Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03629730 |
| Other study ID # |
STU 082017-078 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2019 |
| Est. completion date |
April 1, 2023 |
Study information
| Verified date |
May 2023 |
| Source |
University of Texas Southwestern Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
There is an urgent need for interventions to reduce mobility limitations that affect over 15
million older adults and contribute to falls, disability, hospitalization and death. This
training will give Dr. James the skills to become an independent researcher developing
interventions to decrease mobility limitations, disability and falls in older adults. His
multidisciplinary mentorship team, led by Kathleen Bell, MD, has extensive experience with
externally sponsored research, expertise in the targeted training domains, mentoring new
investigators, and is highly committed to Dr. James' development as a researcher.
Dr. James has identified novel impairments in rhythmic interlimb and gait coordination as
strongly linked to mobility among community-dwelling older adults. Currently, no treatment
for limb coordination exists. In an effort to advance the development of treatments for
mobility limitations, the objective of the proposed research is to examine the dose-response
of an innovative intervention to improve coordination in community-dwelling older adults with
mobility limitations. The intervention uses a metronome to retrain coordination impairments
that develop with age, and consists of practice improving the coordination of the right and
left: a) ankles; b) shoulders; and c) ankles and shoulders, while lying supine, and d) the
arms and legs during walking; by synchronizing movements with a metronome.
This project is significant in that the approach may offer a cost-effective, clinically
applicable, and efficacious means of reducing mobility limitations in older adults. We will
initially refine the intervention, and subsequently conduct a randomized trial of 2-, 4- and
8-week intervention treatments vs. physical activity control with (N=120) community-dwelling
older adults aged >70 years with mobility limitations. These treatment durations correspond
to what rehabilitative care providers would consider a short vs. medium vs. long duration
(dose) of treatment. We will examine the magnitude and duration of change in interlimb ankle
coordination and gait coordination for each group. We will estimate the coordination effect
sizes for a minimal clinically important difference in mobility performance, and explore
changes in upper limb coordination and performance-based and self-reported mobility.
Description:
Concise Summary of Project:
The objective of the proposed research is to examine the dose-response of an intervention to
improve interlimb and gait coordination in community-dwelling older adults with mobility
limitations. The investigators will compare the effects of 3 doses of the intervention and a
physical activity control. The intervention will consist of exercises for performing movement
coordination patterns: 1) plantar flexing and dorsiflexing the right and left ankles; 2)
flexing and extending the right and left shoulders; and 3) synchronizing the steps during
walking with auditory metronome tones. Treatment will mirror outpatient rehabilitative care
in that it will involve 1 weekly visit to the clinical laboratory and 4 days of home
exercises each week, focusing on limb movement coordination. A physical activity control
group will perform a similar treatment program of range of motion exercises that do not
target coordination.
The treatment arms will consist of three doses of an intervention to improve coordination and
a physical activity control arm. The three doses will consist of different durations of daily
training in coordination exercises. Primary outcome variables are the standard deviation of
relative phase of the ankles during rhythmic ankle coordination, and the Phase Coordination
Index (a measure of gait coordination) during normal pace walking. Secondary outcomes will be
the standard deviation of relative phase during rhythmic shoulder coordination, and Short
Physical Performance Battery score. Key study endpoints will be at the end of the 8 week
intervention, and 2-week follow up assessments up to 8-weeks post-intervention.
The maximum number of subjects to be consented, including projected screen failures and early
withdrawals is 250. The study will last five years. Conditions that would result in subjects
exiting the study prior to expected completion are death, moving away from the area, injury,
the development of exclusionary comorbidities, safety reasons, and withdrawal of consent.
Study Procedures:
Recruitment Participants will be recruited through a letter mailed to addresses of
individuals listed on the Dallas, Fort Worth, Irving, and Arlington, TX voter registration
lists as being ≥ 70 years of age. Individuals potentially interested in participating in the
study can contact the Principal Investigator (PI) or Research Coordinator (RC) at the
telephone number or email provided in the letter.
Those who qualify for the study will be given a series of physical movement assessments and
questionnaires. Participants will attend the research study once weekly for 10 weeks (2
weekly screening/baseline assessments, 8 weekly intervention sessions), followed by once
every 2 weeks for another 8 weeks, for a total of 14 laboratory visits. The duration of each
visit will be approximately 60 minutes. On the initial day of intervention or control
training, participants will be scheduled for their subsequent days of weekly participation.
In the event of an emergency the PI or RC will contact ext. 88911 (UTSW Emergency Services).
