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Clinical Trials/NCT03157986
NCT03157986
Completed
Not Applicable

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

Schön Klinik Berchtesgadener Land1 site in 1 country48 target enrollmentMay 15, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Schön Klinik Berchtesgadener Land
Enrollment
48
Locations
1
Primary Endpoint
Change in Balance Performance during semi Tandem stance
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 15, 2017
End Date
August 16, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Klaus Kenn

Head physican (department of pneumology)

Schön Klinik Berchtesgadener Land

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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 Outcomes

  • Change in Peak muscle strength of the knee Flexion muscles(measurement on Day 1 and 21)
  • Change in step symmetry during 20m walking(measurement on Day 1 and 21)
  • 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 6-minute Walk Distance(measurement on Day 1 and 21)
  • Change in 4m Gait Speed Test(measurement on Day 1 and 21)
  • Change in Hospital anxiety and Depression scale(measurement on Day 1 and 21)
  • Change in balance performance during Romberg stance(measurement on Day 1 and 21)
  • Change in Balance Performance during 1-leg stance(measurement on Day 1 and 21)

Study Sites (1)

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