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

Overview

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 (2×1 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.

Full Title of Study: “Effects of a Three Week Whole Body Vibration Training Versus Conventional Balance Training in Patients With Severe Chronic Obstructive Pulmonary Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 1, 2019

Interventions

  • 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.
  • Other: Conventional Balance training
    • n=24 patients with COPD, Exercises will be performed on a Balance pad

Arms, Groups and Cohorts

  • Active Comparator: Whole Body Vibration training
    • Balance Training on a Vibration platform
  • Active Comparator: Conventional Balance training
    • Balance Training on a Balance board

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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
  • 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
  • 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.
  • 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.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Schön Klinik Berchtesgadener Land
  • Provider of Information About this Clinical Study
    • Principal Investigator: Klaus Kenn, Head physican (department of pneumology) – Schön Klinik Berchtesgadener Land
  • Overall Official(s)
    • Klaus Kenn, MD, Principal Investigator, Schoen Klinik Berchtesgadener Land
  • Overall Contact(s)
    • Rainer Gloeckl, PhD, +49 8652 931630, rgloeckl@schoen-kliniken.de

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