Changes in Heart Rate Variability And Heart Rate/Activity Slope After Hospitalization for Acute Exacerbations of COPD

NCT ID: NCT05290831

Last Updated: 2022-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-10

Study Completion Date

2024-04-01

Brief Summary

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The purpose of this study is to observe the variation in time between heart beats and how heart rate changes during activity evolve after hospitalization for an exacerbation of COPD.

Detailed Description

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The investigators will place a monitoring patch that continuously records electrocardiogram and activity. Participants will switch this patch every 7 days for a total of 28 days. From these data the investigators will observe how heart rate variability and heart rate responses to exercise evolve after hospitalization for an exacerbation of COPD.

Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Main study group

Group Type EXPERIMENTAL

VitalPatch

Intervention Type DEVICE

The VitalPatch continuously monitors skin temperature, activity, and electrocardiography.

Interventions

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VitalPatch

The VitalPatch continuously monitors skin temperature, activity, and electrocardiography.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Signed informed consent
2. At least moderate COPD by Global Initiative for Chronic Obstructive Lung Disease spirometry criteria (FEV1/FVC \< 0.7 and FEV1 \< 80% predicted)
3. 10 pack year smoking history
4. Hospitalized with one or more of:

1. increased dyspnea
2. increased sputum
3. change in sputum character
5. Treated with corticosteroids and/or antibiotics for respiratory indications
6. Age \> 40 years old

Exclusion Criteria

1. Discharging home on hospice
2. Inability to follow trial protocols
3. Pacemaker
4. Allergy to a component of the adhesive patches
5. Breastfeeding
6. Permanent/continuous atrial fibrillation
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minneapolis Veterans Affairs Medical Center

FED

Sponsor Role lead

Responsible Party

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David MacDonald

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David MacDonald, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Veterans Affairs Medical Center

Central Contacts

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David MacDonald, MD, MS

Role: CONTACT

612-725-2000

Other Identifiers

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1653926

Identifier Type: -

Identifier Source: org_study_id

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