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

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: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Balance Training on a vibration platform; Other: Conventional Balance training

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in muscle power during counter movement jump	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	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	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	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	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	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	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	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	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	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	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

• Sponsor: Schön Klinik Berchtesgadener Land
• Investigators: Principal Investigator: Klaus Kenn, MD, Schoen Klinik Berchtesgadener Land

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2017
• Primary Completion (Actual): August 16, 2019
• Study Completion (Actual): August 16, 2019

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (Actual): May 17, 2017

Study Record Updates

• Last Update Posted (Actual): December 24, 2019
• Last Update Submitted That Met QC Criteria: December 23, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Balance; exercise; COPD; pulmonary rehabilitation; Whole Body Vibration Training
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID 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