NCT01898143

Brief Summary

Whole body vibration training seems to be a useful adjunct in exercise training in patients with severe COPD. The basic principle relies on reflectory muscle contractions caused by a vibration stimulus. Until now the impact of whole body vibration training on cardiopulmonary parameters remained unknown. Therefore aim of this study is to investigate cardiopulmonary parameters during whole body vibration training in patients with chronic lung disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

1.9 years

First QC Date

June 24, 2013

Last Update Submit

February 23, 2016

Conditions

Keywords

Whole body vibration, cardiorespiratory response

Outcome Measures

Primary Outcomes (1)

  • peak oxygen consumption (VO2 peak)

    subjects perform several short bouts (1 to 3 minutes duration) of squatting exercise with or without whole body vibration. The peak values of each single part is used for comparison.

    during 1 exercise session

Secondary Outcomes (6)

  • heart rate (HR)

    during 1 exercise session

  • minute ventilation (VE)

    during 1 exercise session

  • perceived exertion for dyspnea and leg fatigue (Borg-scale)

    during 1 exercise session

  • Alveolar-arterial oxygen difference (AaDO2)

    during 1 exercise session

  • breathing frequency (BF)

    during 1 exercise session

  • +1 more secondary outcomes

Study Arms (2)

Whole body vibration in COPD

OTHER

Patients with COPD GOLD III or IV

Other: Whole body vibration

Whole body vibration in ILD

OTHER

PAtients with interstitial lung disease

Other: Whole body vibration

Interventions

Whole body vibration in COPDWhole body vibration in ILD

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD stage III or IV according to the Global Initiative for chronic obstructive lung disease \[GOLD\])
  • Interstitial Lung disease (forced vital capacity (FVC) \< 70% pred., diffusion capacity of lung for carbon monoxide (DLCO) 30-70% pred.)

You may not qualify if:

  • Oxygen therapy during exercise required
  • Severe exacerbation of lung disease, with necessity of change in medication or persistent symptoms \> 3days
  • activated arthrosis /arthropathy/ rheumatoid Arthritis/ acute discopathy
  • acute thrombosis
  • acute musculoskeletal inflammation
  • Epilepsy
  • Gallstones

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schön Klinik Berchtesgadener Land

Schönau am Königssee, 83471, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveLung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Physican (department of pneumology)

Study Record Dates

First Submitted

June 24, 2013

First Posted

July 12, 2013

Study Start

June 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

February 24, 2016

Record last verified: 2016-02

Locations