NCT04270695

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

March 3, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2021

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

August 21, 2023

Completed
Last Updated

August 21, 2023

Status Verified

October 1, 2022

Enrollment Period

1.1 years

First QC Date

February 11, 2020

Results QC Date

September 14, 2021

Last Update Submit

October 12, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Muscle Thickness Change of Transverse Abdominis

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

    3,4,5 weeks

Secondary Outcomes (2)

  • Internal Oblique Thickness Change

    baseline,3,4,5 weeks

  • External Oblique Thickness Change

    baseline,3,4,5weeks

Study Arms (2)

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.

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.

Behavioral: sham blood flow restriction

Interventions

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.

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

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects
  • \~35 years old
  • BMI 18.5\~24.99

You may not qualify if:

  • Hypertension
  • Have cardio-vascular disease
  • Used to have abdominal operation or wound
  • Have spinal surgeries or deformities
  • Known neuromuscular or joint disease
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University

Taichung, Taiwan

Location

MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Results Point of Contact

Title
Ms Weng
Organization
China Medical University

Study Officials

  • Yueh-Ling Hsieh

    professor

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

February 11, 2020

First Posted

February 17, 2020

Study Start

March 3, 2020

Primary Completion

April 3, 2021

Study Completion

July 9, 2021

Last Updated

August 21, 2023

Results First Posted

August 21, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations