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

NCT03997513 | Completed Results DMC

• 1 other identifier: F3014-P
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

pulmonary disease, chronic obstructive; pulmonary rehabilitation; muscle atrophy

Outcome Measures

Primary Outcomes (4)

• Quadriceps Muscle Strength Testing Change

  Quadriceps muscle maximal force (kilogram-force, kgf) will be measured with a Keiser leg press. One repetition maximum (1RM) measures will be obtained by progressively increasing resistance until the participant is unable to successfully complete one repetition. Peak muscle power will be measured at 40, 50, 60, 70, 80, and 90 percent of the 1RM 30 minutes after the 1RM measurement was obtained.

  measured at baseline and at ten weeks

• Six Minute Walk Test

  Participants completed a six minute walk test, which consisted of walking in a flat corridor for six minutes with the distance walked measured in feet. Participants were instructed to complete the walk using their home oxygen prescription for exertion. The difference between baseline and ten week walk test was compared between groups.

  measured at baseline and at ten weeks

• Health-related Quality of Life Assessments Change

  Health-related quality of life will be assessed with the Short-Form 36-Item Questionnaire (SF-36) prior to hospital discharge and at ten weeks following an eight week pulmonary telerehabilitation intervention or usual care. The SF-36 consists of 36 questions spanning nine health domains and is a valid measure of health-related quality of life in COPD that is responsive to change following a pulmonary rehabilitation intervention.

  measured at baseline and ten weeks

• Participant Satisfaction Survey

  Participants will be administered a survey by the study coordinator at ten weeks after completion of the eight-week pulmonary telerehabilitation intervention that will require them to respond to statements related to their satisfaction with the home-based program. Statements will address ease of use of the video conferencing modality, acceptability of exercise components, perceptions of impact on muscle strength and exercise endurance, and willingness to participate in additional pulmonary telerehabilitation. Participants randomized to the usual care group will not be administered a survey.

  measured at ten weeks (study completion)

Secondary Outcomes (5)

• Sit-to-stand Test Change

  measured at baseline and ten weeks

• Handgrip Strength

  measured at baseline and ten weeks

• Disease Specific Quality of Life

  measured at baseline and ten weeks

• Symptoms During Sit-to-stand Test

  measured at baseline and ten weeks

• Post-intervention Survey

  measured at ten weeks (study completion)

Study Arms (2)

Pulmonary Telerehabilitation Intervention Group

EXPERIMENTAL

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.

Behavioral: Pulmonary Telerehabilitation

Usual Care Group

NO INTERVENTION

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.

Interventions

Pulmonary Telerehabilitation 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.

Pulmonary Telerehabilitation Intervention Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Related Publications (1)

• 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.

  PMID: 33511633 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Muscular Atrophy

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Limitations and Caveats

The study was significantly impacted by the COVID-19 pandemic due to months of restrictions on human subject research and national trends of fewer hospitalized acute exacerbations of COPD as seen in the COPD population during the height of the pandemic.

Results Point of Contact

• Title: Dr. Jessica Bon Field
• Organization: VA Pittsburgh Healthcare System

jessica.field@va.gov

412-360-6823

Study Officials

• Jessica Bon Field, MD

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 25, 2019
• Study Start: September 1, 2020
• Primary Completion: June 28, 2022
• Study Completion: June 28, 2022
• Last Updated: July 5, 2024
• Results First Posted: July 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)