Does Pulmonary Rehabilitation Improve Frailty?

Overview

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.

Full Title of Study: “Does Pulmonary Rehabilitation Improve Frailty in Chronic Lung Disease?”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 16, 2018

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

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With Frailty Phenotype at Baseline and 6 Months
    • Time Frame: 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 Measures

  • Wasting
    • Time Frame: after pulmonary rehabilation completion, appoximately 8 weeks
    • DXA measurement of body mass index pre- and post- PR.
  • Change in Strength
    • Time Frame: after completion of pulmonary rehab, approximately 8 weeks
    • Change in Grip Strength as measured by hand dynamometer.
  • Change in Gait Speed
    • Time Frame: pre and post pulmonary rehab, approximately 8 weeks
    • gait speed test measured over 15 feet
  • Improvement in Exhaustion
    • Time Frame: 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
    • Time Frame: 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

Participating in This Clinical Trial

Inclusion Criteria

  • Referred for pulmonary rehabilitation – consenting to research Exclusion criteria:

-Under 18 years of age

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Collaborator
    • National Heart, Lung, and Blood Institute (NHLBI)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Cassie C. Kennedy, M.D., Consultant for Critical Care Medicine – Mayo Clinic
  • Overall Official(s)
    • Cassie Kennedy, MD, Principal Investigator, Mayo Clinic

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