Does Pulmonary Rehabilitation Improve Frailty?

Disease, Pulmonary Clinical Trial

Official title:

Does Pulmonary Rehabilitation Improve Frailty in Chronic Lung Disease?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02512874
• Other study ID #: 15-001230
• Secondary ID: K23HL128859
• Status: Completed
• Phase: N/A
• Start date: July 21, 2015
• Est. completion date: October 16, 2018

Study information

• Verified date: June 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: October 16, 2018
• Est. primary completion date: October 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Referred for pulmonary rehabilitation

• consenting to research

Exclusion criteria:

-Under 18 years of age

Related Conditions & MeSH terms

• Disease, Pulmonary
• Frailty
• Lung Diseases

Intervention

Other:
• Pulmonary Rehabilitation
Measures of frailty taken before and after pulmonary rehabilitation.

Device:
• Dynamometer
Grip Test

Radiation:
• DEXA
Body Composition Testing

Other:
• Gait Speed Test
15 foot walk test

Device:
• Activity Monitor
Measures energy expenditure and activity

Other:
• Questionnaires
Health-related questionnaires measuring self-reported exhaustion, emotions and disease symptoms.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline, Six months
Secondary	Wasting	DXA measurement of body mass index pre- and post- PR.	after pulmonary rehabilation completion, appoximately 8 weeks
Secondary	Change in Strength	Change in Grip Strength as measured by hand dynamometer.	after completion of pulmonary rehab, approximately 8 weeks
Secondary	Change in Gait Speed	gait speed test measured over 15 feet	pre and post pulmonary rehab, approximately 8 weeks
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).	pre and post pulmonary rehab, approximately 8 weeks
Secondary	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

External Links

•   Mayo Clinic Clinical Trials