The Impact of a Home-based Pulmonary Telerehabilitation Program in Acute Exacerbations of COPD

NCT ID: NCT03997513

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-06-28

Brief Summary

COPD impacts a significant proportion of the Veteran population. Acute exacerbations, or flare-ups, of COPD are associated with impaired muscle function and worse quality of life. Pulmonary rehabilitation, a formal exercise program for patients with lung disease that includes both endurance and strength training exercises, has been shown to improve muscle function and quality of life after an acute exacerbation of COPD. However, lack of geographically accessible rehabilitation facilities and/or transportation issues are often barriers to pulmonary rehabilitation attendance in the Veteran population. This study will assess the feasibility and impact of an eight-week, three sessions per week, home-based, pulmonary telerehabilitation program in Veterans with COPD following hospitalization for an acute exacerbation of their lung disease. We will measure adherence and satisfaction with the program and muscle strength, physical activity, quality of life, and exercise tolerance pre and post-intervention in Veterans randomized to the pulmonary telerehabilitation arm versus Veterans randomized to the control arm who do not participate in pulmonary rehabilitation.

Detailed Description

Pulmonary telerehabilitation programs have been shown to have a high acceptance and adherence rate and lead to improvement in exercise capacity and quality of life in stable COPD. However, data regarding the feasibility and impact of pulmonary telerehabilitation following hospitalization for an Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) on physical activity levels, muscle function, exercise capacity, and health-related quality of life are lacking. The primary hypothesis is that a home-based pulmonary telerehabilitation program initiated at hospital discharge following an AECOPD is feasible in the Veteran population and will result in increased physical activity and greater improvement in muscle function, exercise capacity, and health-related quality of life compared to usual care. This hypothesis will be tested with the following specific aims: (1) To determine the feasibility of an eight-week home-based pulmonary telerehabilitation program in Veterans with moderate to severe COPD initiated in the immediate post-hospitalization period following an AECOPD. (2) To determine physical activity levels and the magnitude and variability in changes of measurements of muscle strength, functional exercise performance, and health-related quality of life following an eight-week home-based pulmonary telerehabilitation program versus usual care initiated in Veterans with moderate to severe COPD immediately following hospitalization for an AECOPD. The study will randomize (1:1 allocation) 30 male and female Veterans hospitalized with an AECOPD to either an eight-week, three sessions per week, home-based pulmonary telerehabilitation program that includes lower extremity endurance exercises with a cycle ergometer and upper and lower extremity strength training with 1:1 supervision via video conferencing with an exercise physiologist as well as a twice-monthly online support group via video conferencing versus usual care. Changes from baseline in physical activity levels, handgrip and quadriceps muscle strength, exercise endurance, and health-related quality of life will be assessed following the pulmonary telerehabilitation program versus usual care. Findings from this project will contribute to the growing field of pulmonary telerehabilitation and will provide critical preliminary data for the design and implementation of a larger, randomized control trial assessing the impact of pulmonary telerehabilitation on long-term clinical outcomes following AECOPD.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pulmonary Telerehabilitation Intervention Group

The intervention will consist of an eight-week, three sessions per week, home-based pulmonary telerehabilitation program that will incorporate both lower extremity endurance exercise and upper and lower extremity resistance training. Subjects randomized to the study intervention will also participate in a one hour, twice-monthly support group via group video conferencing consisting of an educational topic (i.e. inhaler use, understanding COPD) and group discussion.

Group Type: EXPERIMENTAL

Pulmonary Telerehabilitation

Intervention Type: BEHAVIORAL

The intervention will consist of an eight-week, three sessions per week, home-based pulmonary telerehabilitation program that will incorporate both lower extremity endurance exercise and upper and lower extremity resistance training. Subjects randomized to the study intervention will also participate in a one hour, twice-monthly support group via group video conferencing consisting of an educational topic (i.e. inhaler use, understanding COPD) and group discussion.

Usual Care Group

Participants randomized to the usual care arm will also be enrolled in our institution's telehealth program, will receive an automatic blood pressure monitor, portable pulse oximeter, and scale and will be in regular contact with a telehealth provider. A study team member will meet with participants randomized to the usual care arm to discuss the importance of exercise and will encourage exercise (strength training, light aerobic activity such as walking or cycling) a minimum of 20-40 minutes three times per week at discharge.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pulmonary Telerehabilitation

The intervention will consist of an eight-week, three sessions per week, home-based pulmonary telerehabilitation program that will incorporate both lower extremity endurance exercise and upper and lower extremity resistance training. Subjects randomized to the study intervention will also participate in a one hour, twice-monthly support group via group video conferencing consisting of an educational topic (i.e. inhaler use, understanding COPD) and group discussion.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Veterans
• Moderate or severe COPD with a forced expiratory volume in 1 second - forced vital capacity ratio (FEV1/FVC) < 0.70 and FEV1 < 80% predicted
• Hospitalization with a primary diagnosis of AECOPD, defined as an increase in shortness of breath, cough, and/or sputum production beyond the normal day-to-day variation necessitating a change in regular medication when other causes of increased shortness of breath, cough, and/or sputum production have been ruled out
• Capable of operating a tablet independently with adequate vision and hearing

Exclusion Criteria

• Acute hypercapneic respiratory failure with a requirement for either non-invasive (i.e. bilevel positive airway pressure) or invasive mechanical ventilation during hospitalization
• Hospitalization < 72 hours
• A secondary diagnosis of acute congestive heart failure, myocardial infarction, or pneumonia during hospitalization or unstable cardiac or neurologic disease at discharge
• Enrollment in a pulmonary rehabilitation program within 12 months of hospitalization
• A medical condition that makes exercise unsafe (includes upper and lower limb strength training and lower limb cycle ergometry)

• This will be determined by the following- screen for these through chart review, discussion with the patient (do they have any known cardiac issues, do they have chest pain with exertion, are they lightheaded with exertion), discussion with the physicians caring for the patient in the hospital, and direct observation and assessment during the bedside pulmonary rehab sessions (that were built into this study for safety purposes)
• Inclusion in another greater than minimal risk study

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Bon Field, MD

Role: PRINCIPAL_INVESTIGATOR

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Locations

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.

Reference Type: DERIVED

PMID: 33511633 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

F3014-P

Identifier Type: -

Identifier Source: org_study_id