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

• ClinicalTrials.gov Identifier: NCT03997513
• Recruitment Status: Recruiting
• First Posted: June 25, 2019
• Last Update Posted: November 25, 2020
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pulmonary Disease, Chronic Obstructive	Behavioral: Pulmonary Telerehabilitation	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: September 1, 2020
• Estimated Primary Completion Date: June 30, 2021
• Estimated Study Completion Date: December 31, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Behavioral: 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.
No Intervention: 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.

Outcome Measures

Primary Outcome Measures :

1. quadriceps muscle strength testing change [ Time Frame: measured at baseline and at ten weeks ]
   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.
2. Endurance shuttle walk testing change [ Time Frame: measured at baseline and at ten weeks ]
   Participants will first complete an incremental shuttle walk test (ISWT), which consist of the participant walking on a level, ten meter course at a pace dictated by audio signals, incrementally increasing in frequency each minute, until either the participant is too breathless to maintain the required speed, is unable to complete a ten meter shuttle in the allowed time, or has walked for 20 minutes. Peak oxygen consumption during the ISWT will be estimated using previously described regression equations. The walking speed corresponding to 75% of the estimated peak oxygen consumption will be used to determine the constant speed of the ESWT. Participants will complete one endurance shuttle walk testing (ESWT), consisting of walking at a constant pace (75% of estimated peak oxygen consumption) on the ten meter course until either the participant is too tired or breathless to continue or 20 minutes of walking time has elapsed.
3. Health-related quality of life assessments change [ Time Frame: measured at baseline and ten weeks ]
   Health-related quality of life will be assessed with the Short-Form 36-Item Questionnaire (SF-36) prior to hospital discharge and following eight weeks of either the 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.
4. Participant satisfaction survey [ Time Frame: measured at ten weeks (study completion) ]
   Participants will be administered a survey by the study coordinator 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 using a five point Likert scale (strongly agree, agree, neutral, disagree, strongly disagree). 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.

Secondary Outcome Measures :

1. sit-to-stand test change [ Time Frame: measured at baseline and ten weeks ]
   The one-minute sit-to-stand test has been shown to be reliable, valid, and responsive to change in exercise capacity following pulmonary rehabilitation in individuals with COPD. The test consists of the participant standing at full leg extension from a sitting position at their own pace as often as possible during a one minute testing interval. The participant is permitted to stop at any time during the one minute interval if necessary. An armless chair is used for testing and the participant is asked to fold their arms across their chest during testing. Two tests will be performed on separate days prior to discharge and the test with the greatest number of repetitions will be used as the baseline performance measure. A third test will be performed following eight weeks of either the pulmonary telerehabilitation intervention or usual care.
2. Handgrip strength [ Time Frame: measured at baseline and ten weeks ]
   Handgrip strength of the dominant hand will be measured with a hand dynamometer. Three measurements will be taken with a 60 second recovery period between trials. The average maximal force across trials will be calculated as the final handgrip strength.
3. Disease specific quality of life [ Time Frame: measured at baseline and ten weeks ]
   The St. George's Respiratory Questionnaire (SGRQ) is a disease-specific questionnaire validated to measure health status in patients with COPD. Total SGRQ scores range from 0-100 with higher scores indicating greater symptoms burden. The minimal clinically important difference is a difference of four points in the total SGRQ score.
4. symptoms during sit-to-stand test [ Time Frame: measured at baseline and ten weeks ]
   The participants' perception of dyspnea and exertion during the sit-to-stand test will be assessed following each test with the ten point Borg dyspnea and leg fatigue scale, which measures the degree of dyspnea and leg fatigue with exercise.
5. Post-intervention survey [ Time Frame: measured at ten weeks (study completion) ]
   Questions regarding social support, psychiatric attributes, and other factors potentially associated with program adherence will be asked in order to gain preliminary insights to optimize recruitment for a larger, randomized controlled trial of pulmonary telerehabilitation.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Jessica B Field, MD; (412) 360-6146; Jessica.Field@va.gov

Locations

United States, Pennsylvania

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA; Recruiting

Pittsburgh, Pennsylvania, United States, 15240

Contact: Jessica B Field, MD (412) 360-6146 Jessica.Field@va.gov

Principal Investigator: Jessica Bon Field, MD

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: Jessica Bon Field, MD; VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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:CD013040. doi: 10.1002/14651858.CD013040.pub2.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT03997513
• Other Study ID Numbers: F3014-P
• First Posted: June 25, 2019
• Last Update Posted: November 25, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:

pulmonary disease, chronic obstructive; pulmonary rehabilitation; muscle atrophy

Additional relevant MeSH terms:

Lung Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Lung Diseases, Obstructive