Clinical trial NCT06304207: Telehealth and Onsite Maintenance Exercise in Chronic Lung Disease
Official title: Comparison of Telehealth and Onsite Supervised Maintenance Exercise Program for Adults With Chronic Lung Disease: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Copd
COPD Exacerbation
COPD Bronchitis
Emphysema or COPD
Chronic Lung Disease
Pulmonary Fibrosis
Interstitial Lung Disease
Bronchiectasis
Chronic Asthma
Chronic Asthmatic Bronchitis
Lead sponsor: MGH Institute of Health Professions
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed description: Random Assignment Participants will be randomly assigned using a web-based randomization service (www.randomize.net) to one of three groups: 1) tele-rehab where patient will be at home but will receive supervised intervention remotely, 2) onsite outpatient rehabilitation, and 3) control group, using a computerized random number generator to eliminate risk of bias during allocation.

Subject Enrollment Consent: Potential participants who express interest in the study will be contacted via a phone call by the study team to go over screening and to seek consent for the study. Pre-screening questions will be asked over the phone to confirm eligibility. The letter of informed consent will be read out during the initial phone call and participants will be asked to sign a copy of the consent form prior to their initial visit at the IMPACT Practice Center at MGH Institute of Health Professions via a RedCap link sent to their email. Any questions related to the study will be answered prior to getting a signature on the consent form (See attached consent form). Participants will be informed of the possibility of being in one of three groups. The study Investigators will be involved in obtaining consent. Control group participants will be offered an opportunity to complete an 8-week onsite or tele-rehab intervention upon completion of the study duration. Participants will be able to withdraw from the study at any point with no penalties or any negative consequences. Participation will be voluntary, and participants can choose to step out of the study at any time.

To enhance enrollment of participants from diverse and under-represented backgrounds, free parking will be provided to the onsite location at MGH Institute of Health Professions. For participants assigned to the tele-rehab group, who do not have the means to connect and participate in the intervention, will be loaned an I-pad for the duration of the study. In addition, all participants will be provided with a $50.00 gift card at the end of the study period for their participation in the study.

6. STUDY PROCEDURES

Following informed consent, all participants will undergo a baseline assessment at index date or time point 0. Since the recruitment will occur on a rolling basis, the time 0 will vary for participants.

Outcome Assessments (time 0-time 2)

All outcomes will be recorded at baseline prior to beginning of intervention (time 0), at the end of the study intervention at 8 weeks (time 1), and at 4 months follow-up (time 2) post intervention. Each participant (n=30) will start at time 0 with examination of outcome measurements at the IMPACT practice center at MGH IHP. Outcomes will be assessed by a study team member who will be blinded to the group allocation. Outcomes assessed will include the modified Medical Research Council (mMRC) scale and the dyspnea rating scale for dyspnea, physical function measured by the 30 seconds chair rise test and the 10-meter walk test, functional capacity measured by the six minute walk test, physical activity measured by the International Physical Activity Questionnaire, and quality of life measured by the COPD Assessment Test (CAT) and the PROMIS Global Health Scale Assessment of inspiratory muscle strength will be performed using the maximal inspiratory pressure gauge (MIP). In addition, baseline vitals (heart rate, respiratory rate, oxygen saturation (SpO2) via pulse oximeter, and rating of perceived exertion (RPE) scale at rest will be documented.

The training intensity will be derived from the distance covered on the six-minute walk test. Although participants completing the traditional onsite rehabilitation program at MGH are extensively educated and independent in self-monitoring their oxygen saturation through pulse oximetry, RPE and heart rate, these will be reviewed thoroughly during the initial visit with all participants. In addition to these outcomes, participants will be asked to report any planned or unplanned physician visits, emergency room visits, falls, and injuries. The number of sessions attended by participants will also be recorded.

All participants will receive printed educational resources from the COPD Foundation and Pulmonary Fibrosis Foundation on 1) tips for living well with Chronic Lung Disease, 2) Impact of smoking, and 3) Chronic Lung Disease action plan including resources for disaster preparedness.

Following assessment of outcomes at baseline, participants will begin the 8-week intervention. Supervised visits will occur once every week for both the onsite and tele-rehab groups.

Interventions:

Participants in both intervention groups (onsite and tele-rehab) will receive a 60-minute supervised weekly exercise intervention. Interventions will be delivered by study team members that are licensed physical therapists or students under the supervision of these physical therapists. The study personnel will be paid to provide the intervention and/ collect outcomes. All participants will receive similar interventions as described in Table 1. The interventions received will be similar to standard clinical sessions, however participants and/or their insurers will not be charged for either the on-site or the telehealth interventions.

