Acute Tendon and Nerve Responses to Exercise

July 21, 2014 updated by: Mark S. Nash, Ph.D., FACSM, University of Miami
The purpose of this study is to use ultrasound to analyze the effects of a bout of circuit training on the upper extremity of persons with spinal cord injury and able-bodied controls.

Study Overview

Status

Completed

Conditions

Detailed Description

Background: Manual wheelchair propulsion is a primary source of mobility for many individuals with spinal cord injury (SCI). Propelling a manual wheelchair over an extended period often leads to arm pain and, subsequently, to secondary disability. Over 50% of manual wheelchair users with SCI experience arm pain that limits their activities of daily living. The prevalence of shoulder pain and carpal tunnel syndrome among manual wheelchair users is between 31% and 73%, and 49% and 73% respectively. A circuit training protocol has been developed to strengthen and protect the muscles of people with SCI, and has been shown to improve muscle strength and endurance, and reduce HDLcholesterol levels.

Purpose: The purpose of this study is to use ultrasound to analyze the effects of a bout of circuit training on the upper extremity of persons with SCI and able-bodied controls.

Hypotheses: All subjects will show an increase in nerve cross-sectional area after participation in the circuit training protocol. Nerves and tendons will become less echogenic after participation in the circuit training protocol. These changes will be more pronounced in persons with SCI.

Methods: Data collected will include history of pain, a physical exam, and ultrasound images of the nondominant upper extremity before and after a bout of circuit training, which includes exercises lifting weights and using an arm cycle. Before circuit training, ultrasound images will be collected once. After the circuit training, ultrasound images will be collected every 10 minutes over an hour. These images and will be used to measure the health and properties (such as size) of nerves, muscles, and tendons in the arm. Changes in these properties after a bout of circuit training will be related to history and physical exam information.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • The Miami Project to Cure Paralysis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community sample of persons with spinal cord injury or healthy volunteers.

Description

Inclusion Criteria:

Spinal Cord Injury Cohort:

  • any cause or severity of spinal cord injury
  • at least 1 year post-injury

Able-Bodied Control Cohort:

  • self-reported good health

Exclusion Criteria:

  • history of non-dominant traumatic upper extremity injury to both wrist and shoulder
  • history of cardiopulmonary or other disease for which intense activity carries any risk of harm
  • a progressive or degenerative disability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Spinal Cord Injury
Able-Bodied Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nerve cross-sectional area
Time Frame: 1 day (Visit 1)
Nerve cross-sectional area will be measured via ultrasound. Images will be collected at least once (pre-activity) and up to every 10 minutes over an hour (post-activity).
1 day (Visit 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

August 18, 2010

First Submitted That Met QC Criteria

September 8, 2010

First Posted (Estimate)

September 9, 2010

Study Record Updates

Last Update Posted (Estimate)

July 22, 2014

Last Update Submitted That Met QC Criteria

July 21, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMP-MN-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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