Does Pulmonary Rehabilitation Improve Frailty?

Not Applicable

Completed

• Conditions: Disease, Pulmonary
• Interventions: Other: Pulmonary Rehabilitation; Device: Dynamometer; Radiation: DEXA; Other: Gait Speed Test; Device: Activity Monitor; Other: Questionnaires

• Registration Number: NCT02512874
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2015-07-21
• Study First Submitted: 2015-07-24
• Study First Submitted QC: 2015-07-29
• Study First Posted: 2015-07-31
• Results First Submitted: 2018-08-30
• Results First Submitted QC: 2018-10-04
• Results First Posted: 2018-10-05
• Primary Completion: 2018-10-16
• Study Completion: 2018-10-16
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-10
• Last Update Posted: 2020-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pulmonary Rehabilitation	DEXA	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	Dynamometer	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	Gait Speed Test	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	Activity Monitor	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	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	Questionnaires	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in Strength	after completion of pulmonary rehab, approximately 8 weeks	Change in Grip Strength as measured by hand dynamometer.
Wasting	after pulmonary rehabilation completion, appoximately 8 weeks	DXA measurement of body mass index pre- and post- PR.
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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States