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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| blood flow restriction | Experimental | 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. |
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| sham blood flow restriction | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood flow restriction | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Thickness Change of Transverse Abdominis | muscle thickness change on week3, 4 and 5 compared with baseline | 3,4,5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yueh-Ling Hsieh | professor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University | Taichung | Taiwan |
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of 37 participants, 36 met the inclusion criteria while 1 participant was excluded because of overweighted.
participants were recruited from college aged between 20~35
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| ID | Title | Description |
|---|---|---|
| FG000 | Blood Flow Restriction | An inflatable cuff (14 cm in width * 84 cm in length) is warped around abdominal muscles below ribs and inflated to 160mm-Hg 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 in condition of BFR twice a week, for six weeks. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 14, 2021 |
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| sham blood flow restriction | Behavioral | 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. |
|
| baseline,3,4,5 weeks |
| 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 |
| FG001 | Sham Blood Flow Restriction | An inflatable cuff (14 cm in width * 84 cm in length) is warped around abdominal muscles below ribs without inflation as a sham operation.All participants are instructed to perform abdominal draw-in maneuver in condition of BFR-free twice a week, for six weeks. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Muscle Thickness Change of Transverse Abdominis | muscle thickness change on week3, 4 and 5 compared with baseline | Posted | Mean | Standard Deviation | mm | 3,4,5 weeks |
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| 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. | Posted | Mean | Standard Deviation | mm | baseline,3,4,5 weeks |
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| 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. | Posted | Mean | Standard Deviation | mm | baseline,3,4,5weeks |
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All Mortality, Serious, and Other Adverse Events (ex, injury )were not monitored/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Blood Flow Restriction | An inflatable cuff (14 cm in width * 84 cm in length) is warped around abdominal muscles below ribs and inflated to 160mm-Hg 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 in condition of BFR twice a week, for six weeks. 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Sham Blood Flow Restriction | An inflatable cuff (14 cm in width * 84 cm in length) is warped around abdominal muscles below ribs without inflation as a sham operation.All participants are instructed to perform abdominal draw-in maneuver in condition of BFR-free twice a week, for six weeks. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ms Weng | China Medical University | 0975127007 | chuyu0608@gmail.com |
| Oct 19, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000090003 | Blood Flow Restriction Therapy |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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| Between 18 and 65 years |
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| >=65 years |
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| week 4 |
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| week 5 |
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An inflatable cuff (14 cm in width * 84 cm in length) is warped around abdominal muscles below ribs without inflation as a sham operation.All participants are instructed to perform abdominal draw-in maneuver in condition of BFR-free twice a week, for six weeks. |
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An inflatable cuff (14 cm in width * 84 cm in length) is warped around abdominal muscles below ribs without inflation as a sham operation.All participants are instructed to perform abdominal draw-in maneuver in condition of BFR-free twice a week, for five weeks. |
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