Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00012930

Trial Description

start of 1:1-Block title

Title

Effects of 3-months whole-body vibration training (WBV) in patients with interstitial lung disease: a randomized clinical trial.

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

WBV and fibrosis

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The primary question to be answered in this study is whether a group of ambulatory fibrosis patients who train at least 1x/day 3x3 minutes on 3 days a week for 3 months with the Galileo device as their main endpoint has a longer 6 minute walking distance at discharge than a control group (also fibrosis patients) who train with a 5 Hz sham training. The included fibrosis patients are randomized to either the training group or the sham training group.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Training therapy, as we know from preliminary examinations, has a considerable influence on the quality of life, lung function and performance of patients with lung disease. In recent years, this has also found its way into therapy recommendations and guidelines. The reason for the training success cannot be fully explained at the present time. Besides the targeted strengthening of the muscles of the extremities and the positive influences on the circulation, there are increasing indications that the inflammation markers could also be suppressed by sport.
The training therapies used in the studies are very uneven. The same applies to the frequency of training cycles. Strength and endurance exercises are recommended in the guidelines. In patients with pulmonary fibrosis there are also initial indications of the positive effect of training effects on individual muscle groups. Whether a holistic training approach using whole-body vibration brings success in fibrosis patients has not yet been investigated. One possibility of implementing a holistic therapy approach in a simple and time-saving manner is a device that emits frequencies of different heart intensities via a base plate. The different high frequencies produce different effects. If proprioception and balance are primarily addressed at low frequencies (5-12 Hz), contraction and relaxation cycles are specifically generated at medium frequencies (12-20 Hz) and reflex-controlled muscle function is trained. If the frequency is increased to the high-frequency range (>20 Hz), the relaxation time is aborted prematurely and thus the contraction time is extended with increased effects on muscle performance. As an example, a 25 Hz workout corresponds to 25 step cycles/s. The training of 25 Hz is the equivalent of 25 step cycles/s. The training of 25 Hz corresponds to 25 step cycles/s. At 3 minutes, this results in a step cycle number of 4500. This leads to the training effect as well as to rapid neuromuscular fatigue.
So far, this form of training has found practical application in patients with chronic fatigue syndrome, cystic fibrosis, geriatric patients or stroke patients, but also in healthy people who have been lying for a long time and, as we have recently shown, in exacerbated COPD patients. In the latter study, the Galileo training device from Novotec (Pforzheim, Germany) was used.
The fact that short training cycles are associated with muscle build-up and muscle function preservation is particularly interesting.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00012930
  •   2019/04/18
  •   [---]*
  •   yes
  •   Approved
  •   143/14, Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   J84 -  Other interstitial pulmonary diseases
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Fibrosis patients with whole body vibration training over 3 months, 3 training days with 3x3 minutes increasing intensity (Hz).
  •   Fibrosis patients with Sham Training (WBV) over 3 months, at 3 training days with 3x3 minutes each at steady 5Hz.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Measuring the performance of the patients based on the % of modification of 6 minutes walking distance after 3 months in comparison to the baseline study and the Sham-training control group.
The investigations took place at the time of enrollment (t0) and after 3 months (t1).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Patients have a muscular performance advantage through targeted training with the Galileo compared to the Sham Training Control Group (Tests: Chair Rising Test: 5 times standing up from a chair).
- Whether the quality of life and the degree of depression are different in the two groups studied (SF-36, HADS, UCSD-SOB (dyspnoea scale)).
- Whether patients have a less strongly reduced muscle cross-section of the muscles of the quadriceps femoris muscle by comparison with the control group.
- Whether patients lose their pulmonary function after training, compared with the control group (VC, FVC, DLCO)
- Whether patients under exercise therapy show more reduced inflammation parameters (serum IL-1, -6, -8, TNF-alpha, FGF, BNP) compared to the control group.
- Whether patients under the training therapy have more changed laboratory parameters in the form of iris, MMP-9, TIMP-1, myostatin, telomere lengths (senescence parameters) and PGC1a than the Sham training control group (evaluation takes place in Marburg)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2015/05/04
  •   44
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Inclusion criteria were: the diagnoses of ILD, idiopathic pulmonary fibrosis (IPF), Idiopathic nonspecific interstitial pneumonia (NSIP), acute interstitial pneumonia (AIP), Cryptogenic organizing pneumonia (COP) or Sarcoidosis, written informed consent.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- no pulmonary fibrosis
- sarcoidosis
- withdrawn consent
- Indication of acute pathological cardiac events in the laboratory or ECG (TNI or CK increase, new ST segment changes).
- Concomitant diseases such as heart failure (NYHA III and IV) or COPD
- decompensated cardiac insufficiency
- high blood pressure (>220/120 mmHg)
- more serious mental illnesses
- cognitive limitations
- Restrictions of the musculoskeletal system that make training with the Galileo impossible:
◦ Acute thrombosis
◦ Implants in trained body regions
◦ Acute Arthrosis
◦ Acute tendinopathy
◦ Acute hernia
◦ Acute discopathy
◦ Fresh Fractures
◦ Fresh wounds and/or scars
- neurological diseases that affect training and performance
- acute exacerbations in the last 3 months
- acute inflammation/infections up to 4 weeks before inclusion
- Change in antifibrotic therapy in the last 3 months or participation in a lung sport

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Gießen und Marburg GmbHZentrum für Innere Medizin Schwerpunkt Pneumologie
    • Mr.  Prof. Dr.  Andreas Rembert  Koczulla 
    • Baldingerstraße
    • 35033  Marburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Pneumologie und Beatmungsmedizin, Zentrum für interstitielle und seltene Lungenerkrankungen, Thoraxklinik, Universitätsklinikum Heidelberg.
    • Mr.  Prof. Dr.  Michael  Kreuter 
    • Amalienstr. 5
    • 69126  Heidelberg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Gießen und Marburg GmbHZentrum für Innere Medizin Schwerpunkt Pneumologie
    • Mr.  Prof. Dr.  Andreas Rembert  Koczulla 
    • Baldingerstraße
    • 35033  Marburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsklinikum Gießen und Marburg GmbHZentrum für Innere MedizinSchwerpunkt Pneumologie
    • Mr.  Prof. Dr.  Andreas Rembert  Koczulla 
    • Baldingerstraße
    • 35033  Marburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2017/08/18
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.