In the event of a fall or other emergency and an ambulance must be called, while waiting for
the ambulance to arrive our research personnel will provide assistance to the participant as
instructed by the emergency operator. Participants will arrange for their own transportation
to and from the laboratory.
Physical movement assessments The investigators will assess ankle and shoulder coordination
by having participants lie down in a supine position on a physical therapy table and: a)
plantar- and dorsi-flex their right and left ankles; and b) flex and extend their right and
left arms (directly in front of them). The participants will perform 2 trials of 45 seconds
duration of each task while synchronizing their movements with an auditory metronome we will
play for them. A motion capture system will be used to collect 3-dimensional data on the body
movement while participants perform the physical movement testing. This system is a set of
infrared cameras on tripods that will be situated around participants. The camera system
tracks the 3-D position of small reflective balls will be taped to the back of participants'
arms, feet, head, and upper back. These reflective balls will be taped to elastic bands that
will be wrapped around the participants' body. This camera system records infrared light and
does not capture video images.
Participants will also walk 6-9 times across a 20 foot long walkway, with short rest breaks
given between each pass across the walkway. The researcher will walk alongside (but off the
walkway) the participant. The walkway is an instrumented mat that collects data from
footfalls. This data will be used to assess gait patterns.
Participants will also perform the SPPB every 2 weeks when they come to the lab, using the
same procedures as for exclusionary testing.
Questionnaires The participants will be asked a series of questions on their handedness and
footedness (right or left), their race/ethnicity, years of education, annual family income,
overall health, any chronic medical conditions, history of falling in the past 12 months,
fear of falling, pain, and two connect-the-dot tests (Trail Making Tests A and B) that assess
executive function. There are also a series of questions asked regarding participants'
ability and frequency of performing physical activities (Late Life Function and Disability
Instrument). These questionnaires are included in the IRB application materials.
The questionnaires will be administered during one of the first two days of
screening/baseline assessments, at the end of the intervention (week 12), and on the last
follow up session (week 22). The time for administration of the questionnaires will be
approximately 40 minutes each day.
The total time for administering the physical testing will be approximately 20 minutes. The
physical testing will be conducted on the first two screening/baseline testing sessions,
every two weeks during the intervention (8 weeks), and every two weeks during the 8-week
follow up testing. After completing the 2 screening/baseline testing sessions, participants
will be randomly assigned to one of 4 groups: low, moderate, or high dose intervention; or
physical activity control.
Participants will perform the intervention or physical activity control exercises in the
Mobility Research Laboratory at UT Southwestern once per week for 8 weeks. During each
training session the participants will practice rhythmically moving two parts of their body
at a time. Each practice session will be approximately 30 minutes in duration, including rest
breaks as needed by each individual. The participants will be instructed to make comfortable
movements, to rest as needed and to stop moving if any movement causes them pain.
Participants will be instructed on exercises they are to perform at home on 4 days of the
subsequent week.
Intervention groups The rhythmic coordination exercises will be to synchronize the following
body segments with auditory metronome tones. Exercises 1-4 will be performed supine; exercise
5 will be performed during walking
Body segments: Osteokinematic movement:
1. Right and left ankles Dorsiflexion-plantarflexion
2. Right and left shoulders (glenohumeral joints) Flexion-extension
3. Right shoulder (glenohumeral joint) and ankle. Flexion-extension with
dorsiflexion-plantarflexion, respectively.
4. Left shoulder (glenohumeral joint) and ankle. Flexion-extension with
dorsiflexion-plantarflexion, respectively.
5. Arms and legs during walking. Normal walking arm and leg swing.
Participants assigned to the low, moderate, and high dose intervention groups will practice
synchronizing movements of their right and left ankles, right and left shoulders, and right
and left steps with an auditory metronome. The researchers will provide participants with a
take-home metronome for use during the exercises. These exercises will be varied slightly
each week. This will be a very low impact type of training (it is designed to improve
coordination, not endurance or strength).
The intervention will consist of 8 weeks of exercises to decrease the variability of
participants' body and gait coordination. The intervention will consist of 1 training session
/week in the Mobility Research Laboratory and 4 days of home-based training. In each session
participants will perform 6 trials (of 30 seconds duration) of 4 body coordination exercises
and 1 gait exercise (total duration approximately 30 minutes/session). In the intervention
sessions participants will perform interlimb coordination exercises, synchronizing body
segments with auditory metronome tones. Participants also will perform a gait exercise by
synchronizing steps with an auditory metronome during walking around in their home. The
metronome tone frequency will correspond with a percentage of the participant's normal
walking cadence. The metronome will assist participants to retrain their movement timing to
decrease coordination variability.
