NCT03539211

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

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

Study Start

First participant enrolled

February 25, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 29, 2018

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

September 7, 2020

Completed
Last Updated

September 7, 2020

Status Verified

September 1, 2020

Enrollment Period

1.5 years

First QC Date

May 16, 2018

Results QC Date

August 3, 2020

Last Update Submit

September 3, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in Muscle Thickness

    Musculoskeletal ultrasound measured changes in muscle thickness

    Baseline and 10 minutes post intervention

Secondary Outcomes (1)

  • Changes in Clinical Muscle Assessment Using the Novel Sling Screen

    Baseline and 10 minutes post intervention

Study Arms (2)

Rotation Exercises

EXPERIMENTAL

8 minute program of rotation based exercises

Other: Rotation Exercises

Control Exercises

ACTIVE COMPARATOR

8 minute program of traditional exercises

Other: Control Exercises

Interventions

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

Also known as: Sling Activation Session
Rotation Exercises

The subjects received 7 traditional exercises x 10 reps each

Also known as: Traditional
Control Exercises

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Delaware

Newark, Delaware, 19702, United States

Location

Results Point of Contact

Title
Brian Catania
Organization
ChristianaCare

Study Officials

  • Andrea DiTrani, PhD, ATC

    Neumann University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapy Program Manager

Study Record Dates

First Submitted

May 16, 2018

First Posted

May 29, 2018

Study Start

February 25, 2015

Primary Completion

August 25, 2016

Study Completion

August 25, 2016

Last Updated

September 7, 2020

Results First Posted

September 7, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations