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Clinical Assessment and Thickness Changes of the Oblique and Multifidus Muscles

Clinical Assessment and Thickness Changes of the Oblique and Multifidus Muscles Using a Novel Screening Tool and Exercise Program: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03539211
Enrollment
31
Registered
2018-05-29
Start date
2015-02-25
Completion date
2016-08-25
Last updated
2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Muscles

Brief summary

This study evaluates the effect of a rotation based exercise program on core muscle thickness. Additionally, a second aim is to demonstrate the ability of a clinical assessment tool to identify muscle thickness changes. Half of participants receive the rotation based exercises, while the other half perform a traditional core exercise program. It was hypothesized that the rotation based exercises would result in greater changes in muscle thickness.

Detailed description

A number of exercise programs and assessment tools have been evaluated for their ability to influence and measure the core muscles. Inefficient stability and asymmetrical muscle activity of the core have been linked to a wide range of lower extremity injuries. Training of the abdominal muscles to obtain symmetrical recruitment for optimal trunk stabilization is a widespread clinical practice, however valid and reliable assessment tools and effective intervention protocols are lacking. This study uniquely uses both a clinical assessment tool and musculoskeletal ultrasound to measure changes in the core muscles following an exercise intervention. The overall purpose of this study was to design a valid and reliable assessment tool and an effective training protocol to activate the core muscles.

Interventions

OTHERRotation Exercises

The subjects received 7 trunk rotation stability exercises x 10 reps each

The subjects received 7 traditional exercises x 10 reps each

Sponsors

Christiana Care Health Services
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

° Undergraduate and graduate subjects from the University of the Delaware student community.

Exclusion criteria

* You could be excluded if you have recently undergone surgery in the last 6 months. * Currently suffering from low back pain. * Or have a history of a neurological condition.

Design outcomes

Primary

MeasureTime frameDescription
Changes in Muscle ThicknessBaseline and 10 minutes post interventionMusculoskeletal ultrasound measured changes in muscle thickness

Secondary

MeasureTime frameDescription
Changes in Clinical Muscle Assessment Using the Novel Sling ScreenBaseline and 10 minutes post interventionClinician based assessment of muscle function using the sling screen tool; Kappa coefficients were calculated to examine agreement between the 2 physical therapists that completed the sling screen assessments and to account for chance effects in scoring. A rating system was used for scoring performance. Min value on the scale is 2 and max value = 5; higher score is a better outcome.

Countries

United States

Participant flow

Participants by arm

ArmCount
Rotation Exercises
8 minute program of rotation based exercises Rotation Exercises: The subjects received 7 trunk rotation stability exercises x 10 reps each
16
Control Exercises
8 minute program of traditional exercises Control Exercises: The subjects received 7 traditional exercises x 10 reps each
15
Total31

Baseline characteristics

CharacteristicControl ExercisesTotalRotation Exercises
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
15 Participants31 Participants16 Participants
Age, Continuous20.7 years
STANDARD_DEVIATION 1.5
20.8 years
STANDARD_DEVIATION 1.7
21 years
STANDARD_DEVIATION 1.5
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
15 participants31 participants16 participants
Sex: Female, Male
Female
10 Participants21 Participants11 Participants
Sex: Female, Male
Male
5 Participants10 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 160 / 15
serious
Total, serious adverse events
0 / 160 / 15

Outcome results

Primary

Changes in Muscle Thickness

Musculoskeletal ultrasound measured changes in muscle thickness

Time frame: Baseline and 10 minutes post intervention

Population: External Oblique

ArmMeasureValue (MEAN)
Rotation ExercisesChanges in Muscle Thickness.820 centimeters
Control ExercisesChanges in Muscle Thickness.671 centimeters
Secondary

Changes in Clinical Muscle Assessment Using the Novel Sling Screen

Clinician based assessment of muscle function using the sling screen tool; Kappa coefficients were calculated to examine agreement between the 2 physical therapists that completed the sling screen assessments and to account for chance effects in scoring. A rating system was used for scoring performance. Min value on the scale is 2 and max value = 5; higher score is a better outcome.

Time frame: Baseline and 10 minutes post intervention

Population: Anterior Sling

ArmMeasureValue (MEAN)Dispersion
Rotation ExercisesChanges in Clinical Muscle Assessment Using the Novel Sling Screen-2.02 score on a scaleStandard Deviation 0.04
Control ExercisesChanges in Clinical Muscle Assessment Using the Novel Sling Screen-1.82 score on a scaleStandard Deviation 0.07

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026