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The purpose of this study is to evaluate the clinical outcome and safety of flutter mucus clearance devices in elders of gerocomium.
Respiratory diseases are still increasing in the elderly population. The fluttering mucus clearance technique is expected to be a physical assisting therapy enhancing airway secretion clearance but needs more clinical randomized, controlled trial evidence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | ||
| intervention | Experimental | Intervention group were given flutter valve mucus clearance devices to do pulmonary function exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| flutter mucus clearance device | Device | five minutes every sessions, three sessions per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Cases With Fever (Body Temperature Reach 38 Degree Celsius or Higher) | up to 28 days | |
| MPEF,Mean Peak Expiratory Flow | indicators of pulmonary function, for example, PEF(unit of measurement:Liter per minute) All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study. | up to 28 days |
| FEV1, Forced Expiratory Volume at First Second | indicators of pulmonary function, for example, FEV1(unit of measurement:Liter) All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study. | up to 28 days |
| FVC, Forced Vital Capacity | indicators of pulmonary function, for example, FVC(unit of measurement:Liter) All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study. | up to 28 days |
| FEV1/FVC%, the Ratio of FEV1 to FVC | indicators of pulmonary function, All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study. | up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Cases With Antibiotics Therapy | antibiotics therapy is the indicators of pulmonary infection | up to 28 days |
| Number of Cases With Hospital Visit | up to 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhang Xiangyu, MD | Shanghai Tebth People's Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20979671 | Derived | Wang QX, Zhang XY, Li Q. Effects of a flutter mucus-clearance device on pulmonary function test results in healthy people 85 years and older in China. Respir Care. 2010 Nov;55(11):1449-52. |
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recuitment period: April 19th, May 17th location: Redsun geracomium
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation. |
| FG001 | Control Group | without any intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation. |
| BG001 | Control Group | without any intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Cases With Fever (Body Temperature Reach 38 Degree Celsius or Higher) | Posted | Number | participants | up to 28 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zhang Xiangyu | Shanghai Tenth People's Hospital, Tongji University | 86-21-66307174 | xiangyu62@126.com |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Number of Cases With Antibiotics Therapy | antibiotics therapy is the indicators of pulmonary infection | Posted | Number | participants | up to 28 days |
|
|
|
| Primary | MPEF,Mean Peak Expiratory Flow | indicators of pulmonary function, for example, PEF(unit of measurement:Liter per minute) All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study. | Posted | Mean | Standard Deviation | L/min | up to 28 days |
|
|
|
| Primary | FEV1, Forced Expiratory Volume at First Second | indicators of pulmonary function, for example, FEV1(unit of measurement:Liter) All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study. | Posted | Mean | Standard Deviation | L | up to 28 days |
|
|
|
| Primary | FVC, Forced Vital Capacity | indicators of pulmonary function, for example, FVC(unit of measurement:Liter) All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study. | Posted | Mean | Standard Deviation | L | up to 28 days |
|
|
|
| Primary | FEV1/FVC%, the Ratio of FEV1 to FVC | indicators of pulmonary function, All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study. | Posted | Mean | Standard Deviation | ratios | up to 28 days |
|
|
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| Secondary | Number of Cases With Hospital Visit | Posted | Number | participants | up to 28 days |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Control Group | without any intervention | 0 | 30 | 0 | 30 |
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