contacts

Felix Gerhardt, MD

CONTACT

+4947889413felix.gerhardt@uk-koeln.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

December 16, 2016

First Posted

December 20, 2016

Study Start

January 1, 2018

Primary Completion

November 1, 2019

Study Completion

December 1, 2019

Last Updated

April 26, 2019

Record last verified: 2019-04

Locations

DE(1)