Effects of Whole-Body Vibration Training Versus Balance Training in Patients With Severe Chronic Obstructive Pulmonary Disease

December 23, 2019 updated by: Klaus Kenn, Schön Klinik Berchtesgadener Land

Effects of a Three Week Whole Body Vibration Training Versus Conventional Balance Training in Patients With Severe Chronic Obstructive Pulmonary Disease

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Schoenau Am Koenigssee, Bavaria, Germany, 83471
        • Schön Klinik Berchtesgadener Land

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.)

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Whole Body Vibration training
Balance Training on a Vibration platform
Other: Balance Training on a vibration platform
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.
Active Comparator: Conventional Balance training
Balance Training on a Balance board
Other: Conventional Balance training
n=24 patients with COPD, Exercises will be performed on a Balance pad

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Balance Performance during semi Tandem stance
Time Frame: measurement on Day 1 and 21
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in muscle power during counter movement jump
Time Frame: measurement on Day 1 and 21
patients jump on a force platform as high as possible. The Outcome is Watt per Kilogram Body weight
measurement on Day 1 and 21
Change in performance of the 5-Repetition-Raise-Test
Time Frame: measurement on Day 1 and 21
Patients try to perform 5 repetitions of standing up and sitting down from a chair with crossed arms on a force platform as quick as possible
measurement on Day 1 and 21
Change in performance of the 1-Minute-Chair-Rise-Test
Time Frame: measurement on Day 1 and 21
Patients try to perform as many repetitions as possible of standing up and sitting down from a chair with crossed arms on a force platform during 1 minute
measurement on Day 1 and 21
Change in Peak muscle strength of the knee Extension muscles
Time Frame: measurement on Day 1 and 21
isometric peak torque of the knee extensor muscles are measured in 90° knee angle
measurement on Day 1 and 21
Change in Peak muscle strength of the knee Flexion muscles
Time Frame: measurement on Day 1 and 21
isometric peak torque of the knee flexor muscles are measured in 90° knee angle
measurement on Day 1 and 21
Change in 6-minute Walk Distance
Time Frame: measurement on Day 1 and 21
patients are advised to walk as far as possible on a 30m track
measurement on Day 1 and 21
Change in 4m Gait Speed Test
Time Frame: measurement on Day 1 and 21
patients have to walk 4 meters at their usual Speed. Outcome is the average Speed during the 4m walk.
measurement on Day 1 and 21
Change in step symmetry during 20m walking
Time Frame: measurement on Day 1 and 21
Patients walk 20m while wearing the Mc Roberts move test device (triaxial accelerometer) which performs a gait analysis
measurement on Day 1 and 21
Change in Hospital anxiety and Depression scale
Time Frame: measurement on Day 1 and 21
the Hospital anxiety and Depression scale is a questionnaire that evaluates signs of anxiety or depression
measurement on Day 1 and 21
Change in balance performance during Romberg stance
Time Frame: measurement on Day 1 and 21
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
Change in Balance Performance during 1-leg stance
Time Frame: measurement on Day 1 and 21
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Schön Klinik Berchtesgadener Land

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Klaus Kenn, MD, Schoen Klinik Berchtesgadener Land

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 16, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 16, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WBVT Balance Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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