NCT06304207 · MGH Institute of Health Professions
Telehealth and Onsite Maintenance Exercise in Chronic Lung Disease
(CLD)
What this study is about
The goal of this pilot clinical trial is to compare telehealth and onsite supervised maintenance exercise program for adults with Chronic Lung Disease.
View original scientific description
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.
Interventions
COMBINATION_PRODUCT
Onsite Maintenance Exercise Training
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.
COMBINATION_PRODUCT
Telehealth Maintenance Exercise
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.
Primary outcome measures
Exercise Capacity
Time frame: At baseline
Exercise capacity as measured by the six-minute walk distance
Exercise Capacity
Time frame: At 8 weeks (end of the study)
Exercise capacity as measured by the six-minute walk distance
Exercise Capacity
Time frame: At 4 months follow up
Exercise capacity as measured by the six-minute walk distance
Dyspnea
Time frame: At baseline
Dyspnea measured on the modified Medical Research Council (mMRC) scale score ranges from 0-4 with higher scores indicating greater shortness of breath
Dyspnea
Time frame: At 8 weeks (end of the study)
Dyspnea measured on the modified Medical Research Council (mMRC) scale score ranges from 0-4 with higher scores indicating greater shortness of breath
Dyspnea
Time frame: At 4 months follow up
Dyspnea measured on the modified Medical Research Council (mMRC) scale score ranges from 0-4 with higher scores indicating greater shortness of breath
Physical Function
Time frame: At baseline,
Physical function measured by the 30 seconds chair rise test
Physical Function
Time frame: At 8 weeks (end of the study),
Physical function measured by the 30 seconds chair rise test
Physical Function
Time frame: At 4 months follow up
Physical function measured by the 30 seconds chair rise test
Quality of life measure
Time frame: At baseline
Quality of life measured by the chronic obstructive pulmonary disease Assessment Test (CAT) scale. Score ranges from 0-40, with higher scores indicating a more severe impact on a patient's life
Quality of life measure
Time frame: At 8 weeks (end of study)
Quality of life measured by the chronic obstructive pulmonary disease Assessment Test (CAT) scale. Score ranges from 0-40, with higher scores indicating a more severe impact on a patient's life
Quality of life measure
Time frame: At 4- month follow up
Quality of life measured by the chronic obstructive pulmonary disease Assessment Test (CAT) scale. Score ranges from 0-40, with higher scores indicating a more severe impact on a patient's life
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Have ability to connect to the internet
Exclusion criteria
- • 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)
- Inability to communicate in the English language
Where
- Charlestown, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 1, 2024 · Source of record for eligibility and locations