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The Scale-Up Project Evaluating Responsiveness to Home Exercise And Lifestyle Tele-Health (SUPER-HEALTH) initiative is a large randomized controlled study that aims to overcome logistical barriers to exercise via telehealth for people with physical disabilities. However, at the start of the COVID-19 pandemic, enrollment was halted due to limited operations at the testing site, which included no onsite visits that involved participant data collection. In response to the limited operations, a modified data collection protocol was developed for virtual enrollment of study participants.
This paper presents feasibility data on using teleassessments to enroll people with mobility impairment into a home-based exercise trial.
The modified protocol replaced onsite enrollment and data collection visits with teleassessments using a computer tablet and testing equipment that was shipped to the participants’ home address prior to the synchronous teleassessments conducted by an exercise physiologist through Zoom. The participants were mailed a teleassessment toolkit that included a digital blood pressure cuff, spirometer, hand dynamometer, mini disc cone, and measuring tape (to complete standardized testing). The teleassessment measures included resting blood pressure and heart rate, forced vital capacity, grip strength, Five Times Sit to Stand, and Timed Up and Go. Feasibility metrics included technological effectiveness, efficiency, and safety. The technological effectiveness of the telehealth assessment was determined by the percentage of sessions completed without technical issues with ≥90% criteria set a priori. Efficiency was measured by a session duration of ≤2 hours. Safety was measured by the number of adverse events related to the teleassessments reported.
Data from 36 participants were included in this feasibility study, and 34 (94%) participants completed all teleassessments without technical issues. For efficiency, the teleassessment sessions were completed in a mean time of 65 minutes and a maximum session length of 110 minutes. There were no adverse events reported to indicate concerns with the safety of teleassessments.
The modified teleassessment protocol, in response to COVID-19 restrictions, may be a feasible process for enrolling adults with mobility impairment into a home exercise trial who otherwise would have not been able to participate.
ClinicalTrials.gov NCT03024320; https://clinicaltrials.gov/ct2/show/NCT03024320
People with physical disabilities are at greater risk for primary and secondary health conditions compared with people without a disability [
The SUPER-HEALTH project, which stands for Scale-Up Project Evaluating Responsiveness to Home Exercise And Lifestyle Tele-Health, is an ongoing 48-week exercise trial assessing the utilization of a movement-to-music (M2M) intervention remotely delivered to various disability groups [
SUPER-HEALTH is testing a 48-week, home-based exercise training system among a large sample (N=648) of people with mobility impairments by comparing 3 groups: (1) attention control group (AC) receiving health promotion articles; (2) exercise group (M2M) receiving exercise videos and health promotion articles; and (3) exercise group receiving exercise videos, health promotion articles, and social networking features (M2Mplus). Participants in each group received a Samsung Tab A 10.1 tablet, which was inserted into a protective case and customized with features pertaining to the study. These features included downloads of the study app [
This protocol was approved by the university’s Institutional Review Board (IRB) and is registered with ClinicialTrials.gov (NCT03024320) as a phase III clinical trial. We certify that all applicable institutional and governmental regulations concerning the ethical use of human volunteers were followed during the course of this research.
Participants who were part of the SUPER-HEALTH study and who completed teleassessment were analyzed as part of this feasibility study.
Self-report of a physical disability or mobility impairment
18 to 74 years of age
Not currently enrolled in a structured exercise program over the past 6 months
Have the ability to use upper, lower, or both sets of extremities to exercise
Have the ability to converse and read English
Agree to receiving emails to complete consent, surveys, and teleassessments
Medically unstable to perform home exercise as determined by their physician
Cognitive impairment that may preclude self-directed daily activities
No wireless internet in home (can include hotspot with unlimited data)
In order to avoid the need for participants to commute to the laboratory for onsite data collection, our team developed protocols for synchronous remote assessments (teleassessments) and virtual orientation. The new teleassessment protocol was used for the original study from this point forward. In the following section, we will discuss some aspects of the modified protocol.
As with the original study protocol, consent and survey data collection involved emailing links to participants, connecting them to an electronic form via REDCap (electronic data capture system). Once the participants signed and submitted the electronic consent, they would automatically receive surveys from REDCap. The questionnaires included a demographic and health history questionnaire; a medication list; Godin Leisure Time Exercise Questionnaire (GLTEQ) [
Teleassessment equipment mailed to each participant included a digital blood pressure and heart rate monitor (US $45), hand-held dynamometer (US $30), spirometer (US $25), mini disc cone (US $1), and soft measuring tape (US $2). All of the equipment was lightweight and ready to use out of the box due to preparation by a research assistant prior to shipping. Teleassessment equipment was packaged along with the Samsung Tab A tablet (US $200) and Fitbit Charge 4 device (US $120) (
Teleassessment equipment, which included a digital blood pressure cuff, a hand dynamometer, a spirometer, a mini disc cone, and a 3-meter measuring tape.
A single teleassessor, an exercise and sport science lab assistant with a master’s in exercise physiology, was used to complete the teleassessment session. At the start of the session, the teleassessor instructed the participant to make sure the tablet was on a table propped on case stand and ensured the participant was in full view. They would then go through a script concerning a plan for adverse events (eg, fall) and internet connectivity issues. The session included the following assessments: anthropometrics (2 resting blood pressure readings, 2 resting heart rate readings), grip strength, peak expiratory volume, Five Times Sit to Stand, and Timed Up and Go (
An example of a person completing grip strength assessment with teleassessor on videoconference.
