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The Impact of Intermittent High-Intensity Inspiratory Muscle Training on Diaphragmatic Function and Quality of Life in Tracheostomy Patients: A Randomized Controlled Clinical Trial

The Impact of Intermittent High-Intensity Inspiratory Muscle Training on Diaphragmatic Function and Quality of Life in Tracheostomy Patients: A Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099091
Enrollment
Unknown
Registered
2025-03-18
Start date
2025-03-25
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Respiratory dysfunction in tracheotomy patients

Interventions

High intensity intermittent inspiratory muscle training group:High intensity intermittent inspiratory muscle training

Sponsors

The Sixth Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age: 30-70 years old; 2. Tracheostomy for 1-3 months, the number of suctions per day >=8 times; 3. Stable vital signs, clear consciousness, able to understand and cooperate with training; 4. Fiberoptic bronchoscopy without airway collapse or airway stenosis; 5. Deoxygenation state SPO2>=93%, respiratory rate = 60mmHg,FIO2 = 36.5°C <= 38.5°C; 8. Willing to participate in this study, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Gas cutting casing is metal casing; 2. Inspiratory muscle training is not allowed, such as rib fractures, cardiac insufficiency, multiple pulmonary bullae and asthma attacks; 3. Other cases of eardrum rupture or eardrum that have not been completely healed; 4. Dyspnea abnormal low perception ability; 5. Patients with diseases of important organs; 6. More than one sputum aspiration per hour.

Design outcomes

Primary

MeasureTime frame
Maximum inspiratory pressure;

Secondary

MeasureTime frame
Maximum inspiratory Flow Rate;Endotracheal tube cuff pressure;Cough effectiveness grading;Quality of life /QOL;Anxiety and depression score;Gas cut casing extraction rate;Clinical pulmonary infection score;

Countries

China

Contacts

Public ContactYuling Wang

The Sixth Affiliated Hospital, Sun Yat-sen University

wangyul@mail.sysu.edu.cn+86 130 5444 5587

Outcome results

None listed

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