About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All adult patients 40 years and older with physician diagnosed Chronic Lung Disease within 2 months of discharge following completion of a traditional onsite outpatient rehabilitation or physical therapy or exercise program for their condition
Able to walk independently with or without mobility devices
Able to complete a six-minute walk test at discharge with or without supplemental oxygen maintaining an oxygen saturation at or above 85%
Able to follow commands and instructions in the English language
Disqualifiers
• Those with significant mobility limitations such as those with a history of stroke, neurological comorbidities such as Parkinson's disease or relapsing multiple sclerosis, or significant degenerative osteoarthritis, or any other joint impairments that compromise ability to walk independently with or without an assistive device.
Patients who primarily rely on a wheelchair for mobility
Patients with or without supplemental oxygen who are unable to complete a walking test without a drop in oxygen saturation to below 85% at discharge from traditional outpatient rehabilitation
Patients with baseline hemodynamic compromise, unstable angina, a recent myocardial infarction within a week, uncontrollable atrial fibrillation not managed with medications, advanced stage heart failure (New York Heart Association class 4), or those with mechanical circulatory assist devices for the heart such a ventricular assist device (VADs)
Trial design
Parallel
Treatments tested in this trial
Onsite Maintenance Exercise Training
Combination productParticipants 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 productParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Exercise Capacity
Exercise capacity as measured by the six-minute walk distance
Exercise Capacity
Exercise capacity as measured by the six-minute walk distance
Exercise Capacity
Exercise capacity as measured by the six-minute walk distance
Dyspnea
Dyspnea measured on the modified Medical Research Council (mMRC) scale score ranges from 0-4 with higher scores indicating greater shortness of breath
Secondary outcomes
Inspiratory muscle strength
Inspiratory muscle strength assessed via the maximal inspiratory pressure (MIP)
Inspiratory muscle strength
Inspiratory muscle strength assessed via the maximal inspiratory pressure (MIP)
Inspiratory muscle strength
Inspiratory muscle strength assessed via the maximal inspiratory pressure (MIP)
Physical activity
Physical activity measured by the International Physical Activity Questionnaire (IPAQ)
Sponsors and contacts
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