Does Pulmonary Rehabilitation Improve Frailty?
2 other identifiers
interventional
65
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 21, 2015
CompletedFirst Submitted
Initial submission to the registry
July 24, 2015
CompletedFirst Posted
Study publicly available on registry
July 31, 2015
CompletedResults Posted
Study results publicly available
October 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 16, 2018
CompletedJune 23, 2020
June 1, 2020
3.2 years
July 24, 2015
August 30, 2018
June 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Wasting
after pulmonary rehabilation completion, appoximately 8 weeks
Change in Strength
after completion of pulmonary rehab, approximately 8 weeks
Change in Gait Speed
pre and post pulmonary rehab, approximately 8 weeks
Improvement in Exhaustion
pre and post pulmonary rehab, approximately 8 weeks
Change in Physical Activity Level
pre and post pulmonary rehab, approximately 8 weeks
Study Arms (1)
Pulmonary Rehabilitation
OTHEROne 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.
Interventions
Measures of frailty taken before and after pulmonary rehabilitation.
Health-related questionnaires measuring self-reported exhaustion, emotions and disease symptoms.
Eligibility Criteria
You may qualify if:
- Referred for pulmonary rehabilitation
- consenting to research
You may not qualify if:
- Under 18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Cassie C. Kennedy
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Cassie Kennedy, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant for Critical Care Medicine
Study Record Dates
First Submitted
July 24, 2015
First Posted
July 31, 2015
Study Start
July 21, 2015
Primary Completion
October 16, 2018
Study Completion
October 16, 2018
Last Updated
June 23, 2020
Results First Posted
October 5, 2018
Record last verified: 2020-06