Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04796870 |
| Other study ID # |
Powerbraining |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 28, 2021 |
| Est. completion date |
August 2, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
George Mason University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Brief Summary:
Cognition and balance are known to decline during the aging process. Cognitive performance is
essential for functional independence and determines whether an individual can perform
instrumental daily living activities (e.g., finances, driving, independent living). Balance
is critical for participation in everyday life activities. Impaired balance increases fall
risk, and subsequent injury increased caregiver dependency and decreased independence.
The purpose of this study is to investigate the outcomes of 24 sessions of online mobility
and cognitive training (35 minutes/session, 3x/week, 8-12 weeks) for community-based older
adults. The exercise program is progressively challenging and emphasizes balance,
cardiovascular conditioning, attention, and working memory. The primary outcomes of interest
are cognitive performance and balance changes, with secondary outcomes relating to
self-efficacy, resilience, and physical activity.
Description:
Protocol Overview: Subjects will be recruited from the greater Washington D.C. metro area.
Individuals interested in participating as subjects will complete initial verbal screening to
determine eligibility for inclusion. Those subjects who volunteer to participate will then be
consented and enrolled for participation if exclusion and inclusion criteria are met.
Visit 1: (~120 minutes) Participants meeting study rationale and voluntarily agree to
participate will receive a standardized email generated through the Research Electronic Data
Capture (REDcap) platform. The email will contain a Zoon videoconference link to complete
cognitive assessments (described below) and virtual balance tests (described below) with a
research assistant. That email will also contain a second link to complete all surveys
through the REDcap portal. Only one selected member of the research team will have an
identification key connecting personally identifiable information to returned surveys.
Cognitive assessments will be completed online using REDcap and Q-global Pearson, with a
member of the research team providing verbal instruction via videoconference. After cognitive
assessment completion, participants will perform the virtual balance tests. A team member
will oversee setup via videoconference to ensure the environment's safety and administer the
test. Participants will receive login instructions and access code to the virtual training
sessions with POWER BRAINing.
Visits 2-25: (~35 minutes each) Participants will perform training videos at their
convenience two to three times per week for 8-12 weeks for a total of 24 sessions.
Participants will receive a weekly email and/or phone call from research staff to check
safety, provide encouragement, and answer any questions.
Visit 26: (~120 minutes) Subjects will repeat the same testing procedures, in the same order,
as they did in visit 1.
Study Procedures:
Cognitive Outcome Measures: The following assessments will be administered via
videoconference using the Zoom platform, and data will be stored in REDcap. Directions will
be given verbally using the specified script for each outcome measure.
Digit Span subset of Wechsler Adult Intelligence Scale- 4th Edition (WAIS-IV, 10 minutes):
Digit Span, which has two subsections forward (DS-F) and backward (DS-B), evaluates attention
and auditory working memory respectfully. The DS-F requires participants to repeat numbers in
the same order as they were read aloud by the examiner. The testing administrator will say to
the subject, "I am going to read you a sequence of digits, and I want you to try and repeat
the digits in the same order they were read out loud." To minimize confusion, this example
will be provided, "If I say '4, 7, 1', then you would repeat those same digits in that same
order". The DS-B requires participants to repeat the numbers in reverse order of what was
presented aloud by the examiner. The test administrator will say, "I am going to read you a
sequence of digits, and I want you to try and repeat the digits in the reverse order they
were read out loud. For example, if I say '4, 7, 1', then you would repeat those same digits
backward." In both subsets, the sequences increase in length as the participant progresses,
each length has two different sequences. The DS-F has 16 sequences, and the DS-B has 14
sequences. The maximum raw score of DS-F is 16 and DS-B is 14. The digits will be read in an
even tone, at approximately the rate of one digit per second. The first set of sequences will
begin at three digits. The discontinuation criterion is the failure to reproduce two
sequences of equal length correctly.
Letter-Number Sequencing (LNS, 5 minutes): The LNS requires participants to listen to a
series of number and letter and repeat the sequence starting first with the numbers in
ascending order, followed by the letters in alphabetical order. The testing administrator
will say to the subject " "I am going to say a set of numbers and letter. Your task is report
them by first saying the numbers in ascending order and then the letters in alphabetical
order. For example, if I say '9, T, 3, A', your response would be '3, 9, A, T'." The numbers
and letters will be read in an even tone, at approximately the rate of one digit/number per
second. The first sequence begins at two and increases in length as the participant
progresses. The maximum raw score is 21. Discontinuation criterion is failure to correctly
reproduce three sequences of equal length.
Simple and Choice Reaction Time (10 minutes): The simple (SRT) and choice (CRT) response time
tasks record reaction time to measure the speed of information processing using an online
visual stimulus task. The participant will begin with the SRT and will be asked to "Wait
until you see a black 'X' in the white square. When that happens, press the spacebar. The
goal is to respond as quickly as possible". In the CRT task, there are four possible stimuli
and four possible stimulus-response associations. Directions are as follows, "Wait until you
see a black 'X' in one of the four white squares. When that happens, press the corresponding
key (z, x, ). You can use both hands and may keep your fingers on the keys throughout
the test. The goal is to respond as quickly as possible". The participant will have one
practice round for each task.
