NCT01763112

Brief Summary

Title of study / project: 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). Background and rationale for the proposal:Capacity and the ability to exercise, in patients with PAH is limited. There is a few investigations evaluating the effects of the training with whole body vibration (wbv) in adults. It was shown that wbv-training could improve muscle power, QoL, body balance and had positive effects on the neuromuscular system. Primary scientific question addressed:Changes in muscle power, changes in 6-Minute Walk Distance (6MWD) and changes in QoL are to be evaluated.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

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

Study Start

First participant enrolled

January 1, 2013

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 8, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

2.4 years

First QC Date

January 4, 2013

Last Update Submit

March 30, 2015

Conditions

Pulmonary Artery Hypertension

Keywords

Influence of training with whole body vibration device

Outcome Measures

Primary Outcomes (1)

  • changes in 6-Minute Walk Distance (6MWD)

    baseline and week 4

Secondary Outcomes (3)

  • Changes in Quality of life

    baseline and week 4

  • Changes in peak Vo2

    baseline and week 4

  • Changes in muscle power

    baseline and week 4

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

This group will not do any specific training baseline and week 4 investigation will be done only

Exercise Group Galileo PAH

ACTIVE COMPARATOR

The intervention/exercise group will do whole body vibration training on 4 days a week for 60 minutes over 4 weeks

Device: Exercise Group Galileo PAH

Interventions

Exercise Group Galileo PAHDEVICE

The intervention/exercise group will do whole body vibration training on 4 days a week for 60 minutes over 4 weeks

Exercise Group Galileo PAH

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)
  • Invasively confirmed PAH
  • MWT ≥ 50 m
  • Stable specific therapy for at least 2 months
  • 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 or associated with systemic scleroderma
  • pregnancy
  • acute thrombosis
  • newly implanted Hip or Knee
  • recent bone fracture
  • Disability to confirm consent
  • NYHA/WHO-FC IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spezialambulanz für pulmonale Hypertonie Uniklinik Köln

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Related Publications (1)

  • Gerhardt F, Dumitrescu D, Gartner C, Beccard R, Viethen T, Kramer T, Baldus S, Hellmich M, Schonau E, Rosenkranz S. Oscillatory whole-body vibration improves exercise capacity and physical performance in pulmonary arterial hypertension: a randomised clinical study. Heart. 2017 Apr;103(8):592-598. doi: 10.1136/heartjnl-2016-309852. Epub 2017 Jan 18.

    PMID: 28100544DERIVED

MeSH Terms

Conditions

Familial Primary Pulmonary Hypertension

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Felix Gerhardt, PhD

    Klinik III für Innere Medizin Uniklinik Köln

    PRINCIPAL INVESTIGATOR

  • Stephan Rosenkranz, PhD

    Klinik III für Innere Medizin der Uniklinik Köln

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 4, 2013

First Posted

January 8, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

March 31, 2015

Record last verified: 2015-03

Locations

DE(1)