Trial Outcomes & Findings for Blood Flow Restriction Training Combined With Abdominal draw-in Maneuver on Transverse Abdominis Strengthening (NCT NCT04270695)

NCT ID: NCT04270695

Last Updated: 2023-08-21

Results Overview

muscle thickness change on week3, 4 and 5 compared with baseline

Recruitment status

COMPLETED

Study phase

Target enrollment

34 participants

Primary outcome timeframe

3,4,5 weeks

Results posted on

2023-08-21

Participant Flow

participants were recruited from college aged between 20\~35

of 37 participants, 36 met the inclusion criteria while 1 participant was excluded because of overweighted.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	17	17
Overall Study COMPLETED	17	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Blood Flow Restriction n=17 Participants 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.	Sham Blood Flow Restriction n=17 Participants 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.	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=17 Participants	0 Participants n=17 Participants	0 Participants n=34 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=17 Participants	17 Participants n=17 Participants	34 Participants n=34 Participants
Age, Categorical >=65 years	0 Participants n=17 Participants	0 Participants n=17 Participants	0 Participants n=34 Participants
Age, Continuous	21.47 years STANDARD_DEVIATION 1.33 • n=17 Participants	21.53 years STANDARD_DEVIATION 1.69 • n=17 Participants	21.5 years STANDARD_DEVIATION 1.52 • n=34 Participants
Sex: Female, Male Female	10 Participants n=17 Participants	8 Participants n=17 Participants	18 Participants n=34 Participants
Sex: Female, Male Male	7 Participants n=17 Participants	9 Participants n=17 Participants	16 Participants n=34 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Taiwan	17 participants n=17 Participants	17 participants n=17 Participants	34 participants n=34 Participants
BMI	21.41 kg/m^2 STANDARD_DEVIATION 0.93 • n=17 Participants	21.53 kg/m^2 STANDARD_DEVIATION 1.69 • n=17 Participants	21.5 kg/m^2 STANDARD_DEVIATION 1.7 • n=34 Participants

PRIMARY outcome

Timeframe: 3,4,5 weeks

muscle thickness change on week3, 4 and 5 compared with baseline

Outcome measures

Outcome measures
Measure	Blood Flow Restriction n=17 Participants wrap an inflatable cuff below the 12 ribs and inflated to 160 mmHg	Sham Blood Flow Restriction n=17 Participants wrap an inflatable cuff below the 12 ribs but deflated
Muscle Thickness Change of Transverse Abdominis baseline	0.93 mm Standard Deviation 0.97	0.77 mm Standard Deviation 1.45
Muscle Thickness Change of Transverse Abdominis week 3	1.98 mm Standard Deviation 1.4	0.99 mm Standard Deviation 0.79
Muscle Thickness Change of Transverse Abdominis week 4	2.65 mm Standard Deviation 1.08	0.78 mm Standard Deviation 0.79
Muscle Thickness Change of Transverse Abdominis week 5	2.7 mm Standard Deviation 1.62	0.83 mm Standard Deviation 0.75

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Blood Flow Restriction n=17 Participants wrap an inflatable cuff below the 12 ribs and inflated to 160 mmHg	Sham Blood Flow Restriction n=17 Participants wrap an inflatable cuff below the 12 ribs but deflated
Internal Oblique Thickness Change week 4	0.96 mm Standard Deviation 2.66	0.14 mm Standard Deviation 0.94
Internal Oblique Thickness Change baseline	-0.01 mm Standard Deviation 1.06	-0.2 mm Standard Deviation 1.09
Internal Oblique Thickness Change week 3	0.75 mm Standard Deviation 1.72	0.02 mm Standard Deviation 1.04
Internal Oblique Thickness Change week 5	1.21 mm Standard Deviation 1.53	0.4 mm Standard Deviation 1.78

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Blood Flow Restriction n=17 Participants wrap an inflatable cuff below the 12 ribs and inflated to 160 mmHg	Sham Blood Flow Restriction n=17 Participants wrap an inflatable cuff below the 12 ribs but deflated
External Oblique Thickness Change baseline	-0.77 mm Standard Deviation 1.08	-0.47 mm Standard Deviation 1.04
External Oblique Thickness Change week 3	-0.97 mm Standard Deviation 1.11	-0.41 mm Standard Deviation 0.76
External Oblique Thickness Change week 4	-0.94 mm Standard Deviation 1.09	-0.16 mm Standard Deviation 0.8
External Oblique Thickness Change week 5	-0.95 mm Standard Deviation 1.02	-0.68 mm Standard Deviation 1.13

Adverse Events

Blood Flow Restriction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Blood Flow Restriction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ms Weng

China Medical University

Phone: 0975127007

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place