An interventional study of Pulmonary Rehabilitation and Dynamometer in Disease, Pulmonary, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-23.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Other
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 65 is close to the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
-Under 18 years of age
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.
Other: Pulmonary Rehabilitation · Device: Dynamometer · Radiation: DEXA · Other: Gait Speed Test · Device: Activity Monitor · Other: Questionnaires
Measures of frailty taken before and after pulmonary rehabilitation.
Grip Test
Body Composition Testing
15 foot walk test
Measures energy expenditure and activity
Health-related questionnaires measuring self-reported exhaustion, emotions and disease symptoms.
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
Wasting
DXA measurement of body mass index pre- and post- PR.
Time frame: after pulmonary rehabilation completion, appoximately 8 weeks
Change in Strength
Change in Grip Strength as measured by hand dynamometer.
Time frame: after completion of pulmonary rehab, approximately 8 weeks
Change in Gait Speed
gait speed test measured over 15 feet
Time frame: 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).
Time frame: 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
Time frame: pre and post pulmonary rehab, approximately 8 weeks
| Milestone | Pulmonary Rehabilitation |
|---|---|
| Started | 65 |
| Completed | 63 |
| Not completed | 2 |
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.
| Participants | Pulmonary Rehabilitation |
|---|---|
| Baseline | 24 |
| Six months | 15 |
DXA measurement of body mass index pre- and post- PR.
| kg/m^2 | Pulmonary Rehabilitation |
|---|---|
| Wasting | 0.04 (-0.4 to 1.1) |
Change in Grip Strength as measured by hand dynamometer.
| kg | Pulmonary Rehabilitation |
|---|---|
| Change in Strength | 0 (-1.6 to 2.6) |
gait speed test measured over 15 feet
| seconds | Pulmonary Rehabilitation |
|---|---|
| Change in Gait Speed | -0.6 (-1.5 to 0.5) |
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).
| Participants | Pulmonary Rehabilitation |
|---|---|
| Improvement in Exhaustion | 2 |
Measured by Body Media armband activity monitor using total energy expenditure divided by the resting metabolic rate
| ratio | Pulmonary Rehabilitation |
|---|---|
| Change in Physical Activity Level | 0.4 (-0.4 to 1.1) |
Collected over Adverse event data were collected from baseline through 6 month follow up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pulmonary Rehabilitation | 4/65 (6.2%) | 0/65 (0%) | 0/65 (0%) |
| Age, Continuous(years) | Pulmonary Rehabilitation |
|---|---|
| Median | 65 (59.0 to 73) |
| Sex: Female, Male(Participants) | Pulmonary Rehabilitation |
|---|---|
| Female | 25 |
| Male | 38 |
| Race (NIH/OMB)(Participants) | Pulmonary Rehabilitation |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 54 |
| More than one race | 0 |
| Unknown or Not Reported | 9 |
| Region of Enrollment(participants) | Pulmonary Rehabilitation |
|---|---|
| United States | 63 |
| Primary Pulmonary Diagnosis(Participants) | Pulmonary Rehabilitation |
|---|---|
| Obstructive | 35 |
| Post Lung Transplant | 13 |
| Interstitial Lung Disease | 10 |
| Other | 5 |
| Pulmonary Function - Forced expiratory volume(liters) | Pulmonary Rehabilitation |
|---|---|
| Median | 1.3 (1.0 to 2.0) |
| Pulmonary Function - % Predicted(percent) | Pulmonary Rehabilitation |
|---|---|
| Median | 49 (39 to 66) |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mayo Clinic