Effects of Combined Respiratory Muscle Training and Steam Inhalation

Effect of Respiratory Training and Steam Inhalation With WellO2 Device on Lung Function and Respiratory Symptoms in Patients With Chronic Obstructive Lung Diseases - a Pilot Study

The purpose of this investigation is to obtain more information on the efficacy and safety of respiratory training methods with WellO2 in patients with asthma and COPD. Such a training may offer an additional, non-pharmacological way for treatment and therapy of asthma and COPD.

Study Overview

• Status: Unknown
• Conditions: Asthma; Airway Obstruction; COPD
• Intervention / Treatment: Device: Respiratory muscle training with steam inhalation

Detailed Description

Numerous respiratory muscle training (RMT) experiments with healthy subjects, as well as with patients of chronic obstructive pulmonary disease (COPD), bronchiectasis and asthma, have been reported since 80's. Respiratory training with WellO2 device was used in a clinical pilot study by Huttunen and Rantala to investigate effects of steam inhalation and RMT on voice quality in patients with voice symptoms. No adverse effects were found in that study.

The present study is designed to investigate further the RMT and steam inhalation on lung function and respiratory symptoms with subjects suffering from obstructive diseases such as asthma and COPD. The results may be used later in statistical power calculations and to determine the endpoints of larger clinical trial with the investigational device.

Asthma is still an increasing problem in many countries, even though, incidence of the most severe asthma cases is in decline due to earlier diagnosis, better control and earlier intervention practices. The prevalence of asthma and COPD in western countries is around 10 % and 5 %, respectively. The prevalence of COPD is higher in the countries where smoking and poor quality of inhaled air are common.

The treatment of asthma is based on treatment of eosinophilic inflammation of the airways by inhaled corticosteroids and on treatment of bronchoconstriction by sympathomimetic bronchodilators, short-acting and long-acting. The drugs may, however, induce side effects like voice disorders and cardiac symptoms (palpitation, tachycardia and extrasystoles).

Therefore, in many cases the doses of the drugs cannot continuously be kept at the highest effective level. Therefore, non-pharmacological methods can complement the treatment portfolio. The breathing physiotherapy by respiratory muscle training and warm steam inhalation can offer an additive treatment method for patients with airway obstruction.

It is possible that training with the combination of positive counter pressure and steam inhalation methods can induce significant improvement in ventilatory function variables and respiratory symptoms in asthmatics who have kept their ordinary pharmacological therapy at a constant level. Based on the previous scientific evidence found on the public domains, it can be expected that the respiratory muscle strength will be increased offering a possibility for more effective pulmonary mechanics, ventilation and lung volumes. In addition, exhaling against resistance will induce a positive end expiratory pressure (PEEP) effect which can open narrowed airways and make the distribution of alveolar ventilation less heterogeneous. This can improve gas exchange in the lungs and increase the level of low oxygen saturation in arterial blood.

In COPD, drugs can improve the airway changes, irreversible thickening of the airway walls, and chronic inflammation only partially. Therefore, breathing physiotherapy may offer an additive method to improve lung function and gas exchange, and to diminish dyspnoea and other symptoms like cough. The mechanisms of RMT are principally the same in asthma and COPD. Patients with obstructive airway disease frequently have both COPD and asthma, partly reversible or irreversible.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland, 33210
    • Recruiting
    • Medical Center Johanneksen Klinikka
    • Contact: Jukka Heinijoki, MD; Phone Number: +358(0)400 666676; Email: jukka.heinijoki@johanneksenklinikka.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Signed written informed consent
2. Age 18-65 years
3. Ethnic origin: Finnish
4. Both men and women are included
5. Diagnosed COPD or asthma or both
6. The duration of the illness at least 1 year, and the disease is at a stable stage
7. Pulmonary medication: unchanged for 4 weeks before the start of the study and throughout the study
8. Severity of the disease: mild, moderate or severe
9. The baseline FEV1 45-90 % of predicted normal value (Kainu et al 2016)
10. Eventual previous smoking has been ceased at least four weeks before the study
11. Compliance and commitment to the study (volunteered study subjects)

