Effects of Combined Respiratory Muscle Training and Steam Inhalation

NCT04584398 | Unknown

• 1 other identifier: HA010
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Airway Obstruction; Asthma; COPD

Keywords

Respiration; Respiratory muscle training; Steam inhalation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Change in vital capacity (VC) measured with spirometry

  30 days intervention plus 190 days washout period

• Change in forced vital capacity (FVC) measured with spirometry

  30 days intervention plus 190 days washout period

• Change in peak expiratory flow (PEF) measured with spirometry

  30 days intervention plus 190 days washout period

• Change in forced expiratory volume in one second / vital capacity (FEV1/VC) measured with spirometry

  30 days intervention plus 190 days washout period

• Change in forced expiratory volume in one second / forced vital capacity (FEV1/FVC) measured with spirometry

  30 days intervention plus 190 days washout period

Other Outcomes (1)

• Adverse events

  120 days

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Respiratory muscle training with steam inhalation DEVICE

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• WellO2 Oy: lead
• Oy Medfiles: collaborator

Study Sites (1)

Medical Center Johanneksen Klinikka

Tampere, 33210, Finland

RECRUITING

Related Links

• Manufacturer's web address

MeSH Terms

Conditions

Airway Obstruction; Asthma; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Jukka Heinijoki, MD

  Medical center Johanneksen Klinikka

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilpo Kuronen, PhD

CONTACT

+358(0)451393757; ilpo.kuronen@wello2.com

Katri Lindberg

CONTACT

+358 (0)407373712; katri.lindberg@wello2.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study is conducted as a randomized, single-blind (for evaluators), controlled, 30 days intervention trial with two parallel groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, single-blind parallel design with 50-60 subjects suffering from obstructive diseases such as asthma or COPD or both.

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: October 14, 2020
• Study Start: August 1, 2020
• Primary Completion: March 2, 2021
• Study Completion: March 30, 2021
• Last Updated: October 14, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)