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


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Verified May 2017 by Klinikum Berchtesgadener Land der Schön-Kliniken

Sponsor:

Information provided by (Responsible Party):

Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken

ClinicalTrials.gov Identifier:

NCT03157986

First received: May 16, 2017

Last updated: May 16, 2017

Last verified: May 2017

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.

Chronic Obstructive Pulmonary Disease Other: Balance Training on a vibration platform
Other: Conventional Balance training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Effects of a Three Week Whole Body Vibration Training Versus Conventional Balance Training in Patients With Severe Chronic Obstructive Pulmonary Disease

Primary Outcome Measures:

Secondary Outcome 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.

Estimated Enrollment: 48
Actual Study Start Date: May 15, 2017
Estimated Study Completion Date: June 1, 2018
Estimated Primary Completion Date: May 1, 2018 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03157986

Schön Klinik Berchtesgadener Land
Schoenau am Koenigssee, Bavaria, Germany, 83471
Contact: Rainer Gloeckl, PhD         

Klinikum Berchtesgadener Land der Schön-Kliniken

Principal Investigator: Klaus Kenn, MD Schoen Klinik Berchtesgadener Land

Responsible Party: Klaus Kenn, Head physican (department of pneumology), Klinikum Berchtesgadener Land der Schön-Kliniken
ClinicalTrials.gov Identifier: NCT03157986     History of Changes
Other Study ID Numbers: WBVT Balance Study
Study First Received: May 16, 2017
Last Updated: May 16, 2017
Individual Participant Data  
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Klinikum Berchtesgadener Land der Schön-Kliniken:

COPD
Balance
Whole Body Vibration Training
pulmonary rehabilitation
exercise

Additional relevant MeSH terms:

Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 17, 2017