Abdominal MusclesNCT03539211
Clinical Assessment and Thickness Changes of the Oblique and Multifidus Muscles
A study testing Rotation Exercises in people with Abdominal Muscles, run by Christiana Care Health Services at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Muscles
- What is being tested?
- Rotation Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2015to 25 Aug 2016
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ° Undergraduate and graduate subjects from the University of the Delaware student community.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Assessment and Thickness Changes of the Oblique and Multifidus Muscles Using a Novel Screening Tool and Exercise Program: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Abdominal Muscles
- Being tested
- Rotation Exercises, Control Exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotation ExercisesOther
Also called Sling Activation Session
The subjects received 7 trunk rotation stability exercises x 10 reps each
Control ExercisesOther
Also called Traditional
The subjects received 7 traditional exercises x 10 reps each
| Study group | Role | What they receive |
|---|---|---|
| Rotation Exercises | Experimental | 8 minute program of rotation based exercises Receives: Other: Rotation Exercises |
| Control Exercises | Active comparator | 8 minute program of traditional exercises Receives: Other: Control Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Muscle Thickness
Musculoskeletal ultrasound measured changes in muscle thickness
Measured: Baseline and 10 minutes post intervention
Secondary outcomes (1)
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.
Measured: Baseline and 10 minutes post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start25 Feb 2015
- Primary completion25 Aug 2016
- Study completion25 Aug 2016
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 Abdominal MusclesStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Catania, Christiana Care Health Services
- Investigators
- Andrea DiTrani, PhD, ATC, Study director, Neumann University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539211
- Sponsor's protocol ID
- DDD# 602910
- Status last verified
- Sep 2020
- First submitted
- 16 May 2018
- Last updated
- 7 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment and Thickness Changes of the Oblique and Multifidus Muscles Using a Novel Screening Tool and Exercise Program: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03539211
- Acronym / sponsor ID
- DDD# 602910
- Conditions
- Abdominal Muscles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- 25 Feb 2015 (actual)
- Primary completion
- 25 Aug 2016 (actual)
- Study completion
- 25 Aug 2016 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Posted 7 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotation Exercises | Experimental | Other: Rotation Exercises8 minute program of rotation based exercises |
| Control Exercises | Active comparator | Other: Control Exercises8 minute program of traditional exercises |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ° Undergraduate and graduate subjects from the University of the Delaware student community.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Rotation ExercisesAlso: Sling Activation SessionThe subjects received 7 trunk rotation stability exercises x 10 reps each | Other | Rotation Exercises |
| Control ExercisesAlso: TraditionalThe subjects received 7 traditional exercises x 10 reps each | Other | Control Exercises |
Primary outcome
Changes in Muscle Thickness
Time frame: Baseline and 10 minutes post intervention
Musculoskeletal ultrasound measured changes in muscle thickness
1 secondary outcome
Changes in Clinical Muscle Assessment Using the Novel Sling Screen
Time frame: Baseline and 10 minutes post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Abdominal Muscles
Enrolling by invitationObservational study
WSACS 2026 Delphi Consensus on the Practical Management of Intra-abdominal Hypertension and Abdominal Compartment Syndrome
Intra-Abdominal Hypertension, Abdominal Compartment Syndrome
Recruiting
Impact of rTMS on Abnormal Cortical fMRI in Patients With Dystonia
Dystonia Disorder
Not yet recruiting
Abdominal Air-Pressure Resistance Versus Abdominal Weight Training for Improving Diaphragm Function in Healthy Young Adults
Diaphragm Thickness, Dyspnoea
Not yet recruitingObservational study
From Blast Injury to Multicompartment Dysfunction:
Compartment Syndrome, Compartment Syndrome Nontraumatic Lower Extremity
Not yet recruitingObservational study
Intra-Abdominal Pressure, Respiratory Mechanics, and Ventilator Liberation After Emergency Major Laparotomy
Intra-Abdominal Hypertension, Respiratory Mechanics
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.
Andrea DiTrani, PhD, ATC study director
Neumann University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rotation Exercises in people with Abdominal Muscles, run by Christiana Care Health Services at 1 site in United States.
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 1 inclusion and 3 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 7 Sep 2020. 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 United States. 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. 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 7 Sep 2020). 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?
Changes in Muscle Thickness (time frame: Baseline and 10 minutes post intervention). 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 7 Sep 2020.