Clinical trial NCT03997513: The Impact of a Home-based Pulmonary Telerehabilitation Program in Acute Exacerbations of COPD
Official title: The Impact of a Home-based Pulmonary Telerehabilitation Program on Muscle Function and Quality of Life Following Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: pulmonary disease, chronic obstructive
pulmonary rehabilitation
muscle atrophy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-06-25
Enrollment: 5
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Quadriceps Muscle Strength Testing Change
timeFrame: measured at baseline and at ten weeks
measure: Six Minute Walk Test
timeFrame: measured at baseline and at ten weeks
measure: Health-related Quality of Life Assessments Change
timeFrame: measured at baseline and ten weeks
measure: Participant Satisfaction Survey
timeFrame: measured at ten weeks (study completion)
Secondary outcomes:
measure: Sit-to-stand Test Change
timeFrame: measured at baseline and ten weeks
measure: Handgrip Strength
timeFrame: measured at baseline and ten weeks
measure: Disease Specific Quality of Life
timeFrame: measured at baseline and ten weeks
measure: Symptoms During Sit-to-stand Test
timeFrame: measured at baseline and ten weeks
measure: Post-intervention Survey
timeFrame: measured at ten weeks (study completion)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
Study officials:
affiliation: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
name: Jessica Bon Field, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.