Recruiting

Telehealth & Exercise

Sponsor:

MGH Institute of Health Professions

Code:

NCT06304207

Conditions

Copd

COPD Exacerbation

COPD Bronchitis

Emphysema or COPD

Chronic Lung Disease

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Onsite Maintenance Exercise Training

Telehealth Maintenance Exercise

Study Details

Brief summary:

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.

Conditions

Copd

COPD Exacerbation

COPD Bronchitis

Emphysema or COPD

Chronic Lung Disease

Study ID

NCT06304207

Start date

Sep 1, 2023

Status verified date

Jul, 2024

Completion date

Mar 1, 2026

Anticipated

Primary completion date

Dec 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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.

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 measure

  • Exercise Capacity [ Time Frame: At baseline ]
  • Exercise Capacity [ Time Frame: At 8 weeks (end of the study) ]
  • Exercise Capacity [ Time Frame: At 4 months follow up ]
  • Dyspnea [ Time Frame: At baseline ]
  • Dyspnea [ Time Frame: At 8 weeks (end of the study) ]
  • Dyspnea [ Time Frame: At 4 months follow up ]
  • Physical Function [ Time Frame: At baseline, ]
  • Physical Function [ Time Frame: At 8 weeks (end of the study), ]
  • Physical Function [ Time Frame: At 4 months follow up ]
  • Quality of life measure [ Time Frame: At baseline ]
  • Quality of life measure [ Time Frame: At 8 weeks (end of study) ]
  • Quality of life measure [ Time Frame: At 4- month follow up ]

Central Contacts and Locations

Central contacts

Shweta Gore, PhD

9895256619sgore@mghihp.edu

Jane Baldwin, DPT

6177242230JBALDWIN@MGHIHP.EDU

Locations

MGH Institute of Health Professions

Recruiting

Charlestown, Massachusetts, United States, 02129

Contacts

Shweta Gore, PhD

617-643-6326sgore@mghihp.edu

Jane Bladwin, DPT

jbaldwin@mghihp.edu

More Information

Sponsor

MGH Institute of Health Professions

Last update posted

Aug 1, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MGH Institute of Health Professions on 2024-08-01.