Pulmonary Disease
Conditions
Keywords
geriatric, pulmonary disease, flutter, sputum, physical therapy techniques
Brief summary
The purpose of this study is to evaluate the clinical outcome and safety of flutter mucus clearance devices in elders of gerocomium.
Detailed description
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.
Interventions
five minutes every sessions, three sessions per day
Sponsors
Tongji University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
85 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* available to perform the device, the elders in geracomium * male and female * aging 85 years or more
Exclusion criteria
* not available to perform the procedure * untreated pneumothorax * diffusion interstitial lung disease * acute coronary syndrome * third stage hypertension * advanced cancer * severe heart, liver, renal, blood system and endocrine system dysfunction * noninvasive mechanical ventilation * active hemoptysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MPEF,Mean Peak Expiratory Flow | up to 28 days | 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. |
| FVC, Forced Vital Capacity | up to 28 days | 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. |
| FEV1/FVC%, the Ratio of FEV1 to FVC | up to 28 days | 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. |
| Number of Cases With Fever (Body Temperature Reach 38 Degree Celsius or Higher) | up to 28 days | — |
| FEV1, Forced Expiratory Volume at First Second | up to 28 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Cases With Hospital Visit | up to 28 days | — |
| Number of Cases With Antibiotics Therapy | up to 28 days | antibiotics therapy is the indicators of pulmonary infection |
Participant flow
Recruitment details
recuitment period: April 19th, May 17th location: Redsun geracomium
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation. | 30 |
| Control Group without any intervention | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 |
Baseline characteristics
| Characteristic | Control Group | Intervention Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 30 Participants | 30 Participants | 60 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 87.57 years STANDARD_DEVIATION 2.95 | 86.81 years STANDARD_DEVIATION 2.06 | 87.20 years STANDARD_DEVIATION 2.56 |
| Region of Enrollment China | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 24 Participants | 21 Participants | 45 Participants |
| Sex: Female, Male Male | 6 Participants | 9 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
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.
Time frame: up to 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | FEV1, Forced Expiratory Volume at First Second | 1.01 L | Standard Deviation 0.37 |
| Control Group | FEV1, Forced Expiratory Volume at First Second | 1.02 L | Standard Deviation 0.35 |
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.
Time frame: up to 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | FEV1/FVC%, the Ratio of FEV1 to FVC | 50.67 ratios | Standard Deviation 16.83 |
| Control Group | FEV1/FVC%, the Ratio of FEV1 to FVC | 59.04 ratios | Standard Deviation 13.82 |
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.
Time frame: up to 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | FVC, Forced Vital Capacity | 2.06 L | Standard Deviation 0.73 |
| Control Group | FVC, Forced Vital Capacity | 1.77 L | Standard Deviation 0.63 |
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.
Time frame: up to 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | MPEF,Mean Peak Expiratory Flow | 117.59 L/min | Standard Deviation 50.39 |
| Control Group | MPEF,Mean Peak Expiratory Flow | 103.93 L/min | Standard Deviation 41.53 |
Primary
Number of Cases With Fever (Body Temperature Reach 38 Degree Celsius or Higher)
Time frame: up to 28 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Number of Cases With Fever (Body Temperature Reach 38 Degree Celsius or Higher) | 0 participants |
| Control Group | Number of Cases With Fever (Body Temperature Reach 38 Degree Celsius or Higher) | 2 participants |
Secondary
Number of Cases With Antibiotics Therapy
antibiotics therapy is the indicators of pulmonary infection
Time frame: up to 28 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Number of Cases With Antibiotics Therapy | 1 participants |
| Control Group | Number of Cases With Antibiotics Therapy | 3 participants |
Secondary
Number of Cases With Hospital Visit
Time frame: up to 28 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Number of Cases With Hospital Visit | 2 participants |
| Control Group | Number of Cases With Hospital Visit | 3 participants |