The Effects of Two Functional Electrical Stimulation Cycling Paradigms

This study has been completed.
Sponsor:
Collaborators:
The Craig H. Neilsen Foundation
Magee Rehabilitation Hospital
Temple University
University of Delaware
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01244594
First received: November 15, 2010
Last updated: January 7, 2014
Last verified: January 2014

November 15, 2010
January 7, 2014
July 2010
October 2013   (final data collection date for primary outcome measure)
  • Bone density and bone microarchitecture [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Bone is measured using dexascan and Magnetic Resonance Imaging (MRI) to examine different types of bone (cortical and trabecular).
  • Bone density and bone microarchitecture [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Bone is measured using dexascan and Magnetic Resonance Imaging (MRI) to examine different types of bone (cortical and trabecular).
  • Muscle volume [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Muscle volume is assessed using MRI
  • Muscle volume [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Muscle volume is assessed using MRI
Same as current
Complete list of historical versions of study NCT01244594 on ClinicalTrials.gov Archive Site
  • Muscle strength [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Muscle strength is assessed by stimulating the muscle using a max twitch technique and measuring the isometric force output on a dynamometer.
  • Muscle strength [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Muscle strength is assessed by stimulating the muscle using a max twitch technique and measuring the isometric force output on a dynamometer.
  • Muscle strength [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Muscle strength is assessed by stimulating the muscle using a max twitch technique and measuring the isometric force output on a dynamometer.
  • Bone markers [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Bone markers are assessed through blood and urine analysis.
  • Bone markers [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Bone markers are assessed through blood and urine analysis.
  • Bone markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Bone markers are assessed through blood and urine analysis.
  • Fat free soft tissue [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Fat free mass is assessed using a bioimpedance monitor.
  • Fat free soft tissue [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Fat free mass is assessed using a bioimpedance monitor.
  • Fat free soft tissue [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Fat free mass is assessed using a bioimpedance monitor.
Same as current
Not Provided
Not Provided
 
The Effects of Two Functional Electrical Stimulation Cycling Paradigms
The Effects of Two Functional Electrical Stimulation Cycling Paradigms

Background:

People with spinal cord injury (SCI) are at risk for many health conditions, some of which can be decreased with exercise. Cycling with Functional Electrical Stimulation (FES) is one way to obtain exercise after SCI. However, cycling with FES has only been done one way, which involves pedaling more quickly with less force to work against. Pedaling more slowly would allow the person to work against more force, which may lead to greater improvements in bone mineral density and muscle size. It may also lead to greater changes in bone make-up, body fat, and cholesterol levels. All of these improvements may lead to a decrease in bone fractures and cardiovascular disease, two major medical issues that exist in the SCI population. Study Aims: This study will compare the outcomes on bone, muscle and cardiovascular health between the commonly used method of pedaling more quickly to a new method of pedaling more slowly. Both groups will work against the maximal force possible. It is expected that the group pedaling more slowly will work against greater force and thus will have improved outcomes compared to other group pedaling faster. Methods: Twenty people with SCI, ages 18-65 years, will be randomly assigned to a treatment group and will participate in three 60-minute sessions per week for 6 months at an outpatient rehabilitation center. All subjects must have complete paralysis of both legs, but may have sensation preserved. Before and after 6 months of exercise, subjects will have an MRI scan to assess muscle size and bone, a dexascan to assess bone, a strength test using electrical stimulation to assess muscle force, an analysis of fat free body tissue, and lab work to measure cholesterol, bone factors that provide insight into bone change, and nutritional status. Relevance: If the protocol of pedaling more slowly results in greater improvements, this technique can be applied to clinical practice. Some people with SCI have FES cycles in their homes and many have been cycling for many years. This new technique may allow them to obtain more benefits than what they currently are receiving from FES cycling. In addition, it is important to maintain overall bone, muscle and cardiovascular health so that people with SCI are health and ready when spinal cord regeneration becomes clinically available.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Spinal Cord Injury
Other: Cycling with functional electrical stimulation
Subjects will cycle with functional electrical stimulation for one hour, 3 times per week at Magee Rehab's outpatient center. Subjects will cycle for a total of 26 weeks (6 months).
  • Experimental: High cadence, low resistance
    Subjects in this arm will cycle with functional electrical stimulation at a higher cadence (speed) and a lower resistance.
    Intervention: Other: Cycling with functional electrical stimulation
  • Experimental: Low cadence, high resistance
    Subjects in this arm will cycle with functional electrical stimulation at a lower cadence (speed) and a higher resistance.
    Intervention: Other: Cycling with functional electrical stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Cervical or thoracic SCI of greater than 6 months duration
  • American Spinal Injury Association Impairment Scale (AIS) levels A (motor and sensory complete) or B (motor complete)
  • Intact lower motor neurons to the quadriceps, hamstrings, and gluteal muscles

Exclusion Criteria:

  • History of renal or bladder stones or renal impairment
  • Presence of conditions that require chronic steroids
  • Symptomatic or known cardiac disease
  • Pulmonary disease limiting exercise tolerance
  • Ventilator dependency
  • Implanted devices that may be adversely affected by the FES system
  • Lower extremity fragility fractures in the previous 3 months
  • Severe spasticity in legs
  • Presence of a Grade 2 or higher pressure ulcer
  • Severely limited range of joint motion
  • Heterotopic ossification of joints in the lower extremities
  • Uncontrolled autonomic dysreflexia
  • Dislocation of one or both hips
  • Pregnancy or plans to become pregnant during the study
  • Post menopausal, if female
  • Current seizure disorder
  • Participation in activities involving electrical stimulation or activity based therapy within the past 3 months
  • Participation in a neuroregenerative intervention within the past 12 months
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01244594
164600
No
Thomas Jefferson University
Thomas Jefferson University
  • The Craig H. Neilsen Foundation
  • Magee Rehabilitation Hospital
  • Temple University
  • University of Delaware
Principal Investigator: Therese E Johnston, PT, PhD, MBA Thomas Jefferson University
Thomas Jefferson University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP