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A randomized controlled clinical trial of comprehensive pulmonary rehabilitation in patients with silicosis

A randomized controlled clinical trial of comprehensive pulmonary rehabilitation in patients with silicosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16008710
Enrollment
Unknown
Registered
2016-06-23
Start date
2016-08-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

silicosis

Interventions

phrenic nerve stimulation group A:phrenic nerve stimulation and routine rehabilitation therapy
Inspiratory muscle training group A:Inspiratory muscle training and routine rehabilitation therapy
Expiratory muscle training group A:Expiratory muscle training and routine rehabilitation therapy
Control group A:routine rehabilitation therapy
phrenic nerve stimulation group B:phrenic nerve stimulation and routine rehabilitation therapy
Inspiratory muscle training group B:Inspiratory muscle training and routine rehabilitation therapy
Expiratory muscle training group B:Expiratory muscle training and routine rehabilitation therapy
Control group B:routine rehabilitation therapy

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Male, aged from 18 to 70 years; 2. Patients have a clear career history, diagnosised by the occupational disease diagnosis group,in accordance with GBZTO-2015 ; 3. Patients at a stable stage of disease, there are respiratory dysfunction symptoms, exercise tolerance reduced and daily activities limited; 4. Patients be able to complete pulmonary function tests; 5. The subjects must sign written informed consent, and have ability to comply with the research steps.

Exclusion criteria

Exclusion criteria: 1. Silicosis complicated with acute pulmonary tuberculosi or spontaneous pneumothorax; 2. Situation with infection or high fever; 3. Patients have a history of malignant tumor; 4. Patients with motor dysfunction caused by diseases such as the circulatory system, nervous system, bone and joint system; 5. Patients require long-term home oxygen therapy,SPo2<90%,or need assisted mechanical ventilation; 6. There are interference in the study of therapeutic efficacy and safety of the Patients, such as severe pulmonary hypertension, coronary heart disease with angina, recent myocardial infarction, etc.; 7. The ECG, laboratory tests, chest X-ray, and other examination were found to be significantly abnormal within one week before the selection,and patients will face risk if be selected to study; 8. Patients with pulmonary rehabilitation treatment contraindications, such as pneumothorax, unstable rib fracture; 9. During the study period, patients need to be treated for elective surgery; 10. Patients had participated in a pulmonary rehabilitation programme in the past 12 months.

Design outcomes

Primary

MeasureTime frame
6 minute walk test (6MWT);

Secondary

MeasureTime frame
pulmonary function;blood gas analysis;inspiratory muscle function test;dyspnea score;anxiety and depression score;quality of life assessment;

Countries

China

Contacts

Public ContactZhen Feng

The First Affiliated Hospital of Nanchang University

fengzhenly@sina.com+86 13970038111

Outcome results

None listed

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