Spatial Addition subset of Wechsler Memory Scale- 4th Edition (WMS-IV, 15 minutes): This
subtest examines visual-spatial working memory and will be administered using the Q-global
Pearson platform. The participant is shown two 4x4 grids for five seconds each. Both stimuli
will contain blue dots, red dots, or both. The participant must memorize the dots' color and
location in each stimulus to create a final grid that adds the blue dots' locations, ignores
any red dots, and subtracts the location of blue dots that overlap. The instructions will
include: "In this next task, you will be shown two grids for 5 seconds each that contain red
or blue dots. Your task in the third grid is to create a final grid that adds the spatial
location of the blue dots, subtracting any blue dots that overlapped and ignore any red
dots". Participants will be shown an example of this task.
Balance outcome measures: The following assessments will be performed via videoconference
using Zoom with a research team member who will oversee the participants' setup for optimal
safety and visualization. The participant will be cued to prioritize safety, upright balance
during tests. Participants are encouraged to position themselves with the back of a chair, a
countertop, or a wall within reach to their front or side, as they perform these tests. The
virtual test administrator will ensure a safe environment before starting the test.
30-second Chair Stand (~5 minutes): A test of leg strength where the number of times a
participant can stand up fully and sit back down within 30 seconds with arms crossed over
their chest. Ideally, the chair has a straight back that does not have armrests and, ideally,
without armrests with the seat seventeen inches above the floor. Most importantly for this
assessment is using the same chair during pre- and post-assessments. Participants will place
the chair against a wall to ensure it will not move. Ideally, camera orientation is lateral
to the participant to verify achieving full stand and sit for each repetition and not bracing
knees/legs against the chair. Participants must use the same chair during baseline and
follow-up testing.
Four-Stage Balance Test (~10 minutes): The purpose is to assess static balance in a standing
position without using an assistive device. Patients will balance with their feet in four
positions that get progressively more challenging. Positions include feet together,
staggered, heel-to-toe, and single leg. Participants will stand up to 10 seconds in the first
three positions and up to 30 seconds while in a single leg stance to minimize a ceiling
effect. The participant may adjust their arms to maintain balance, but the test is over if
they grab a support surface or changes foot-position. Test administrator times each position
stance when the participant achieves the testing position without UE support. If the person
holds a position for 10 seconds without moving their feet or needing support, that position
is complete, and the participant returns to a bilateral stance. If the participant cannot
hold the position for 10 seconds, the time is over, and the sustained time is documented
(i.e., the participant does not progress to the next test position). The final position
(single-limb stance) is held for up to 30 seconds, with documentation of the length of time
held in seconds.
Questionnaires:
Screening Tool: This questionnaire is study-specific, developed to assess the eligibility
criteria of inquiring individuals and provide standardized information on the purpose of this
study. It is administered by research staff via phone call and recorded in the REDcap
platform.
Testing/Forms:
Physical Activity Readiness Questionnaire (PAR-Q, 5 minutes): The PAR-Q is a 7 question
screening tool used to assess an individual's physical fitness level and ability to engage in
physical activity. The PAR-Q will be administered in REDcap after meeting the criteria via
phone screening.
Connor Davidson Resilience Scale (~10 minutes): The Connor Davidson Resilience Scale is a
one-dimensional self-reported scale consisting of 25 items measuring resilience and will be
administered through an online survey REDcap on visit-1 and visit 26.
Activities-Specific Balance Confidence Scale (ABC Scale, 5-10 minutes): The ABC scale is a
16-item self-report rating confidence in performing various activities. The ABC Scale will be
administered through an online survey through REDcap on visit-1 and visit-26.
Outpatient Physical Therapy Improvement in Movement Assessment Log (OPTIMAL, 20 minutes): The
OPTIMAL scale measures self-confidence and difficulty performing 21 functional activities and
will be administered through an online survey through REDcap on visit-1 and visit-26.
International Physical Activity Questionnaire- Long Form (~15-30 minutes): The IPAQ is a
27-item self-reported measure of physical activity to compare levels between populations
internationally. It will be administered through an online survey through REDcap on visit-1
and visit-26.
Online Video Intervention: The intervention intends to encompass cardiovascular conditioning,
cognitive performance, and balance performance improvements. The exercises are structured to
keep the participant in motion to promote cardiovascular conditioning while maintaining an
elevated heart rate using techniques such as squats, marching, and upper extremity movements.
The video provides adaptations to increase or decrease the challenge based on subject
ability. Participants will be asked to complete simple and complex cognitive tasks to promote
cognitive performance, such as arithmetic, spatial memory recall, and attention while
completing the physical exercises. The videos include single-limb stance and weight shifting
tasks to promote balance performance. Videos are presented in a progressively challenging
manner for all domains.
