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Completed

NCT Number: NCT03157986

Effects of Whole-Body Vibration Training Versus 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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Behavior Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schön Klinik Berchtesgadener Land

Schönau am Königssee, Bavaria, 83471, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Balance Training on a vibration platform

Other

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.

Conventional balance training

Other

n=24 patients with COPD, Exercises will be performed on a Balance pad

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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

  9. 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

  10. 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.

  11. 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.

Sponsors and collaborators

Lead sponsor

Schön Klinik Berchtesgadener Land

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 17, 2017
Registry last updated
Dec 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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