NCT02512874

Does Pulmonary Rehabilitation Improve Frailty?

Completed NA Results posted Last updated 23 June 2020

What this trial tests

NA trial testing Pulmonary Rehabilitation in Disease, Pulmonary in 65 participants. Completed in 16 October 2018.

Timeline

21 July 2015

Primary endpoint
16 October 2018

16 October 2018

Quick facts

Lead sponsor	Mayo Clinic
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	65
Start date	21 July 2015
Primary completion	16 October 2018
Estimated completion	16 October 2018
Sites	1 location across United States

Drugs / interventions tested

• Pulmonary Rehabilitation
• Dynamometer
• DEXA
• Gait Speed Test
• Activity Monitor
• Questionnaires

Conditions studied

• Disease, Pulmonary — all drugs for Disease, Pulmonary →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Disease, Pulmonary. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Frailty Phenotype at Baseline and 6 Months Primary · 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.

Baseline

Group	Value	95% CI
Pulmonary Rehabilitation	24

Six months

Group	Value	95% CI
Pulmonary Rehabilitation	15

Wasting Secondary · after pulmonary rehabilation completion, appoximately 8 weeks

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

Group	Value	95% CI
Pulmonary Rehabilitation	0.04	-0.4 – 1.1

Change in Strength Secondary · after completion of pulmonary rehab, approximately 8 weeks

Change in Grip Strength as measured by hand dynamometer.

Group	Value	95% CI
Pulmonary Rehabilitation	0	-1.6 – 2.6

Change in Gait Speed Secondary · pre and post pulmonary rehab, approximately 8 weeks

gait speed test measured over 15 feet

Group	Value	95% CI
Pulmonary Rehabilitation	-0.6	-1.5 – 0.5

Improvement in Exhaustion Secondary · 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).

Group	Value	95% CI
Pulmonary Rehabilitation	2

Change in Physical Activity Level Secondary · 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

Group	Value	95% CI
Pulmonary Rehabilitation	0.4	-0.4 – 1.1

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.