Telehealth and Onsite Maintenance Exercise in Chronic Lung Disease

Part of paid clinical trials in Charlestown, Massachusetts.

Sponsor
MGH Institute of Health Professions
Study ID
NCT06304207
Status
Recruiting

Conditions

  • Bronchiectasis
  • COPD Bronchitis
  • COPD Exacerbation
  • Chronic Asthma
  • Chronic Asthmatic Bronchitis
  • Chronic Lung Disease
  • Copd
  • Emphysema or COPD
  • Interstitial Lung Disease
  • Pulmonary Fibrosis

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Onsite Maintenance Exercise Training — COMBINATION_PRODUCT
    Participants will receive a 60-minute supervised weekly exercise intervention for 8-weeks.Each 60-minute session will be broken down into a brief 5-minute training on inspiratory muscle training using a Threshold Inspiratory Muscle Trainer (IMT), 5-minute education on self-management of airway clearance and importance of maintaining regular physical activity; a 5-minute warm-up, and 25 minutes of aerobic training. The training intensity will be derived from the distance covered on the six-minute walk test administered at baseline. Training will be performed at 60-85% of VO2 reserve and converted to walking distance and speed using American College of Sports Medicine walking equations for treadmill and overground walking activities or a corresponding rating of perceived exertion (RPE) of 13-16 for non-walking activities. This will be followed by 15-minutes of functional strength training focusing on the lower extremity muscles, and 5 minutes of cool down with stretching exercises.
  • Telehealth Maintenance Exercise — COMBINATION_PRODUCT
    Participants in the tele-rehab group will also receive the same intervention as outlined for the onsite group. The mode of aerobic exercise will vary based on availability of equipment in patient homes. The intervention will be delivered remotely via previously researched models using a tablet computer. I-pads will be provided to the participants on a need basis to take home for the duration of the study. Videoconferencing will be via Partners log in enabled Zoom videoconferencing software (San Jose, California, USA) that allows all participants to see and speak to each other. To ensure safety and understanding of equipment operation and the exercise program, the initial training session and establishment of the home exercise program will occur during the initial onsite visit in the clinic at MGH Institute of Health Professions.

Study Details

The goal of this pilot clinical trial is to compare telehealth and onsite supervised maintenance exercise program for adults with Chronic Lung Disease. 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 Chronic Lung Disease 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 Chronic Lung Disease 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.

Key Dates

Start date
Sep 1, 2023
Status verified
Jul 2024
Primary completion
Dec 30, 2025
Completion
Mar 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: Control
    Control group participants will only be seen during the outcomes assessments at the MGH Institute of Health Professions at times 0, 1, and 2, but will receive no active supervised intervention. Control group participants will go home with discharge instructions to maintain a home exercise routine provided to them at discharge. Bi-weekly check in phone calls from the study team will continue to ensure participant engagement in the study. During the phone calls, participants will be encouraged to keep a log of their weekly activities in a journal.
  • Experimental: Onsite Pulmonary Rehab
    Supervised pulmonary rehabilitation including exercise training, activity counselling, and education provided onsite.
  • Experimental: Telehealth Pulmonary Rehab
    Supervised pulmonary rehabilitation including exercise training, activity counselling, and education provided remotely using Zoom videoconferencing technology.

Primary Outcome Measure

Exercise Capacity [ Time Frame: At baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MGH Institute of Health ProfessionsCharlestownMassachusetts02129
Shweta Gore, PhD
617-643-6326
Jane Bladwin, DPT

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