Each 60-minute session will be broken down into separate sections. These include a brief 5-minute training on inspiratory muscle training using a Threshold Inspiratory Muscle Trainer (IMT), Respironics Threshold PEP and 5-minute check-in a review of their activities during the week at home and any changes in symptoms as well as education on self-management of airway clearance and importance of maintaining regular physical activity. This will be followed by a 5-minute warm-up and 25 minutes of aerobic training in the form of walking, cycling, stair climbing, or NuStep (based on availability and patient preference). The training intensity will be derived from the distance covered on the six-minute walk test administered at baseline. Peak oxygen consumption (VO2) will be estimated based on previously published regression equations. 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 (cycling, stair climbing). Aerobic training may be completed in shorter intervals if continuous training is limited by symptoms (e.g., 2 × 12.5 minutes or 3 × 8.3 minutes). This will be followed by 15-minutes of functional strength training focusing on the lower extremity muscles such as partial squats, sit to stand exercise, lunges, and step ups and downs.

Progression of exercise will occur each week as: increase in walking or stair climbing speed, increase in wattage of cycle ergometer and NuStep by 5-10% while maintaining dyspnea levels of 3-4/10 on the dyspnea rating scale and maintaining an RPE of 13-16. Functional strengthening exercises will be progressed by increasing number repetitions while maintaining the dyspnea rating scale at 3-4/10. Inspiratory muscle training will progress by 5% each week to maintain dyspnea levels of 3-4/10 on the dyspnea rating scale. If the progression in any of the components elicits dyspnea more than 4, the same training intensity will be continued for another week.

All participants will be encouraged to maintain a log of activities performed during the week.

Tele-rehab group:

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 (see table 1). 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.

Although participants completing the traditional onsite rehabilitation program are familiar with and educated on independent in self-monitoring their SpO2, RPE, and heart rate, these will be reviewed during the initial visit with all participants. Pulse oximeters will be provided to participants for the duration of the study.

Fidelity of the exercise training intervention for both groups will be facilitated through regular staff training, and audit of exercise prescription and progression, and assessment of participant engagement.

Control group 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.

Data Collection The data that is collected from each patient will include participant demographics (age, sex, comorbidities, body mass index, race, education, work status, living situation (living alone or with partner/caregiver, in independent home or institutionalized), details of interventions provided each visit, log of activities performed during the week, outcome measures, and the number of sessions attended, along with any planned or unplanned physician visits, emergency room visits, hospitalizations, falls, and injuries.

Termination Criteria If a participant is to experience an adverse event during the course of the study, they will be terminated from the study until they receive medical clearance. Adverse events include any falls (with or without injury), hospitalizations, or unplanned visits to their physician for Chronic Lung Disease related symptoms. If patient is unable to return to the study, any data collected up until time of adverse event will be included in study, and the adverse event will be noted. Any adverse events will be reported to the IRB. If patient is allowed to return to regular exercise, the event will still be noted and reported. Any changes in medication or medical status will be monitored.

Remuneration All participants will be given $50.00 in total at the end of the study.

Eligibility criteria: 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

Primary outcomes:
measure: Exercise Capacity
timeFrame: At baseline
measure: Exercise Capacity
timeFrame: At 8 weeks (end of the study)
measure: Exercise Capacity
timeFrame: At 4 months follow up
measure: Dyspnea
timeFrame: At baseline
measure: Dyspnea
timeFrame: At 8 weeks (end of the study)
measure: Dyspnea
timeFrame: At 4 months follow up
measure: Physical Function
timeFrame: At baseline,
measure: Physical Function
timeFrame: At 8 weeks (end of the study),
measure: Physical Function
timeFrame: At 4 months follow up
measure: Quality of life measure
timeFrame: At baseline
measure: Quality of life measure
timeFrame: At 8 weeks (end of study)
measure: Quality of life measure
timeFrame: At 4- month follow up
Secondary outcomes:
measure: Inspiratory muscle strength
timeFrame: At baseline, 8 weeks (end of the study), and at 4 months follow up
measure: Inspiratory muscle strength
timeFrame: At baseline
measure: Inspiratory muscle strength
timeFrame: At 8 weeks (end of the study)
measure: Physical activity
timeFrame: At baseline
measure: Physical activity
timeFrame: At 8 weeks (end of study)
measure: Physical activity
timeFrame: At 4 months follow up
measure: Participants adherence to the program
timeFrame: 8 weeks
measure: Healthcare utilization
timeFrame: 8 weeks
measure: Adverse events
timeFrame: 8 weeks
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global 10 score
timeFrame: At baseline
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global 10 score
timeFrame: At 8 weeks (end of study)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global 10 score
timeFrame: At 4-month follow up
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: MGH Institute of Health Professions
state: Massachusetts
Study officials:
affiliation: MGH Institute of Health Professions
name: Shweta Gore, PhD
role: PRINCIPAL_INVESTIGATOR
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