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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04270695
Other study ID # CRREC-109-007
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 3, 2020
Est. completion date July 9, 2021

Study information

Verified date October 2022
Source China Medical University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study expects to provide a new alternative way to improve the muscle activation, strength and activation of transverse abdominis in abdominal draw-in maneuver combined with blood flow restriction.


Description:

The transverse abdominis (TrA) is the deepest muscle layer of lateral and anterior abdominal wall and also known as a significant component of core stability. Abdominal draw-in maneuver (ADIM) is the main for the strengthening of the deep muscle, however, sufficient activation of TrA by ADIM is limited. Blood flow restriction (BFR) training is a technique combined with low intensity exercise that produces similar results to high intensity training. However, there is few evidences for BFR training on core muscles. Healthy adults (age ranged 18-34 years and BMI between 18.5~24.99) were randomly recruited in the study. For the intervention group, an inflatable cuff (14 cm in width * 84 cm in length) is warped around abdominal muscles below ribs which may cause to at least 60% restriction of blood flow detected by Power Doppler ultrasonography. All participants are instructed to perform ADIM both condition of BFR and BFR-free twice a week, for six weeks. Outcome measurements include Double leg lowering test (DLLT) for muscle strength, brightness mode ultrasound (USD) for muscle hypertrophy and electromyography (EMG) muscle activation. The same physical therapist will do the measurement at first week, third week and the sixth week.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date July 9, 2021
Est. primary completion date April 3, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria: - Healthy subjects - 20~35 years old - BMI 18.5~24.99 Exclusion Criteria: - Hypertension - Have cardio-vascular disease - Used to have abdominal operation or wound - Have spinal surgeries or deformities - Known neuromuscular or joint disease - Pregnant

Study Design


Intervention

Behavioral:
blood flow restriction
an inflatable cuff (14 cm in width * 84 cm in length) is warped around abdominal muscles below ribs which may cause to at least 60% restriction of blood flow detected by Power Doppler ultrasonography. All participants are instructed to perform abdominal draw-in maneuver.
sham blood flow restriction
an inflatable cuff (14 cm in width * 84 cm in length) is warped around abdominal muscles below ribs without inflation. All participants are instructed to perform abdominal draw-in maneuver.

Locations

Country Name City State
Taiwan China Medical University Taichung

Sponsors (1)

Lead Sponsor Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle Thickness Change of Transverse Abdominis muscle thickness change on week3, 4 and 5 compared with baseline 3,4,5 weeks
Secondary Internal Oblique Thickness Change Data represents the muscle thickness change on week 3, 4 and 5 compared with baseline. The thickness of the muscle was calculated by the differences between the muscle thickness during contraction and the muscle thickness during resting position. If the muscle thickness during contraction was smaller than the muscle thickness during the resting position, therefore, the values would be negative. The values in baseline presented as negative may be because the internal oblique muscle thickness during contraction was smaller before receiving any training. Previous studies stated that after receiving ADIM and BFR training, the internal oblique muscle thickness will be thicker. Therefore, it was reasonable that the results in baseline presented negative values while the values became positive after receiving training. baseline,3,4,5 weeks
Secondary External Oblique Thickness Change Data represents the muscle thickness change on week 3, 4 and 5 compared with baseline. The thickness of the muscle was calculated by the differences between the muscle thickness during contraction and the muscle thickness during resting position. If the muscle thickness during contraction was smaller than the muscle thickness during the resting position, therefore, the values would be negative. The values in baseline presented as negative may be because the external oblique muscle thickness during contraction was smaller before receiving any training. After receiving ADIM and BFR training, the tranverse abdominis and internal oblique muscle thickness will be thicker while the external oblique will be thinner due to the compression from the TrA and IO muscles. baseline,3,4,5weeks
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