Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05145335 |
| Other study ID # |
BC-11035 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 2, 2021 |
| Est. completion date |
April 3, 2022 |
Study information
| Verified date |
November 2023 |
| Source |
University Ghent |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
BFR training is growing in popularity and a variety of devices are on the market for clinical
use. One way in which it is thought that BFR resistance training safety can be increased is
by using a BFR cuff that regulates the applied pressure to the limb during each repetition.
This is thought to reduce perceptual, hemodynamic and cardiovascular responses to
non-autoregulated approaches, theoretically increasing long-term compliance and safety with
BFR training.
Description:
BFR training is growing in popularity and a variety of devices are on the market for clinical
use. One way in which it is thought that BFR resistance training safety can be increased is
by using a BFR cuff that regulates the applied pressure to the limb during each repetition.
This is thought to reduce perceptual, hemodynamic and cardiovascular responses to
non-autoregulated approaches, theoretically increasing long-term compliance and safety with
BFR training.
However, only one study has directly compared the effect of an autoregulated vs.
non-autoregulated and their design did not standardize the cuff width between the
autoregulated and the non-autoregulated cuff, potentially leading to differences in observed
outcomes. That study concluded that autoregulated cuffs better manage the hemodynamic and
perceptual responses to non-failure training protocols while providing a more accurate
cuff-limb interface pressure, thus increasing safety profile. Moreover, BFR resistance
training is commonly performed to failure so it is unknown whether the use of regulated
pressures influences fatiguability or alters perceptual, cardiovascular and hemodynamic
responses compared to a non-autoregulated cuff.
Therefore, the purpose of this study is to compare the perceptual, hemodynamic and
cardiovascular responses using either an autoregulated pressure or a non-autoregulated
pressure during a 20% 1RM leg extension non-failure and failure protocol in healthy,
recreationally active male and female participants (without any history of BFR training)
using the SmartTools Pro model (a device able to be autoregulated and non-autoregulated based
on setting, providing an ability to directly compare autoregulation to non-autoregulation
with a cuff of similar width).
Each participant will perform one familiarization session to determine 1RM, take baseline
data for participant characteristics including limb occlusion pressure and relevant
hemodynamic and cardiovascular measures, acclimate to the non-failure protocol without blood
flow restriction and anchor perceptual baselines. Following familiarization session and at
least 6 days between sessions, the dominant leg of each participant will be randomized to
either the autoregulated or non-autoregulated pressure setting. Each participant will perform
4 sets of exercise applied in a continuous application setting using a commonly recommended
protocol of 30-15-15-15 using a 2 second concentric/2 second eccentric tempo with 30-45
seconds of interset rest. The BFR cuff will either be set to autoregulation or
non-autoregulated pressure setting. Following completion of the protocol, with the cuffs
still inflated, all variables will be assessed again before deflating. Participants will
return to the lab at least 6 days later at a similar time and perform the same protocol with
the opposite condition.
To assess the differences in all relevant outcome measures during a failure routine, the same
protocol will be completed 6 days later with each participant randomized to either the
autoregulated or non-autoregulated group. Participants will complete a similar resistance
training program using 4 sets to volitional fatigue instead of the non-failure protocol. The
data provided within this study could greatly inform clinical practice if responses to
non-autoregulated cuff applications in both non-failure and failure routines are heightened
compared to autoregulated cuff applications. This study will also provide preliminary data
for application in clinical populations such as those with knee osteoarthritis as well as
applying a similar strategy to healthy populations in the upper extremity to determine if
similar responses exist between limbs.
