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
  Purpose

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.


Condition Intervention Phase
Spinal Cord Injury
Other: Cycling with functional electrical stimulation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Two Functional Electrical Stimulation Cycling Paradigms

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 17
Study Start Date: July 2010
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High cadence, low resistance
Subjects in this arm will cycle with functional electrical stimulation at a higher cadence (speed) and a lower resistance.
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: Low cadence, high resistance
Subjects in this arm will cycle with functional electrical stimulation at a lower cadence (speed) and a higher resistance.
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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01244594

Locations
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Magee Rehabilitation Hospital
Philadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Thomas Jefferson University
The Craig H. Neilsen Foundation
Magee Rehabilitation Hospital
Temple University
University of Delaware
Investigators
Principal Investigator: Therese E Johnston, PT, PhD, MBA Thomas Jefferson University
  More Information

No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01244594     History of Changes
Other Study ID Numbers: 164600
Study First Received: November 15, 2010
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
Spinal Cord Injury
Cycling
Functional Electrical Stimulation

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

ClinicalTrials.gov processed this record on September 22, 2014