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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL128859 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Frailty is a state of health with predisposition to adverse events, morbidity and mortality. Frailty consists of weakness, slowness, low physical activity, exhaustion, and wasting. Frailty is associated with increased hospitalizations and death in lung disease. It is unknown if pulmonary rehabilitation will improve frailty markers.
Individuals referred to pulmonary rehabilitation will be examined for frailty markers. After completing pulmonary rehabilitation, the same tests will be performed. The effects of pulmonary rehabilitation will be examined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary Rehabilitation | Other | One arm study - all participants will go to pulmonary rehabilitation, received questionnaires, Dual-energy X-ray absorptiometry (DEXA) scans, Dynamometer and gait speed tests and activity measured through an activity monitor. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary Rehabilitation | Other | Measures of frailty taken before and after pulmonary rehabilitation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Frailty Phenotype at Baseline and 6 Months | Frailty phenotype is 3 or more of: slow gait speed, exhaustion, decreased hand grip strength, decreased activity level, or wasting. Grip strength parameters, gait speed, exhaustion per Fried et al. 2001. Wasting is defined as further decrease in fat free mass by body composition measurement using DEXA. Low physical activity would be activity monitor in lower quartile. | Baseline, Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Wasting | DXA measurement of body mass index pre- and post- PR. | after pulmonary rehabilation completion, appoximately 8 weeks |
| Change in Strength | Change in Grip Strength as measured by hand dynamometer. |
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Inclusion criteria:
Exclusion criteria:
-Under 18 years of age
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| Name | Affiliation | Role |
|---|---|---|
| Cassie Kennedy, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pulmonary Rehabilitation | One arm study - all participants will go to pulmonary rehabilitation, received questionnaires, DEXA scans, Dynamometer and gait speed tests and activity measured through an activity monitor. Pulmonary Rehabilitation: Measures of frailty taken before and after pulmonary rehabilitation. Dynamometer: Grip Test DEXA: Body Composition Testing Gait Speed Test: 15 foot walk test Activity Monitor: Measures energy expenditure and activity Questionnaires: Health-related questionnaires measuring self-reported exhaustion, emotions and disease symptoms. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pulmonary Rehabilitation | One arm study - all participants will go to pulmonary rehabilitation, received questionnaires, DEXA scans, Dynamometer and gait speed tests and activity measured through an activity monitor. Pulmonary Rehabilitation: Measures of frailty taken before and after pulmonary rehabilitation. Dynamometer: Grip Test DEXA: Body Composition Testing Gait Speed Test: 15 foot walk test Activity Monitor: Measures energy expenditure and activity Questionnaires: Health-related questionnaires measuring self-reported exhaustion, emotions and disease symptoms. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 Participants With Frailty Phenotype at Baseline and 6 Months | Frailty phenotype is 3 or more of: slow gait speed, exhaustion, decreased hand grip strength, decreased activity level, or wasting. Grip strength parameters, gait speed, exhaustion per Fried et al. 2001. Wasting is defined as further decrease in fat free mass by body composition measurement using DEXA. Low physical activity would be activity monitor in lower quartile. | Forty-nine participants (77.8%) of the 63 participants completed at lease one follow-up frailty parameter assessment after completion of pulmonary rehabilitation. | Posted | Count of Participants | Participants | Baseline, Six months |
|
Adverse event data were collected from baseline through 6 month follow up.
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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 | Pulmonary Rehabilitation | One arm study - all participants will go to pulmonary rehabilitation, received questionnaires, Dual-energy X-ray absorptiometry (DEXA) scans, Dynamometer and gait speed tests and activity measured through an activity monitor. Pulmonary Rehabilitation: Measures of frailty taken before and after pulmonary rehabilitation. Dynamometer: Grip Test DEXA: Body Composition Testing Gait Speed Test: 15 foot walk test Activity Monitor: Measures energy expenditure and activity Questionnaires: Health-related questionnaires measuring self-reported exhaustion, emotions and disease symptoms. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cassie C. Kennedy | Mayo Clinic | 507-266-3958 | kennedy.cassie@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 23, 2015 | Aug 30, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D053581 | Muscle Strength Dynamometer |
| D000072936 | Fitness Trackers |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
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| Dynamometer | Device | Grip Test |
|
| DEXA | Radiation | Body Composition Testing |
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| Gait Speed Test | Other | 15 foot walk test |
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| Activity Monitor | Device | Measures energy expenditure and activity |
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| Questionnaires | Other | Health-related questionnaires measuring self-reported exhaustion, emotions and disease symptoms. |
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| after completion of pulmonary rehab, approximately 8 weeks |
| Change in Gait Speed | gait speed test measured over 15 feet | pre and post pulmonary rehab, approximately 8 weeks |
| Improvement in Exhaustion | Self-reported exhaustion - measured by two questions in the Center for the Epidemiological Studies in Depression (CES-D) scale and reported as a dichotomous variable (exhausted or not exhausted). | pre and post pulmonary rehab, approximately 8 weeks |
| Change in Physical Activity Level | Measured by Body Media armband activity monitor using total energy expenditure divided by the resting metabolic rate | pre and post pulmonary rehab, approximately 8 weeks |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary Pulmonary Diagnosis | Count of Participants | Participants |
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| Pulmonary Function - Forced expiratory volume | The forced expiratory volume in one second (FEV1) measurement shows the amount of air in liters a person can forcefully exhale in one second. | Median | Inter-Quartile Range | liters |
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| Pulmonary Function - % Predicted | The % predicted represents the percent of the lung size that can be exhaled in one second. | Median | Inter-Quartile Range | percent |
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| Secondary | Wasting | DXA measurement of body mass index pre- and post- PR. | Data for 37 participants was available for analysis. | Posted | Median | Inter-Quartile Range | kg/m^2 | after pulmonary rehabilation completion, appoximately 8 weeks |
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|
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| Secondary | Change in Strength | Change in Grip Strength as measured by hand dynamometer. | Data for 45 participants was available for analysis. | Posted | Median | Inter-Quartile Range | kg | after completion of pulmonary rehab, approximately 8 weeks |
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| Secondary | Change in Gait Speed | gait speed test measured over 15 feet | Data for 43 participants was available for analysis. | Posted | Median | Inter-Quartile Range | seconds | pre and post pulmonary rehab, approximately 8 weeks |
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| Secondary | Improvement in Exhaustion | Self-reported exhaustion - measured by two questions in the Center for the Epidemiological Studies in Depression (CES-D) scale and reported as a dichotomous variable (exhausted or not exhausted). | Data for 39 participants was available for analysis. 19 participants were exhausted pre-pulmonary rehabilitation. 17 were exhausted following pulmonary rehab. | Posted | Count of Participants | Participants | pre and post pulmonary rehab, approximately 8 weeks |
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| Secondary | Change in Physical Activity Level | Measured by Body Media armband activity monitor using total energy expenditure divided by the resting metabolic rate | Data for 47 participants was available for analysis. | Posted | Median | Inter-Quartile Range | ratio | pre and post pulmonary rehab, approximately 8 weeks |
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| 4 |
| 65 |
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| 65 |
| 0 |
| 65 |
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| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |