NCT03157986

Brief Summary

Aim of this study is to compare the effects of whole-body Vibration Training versus conventional Balance Training on Balance performance, gait quality and exercise capacity in patients with severe chronic obstructive pulmonary disease. Patients will be recruited during a 3-week inpatient pulmonary rehabilitation program and will be randomized into one of two intervention groups. On top of a standardized endurance and strength Training program (5 days per week) patients in both groups will perform an additional Balance Training (on 3 days per week). Patients in both Groups will perform the same 4 different Balance exercises (2x1 Minute each): dynamic squats with closed eyes, heel raise, semi-Tandem stance and single leg stance but on a different surface. The Vibration Training Group will perform the exercises on a side-alternating Vibration platform (Galileo) at frequencies between 15 to 26 Hertz and the control Group will perform exercises on instable objects like Balance pads. The degree of difficulty in both Groups will be individually adjusted and will be progressively increased, if possible.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started May 2017

Typical duration for not_applicable chronic-obstructive-pulmonary-disease

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 16, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2019

Completed
Last Updated

December 24, 2019

Status Verified

December 1, 2019

Enrollment Period

2.3 years

First QC Date

May 16, 2017

Last Update Submit

December 23, 2019

Conditions

Keywords

COPDBalanceWhole Body Vibration Trainingpulmonary rehabilitationexercise

Outcome Measures

Primary Outcomes (1)

  • Change in Balance Performance during semi Tandem stance

    patients stand still for 10 seconds with closed eyes on a force platform that measures absolute path length of the center of force.

    measurement on Day 1 and 21

Secondary Outcomes (11)

  • Change in muscle power during counter movement jump

    measurement on Day 1 and 21

  • Change in performance of the 5-Repetition-Raise-Test

    measurement on Day 1 and 21

  • Change in performance of the 1-Minute-Chair-Rise-Test

    measurement on Day 1 and 21

  • Change in Peak muscle strength of the knee Extension muscles

    measurement on Day 1 and 21

  • Change in Peak muscle strength of the knee Flexion muscles

    measurement on Day 1 and 21

  • +6 more secondary outcomes

Study Arms (2)

Whole Body Vibration training

ACTIVE COMPARATOR

Balance Training on a Vibration platform

Other: Balance Training on a vibration platform

Conventional Balance training

ACTIVE COMPARATOR

Balance Training on a Balance board

Other: Conventional Balance training

Interventions

n=24 patients with severe chronic obstructive pulmonary disease. Exercises will be performed on a side-alternating Vibration platform (Galileo) at frequencies between 15 to 26 Hertz.

Whole Body Vibration training

n=24 patients with COPD, Exercises will be performed on a Balance pad

Conventional Balance training

Eligibility Criteria

Age50 Years - 80 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
  • impaired exercise capacity (6 Minute walk distance of less than 70% of the reference value from Troosters et al.)

You may not qualify if:

  • current acute exacerbation of COPD
  • carbon dioxide pressure of more than 45 mmHg at rest
  • any contraindication for vibration Training (e.g. acute deep vein thrombosis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schön Klinik Berchtesgadener Land

Schönau am Königssee, Bavaria, 83471, Germany

Location

Related Publications (1)

  • Gloeckl R, Schneeberger T, Leitl D, Reinold T, Nell C, Jarosch I, Kenn K, Koczulla AR. Whole-body vibration training versus conventional balance training in patients with severe COPD-a randomized, controlled trial. Respir Res. 2021 May 4;22(1):138. doi: 10.1186/s12931-021-01688-x.

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Klaus Kenn, MD

    Schoen Klinik Berchtesgadener Land

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head physican (department of pneumology)

Study Record Dates

First Submitted

May 16, 2017

First Posted

May 17, 2017

Study Start

May 15, 2017

Primary Completion

August 16, 2019

Study Completion

August 16, 2019

Last Updated

December 24, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will share

Locations