Does Pulmonary Rehabilitation Improve Frailty?

Does Pulmonary Rehabilitation Improve Frailty in Chronic Lung Disease?

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.

Study Overview

• Status: Completed
• Conditions: Disease, Pulmonary
• Intervention / Treatment: Other: Pulmonary Rehabilitation; Device: Dynamometer; Radiation: DEXA; Other: Gait Speed Test; Device: Activity Monitor; Other: Questionnaires

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Referred for pulmonary rehabilitation
• consenting to research

Exclusion criteria:

-Under 18 years of age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: July 21, 2015
• Primary Completion (Actual): October 16, 2018
• Study Completion (Actual): October 16, 2018

Study Registration Dates

• First Submitted: July 24, 2015
• First Submitted That Met QC Criteria: July 29, 2015
• First Posted (Estimate): July 31, 2015

Study Record Updates

• Last Update Posted (Actual): June 23, 2020
• Last Update Submitted That Met QC Criteria: June 10, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Frailty
• Other Study ID Numbers: 15-001230; K23HL128859 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes