Disease, Pulmonary
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERPulmonary Rehabilitation
Measures of frailty taken before and after pulmonary rehabilitation.
DEVICEDynamometer
Grip Test
RADIATIONDEXA
Body Composition Testing
OTHERGait Speed Test
15 foot walk test
DEVICEActivity Monitor
Measures energy expenditure and activity
OTHERQuestionnaires
Health-related questionnaires measuring self-reported exhaustion, emotions and disease symptoms.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Referred for pulmonary rehabilitation * consenting to research
Exclusion criteria
-Under 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Frailty Phenotype at Baseline and 6 Months | Baseline, Six 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wasting | after pulmonary rehabilation completion, appoximately 8 weeks | DXA measurement of body mass index pre- and post- PR. |
| Change in Strength | after completion of pulmonary rehab, approximately 8 weeks | Change in Grip Strength as measured by hand dynamometer. |
| Change in Gait Speed | pre and post pulmonary rehab, approximately 8 weeks | gait speed test measured over 15 feet |
| Improvement in Exhaustion | pre and post pulmonary rehab, approximately 8 weeks | 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). |
| Change in Physical Activity Level | pre and post pulmonary rehab, approximately 8 weeks | Measured by Body Media armband activity monitor using total energy expenditure divided by the resting metabolic rate |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 63 |
| Total | 63 |
Baseline characteristics
| Characteristic | Pulmonary Rehabilitation |
|---|---|
| Age, Continuous | 65 years |
| Primary Pulmonary Diagnosis Interstitial Lung Disease | 10 Participants |
| Primary Pulmonary Diagnosis Obstructive | 35 Participants |
| Primary Pulmonary Diagnosis Other | 5 Participants |
| Primary Pulmonary Diagnosis Post Lung Transplant | 13 Participants |
| Pulmonary Function - Forced expiratory volume | 1.3 liters |
| Pulmonary Function - % Predicted | 49 percent |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) White | 54 Participants |
| Region of Enrollment United States | 63 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 65 |
| other Total, other adverse events | 0 / 65 |
| serious Total, serious adverse events | 0 / 65 |
Outcome results
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.
Time frame: Baseline, Six months
Population: Forty-nine participants (77.8%) of the 63 participants completed at lease one follow-up frailty parameter assessment after completion of pulmonary rehabilitation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pulmonary Rehabilitation | Number of Participants With Frailty Phenotype at Baseline and 6 Months | Baseline | 24 Participants |
| Pulmonary Rehabilitation | Number of Participants With Frailty Phenotype at Baseline and 6 Months | Six months | 15 Participants |
p-value: 0.62Chi-squared
Secondary
Change in Gait Speed
gait speed test measured over 15 feet
Time frame: pre and post pulmonary rehab, approximately 8 weeks
Population: Data for 43 participants was available for analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pulmonary Rehabilitation | Change in Gait Speed | -0.6 seconds |
Secondary
Change in Physical Activity Level
Measured by Body Media armband activity monitor using total energy expenditure divided by the resting metabolic rate
Time frame: pre and post pulmonary rehab, approximately 8 weeks
Population: Data for 47 participants was available for analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pulmonary Rehabilitation | Change in Physical Activity Level | 0.4 ratio |
Secondary
Change in Strength
Change in Grip Strength as measured by hand dynamometer.
Time frame: after completion of pulmonary rehab, approximately 8 weeks
Population: Data for 45 participants was available for analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pulmonary Rehabilitation | Change in Strength | 0 kg |
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).
Time frame: pre and post pulmonary rehab, approximately 8 weeks
Population: Data for 39 participants was available for analysis. 19 participants were exhausted pre-pulmonary rehabilitation. 17 were exhausted following pulmonary rehab.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pulmonary Rehabilitation | Improvement in Exhaustion | 2 Participants |
Secondary
Wasting
DXA measurement of body mass index pre- and post- PR.
Time frame: after pulmonary rehabilation completion, appoximately 8 weeks
Population: Data for 37 participants was available for analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pulmonary Rehabilitation | Wasting | 0.04 kg/m^2 |