- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07754162
Inter-Rater Reliability of Ultra Sound Based Rectus Abdominis Thickness Following Blood Flow Restriction Training
Inter-Rater Reliability of Ultra Sound Based Rectus Abdominis Thickness Following Blood Flow Restriction Training : A Retrospective Analysis.
Study Overview
Status
Conditions
Detailed Description
A retrospective methodological reliability study design will be employed to evaluate the inter-rater reliability of ultrasound-based measurements of rectus abdominis muscle thickness following a standardized blood flow restriction (BFR) training protocol. The study will utilize previously collected B-mode ultrasound images obtained from healthy young adult male participants who completed the original BFR training protocol. The existing dataset will be reviewed according to predefined eligibility criteria, and only ultrasound images of sufficient quality for identification and measurement of the rectus abdominis muscle will be included in the analysis.
The original BFR training protocol involved low-load resistance exercise performed under blood flow restriction. During the intervention, pneumatic cuffs were applied to the limbs, and participants performed a standardized squat exercise protocol at a low percentage of one-repetition maximum with prescribed repetitions and rest intervals. Ultrasound images of the rectus abdominis obtained according to the standardized imaging protocol will be analyzed retrospectively. The rectus abdominis was selected because it is a superficial abdominal muscle that can be visualized using B-mode ultrasonography and has relatively well-defined anatomical boundaries, allowing its thickness to be assessed using a standardized measurement procedure. Furthermore, the rectus abdominis contributes to trunk stabilization during functional and resistance exercises.
Ultrasound images will be analyzed using ImageJ software. Two independent raters will perform the measurements of rectus abdominis muscle thickness using the same standardized measurement protocol. The raters will independently identify the anatomical boundaries of the rectus abdominis and obtain linear thickness measurements from the ultrasound images. The use of a single standardized image-analysis platform and identical measurement procedures for both raters will minimize variability related to software and measurement techniques. The primary outcome will be the rectus abdominis muscle thickness measured in millimeters (mm).
Inter-rater reliability will be assessed using the Intraclass Correlation Coefficient (ICC) with a two-way random-effects model for absolute agreement and single measurements [ICC (2,1)], reported with the corresponding 95% confidence interval. ICC values below 0.50 will be interpreted as poor reliability, values from 0.50 to 0.75 as moderate reliability, values from 0.75 to 0.90 as good reliability, and values above 0.90 as excellent reliability. Absolute reliability and measurement error will additionally be assessed using the Standard Error of Measurement (SEM) and Minimal Detectable Change at the 95% confidence level (MDC95), where appropriate. Bland-Altman analysis will be performed to evaluate systematic differences and limits of agreement between the two raters. All statistical analyses will be conducted using SPSS, with the level of statistical significance set at p < 0.05.
If the ultrasound-based rectus abdominis thickness measurement demonstrates good to excellent inter-rater reliability, the findings will support the reproducibility of the standardized measurement protocol and its application in future research involving abdominal muscle morphology. The study may provide a methodological foundation for future investigations examining changes in abdominal muscle morphology following BFR and other exercise interventions, with potential relevance to sports physiotherapy, rehabilitation, and exercise science.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Muhammad Haris, DPT
- Phone Number: 03437181808
- Email: harismughal5154@gmail.com
Study Contact Backup
- Name: Dr Saad Rauf, PhD
- Phone Number: 03325957732
Study Locations
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Islamabad, Pakistan, 44000
- Recruiting
- Faculty of Rehabilitation for Data Collection and Research Work
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Contact:
- Muhammad Haris
- Phone Number: 03437181808
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Recreationally Active
Exclusion Criteria:
- Known Musculoskeletal injury
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Retrospective BFR Cohort
Healthy active male participants who underwent a short-duration blood flow restriction (BFR) training protocol.
Pre- and post-training ultrasound images of the rectus abdominis muscle were retrospectively analyzed to assess inter-rater reliability of ultrasound-based muscle thickness measurements.
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Group 1
Healthy active male participants assessed before the BFR training program.
Baseline B-mode ultrasound images of the rectus abdominis muscle were obtained and used for measurement of muscle thickness.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Inter-rater reliability of ultrasound-based rectus abdominis muscle thickness measurement
Time Frame: Baseline (pre-training) and post-training ultrasound images obtained at the completion of the two-week BFR training protocol.
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Inter-rater reliability between two independent raters in measuring rectus abdominis muscle thickness from B-mode ultrasound images using ImageJ software.
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Baseline (pre-training) and post-training ultrasound images obtained at the completion of the two-week BFR training protocol.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Inter-rater reliability of ultrasound-based rectus abdominis muscle thickness measurement
Time Frame: Pre-training and immediately post-training.
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Rectus abdominis muscle thickness
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Pre-training and immediately post-training.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Saad Rauf, PhD, Riphah International University, Isra University, Islamabad
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- REC/MS-PT/02569
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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