The long term oxygen therapy dosing under stress trial - 6 Minute Walking Test vs. Stress Pulse Oximetry

The long term oxygen therapy dosing under stress trial - 6 Minute Walking Test vs. Stress Pulse Oximetry - LOTUS

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00032079

Enrollment

100

Registered

2023-06-22

Start date

2023-03-14

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

J96.1

Interventions

Group 1: Patients wit hypoxemia/stress hypoxemia for whom longterm oxygen treatment is indicated and whose oygen treatment is titrated based on the six-minute walk test on day 1 and tested on day 2 us

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with hypoxemia/stress hypoxemia with indication for LTOT according to current guidelines of the German Respiratory Society (DGP)

Exclusion criteria

Exclusion criteria: • Pneumothorax • Myocardial infarction in the last month • unstable angina pectoris • heart rate at rest > 130/min • blood pressure at rest > 180/100mmHg

Design outcomes

Primary

Measure	Time frame
A combined endpoint of patients presenting either with severe hypoxemia and/or hyperoxigenation after completed O2 titration (pO2 =60mmHg or SpO2 >90%) during 6 MWT or SPO	—

Secondary

Measure	Time frame
• Stress hypoxemia prior to oxygen titration measured by blood gas analysis (BGA) and pulse oximetry at the specification a. to walk a maximum walking distance within 6 minutes b. to walk a distance at normal and accustomed walking speed with a self-selected walking duration (max. 6 minutes) • After completed O2 titration (pO2 =60mmHg or SpO2 >90%) by means of a. SPO, how many patients present with hypoxemia during 6 MWT (SpO2 93% ) • Time required for the 6 MWT and the SPO for guideline-compliant LTOT titration during exercise (target: pO2 =60mmHg or SpO2 90-92%) • Symptoms (dyspnea, feeling of exhaustion) of patients with standardized implementation of a 6 MWTs vs. SPO measured by Borg´s CR-10 scale	—

Measure

Time frame

• Stress hypoxemia prior to oxygen titration measured by blood gas analysis (BGA) and pulse oximetry at the specification a. to walk a maximum walking distance within 6 minutes b. to walk a distance at normal and accustomed walking speed with a self-selected walking duration (max. 6 minutes) • After completed O2 titration (pO2 =60mmHg or SpO2 >90%) by means of a. SPO, how many patients present with hypoxemia during 6 MWT (SpO2 93% ) • Time required for the 6 MWT and the SPO for guideline-compliant LTOT titration during exercise (target: pO2 =60mmHg or SpO2 90-92%) • Symptoms (dyspnea, feeling of exhaustion) of patients with standardized implementation of a 6 MWTs vs. SPO measured by Borg´s CR-10 scale

—

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026