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Evaluation of the Efficacy and Safety of a Multi-Parameter Respiratory Training Device

Evaluation of the Efficacy and Safety of a Multi-Parameter Respiratory Training Device

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116557
Enrollment
Unknown
Registered
2026-01-12
Start date
2024-10-17
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)

Interventions

Group A:A new multi-parameter breathing training device was used for respiratory rehabilitation training, twice a day for 10-15 minutes each time, for 7 days.
Group B:Use the three-ball breathing trainer for respiratory rehabilitation training, twice a day for 10-15 minutes each time, for 7 days
Group C:Respiratory rehabilitation training with routine respiratory muscle function training (lip-enclosed abdominal breathing) was performed twice a day for 10-15 minutes each time for 7 days.

Sponsors

Henan Provincial People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients meeting the COPD diagnostic criteria in the "Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (2021 Revised Edition)" must demonstrate airflow limitation at GOLD 2-3 levels, be in an acute exacerbation phase, and have an age range of 18 to 75 years.

Exclusion criteria

Exclusion criteria: 1. Concurrent conditions including bronchiectasis, diabetes mellitus, or systemic disorders such as cardiac, hepatic, or renal diseases; 2. Lower limb dysfunction rendering patients incapable of completing the 6-minute walk test; 3. Giant pulmonary bullae; 4. Malignant hypertension; 5. Presence of cognitive impairment; 6. Concurrent malignant tumors; 7. Acute cerebrovascular events (e.g., cerebral infarction or hemorrhage) occurring within the past three months.

Design outcomes

Primary

MeasureTime frame
6-minute walking distance (6MWD);COPD Assessment Test (CAT) score;Modified British Medical Research Council (mMRC) dyspnea scale score;

Secondary

MeasureTime frame
Forced expiratory volume in 1 second (FEV1);Forced vital capacity (FVC);FEV1/FVC;Self-rating Depression Scale (SDS) score;Self-rating Anxiety Scale (SAS) score;Incidence of adverse events;

Countries

China

Contacts

Public ContactLimin zhao

Henan Provincial People’s Hospital

zlm9898@126.com+86 185 3829 7806

Outcome results

None listed

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