Trial Outcomes & Findings for Does Pulmonary Rehabilitation Improve Frailty? (NCT NCT02512874)

Last Updated: 2020-06-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

65 participants

Primary outcome timeframe

Baseline, Six months

Results posted on

2020-06-23

Participant Flow

Participant milestones

Participant milestones
Measure	Pulmonary Rehabilitation One arm study - all participants will go to pulmonary rehabilitation, received questionnaires, DEXA scans, Dynamometer and gait speed tests and activity measured through an activity monitor. Pulmonary Rehabilitation: Measures of frailty taken before and after pulmonary rehabilitation. Dynamometer: Grip Test DEXA: Body Composition Testing Gait Speed Test: 15 foot walk test Activity Monitor: Measures energy expenditure and activity Questionnaires: Health-related questionnaires measuring self-reported exhaustion, emotions and disease symptoms.
Overall Study STARTED	65
Overall Study COMPLETED	63
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Does Pulmonary Rehabilitation Improve Frailty?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pulmonary Rehabilitation n=63 Participants One arm study - all participants will go to pulmonary rehabilitation, received questionnaires, DEXA scans, Dynamometer and gait speed tests and activity measured through an activity monitor. Pulmonary Rehabilitation: Measures of frailty taken before and after pulmonary rehabilitation. Dynamometer: Grip Test DEXA: Body Composition Testing Gait Speed Test: 15 foot walk test Activity Monitor: Measures energy expenditure and activity Questionnaires: Health-related questionnaires measuring self-reported exhaustion, emotions and disease symptoms.
Age, Continuous	65 years n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	54 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants
Region of Enrollment United States	63 participants n=5 Participants
Primary Pulmonary Diagnosis Obstructive	35 Participants n=5 Participants
Primary Pulmonary Diagnosis Post Lung Transplant	13 Participants n=5 Participants
Primary Pulmonary Diagnosis Interstitial Lung Disease	10 Participants n=5 Participants
Primary Pulmonary Diagnosis Other	5 Participants n=5 Participants
Pulmonary Function - Forced expiratory volume	1.3 liters n=5 Participants
Pulmonary Function - % Predicted	49 percent n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Six months

Population: Forty-nine participants (77.8%) of the 63 participants completed at lease one follow-up frailty parameter assessment after completion of pulmonary rehabilitation.

Outcome measures

Outcome measures
Measure	Pulmonary Rehabilitation n=63 Participants One arm study - all participants will go to pulmonary rehabilitation, received questionnaires, DEXA scans, Dynamometer and gait speed tests and activity measured through an activity monitor. Pulmonary Rehabilitation: Measures of frailty taken before and after pulmonary rehabilitation. Dynamometer: Grip Test DEXA: Body Composition Testing Gait Speed Test: 15 foot walk test Activity Monitor: Measures energy expenditure and activity Questionnaires: Health-related questionnaires measuring self-reported exhaustion, emotions and disease symptoms.
Number of Participants With Frailty Phenotype at Baseline and 6 Months Baseline	24 Participants
Number of Participants With Frailty Phenotype at Baseline and 6 Months Six months	15 Participants

SECONDARY outcome

Timeframe: after pulmonary rehabilation completion, appoximately 8 weeks

Population: Data for 37 participants was available for analysis.

DXA measurement of body mass index pre- and post- PR.

Outcome measures

Outcome measures
Measure	Pulmonary Rehabilitation n=37 Participants One arm study - all participants will go to pulmonary rehabilitation, received questionnaires, DEXA scans, Dynamometer and gait speed tests and activity measured through an activity monitor. Pulmonary Rehabilitation: Measures of frailty taken before and after pulmonary rehabilitation. Dynamometer: Grip Test DEXA: Body Composition Testing Gait Speed Test: 15 foot walk test Activity Monitor: Measures energy expenditure and activity Questionnaires: Health-related questionnaires measuring self-reported exhaustion, emotions and disease symptoms.
Wasting	0.04 kg/m^2 Interval -0.4 to 1.1

SECONDARY outcome

Timeframe: after completion of pulmonary rehab, approximately 8 weeks

Population: Data for 45 participants was available for analysis.

Change in Grip Strength as measured by hand dynamometer.

Outcome measures

Outcome measures
Measure	Pulmonary Rehabilitation n=45 Participants One arm study - all participants will go to pulmonary rehabilitation, received questionnaires, DEXA scans, Dynamometer and gait speed tests and activity measured through an activity monitor. Pulmonary Rehabilitation: Measures of frailty taken before and after pulmonary rehabilitation. Dynamometer: Grip Test DEXA: Body Composition Testing Gait Speed Test: 15 foot walk test Activity Monitor: Measures energy expenditure and activity Questionnaires: Health-related questionnaires measuring self-reported exhaustion, emotions and disease symptoms.
Change in Strength	0 kg Interval -1.6 to 2.6

SECONDARY outcome

Timeframe: pre and post pulmonary rehab, approximately 8 weeks

Population: Data for 43 participants was available for analysis.

gait speed test measured over 15 feet

Outcome measures

Outcome measures
Measure	Pulmonary Rehabilitation n=43 Participants One arm study - all participants will go to pulmonary rehabilitation, received questionnaires, DEXA scans, Dynamometer and gait speed tests and activity measured through an activity monitor. Pulmonary Rehabilitation: Measures of frailty taken before and after pulmonary rehabilitation. Dynamometer: Grip Test DEXA: Body Composition Testing Gait Speed Test: 15 foot walk test Activity Monitor: Measures energy expenditure and activity Questionnaires: Health-related questionnaires measuring self-reported exhaustion, emotions and disease symptoms.
Change in Gait Speed	-0.6 seconds Interval -1.5 to 0.5

SECONDARY outcome

Timeframe: pre and post pulmonary rehab, approximately 8 weeks

Population: Data for 39 participants was available for analysis. 19 participants were exhausted pre-pulmonary rehabilitation. 17 were exhausted following pulmonary rehab.

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).

Outcome measures

Outcome measures
Measure	Pulmonary Rehabilitation n=39 Participants One arm study - all participants will go to pulmonary rehabilitation, received questionnaires, DEXA scans, Dynamometer and gait speed tests and activity measured through an activity monitor. Pulmonary Rehabilitation: Measures of frailty taken before and after pulmonary rehabilitation. Dynamometer: Grip Test DEXA: Body Composition Testing Gait Speed Test: 15 foot walk test Activity Monitor: Measures energy expenditure and activity Questionnaires: Health-related questionnaires measuring self-reported exhaustion, emotions and disease symptoms.
Improvement in Exhaustion	2 Participants

SECONDARY outcome

Timeframe: pre and post pulmonary rehab, approximately 8 weeks

Population: Data for 47 participants was available for analysis.

Measured by Body Media armband activity monitor using total energy expenditure divided by the resting metabolic rate

Outcome measures

Outcome measures
Measure	Pulmonary Rehabilitation n=47 Participants One arm study - all participants will go to pulmonary rehabilitation, received questionnaires, DEXA scans, Dynamometer and gait speed tests and activity measured through an activity monitor. Pulmonary Rehabilitation: Measures of frailty taken before and after pulmonary rehabilitation. Dynamometer: Grip Test DEXA: Body Composition Testing Gait Speed Test: 15 foot walk test Activity Monitor: Measures energy expenditure and activity Questionnaires: Health-related questionnaires measuring self-reported exhaustion, emotions and disease symptoms.
Change in Physical Activity Level	0.4 ratio Interval -0.4 to 1.1

Adverse Events

Pulmonary Rehabilitation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Cassie C. Kennedy

Mayo Clinic

Phone: 507-266-3958

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place