Clinical Trial: Frolov Device (TDI-01) for Patients with Acute COPD (Chronic Obstructive Pulmonary Disease)

- Updated on October 12, 2020

Safety and efficiency of the Frolov device (FDA’s approval)

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

Doctors and patients 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 the efficiency and safety of this therapy for this group of patients
– to investigate the possibility of reduction (elimination) of medication as a result of the Frolov breathing exercises therapy
– to investigate the criteria of efficiency and safety of the method.

Experimental group

Woman coughing 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 patients.)

The initial duration of breathing exercises was 10 minutes with 1 additional minute increase after every 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). The 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).

Control group

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.

The respiratory system 1. During the investigation of the Frolov breathing device therapy (TDI-01) on patients with COPD (stable state, moderate severity), there were no complications or side effects that could be dangerous for health. Clinical observations showed the safety of its application. This can be explained by the fact that this method is drug-free and is based on the activation of physiological processes.

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 therapy.

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.

Lungs alveoli without COPD 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 a 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 centers.

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)
Parameter Group Initial Day 22 Day 42 Day 60 Day 90
Control 62,1+-1,8 62,8+-1,9 63,9+-2,2 64,8+-2,4 65,4+-3,7
Experimental 61,3+-1,6 61,3+-1,2 65,8 +-1,2 67,1+-1,4 67,9+-1,3
FEV1 Control 61,6+-2,4 63,0+-3, 64,2+-2,9 65,5+-4,2 66,2+-6,1
Experimental 62,1 +-2,1 64,6 +-1,8 66,9+-1,6 67,2+-1,7 67,7+-2,3
PEF Control 46,9+-5,9 51,1+-5,5 55,2+-6,0 57,3+-6,2 60,9+-7,5
Experimental 47,5+-5,4 53,9+-5,3 58,2+-5,8 60,1+-5,2 63,4+-5,1
RV Control 132,2+-5,7 128,1+-4,3 125,5+-5,3 122,2+-5,8 119,0+-6,4
Experimental 130,9+-5,1 122,8+-4,6 117,5+-3,2 115,8+-3,5 113,2+-3,8
TLC Control 107,3+-7,4 106,5+-7,2 105,3+-6,8 104,9+-7,2 104,2+-8,1
Experimental 106,9+-7,8 105,1+-6,9 104,9+-5,8 104,7+-6,1 104,3+-6,9
FRC Control 103,4+-3,8 102,8+-3,5 102,1+-3,7 102,5+-3,9 102,9+-4,8
Experimental 102,9+-3,6 102,6+-3,1 102,9+-2,8 101,5+-3,3 101,7+-3,4
FEV/FVC,% Control 53,4+-3,6 58,2+-4,8 60,2+-4,5 58,1+-3,4 58,8+-5,2
Experimental 55,2+-3,6 57,4+-4,2 58,4+-6,4 64,8+-5,6 64,7+-4,4

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.

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 Clinical Trial
Buy Frolov Breathing Device

Below are authentic comments, questions, and testimonials from the same page on the old PHP site before we converted it to WordPress.

On 2018-11-18T08:19:55, Dr. Artour (mod) wrote:
Great to hear, Tom. If you apply the Buteyko lifestyle and get up to 35 s morning CP with your pulse below 70, the body will restore alveoli in your lungs so that X-ray would show normal lungs after some years of practice. There are many students who reserved emphysema completely with X-ray confirmations, especially from the Moscow Buteyko Clinic.

On 2018-11-18T06:59:18, Tom Smith wrote:
I purchased the Breathslim device here in the U.S. The Breathslim device is the same as the Frolov device. The Breathslim device is no longer marketed in the U.S. I’m not one for numbers, charts, statistics, etc but I can attest to this: I do the Frolov breathing protocol every day for 20 minutes to the best of my ability and it allows me to go through the day without even noticing my emphysema.