Palliative Strategies in Spinal Cord Injury (SCI) - Study Results

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Spinal Cord Injury
Intervention:	Device: Motorized bicycle exercise training

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients recruited from my outpatient and inpatient clinical service who had a spinal cord injury starting on 4/1/2003 and ending on 3/9/2010

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were excluded from the study if we were unable to obtain an H-reflex on nerve conduction study due to this being the primary endpoint we were assessing.

Reporting Groups

	Description
Passive Exercise With Motorized Bicycle	The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise.

Description

Passive Exercise With Motorized Bicycle

The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise.

Participant Flow: Overall Study

	Passive Exercise With Motorized Bicycle
STARTED	17
COMPLETED	12
NOT COMPLETED	5
Physician Decision	5

Baseline Characteristics

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Reporting Groups

	Description
Passive Exercise With Motorized Bicycle	The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise.

Description

Passive Exercise With Motorized Bicycle

The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise.

Baseline Measures

	Passive Exercise With Motorized Bicycle
Number of Participants [units: participants]	17
Age [units: participants]
<=18 years	0
Between 18 and 65 years	17
>=65 years	0
Age [units: years] Mean ± Standard Deviation	35.38 ± 14.4314
Gender [units: participants]
Female	4
Male	13
Region of Enrollment [units: participants]
United States	17

Outcome Measures

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1. Primary:

Muscle Mass Via Dual-Energy X-ray Absortiometry (DEXA)Scan Data [ Time Frame: baseline and 3 months ]

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2. Secondary:

Bone Density Via Dual-Energy X-ray Absortiometry (DEXA) Scan [ Time Frame: baseline and 3 months Post-exercise ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This was a pilot study to determine if a passive exercise bicycle would suppress the H-reflex after a spinal cord injury. We were not able to collect stable H-reflex data. However, the Dual-Energy X-ray Absortiometry (DEXA) scan data was useable.

Results Point of Contact:

Name/Title: Thomas S. Kiser
Organization: Dept of PM&R; University of Arkansas for Medical Sciences
phone: 501-221-1311
e-mail: kiserthomass@uams.edu

No publications provided

Responsible Party:	Edgar Garcia-Rill, Director, Center for Translational Neuroscience
ClinicalTrials.gov Identifier:	NCT00594178 History of Changes
Other Study ID Numbers:	24179, PRN # 12903 NIH
Study First Received:	January 3, 2008
Results First Received:	October 1, 2010
Last Updated:	December 13, 2010
Health Authority:	United States: NIH; United States: Institutional Review Board