Blood Flow RestrictionNCT04270695
Blood Flow Restriction Training Combined With Abdominal draw-in Maneuver on Transverse Abdominis Strengthening
A study testing blood flow restriction in people with Blood Flow Restriction and draw-in Maneuver, run by China Medical University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Flow Restriction, draw-in Maneuver, Transverse Abdominis
- What is being tested?
- blood flow restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Mar 2020to 9 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
- 20~35 years old
- BMI 18.5~24.99
Who cannot join
- Hypertension
- Have cardio-vascular disease
- Used to have abdominal operation or wound
- Have spinal surgeries or deformities
- Known neuromuscular or joint disease
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Blood Flow Restriction Training Combined With Abdominal draw-in Maneuver on Transverse Abdominis Strengthening
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.
Read the 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.
- Being tested
- blood flow restriction, sham blood flow restriction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood flow restrictionBehavioural
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 restrictionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: blood flow restriction |
| 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. Receives: Behavioral: sham blood flow restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Thickness Change of Transverse Abdominis
muscle thickness change on week3, 4 and 5 compared with baseline
Measured: 3,4,5 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: baseline,3,4,5weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start3 Mar 2020
- Primary completion3 Apr 2021
- Study completion9 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Blood Flow RestrictionStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yueh-Ling Hsieh, China Medical University Hospital
- Investigators
- Yueh-Ling Hsieh, Study director, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270695
- Sponsor's protocol ID
- CRREC-109-007
- Status last verified
- Oct 2022
- First submitted
- 11 Feb 2020
- Last updated
- 21 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blood Flow Restriction Training Combined With Abdominal draw-in Maneuver on Transverse Abdominis Strengthening
- ClinicalTrials.gov ID
- NCT04270695
- Acronym / sponsor ID
- CRREC-109-007
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 3 Apr 2021 (actual)
- Study completion
- 9 Jul 2021 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Posted 21 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| blood flow restriction | Experimental | Behavioral: blood flow restrictionAn 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. |
| sham blood flow restriction | Sham comparator | Behavioral: sham blood flow restrictionan 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subjects
- 20~35 years old
- BMI 18.5~24.99
Key exclusion criteria (6 listed)
- Hypertension
- Have cardio-vascular disease
- Used to have abdominal operation or wound
- Have spinal surgeries or deformities
- Known neuromuscular or joint disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood flow restrictionan 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. | Behavioural | blood flow restriction |
| sham blood flow restrictionan 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. | Behavioural | sham blood flow restriction |
Primary outcome
Muscle Thickness Change of Transverse Abdominis
Time frame: 3,4,5 weeks
muscle thickness change on week3, 4 and 5 compared with baseline
2 secondary outcomes
Internal Oblique Thickness Change
Time frame: baseline,3,4,5 weeks
External Oblique Thickness Change
Time frame: baseline,3,4,5weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yueh-Ling Hsieh study director
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood flow restriction in people with Blood Flow Restriction and draw-in Maneuver, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Thickness Change of Transverse Abdominis (time frame: 3,4,5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.