Effects of Whole-Body Vibration Training Versus Balance Training in Patients With Severe Chronic Obstructive Pulmonary Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Balance Training on a vibration platform
Conventional Balance training
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Balance, Whole Body Vibration Training, pulmonary rehabilitation, exercise
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)
Sites / Locations
- Schön Klinik Berchtesgadener Land
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Whole Body Vibration training
Conventional Balance training
Arm Description
Balance Training on a Vibration platform
Balance Training on a Balance board
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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
Change in Peak muscle strength of the knee Extension muscles
isometric peak torque of the knee extensor muscles are measured in 90° knee angle
Change in Peak muscle strength of the knee Flexion muscles
isometric peak torque of the knee flexor muscles are measured in 90° knee angle
Change in 6-minute Walk Distance
patients are advised to walk as far as possible on a 30m track
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.
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
Change in Hospital anxiety and Depression scale
the Hospital anxiety and Depression scale is a questionnaire that evaluates signs of anxiety or depression
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.
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.
Full Information
NCT ID
NCT03157986
First Posted
May 16, 2017
Last Updated
December 23, 2019
Sponsor
Schön Klinik Berchtesgadener Land
1. Study Identification
Unique Protocol Identification Number
NCT03157986
Brief Title
Effects of Whole-Body Vibration Training Versus Balance Training in Patients With Severe Chronic Obstructive Pulmonary Disease
Official Title
Effects of a Three Week Whole Body Vibration Training Versus Conventional Balance Training in Patients With Severe Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
August 16, 2019 (Actual)
Study Completion Date
August 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schön Klinik Berchtesgadener Land
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, Balance, Whole Body Vibration Training, pulmonary rehabilitation, exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Whole Body Vibration training
Arm Type
Active Comparator
Arm Description
Balance Training on a Vibration platform
Arm Title
Conventional Balance training
Arm Type
Active Comparator
Arm Description
Balance Training on a Balance board
Intervention Type
Other
Intervention Name(s)
Balance Training on a vibration platform
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Balance training
Intervention Description
n=24 patients with COPD, Exercises will be performed on a Balance pad
Primary Outcome Measure Information:
Title
Change in Balance Performance during semi Tandem stance
Description
patients stand still for 10 seconds with closed eyes on a force platform that measures absolute path length of the center of force.
Time Frame
measurement on Day 1 and 21
Secondary Outcome Measure Information:
Title
Change in muscle power during counter movement jump
Description
patients jump on a force platform as high as possible. The Outcome is Watt per Kilogram Body weight
Time Frame
measurement on Day 1 and 21
Title
Change in performance of the 5-Repetition-Raise-Test
Description
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
Time Frame
measurement on Day 1 and 21
Title
Change in performance of the 1-Minute-Chair-Rise-Test
Description
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
Time Frame
measurement on Day 1 and 21
Title
Change in Peak muscle strength of the knee Extension muscles
Description
isometric peak torque of the knee extensor muscles are measured in 90° knee angle
Time Frame
measurement on Day 1 and 21
Title
Change in Peak muscle strength of the knee Flexion muscles
Description
isometric peak torque of the knee flexor muscles are measured in 90° knee angle
Time Frame
measurement on Day 1 and 21
Title
Change in 6-minute Walk Distance
Description
patients are advised to walk as far as possible on a 30m track
Time Frame
measurement on Day 1 and 21
Title
Change in 4m Gait Speed Test
Description
patients have to walk 4 meters at their usual Speed. Outcome is the average Speed during the 4m walk.
Time Frame
measurement on Day 1 and 21
Title
Change in step symmetry during 20m walking
Description
Patients walk 20m while wearing the Mc Roberts move test device (triaxial accelerometer) which performs a gait analysis
Time Frame
measurement on Day 1 and 21
Title
Change in Hospital anxiety and Depression scale
Description
the Hospital anxiety and Depression scale is a questionnaire that evaluates signs of anxiety or depression
Time Frame
measurement on Day 1 and 21
Title
Change in balance performance during Romberg stance
Description
patients stand still for 10 seconds with closed eyes on a force platform that measures absolute path length of the center of force.
Time Frame
measurement on Day 1 and 21
Title
Change in Balance Performance during 1-leg stance
Description
patients stand still for 10 seconds with closed eyes on a force platform that measures absolute path length of the center of force.
Time Frame
measurement on Day 1 and 21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Kenn, MD
Organizational Affiliation
Schoen Klinik Berchtesgadener Land
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schön Klinik Berchtesgadener Land
City
Schoenau Am Koenigssee
State/Province
Bavaria
ZIP/Postal Code
83471
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
33947416
Citation
Gloeckl R, Schneeberger T, Leitl D, Reinold T, Nell C, Jarosch I, Kenn K, Koczulla AR. Whole-body vibration training versus conventional balance training in patients with severe COPD-a randomized, controlled trial. Respir Res. 2021 May 4;22(1):138. doi: 10.1186/s12931-021-01688-x.
Results Reference
derived
Learn more about this trial
Effects of Whole-Body Vibration Training Versus Balance Training in Patients With Severe Chronic Obstructive Pulmonary Disease
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