protocolSection identificationModule nctId: NCT06304207, orgStudyIdInfo id: 300423, briefTitle: Telehealth and Onsite Maintenance Exercise in COPD, acronym: COPD, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: MGH Institute of Health Professions, class: OTHER, descriptionModule briefSummary: The goal of this pilot clinical trial is to compare telehealth and onsite supervised maintenance exercise program for adults with COPD.The specific aims of the study are:* To compare 8-week supervised maintenance program delivered onsite and via tele-rehab with no maintenance for patients with COPD following discharge from traditional exercise or physical therapy or onsite outpatient rehabilitation programs on clinical outcomes (dyspnea, exercise capacity, physical function, physical activity, and quality of life) at 8 weeks and 4-months post-intervention.* To compare the differences in dyspnea, exercise capacity, physical function, physical activity, and quality of life between an 8-week maintenance program delivered onsite and via tele-rehab at 8-weeks and 4-months post-intervention in patients with COPD following discharge from traditional onsite outpatient rehabilitation.Participants in both intervention groups (onsite and tele-rehab) will undergo a baseline onsite assessment followed by an 8-week supervised exercise intervention either onsite or in a telehealth setting. Control group will receive biweekly check in calls, but no active intervention., conditionsModule conditions: Copd, conditions: COPD Exacerbation, conditions: COPD Bronchitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study design will be a pilot randomized controlled, assessor-blinded trial with three groups: 1) Tele-rehab where patient will be at home but will receive supervised intervention remotely, 2) Onsite outpatient physical therapy, 3) Control group., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: All baseline and follow up outcomes assessment will be conducted by a study team member blinded to the subject group allocation., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Onsite Maintenance Exercise Training, interventions name: Telehealth Maintenance Exercise, outcomesModule primaryOutcomes measure: Exercise Capacity, primaryOutcomes measure: Exercise Capacity, primaryOutcomes measure: Exercise Capacity, primaryOutcomes measure: Dyspnea, primaryOutcomes measure: Dyspnea, primaryOutcomes measure: Dyspnea, primaryOutcomes measure: Physical Function, primaryOutcomes measure: Physical Function, primaryOutcomes measure: Physical Function, primaryOutcomes measure: Quality of life measure, primaryOutcomes measure: Quality of life measure, primaryOutcomes measure: Quality of life measure, secondaryOutcomes measure: Inspiratory muscle strength, secondaryOutcomes measure: Inspiratory muscle strength, secondaryOutcomes measure: Inspiratory muscle strength, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Participants adherence to the program, secondaryOutcomes measure: Healthcare utilization, secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: PROMIS Global 10 score, secondaryOutcomes measure: PROMIS Global 10 score, secondaryOutcomes measure: PROMIS Global 10 score, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MGH Institute of Health Professions, status: RECRUITING, city: Charlestown, state: Massachusetts, zip: 02129, country: United States, contacts name: Shweta Gore, PhD, role: CONTACT, phone: 617-643-6326, email: sgore@mghihp.edu, contacts name: Jane Bladwin, DPT, role: CONTACT, email: jbaldwin@mghihp.edu, geoPoint lat: 42.37787, lon: -71.062, hasResults: False