Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06545851

Automatic Oxygen Titration Versus Constant Oxygen Flow Rates During Exercise Training in Hypoxemic People With Chronic Lung Disease - a Randomized, Double-blind, Controlled Cross-over Pilot Study

Led by Schön Klinik Berchtesgadener Land · Updated on 2024-08-13

15

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the effects of automatic oxygen titration compared to prescribed constant oxygen flow rates on the perception of breathlessness during exercise in people with chronic lung disease and hypoxaemia. Hypoxaemia, a condition marked by low oxygen levels in the blood, often limits exercise tolerance in these patients. The study is designed as a randomized, double-blind, controlled cross-over trial to better understand whether adjusting oxygen flow automatically during exercise can improve symptoms and endurance. Participants will undergo an initial test to determine their peak work rate on a cycle. They will then complete two sets of five endurance exercise training sessions each. In one set, supplemental oxygen will be delivered at a constant flow rate as prescribed for the individual. In the other, oxygen flow will be automatically adjusted to maintain oxygen saturation between 90-94%. The order of these two training sets will be randomized to compare the effects of both oxygen delivery methods. During the study, participants' breathlessness will be measured throughout the training sessions, along with oxygen saturation, carbon dioxide levels, heart rate, and leg fatigue. The study will also assess participants' experiences with the oxygen delivery systems. These evaluations will take place during both five-session training periods, allowing researchers to compare the outcomes of automatic versus constant oxygen flow. The total study period includes these exercise training sessions and monitoring of physiological and subjective responses.

CONDITIONS

Brief Title

Effects of an Automatic Oxygen Titration System in People With Hypoxemia During Exercise Training

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Chronic lung disease
  • Hypoxemia (pO2 < 55mmHg) at rest or during exercise or SpO2 < 88% during exercise
  • Established long-term oxygen therapy or indication for long-term oxygen or supplemental oxygen therapy during exercise
  • Age between 18 and 80 years
  • Participation in an inpatient pulmonary rehabilitation program at Schoen Klinik Berchtesgadener Land, Germany
  • Written informed consent
Not Eligible

You will not qualify if you...

  • Acute exacerbation of underlying pulmonary disease requiring cessation of exercise training

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Baseline Testing

Duration - 1 day

Participants undergo a cycle-based peak work rate test to determine their individual maximal peak work rate before starting exercise training.

1 visit (in-person)

Exercise Training with Oxygen Therapy

Duration - Approximately 2 weeks

Participants complete two sets of five endurance training sessions each, one set with automatic oxygen titration and the other with constant oxygen flow rates. The order of these sessions is randomized.

10 visits (in-person), 5 visits per oxygen therapy type

Trial Site Locations

Total: 1 location

1

Klinikum Berchtesgadener Land, Schön Kliniken

Schönau am Königssee, Bavaria, Germany, 83471

Actively Recruiting

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Research Team

A

Andreas Rembert Koczulla, Prof. Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Effect of Automated Oxygen Titration during Walking on Dyspnea and Endurance in Chronic Hypoxemic Patients with COPD: A Randomized Crossover Trial.

Linette Marie Kofod, Elisabeth Westerdahl, Morten Tange Kristensen...

https://pubmed.ncbi.nlm.nih.gov/34768338

Automatic oxygen titration versus constant oxygen flow rates during walking in COPD: a randomised controlled, double-blind, crossover trial.

Tessa Schneeberger, Inga Jarosch, Daniela Leitl...

https://pubmed.ncbi.nlm.nih.gov/34656996

Automated O2 titration improves exercise capacity in patients with hypercapnic chronic obstructive pulmonary disease: a randomised controlled cross-over trial.

Isabelle Vivodtzev, Erwan L'Her, Gabrielle Vottero...

https://pubmed.ncbi.nlm.nih.gov/30166425