Clinical trial NCT03157986: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Balance
Whole Body Vibration Training
pulmonary rehabilitation
exercise
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 48
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change in Balance Performance during semi Tandem stance
timeFrame: measurement on Day 1 and 21
Secondary outcomes:
measure: Change in muscle power during counter movement jump
timeFrame: measurement on Day 1 and 21
measure: Change in performance of the 5-Repetition-Raise-Test
timeFrame: measurement on Day 1 and 21
measure: Change in performance of the 1-Minute-Chair-Rise-Test
timeFrame: measurement on Day 1 and 21
measure: Change in Peak muscle strength of the knee Extension muscles
timeFrame: measurement on Day 1 and 21
measure: Change in Peak muscle strength of the knee Flexion muscles
timeFrame: measurement on Day 1 and 21
measure: Change in 6-minute Walk Distance
timeFrame: measurement on Day 1 and 21
measure: Change in 4m Gait Speed Test
timeFrame: measurement on Day 1 and 21
measure: Change in step symmetry during 20m walking
timeFrame: measurement on Day 1 and 21
measure: Change in Hospital anxiety and Depression scale
timeFrame: measurement on Day 1 and 21
measure: Change in balance performance during Romberg stance
timeFrame: measurement on Day 1 and 21
measure: Change in Balance Performance during 1-leg stance
timeFrame: measurement on Day 1 and 21
Other outcomes:
Locations:
city: Schoenau Am Koenigssee
country: Germany
facility: Schön Klinik Berchtesgadener Land
state: Bavaria
Study officials:
affiliation: Schoen Klinik Berchtesgadener Land
name: Klaus Kenn, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.