Effects of Whole-Body Vibration Training Versus Balance Training in Patients With Severe Chronic Obstructive Pulmonary Disease
Effects of a Three Week Whole Body Vibration Training Versus Conventional Balance Training in Patients With Severe Chronic Obstructive Pulmonary Disease
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease
Started May 2017
Typical duration for not_applicable chronic-obstructive-pulmonary-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2017
CompletedFirst Submitted
Initial submission to the registry
May 16, 2017
CompletedFirst Posted
Study publicly available on registry
May 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 16, 2019
CompletedDecember 24, 2019
December 1, 2019
2.3 years
May 16, 2017
December 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
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 Peak muscle strength of the knee Flexion muscles
measurement on Day 1 and 21
- +6 more secondary outcomes
Study Arms (2)
Whole Body Vibration training
ACTIVE COMPARATORBalance Training on a Vibration platform
Conventional Balance training
ACTIVE COMPARATORBalance Training on a Balance board
Interventions
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.
n=24 patients with COPD, Exercises will be performed on a Balance pad
Eligibility Criteria
You may qualify if:
- 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.)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Schön Klinik Berchtesgadener Land
Schönau am Königssee, Bavaria, 83471, Germany
Related Publications (1)
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.
PMID: 33947416DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Klaus Kenn, MD
Schoen Klinik Berchtesgadener Land
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head physican (department of pneumology)
Study Record Dates
First Submitted
May 16, 2017
First Posted
May 17, 2017
Study Start
May 15, 2017
Primary Completion
August 16, 2019
Study Completion
August 16, 2019
Last Updated
December 24, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will share