Acute Tendon and Nerve Responses to Exercise

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark S. Nash, Ph.D., FACSM, University of Miami
ClinicalTrials.gov Identifier:
NCT01197599
First received: August 18, 2010
Last updated: July 21, 2014
Last verified: July 2014
  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 spinal cord injury and able-bodied controls.


Condition
Spinal Cord Injury

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Acute Tendon and Nerve Responses to Exercise

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Nerve cross-sectional area [ Time Frame: 1 day (Visit 1) ] [ Designated as safety issue: No ]
    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).


Enrollment: 50
Study Start Date: December 2008
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Spinal Cord Injury
Able-Bodied Control

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01197599

Locations
United States, Florida
The Miami Project to Cure Paralysis
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Mark S Nash, PhD University of Miami, The Miami Project to Cure Paralysis
  More Information

Additional Information:
No publications provided

Responsible Party: Mark S. Nash, Ph.D., FACSM, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01197599     History of Changes
Other Study ID Numbers: TMP-MN-003
Study First Received: August 18, 2010
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Healthy Control

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 28, 2014