Back to resultsDoes Pulmonary Rehabilitation Improve Frailty?
Primary Purpose
Disease, Pulmonary
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pulmonary Rehabilitation
Dynamometer
DEXA
Gait Speed Test
Activity Monitor
Questionnaires
Sponsored by
About this trial
This is an interventional other trial for Disease, Pulmonary
Eligibility Criteria
Inclusion criteria:
- Referred for pulmonary rehabilitation
- consenting to research
Exclusion criteria:
-Under 18 years of age
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Pulmonary Rehabilitation
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Wasting
DXA measurement of body mass index pre- and post- PR.
Change in Strength
Change in Grip Strength as measured by hand dynamometer.
Change in Gait Speed
gait speed test measured over 15 feet
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).
Change in Physical Activity Level
Measured by Body Media armband activity monitor using total energy expenditure divided by the resting metabolic rate
Full Information
NCT ID
NCT02512874
First Posted
July 24, 2015
Last Updated
June 10, 2020
Sponsor
Mayo Clinic
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT02512874
Brief Title
Does Pulmonary Rehabilitation Improve Frailty?
Official Title
Does Pulmonary Rehabilitation Improve Frailty in Chronic Lung Disease?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 21, 2015 (undefined)
Primary Completion Date
October 16, 2018 (Actual)
Study Completion Date
October 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disease, Pulmonary
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary Rehabilitation
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pulmonary Rehabilitation
Intervention Description
Measures of frailty taken before and after pulmonary rehabilitation.
Intervention Type
Device
Intervention Name(s)
Dynamometer
Intervention Description
Grip Test
Intervention Type
Radiation
Intervention Name(s)
DEXA
Intervention Description
Body Composition Testing
Intervention Type
Other
Intervention Name(s)
Gait Speed Test
Intervention Description
15 foot walk test
Intervention Type
Device
Intervention Name(s)
Activity Monitor
Intervention Description
Measures energy expenditure and activity
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
Health-related questionnaires measuring self-reported exhaustion, emotions and disease symptoms.
Primary Outcome Measure Information:
Title
Number of Participants With Frailty Phenotype at Baseline and 6 Months
Description
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.
Time Frame
Baseline, Six months
Secondary Outcome Measure Information:
Title
Wasting
Description
DXA measurement of body mass index pre- and post- PR.
Time Frame
after pulmonary rehabilation completion, appoximately 8 weeks
Title
Change in Strength
Description
Change in Grip Strength as measured by hand dynamometer.
Time Frame
after completion of pulmonary rehab, approximately 8 weeks
Title
Change in Gait Speed
Description
gait speed test measured over 15 feet
Time Frame
pre and post pulmonary rehab, approximately 8 weeks
Title
Improvement in Exhaustion
Description
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).
Time Frame
pre and post pulmonary rehab, approximately 8 weeks
Title
Change in Physical Activity Level
Description
Measured by Body Media armband activity monitor using total energy expenditure divided by the resting metabolic rate
Time Frame
pre and post pulmonary rehab, approximately 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Referred for pulmonary rehabilitation
consenting to research
Exclusion criteria:
-Under 18 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cassie Kennedy, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
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Does Pulmonary Rehabilitation Improve Frailty?
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