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.
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