- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04270695
Blood Flow Restriction Training Combined With Abdominal draw-in Maneuver on Transverse Abdominis Strengthening
Effects of Blood Flow Restriction Training Combined With Abdominal draw-in Maneuver on Transverse Abdominis Strengthening
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yueh-Ling Hsieh
- Phone Number: 7312 886-4-22053366
- Email: sherrie@mail.cmu.edu.tw
Study Locations
-
-
-
Taichung, Taiwan
- China Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 both condition of BFR and BFR-free twice a week, for six weeks.
|
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 Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle Thickness Change of Transverse Abdominis
Time Frame: 3,4,5 weeks
|
muscle thickness change on week3, 4 and 5 compared with baseline
|
3,4,5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Internal Oblique Thickness Change
Time Frame: baseline,3,4,5 weeks
|
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
|
External Oblique Thickness Change
Time Frame: baseline,3,4,5weeks
|
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
|
Collaborators and Investigators
Investigators
- Study Director: Yueh-Ling Hsieh, Professor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CRREC-109-007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Blood Flow Restriction
-
Utah State UniversityNot yet recruitingBlood Flow Restriction
-
George Fox UniversityRecruitingBlood Flow Restriction TrainingUnited States
-
Baylor UniversityCompletedBlood Flow Restriction Training | Betaine SupplementationUnited States
-
Utah State UniversityWithdrawnBlood Flow RestrictionUnited States
-
University of Mary Hardin-BaylorCompletedBlood Flow Restriction | Growth Hormone | Arginine | Strength OutcomesUnited States
-
Riphah International UniversityRecruitingAnterior Cruciate Ligament Reconstruction | Resistance Training | Volleyball | Blood Flow Restriction TherapyPakistan
-
University of KansasCompletedBlood Flow Restriction and Low-Intensity Resistance TrainingUnited States
-
Istanbul Medipol University HospitalBahçeşehir University; Medipol UniversityRecruitingExercise Training | Geriatrics | Blood Flow Restriction TrainingTurkey
-
Halic UniversityCompletedHigh-Intensity Interval Training | Blood Flow Restriction ExerciseTurkey
-
Henry Ford Health SystemRecruiting
Clinical Trials on blood flow restriction
-
George Fox UniversityUnknownMuscle Weakness | Can Blood Flow Restriction Therapy Augments Strength Gains in the Rotator CuffUnited States
-
Rush University Medical CenterWithdrawnAnterior Cruciate Ligament Injuries | Physical Therapy | ACL
-
Wake Forest University Health SciencesRecruitingShoulder InjuryUnited States
-
University of West AtticaNot yet recruiting
-
Caitlin ConleyThe Cleveland ClinicRecruitingWounds and Injuries | Knee Injuries | Patellar Dislocation | Leg InjuryUnited States
-
University of MinnesotaFairview Health ServicesCompleted
-
University of Colorado, DenverRecruitingMuscle Weakness | Muscle AtrophyUnited States
-
Womack Army Medical CenterThe Geneva Foundation; Telemedicine & Advanced Technology Research CenterTerminatedAchilles TendinopathyUnited States
-
Universitat Internacional de CatalunyaUnknownBone Diseases | Exercise | Osteoporosis | Osteoporosis, Postmenopausal
-
University of IowaCompletedKnee Osteoarthritis | Symptomatic Knee OsteoarthritisUnited States