Once the teleassessment was completed, the participant received a virtual equipment orientation via Zoom to notify which group they had been allocated to. They were also mailed a US $25 Visa gift card via UPS mail delivery. The purpose of this meeting was to inform the participants of which group they had been randomized to and how to use each piece of equipment correctly (ie, Fitbit and tablet) for the purposes of the intervention.
Since the COVID-19 modifications were focused on the application of a technological medium (videoconferencing), we chose to assess the feasibility of the teleassessment process [
Effectiveness was defined as the percentage of sessions completed successfully without technical or logistical difficulty. These difficulties could have included any issues with information communication technology (ie, tablet, internet, videoconference software, or assessment equipment) experienced by the participant or teleassessor. Physiologic testing issues, such as high resting blood pressure or heart rate or an inability to complete an assessment due to mobility level (eg, wheelchair use), were excluded because these cases would have also excluded the participants from completing assessments onsite. We established an a priori criterion for acceptable effectiveness at 90% used previously with this population [
Efficiency was defined as the amount of time to complete teleassessments. The timer started once the participant and teleassessor logged on to the videoconferencing session and ended at the point of logging off. The criterion for reasonable efficiency was set at 2 hours or less a priori as this was the time allotted for onsite visits.
Adverse events, defined by the university’s IRB as “…any untoward or unfavorable medical occurrence in a human subject,” were reported by the teleassessor with a written description of the event. The event was then recorded in a medical oversight form, which was reviewed by the study physician who classified the event as serious or non-serious and whether it was due to study procedures. Any adverse event was then reported to the IRB. Examples of adverse events would include falls or injury during testing.
Data from a convenience sample of 36 people were included within this feasibility report. The participants were primarily female and African American (
Demographic data of participants (N=36).
Characteristic | Value | |
Age (years), mean (SD) | 51.08 (16.64) | |
|
|
|
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Male | 11 (31) |
|
Female | 25 (69) |
|
|
|
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African American | 21 (58) |
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White | 13 (36) |
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Other | 2 (6) |
|
|
|
|
Spinal cord injury | 5 (14) |
|
Spina bifida | 5 (14) |
|
Arthritis | 11 (31) |
|
Stroke | 3 (8) |
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Other | 12 (33) |
|
|
|
|
Wheelchair only | 6 (17) |
|
Cane only | 6 (17) |
|
Motorized scooter only | 2 (6) |
|
Other | 1 (3) |
|
No assistive devices | 11 (31) |
Out of the 36 participants in the sample, 34 (94%) completed all teleassessments without issues, which met the criteria for acceptability (>90%) set a priori. This resulted in the successful completion of 188 assessments. The reasons for the 2 participants not completing all teleassessments included: incomplete spirometry test due to confusion regarding manual peak flow meter and incomplete Timed Up and Go assessment due to technical difficulties with videoconferencing on the tablet.
The mean time for the completion of a teleassessment session for the sample of 36 participants was 65.03 (SD 15.51) minutes, which met our a priori criterion for acceptability (maximum session length: 110.00 minutes). Therefore, the criterion for completing the sessions in under 2 hours was met by all participants (N=36, 100%) of the sample. The reasons reported for the longest session times included tablet not being charged prior to the visit and internet connection issues.
There were no adverse events reported from the sample of 36 teleassessment sessions.
Many trials have been halted due to the restriction of onsite visits by research participants during the COVID-19 pandemic. Given that a significant percentage of the population is either not yet vaccinated or elects not to be vaccinated [
SUPER-HEALTH is inclusive to varying levels of disability and functionality of all participating users. Thus, the use of telecommunication, teleintervention, and interactive methods were specifically designed to collect the same data virtually as it is carried out onsite. Along with these modifications, the virtual face-to-face interactions between the participants and the study staff suggest that telecommunication is still personable and equally as effective [
These findings are an extension of our work related to modifying specific fitness assessment protocols for people with disabilities to be completed remotely [
A challenge often found in exercise trials involving people with disabilities is recruitment. One of the most limiting factors is enrolling large samples in exercise research for this population. A scoping review reported a lack of descriptive details on study participants and noted that many of the published studies have small sample sizes, which were primarily due to individuals being excluded, declining to participate, or dropping out [
It is important to recognize the limitations of the study. First, the study excluded people who did not have internet access at home, which may have affected the representativeness of the sample. Second, the study included 12 participants who were non-ambulatory (wheelchair users) and were unable to complete two of the functional tests (Five Times Sit to Stand and Timed Up and Go), which reduced the time for completing the teleassessment session. Third, although the sample size meets the recommendations for feasibility studies [
The use of teleassessments to enroll patients with physical disability into an exercise trial may be technologically effective, efficient, and safe. Due to the COVID-19 pandemic, many clinical trials have been suspended. The procedures described in this study can be replicated by researchers and health professionals to circumvent the barriers to conducting exercise trials during the pandemic.
Institutional Review Board
movement-to-music
Scale-Up Project Evaluating Responsiveness to Home Exercise And Lifestyle Tele-Health
This research was sponsored by a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (5R01HD085186) and a Mentored Career Development Award from the National Center for Advancing Translational Research (KL2 TR 003097).
We would also like to thank the University of Alabama at Birmingham/Lakeshore Foundation Research Collaborative. The development of this project would not have been possible without the collaboration of various experts within the collaborative.
JW, BL, and MC created the initial manuscript draft. BL, MC, JG, and JW developed the teleassessment protocol. H-JY, TM, MT, and JR designed the study procedures related to the teleassessments. All authors contributed equally to later manuscript drafts.
None declared.