Acute Tendon and Nerve Responses to Exercise

Spinal Cord Injury Clinical Trial

Official title:

Acute Tendon and Nerve Responses to Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197599
• Other study ID #: TMP-MN-003
• Status: Completed
• Phase: N/A
• First received: August 18, 2010
• Last updated: July 21, 2014
• Start date: December 2008
• Est. completion date: February 2012

Study information

• Verified date: July 2014
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Locations

Country	Name	City	State
United States	The Miami Project to Cure Paralysis	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nerve cross-sectional area	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)	No

External Links

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