Exclusion Criteria:

1. Previous history of pneumothorax
2. Unstable emphysema
3. Chest, abdominal, or cerebral aneurysms
4. Epilepsy
5. Chronic nose bleeding
6. Recent (< 3 months) surgical operations
7. Pregnancy
8. Unstable mental health issues
9. Alcohol consumption more than 10 portions/week (one portion is e.g. 4 cl of strong drinks including 40 % alcohol by volume)
10. Drug addiction
11. Non-compliance to the study protocol
12. History of worsening asthma symptoms at sauna
13. Any other pulmonary disease than asthma or COPD
14. Any other major illnesses such as heart failure, coronary artery disease, neurological diseases or type 1 diabetes
15. Smoking during the study period of 16 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The intervention group (A) will perform respiratory muscle training and steam inhalation with WellO2 device for 30 days.	Device: Respiratory muscle training with steam inhalation
No Intervention: Control; The control group (B) will continue on their conventional treatment without respiratory muscle training or steam inhalation with WellO2. After 30 days, the group B performs the same 30-day intervention with the WellO2 device (test) as the group A.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in forced expiratory volume in one second (FEV1) measured with spirometry	Statistical difference of FEV1 between and within the arms compared to the baseline	30 days intervention plus 190 days washout period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in vital capacity (VC) measured with spirometry	Statistical difference between and within the arms compared to the baseline	30 days intervention plus 190 days washout period
Change in forced vital capacity (FVC) measured with spirometry	Statistical difference between and within the arms compared to the baseline	30 days intervention plus 190 days washout period
Change in peak expiratory flow (PEF) measured with spirometry	Statistical difference between and within the arms compared to the baseline	30 days intervention plus 190 days washout period
Change in forced expiratory volume in one second / vital capacity (FEV1/VC) measured with spirometry	Statistical difference between and within the arms compared to the baseline	30 days intervention plus 190 days washout period
Change in forced expiratory volume in one second / forced vital capacity (FEV1/FVC) measured with spirometry	Statistical difference between and within the arms compared to the baseline	30 days intervention plus 190 days washout period
Change in maximum expiratory flow at 50% of FVC (MEF50) measured with spirometry	Statistical difference between and within the arms compared to the baseline	30 days intervention plus 190 days washout period
Change in maximal mid-expiratory flow (MMEF) measured with spirometry	Statistical difference between and within the arms compared to the baseline	30 days intervention plus 190 days washout period
Bronchodilatation test with inhaled salbutamol (0,4 mg)	Statistical difference between and within the arms compared to the baseline	30 days intervention plus 190 days washout period
Change in arterial oxygen saturation SpO2 (%)	Statistical difference between and within the arms compared to the baseline	30 days intervention plus 190 days washout period
Change in maximal expiratory and inspiratory airway pressures (MEP and MIP)	Statistical difference between and within the arms compared to the baseline	30 days intervention plus 190 days washout period
Change in systolic and diastolic blood pressure at rest	Statistical difference between and within the arms compared to the baseline	30 days intervention plus 190 days washout period
Change in heart rate at rest	Statistical difference between and within the arms compared to the baseline	30 days intervention plus 190 days washout period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Total number and severity of adverse events between the test and control group during the intervention	120 days

Collaborators and Investigators

• Sponsor: WellO2 Oy
• Collaborators: Oy Medfiles
• Investigators: Principal Investigator: Jukka Heinijoki, MD, Medical Center Johanneksen Klinikka

Publications and helpful links

Helpful Links

• Manufacturer's web address

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): March 2, 2021
• Study Completion (Anticipated): March 30, 2021

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: October 5, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Respiration; Respiratory muscle training; Steam inhalation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Respiratory Aspiration; Airway Obstruction
• Other Study ID Numbers: HA010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No