Home Pulmonary Rehabilitation for COPD

NCT03480386 | Completed Results

• 2 other identifiers: 17-009449R01HL140486-01
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 3

Brief Summary

Regular physical activity has been found to be important in maintaining health and well-being in people with COPD. The purpose of this study is to test new technology and health coaching aimed to help people with COPD become more physically active in their daily lives.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Emphysema

Keywords

Pulmonary Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Quality of Life

  The Chronic Respiratory Questionnaire (CRQ) is a validated tool, completed by participants at baseline and 3 months and measured health-related quality of life. This questionnaire measures both physical and emotional aspects of chronic respiratory disease. All scores have a range of 1 to 7, a higher number being better health-related quality of life. We reported the difference between baseline and 3 months on the CRQ emotional summary score (comprised of the mastery and emotional domains) and the physical summary score (comprised of dyspnea and fatigue domains). 0.5 points is the minimal clinically important difference for this tool.

  Baseline, 3 months

Secondary Outcomes (9)

• Change in Self-management Abilities

  Baseline, 3 months

• Change in Physical Activity

  Baseline, 3 months

• Change in Daily Step Counts

  Baseline, 3 months

• Change in Depression

  Baseline, 3 months

• Social Support

  Baseline, 3 months

Study Arms (2)

Pulmonary Rehabilitation Program Intervention

EXPERIMENTAL

Subjects will receive 12 weeks home pulmonary rehabilitation (PR) with health coaching.

Behavioral: Home Based Pulmonary Rehabilitation

Usual Care

NO INTERVENTION

Subjects will receive 12 weeks of usual care.

Interventions

Home Based Pulmonary Rehabilitation BEHAVIORAL

Twice daily exercise routine six days a week of 3 minutes of personal breathing, 5 exercises with 10 reps each, and 6 minutes of walking with weekly health coach calls.

Pulmonary Rehabilitation Program Intervention

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of COPD, confirmed by spirometry
• Age ≥40 years (to avoid recruiting participants with asthma rather than COPD)
• Current or previous smoker (≥10 packs per year)
• Confidence in using the proposed pulmonary rehabilitation (PR) system
• English language fluency

You may not qualify if:

• Study candidate experiencing an acute COPD exacerbation (can be included after the acute event)
• Inability to walk (orthopedic-neurologic problems or confined to a bed)
• Currently in PR or finished PR in the last three months (unlikely to improve)
• Pregnant women
• Live in an area where cell phones do not work/

Sponsors & Collaborators

• Mayo Clinic: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (3)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Health Partners

Minneapolis, Minnesota, 55122, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• Benzo R, Hoult J, McEvoy C, Clark M, Benzo M, Johnson M, Novotny P. Promoting Chronic Obstructive Pulmonary Disease Wellness through Remote Monitoring and Health Coaching: A Clinical Trial. Ann Am Thorac Soc. 2022 Nov;19(11):1808-1817. doi: 10.1513/AnnalsATS.202203-214OC.

  PMID: 35914215 RESULT

• Benzo M, Lee M, Clark MM, Benzo R. The Basic Science of Behavior Change in COPD: Testing Self-Determination Theory to Support Home-Based Rehabilitation With Health Coaching. J Cardiopulm Rehabil Prev. 2025 Jul 1;45(4):286-293. doi: 10.1097/HCR.0000000000000957. Epub 2025 Jun 26.

  PMID: 40476761 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Roberto P. Benzo, MD
• Organization: Mayo Clinic

Benzo.Roberto@mayo.edu

507-284-0561

Study Officials

• Roberto P Benzo

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomization will be stratified by whether the participant has poor lung function (forced expiratory volume \[FEV1\] \<50% predicted) and whether the participant has severe dyspnea (recorded modified Medical Research Council Dyspnea Scale \[mMRC\] score, 3-4; scale, 0-4); critical factors that can make the study arms unbalanced regarding risk factors.

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 29, 2018
• Study Start: January 1, 2019
• Primary Completion: February 16, 2022
• Study Completion: February 16, 2022
• Last Updated: February 13, 2024
• Results First Posted: February 13, 2024

Record last verified: 2024-01

Locations

US (3)