Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06396247 |
| Other study ID # |
STUDY00024492 |
| Secondary ID |
R01AG079938 |
| Status |
Not yet recruiting |
| Phase |
Phase 2/Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
September 26, 2024 |
| Est. completion date |
September 25, 2028 |
Study information
| Verified date |
May 2024 |
| Source |
Milton S. Hershey Medical Center |
| Contact |
Christopher Sciamanna, MD, MPH |
| Phone |
610-585-9765 |
| Email |
cns10[@]psu.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In this study, we will randomly assign 360 older adults to 12 months of 5 minutes per day of
functional resistance training or to a delayed treatment control condition, and measure the
impact of the training on measures of lower extremity performance and walking ability.
Description:
One of the most common, and untreated, health problems among older adults is mobility
disability, observed in nearly one in five (17.9%) of older adults. Mobility disability is
typically the first disability to develop and increases future risk for additional
disabilities and death. Though the most effective treatments for mobility disability are
forms of exercise, especially resistance training (RT), they are rarely used, with fewer than
20% of older adults meeting RT guidelines and even fewer among those with mobility
disability. The core problem of disseminating the benefits of RT to older adults is
adherence. One potential opportunity to enhance adherence to RT, which has not been tested,
is to make RT programs shorter. Studies show that most of the benefits of RT accrue with the
first few sets per week, consistent with the law of diminishing utility. While traditional RT
programs for older adults, like those offered by Silver Sneakers, are typically 45 minutes
three times weekly, fewer than 5% of older adults with free access to these programs
participate. Our qualitative work shows that older adults often feel that 45 minute sessions
are too challenging (e.g., "I don't think I have the strength to do it for 45 minutes") and
75% of older adults we surveyed preferred a 5 minute RT to a 45 minute RT option, assuming
they were equally effective. In 2020, we set out to design a brief, home-based RT program
that would lead to both high levels of adherence and functional improvement. We called the
program FAST (Functional Activity Strength Training) and, to overcome its brevity, FAST was
augmented with several standard behavior change techniques (e.g., feedback, reminders,
self-monitoring) and a novel form of goal- setting, rarely used in RT studies, for the number
of additional repetitions participants should be able to do during the study. In FAST-1, 24
healthy older adults were prescribed 30 seconds of squats and push-ups each day and given no
personal supervision. Over 6 months, they performed the exercises on 73% of days and showed
large increases in squat and push-up performance (Cohen's d > 1.0). In FAST-2, we randomly
assigned 97 older adults with mobility disability, and those assigned to 30 seconds each of
chair stands and steps onto a stepper each day completed exercises on 81% of days (5.7 days
per week) and improved their 5 time sit-to-stand test (-2.8 seconds, Cohen's d=0.53), 30
second chair stand test (+4.2 repetitions, d=1.1) and One Leg Stand test (+3.7 seconds,
d=0.40), versus controls. In this multicenter study, we will randomly assign 360 older adults
with an SPPB score < 8 to 6 months of daily FAST or to a delayed control group. We will test
the impact of FAST on physical performance, walking ability, falls and functional
limitations. We hypothesize that FAST will improve these measures more than controls, and
that those with greater adherence and perceived effort will improve the most. By rigorously
testing FAST, we hope to change the paradigm of RT prescription from "More is better" to
"What will people do that works?" and, if FAST proves superior, a future study will test
whether FAST leads more older adults to do RT and, thereby, improve the public's health.
