Clinical Investigation of Frolov Breathing Device
(TDI-01) in Complex Therapy of Patients
with COPD (Chronic Obstructive Pulmonary Disease)
- Safety and efficiency of the Frolov device (FDA's approval)
- Last updated on September 25, 2018
Scientific Research Institute of Physiology, Siberian Division,
Russian Academy of Medical Sciences
Sergey Georgievich Krivoschekov, MD, PhD, Professor, Manager of the
Laboratory of Functional Reserves of the Human Organism
Irina Vladimirovna Savitskaya, MD, Chief Physician of the Clinic of the
Institute of Physiology
(Siberian Division, Russian Academy of Medical Sciences)
Olga Vladimirovna Gilinskaya, MD, Pulmonary Physician
This controlled randomized study was conducted from March 10, 1998 to May
15, 2000. The objectives of the research were:
- to investigate the influence of the individual device TDI-01 (Frolov
breathing device) exercises on the respiratory system of patients with COPD
- to compare efficiency and safety of this therapy for this group of
- to investigate the possibility of reduction (elimination) of medication as
a result of the Frolov breathing exercises therapy
- to investigate criteria of efficiency and safety of the method.
The experimental group had 40
hospitalized patients with COPD of moderate severity, 55-60 years old,
with COPD duration from 5 to 8 years. (This was a group of typical COPD
The initial duration of breathing exercises was 10 minutes with 1 additional minute
increase after each 2 days. On the 42nd day, the duration of the breathing
exercises was 30 min and then it remained unchanged until the end of the study
(day 90). Initial duration of the breathing cycle was 4-7 seconds and after
the patients achieved 30 s, it was suggested to keep it unchanged.
All patients were discharged from the hospital on the 18th day. Their
medication reduction (day 18) was 20%. Additional investigations were conducted
on days 42, 60 and 90. By day 90, the reduction of the medication dose was about
60% (40% of the initial dose). The results of lung function and other tests are
provided below (see the Table).
The control group had 42 patients with COPD of moderate severity, 55-60 years old, duration of
the disease was from 4.7 to 9.2 years.
These patients did not practice breathing exercises and were also discharged from the hospital on
the 18th day. Reduction
in medication: 10% at the time of their discharge from the hospital and
30-40% at days 60 and 90.
1. During investigation
of the Frolov breathing device therapy (TDI-01) on patients
with COPD (stable state, moderate severity), there were no complications or
side effects which could be dangerous for health. Clinical observations
showed the safety of its application. This can be explained by that fact that
this method is drug-free and is based on activation of physiological
2. Breathing exercises with the TDI-01 have a positive effect on the lung
function test in COPD and this effect increases with the duration of the
therapy and duration of the breathing cycle.
3. The most informative parameters of effectiveness and control during
application of the TDI-01 for patients with COPD are: FEV1 (forced
expiratory volume in 1 second);
RV (residual volume); EVC (expiratory vital capacity); FEV\FVC, end tidal
O2, and end-tidal CO2.
4. The TDI-01 therapy for patients with COPD (stable state, moderate
severity) is effective and this has been confirmed by better lung function
tests and reduction in medication for patients of the experimental group in
comparison with patients of the control group who had only medication
5. The positive effect of the TDI-01 lung function test results in patients
with COPD could be explained by positive air pressure during exhalations and
improved bronchial conductivity.
6. One of the positive effects of the TDI-01 is a favorable positive effect
of systematic breathing exercises, and this improves the respiratory
function at rest and during exercise.
7. During systematic
application of the TDI-01, there is an improvement in
ventilation-perfusion parameters, optimization of gas exchange, long-term
adaptation to systematic training in conditions of alveolar hypoxia / hypercapnia.
This simultaneously helps the anti-infective host defense, increased
resistance of the organism, and stable improvements in the health of patients
with reduction in medication.
8. Application of the TDI-01 for patients with COPD is economically effective
and can be used in hospitals, clinics, and rehabilitation
9. Effective application of the TDI-01 for treatment of patients with
moderate severity of COPD shows its effectiveness for patients with light
severity of COPD.
Dynamics of Lung Function Parameters in Patients with
COPD (Control and Experimental Groups)
|| Day 42
|| Day 60
Table abbreviations: VC (vital capacity); FEV1 (forced expiratory
volume in 1 second); PEF (Peak Expiratory Flow); RV (residual volume); TLC
(total lung capacity); FRC (Functional residual capacity); FEV/FVC ratio ,%
/ Translated by Artour Rakhimov, February 2011
Observation. It is possible to notice that if the control group had
a certain improvement in some lung function parameter (VC, FEV, and so on), the
improvement in the experimental group was about 2 times larger.
Other pages of this site explain details of Buteyko breathing exercises (see
"Learn" Section) that are to be used as breathing exercises for COPD.
What is COPD? (From COPD Fundation)
COPD (From MAYO CLINIC)
What Is COPD? (From nhlbi.nih.gov)
Related links and web pages:
COPD Breathing exercises
Frolov Breathing Device
Frolov Device History and
origins are connected with the Buteyko breathing technique
Frolov Device: How Does It Work
explains the main physiological mechanism (hypercapnic hypoxic training)
Frolov Device Effects
Acute Asthma Exacerbation
Buy Frolov Breathing Device
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