Trial Outcomes & Findings for Low Intensity Blood Flow Restriction Training Study (NCT NCT03055260)

NCT ID: NCT03055260

Last Updated: 2020-02-28

Results Overview

One repetition maximum on the single leg press. Isometric quadriceps extension strength.

Recruitment status

COMPLETED

Study phase

Target enrollment

8 participants

Primary outcome timeframe

6 weeks

Results posted on

2020-02-28

Participant Flow

Participant milestones

Participant milestones
Measure	Blood Flow Restriction Cuff This group will receive an active cuff that partially restricts blood flow to the experimental limb. Blood flow restriction cuff: The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.	Blood Flow Restriction Cuff-Placebo This group will wear a placebo cuff, of which will not restrict blood flow at all. Blood Flow restriction Cuff-Placebo: The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.
Overall Study STARTED	8	0
Overall Study COMPLETED	7	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Blood Flow Restriction Cuff This group will receive an active cuff that partially restricts blood flow to the experimental limb. Blood flow restriction cuff: The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.	Blood Flow Restriction Cuff-Placebo This group will wear a placebo cuff, of which will not restrict blood flow at all. Blood Flow restriction Cuff-Placebo: The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

8 participants were enrolled. 1 participants dropped-out prior to collection of this data measure.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 6 weeks

Population: No participants completed the placebo arm.

One repetition maximum on the single leg press. Isometric quadriceps extension strength.

Outcome measures

Outcome measures
Measure	Blood Flow Restriction Cuff n=7 Participants This group will receive an active cuff that partially restricts blood flow to the experimental limb. Blood flow restriction cuff: The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.	Blood Flow Restriction Cuff-Placebo This group will wear a placebo cuff, of which will not restrict blood flow at all. Blood Flow restriction Cuff-Placebo: The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.
One Repetition Maximum	302.9 pounds Standard Deviation 67.1	—

SECONDARY outcome

Timeframe: 6 weeks

Population: No participants completed the placebo arm.

Difference between groups in the measurement of the muscle thickness of the quadriceps muscle via ultrasound.

Outcome measures

Outcome measures
Measure	Blood Flow Restriction Cuff n=7 Participants This group will receive an active cuff that partially restricts blood flow to the experimental limb. Blood flow restriction cuff: The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.	Blood Flow Restriction Cuff-Placebo This group will wear a placebo cuff, of which will not restrict blood flow at all. Blood Flow restriction Cuff-Placebo: The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.
Quadriceps Muscle Thickness	45 centimeters Standard Deviation 13.4	—

Adverse Events

Blood Flow Restriction Cuff

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Blood Flow Restriction Cuff-Placebo

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

Russel Giveans

University of Minenesota

Phone: 5042314007

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Blood Flow Restriction Cuff n=8 Participants This group will receive an active cuff that partially restricts blood flow to the experimental limb. Blood flow restriction cuff: The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.	Blood Flow Restriction Cuff-Placebo This group will wear a placebo cuff, of which will not restrict blood flow at all. Blood Flow restriction Cuff-Placebo: The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=8 Participants	0 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=8 Participants	0 Participants	8 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=8 Participants	0 Participants	0 Participants n=8 Participants
Age, Continuous	28.1 years STANDARD_DEVIATION 6.2 • n=8 Participants	—	28.1 years STANDARD_DEVIATION 6.2 • n=8 Participants
Sex: Female, Male Female	7 Participants n=8 Participants	0 Participants	7 Participants n=8 Participants
Sex: Female, Male Male	1 Participants n=8 Participants	0 Participants	1 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=8 Participants	0 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=8 Participants	0 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=8 Participants	0 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=8 Participants	0 Participants	0 Participants n=8 Participants
Race (NIH/OMB) White	8 Participants n=8 Participants	0 Participants	8 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=8 Participants	0 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants	0 Participants	0 Participants n=8 Participants
Region of Enrollment United States	8 participants n=8 Participants	—	8 participants n=8 Participants
One Repetition Maximum	267.1 pounds STANDARD_DEVIATION 63.2 • n=7 Participants • 8 participants were enrolled. 1 participants dropped-out prior to collection of this data measure.	—	267.1 pounds STANDARD_DEVIATION 63.2 • n=7 Participants • 8 participants were enrolled. 1 participants dropped-out prior to collection of this data measure.
Quadriceps Muscle Thickness	42.4 centimeters STANDARD_DEVIATION 10.2 • n=7 Participants • 8 participants were enrolled. 1 participants dropped-out prior to collection of this data measure.	—	42.4 centimeters STANDARD_DEVIATION 10.2 • n=7 Participants • 8 participants were enrolled. 1 participants dropped-out prior to collection of this data measure.