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ARC: Assessment of Muscle Function and Size in Older Adults With Rotator Cuff Tear

Sponsor
Wake Forest University (Other)
Overall Status
Completed
CT.gov ID
NCT01459536
Collaborator
(none)
25
Enrollment
1
Location
27
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Adequate upper limb function is critically important to maintenance of independence and prevention of disability in older adults. The goal of this work is to identify factors that contribute to rotator cuff rupture and improved outcomes for repair. Ultimately, the investigators seek to identify patients most at risk for rupture and to guide clinicians on optimal surgical and rehabilitation strategies. This pilot study will quantitatively characterize the morphological (muscle volume and fatty infiltration) and functional (shoulder isometric joint strength, movement when performing typical task) changes in the muscles of the rotator cuff following supraspinatus tear and surgical repair. The investigators hypothesize that patients with supraspinatus tear will have reduced muscle volume and increased fatty infiltration of rotator cuff muscles compared to their contralateral arm and age-matched controls, which will increase following surgery. The investigators further hypothesize that isometric joint strength in these individuals will be associated with muscle volume and the degree of fatty infiltration, and that older adults with a rotator cuff tear will use a restricted range of motion to accomplish functional tasks. This study emphasizes muscle function and composition with application to rehabilitation of upper limb function, which complements the theme of the Pepper Center.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    25 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Rotator Cuff Function and Muscle Morphology in Older Adults With Rotator Cuff Tear
    Study Start Date :
    Sep 1, 2011
    Actual Primary Completion Date :
    Dec 1, 2013
    Actual Study Completion Date :
    Dec 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Rotator Cuff Tear-surgical
    Health Older Adult Control
    Rotator cuff tear - non surgical

    Outcome Measures

    Primary Outcome Measures

    1. Shoulder strength [baseline]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • adults ≥ 60 years of age

    • free of any medical condition that might be exacerbated by physical testing

    • patients: major thickness supraspinatus tear

    • control subjects: no history of significant injury or pathology in either upper limb

    Exclusion Criteria:

    • contraindication to undergoing MRI

    • history of neuromuscular disorder, or any injury that may affect the upper limb (e.g. any history of stroke, Parkinson's, or spinal cord injury, or being confined to a wheelchair)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157

    Sponsors and Collaborators

    • Wake Forest University

    Investigators

    • Principal Investigator: Katherine Saul, PhD, Wake Forest University Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University
    ClinicalTrials.gov Identifier:
    NCT01459536
    Other Study ID Numbers:
    • 14547
    First Posted:
    Oct 25, 2011
    Last Update Posted:
    Nov 7, 2017
    Last Verified:
    Mar 1, 2017
    Keywords provided by Wake Forest University
    Aging
    Additional relevant MeSH terms:
    Rotator Cuff Injuries

    Study Results

    No Results Posted as of Nov 7, 2017