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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03157986
• Other study ID #: WBVT Balance Study
• Status: Completed
• Phase: N/A
• Start date: May 15, 2017
• Est. completion date: August 16, 2019

Study information

• Verified date: December 2019
• Source: Schön Klinik Berchtesgadener Land
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 16, 2019
• Est. primary completion date: August 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
Germany	Schön Klinik Berchtesgadener Land	Schoenau Am Koenigssee	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Schön Klinik Berchtesgadener Land

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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