Disease, PulmonaryNCT02512874

Does Pulmonary Rehabilitation Improve Frailty?

A study testing Pulmonary Rehabilitation, Dynamometer and DEXA in people with Disease, Pulmonary, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Disease, Pulmonary
What is being tested?: Pulmonary Rehabilitation, Dynamometer and DEXA
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 1 siteUnited States
Study dates: 21 Jul 2015to 16 Oct 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Referred for pulmonary rehabilitation
consenting to research

Who cannot join

-Under 18 years of age

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Does Pulmonary Rehabilitation Improve Frailty in Chronic Lung Disease?

Read the 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.

Conditions: Disease, Pulmonary
Being tested: Pulmonary Rehabilitation, Dynamometer, DEXA, Gait Speed Test, Activity Monitor
Medical subject headings: Lung Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pulmonary RehabilitationOther
Measures of frailty taken before and after pulmonary rehabilitation.
DynamometerDevice
Grip Test
DEXARadiation
Body Composition Testing
Gait Speed TestOther
15 foot walk test
Activity MonitorDevice
Measures energy expenditure and activity
QuestionnairesOther
Health-related questionnaires measuring self-reported exhaustion, emotions and disease symptoms.

Study groups in NCT02512874
Study group	Role	What they receive
Pulmonary Rehabilitation	Other	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. Receives: Other: Pulmonary Rehabilitation; Device: Dynamometer; Radiation: DEXA; Other: Gait Speed Test; Device: Activity Monitor; Other: Questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, Six months

Secondary outcomes (5)

Wasting
DXA measurement of body mass index pre- and post- PR.
Measured: after pulmonary rehabilation completion, appoximately 8 weeks
Change in Strength
Change in Grip Strength as measured by hand dynamometer.
Measured: after completion of pulmonary rehab, approximately 8 weeks
Change in Gait Speed
gait speed test measured over 15 feet
Measured: pre and post pulmonary rehab, approximately 8 weeks
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).
Measured: pre and post pulmonary rehab, approximately 8 weeks
Change in Physical Activity Level
Measured by Body Media armband activity monitor using total energy expenditure divided by the resting metabolic rate
Measured: pre and post pulmonary rehab, approximately 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jul 201516 Oct 2018

First posted31 Jul 2015 (estimated)
Study start21 Jul 2015
Primary completion16 Oct 2018
Study completion16 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Disease, PulmonaryStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02512874
Sponsor's protocol ID: 15-001230
Other IDs: K23HL128859
Status last verified: Jun 2020
First submitted: 24 Jul 2015
Last updated: 23 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
RecruitingEarly Phase 1
Testing the Safety of Dapagliflozin Prior to Surgery for the Treatment of Patients With Stage IA Lung Adenocarcinoma
Lung Adenocarcinoma, Stage IA1 Lung Cancer American Joint Committee on Cancer (AJCC) v8
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)
Non-small Cell Carcinoma, Non-Small Cell Lung Cancer Metastatic

All Disease, Pulmonary trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Does Pulmonary Rehabilitation Improve Frailty in Chronic Lung Disease?
ClinicalTrials.gov ID: NCT02512874
Acronym / sponsor ID: 15-001230
Conditions: Disease, Pulmonary
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 21 Jul 2015
Primary completion: 16 Oct 2018 (actual)
Study completion: 16 Oct 2018 (actual)
First posted: 31 Jul 2015 (estimated)
Results: Posted 5 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Pulmonary Rehabilitation	Other	Other: Pulmonary Rehabilitation, Device: Dynamometer, Radiation: DEXA, Other: Gait Speed Test, Device: Activity Monitor, Other: QuestionnairesOne 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Referred for pulmonary rehabilitation
consenting to research

Key exclusion criteria (1 listed)

-Under 18 years of age

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pulmonary RehabilitationMeasures of frailty taken before and after pulmonary rehabilitation.	Other	Pulmonary Rehabilitation
DynamometerGrip Test	Device	Pulmonary Rehabilitation
DEXABody Composition Testing	Radiation	Pulmonary Rehabilitation
Gait Speed Test15 foot walk test	Other	Pulmonary Rehabilitation
Activity MonitorMeasures energy expenditure and activity	Device	Pulmonary Rehabilitation
QuestionnairesHealth-related questionnaires measuring self-reported exhaustion, emotions and disease symptoms.	Other	Pulmonary Rehabilitation

Primary outcome

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.

5 secondary outcomes

Wasting
Time frame: after pulmonary rehabilation completion, appoximately 8 weeks
Change in Strength
Time frame: after completion of pulmonary rehab, approximately 8 weeks
Change in Gait Speed
Time frame: pre and post pulmonary rehab, approximately 8 weeks
Improvement in Exhaustion
Time frame: pre and post pulmonary rehab, approximately 8 weeks
Change in Physical Activity Level
Time frame: pre and post pulmonary rehab, approximately 8 weeks

Results and safety

Results posted to the registry on 5 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pulmonary Rehabilitation	65	63

Primary outcome: Number of Participants With Frailty Phenotype at Baseline and 6 Months

Time frame: Baseline, Six months. Count of participants. Unit: Participants

Measure	Pulmonary Rehabilitation n = 63
Baseline	24
Six months	15

Pulmonary Rehabilitation: p = 0.62, Chi-squared

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

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from baseline through 6 month follow up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pulmonary Rehabilitation	0 of 65 (0%)	0 of 65 (0%)	4 of 65

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mayo Clinic Clinical TrialsLink provided by the sponsor.

Related trials for Disease, Pulmonary

RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
RecruitingEarly Phase 1
Testing the Safety of Dapagliflozin Prior to Surgery for the Treatment of Patients With Stage IA Lung Adenocarcinoma
Lung Adenocarcinoma, Stage IA1 Lung Cancer American Joint Committee on Cancer (AJCC) v8
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)
Non-small Cell Carcinoma, Non-Small Cell Lung Cancer Metastatic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cassie Kennedy, MD principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pulmonary Rehabilitation, Dynamometer and DEXA in people with Disease, Pulmonary, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Frailty Phenotype at Baseline and 6 Months (time frame: Baseline, Six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02512874.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2020.