NCT01244594

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2010

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

January 8, 2014

Status Verified

January 1, 2014

Enrollment Period

3.3 years

First QC Date

November 15, 2010

Last Update Submit

January 7, 2014

Conditions

Spinal Cord Injury

Keywords

Spinal Cord InjuryCyclingFunctional Electrical Stimulation

Outcome Measures

Primary Outcomes (4)

  • Bone density and bone microarchitecture

    Bone is measured using dexascan and Magnetic Resonance Imaging (MRI) to examine different types of bone (cortical and trabecular).

    Baseline

  • Bone density and bone microarchitecture

    Bone is measured using dexascan and Magnetic Resonance Imaging (MRI) to examine different types of bone (cortical and trabecular).

    6 months

  • Muscle volume

    Muscle volume is assessed using MRI

    Baseline

  • Muscle volume

    Muscle volume is assessed using MRI

    6 months

Secondary Outcomes (9)

  • Muscle strength

    Baseline

  • Muscle strength

    3 months

  • Muscle strength

    6 months

  • Bone markers

    baseline

  • Bone markers

    3 months

  • +4 more secondary outcomes

Study Arms (2)

High cadence, low resistance

EXPERIMENTAL

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

Low cadence, high resistance

EXPERIMENTAL

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

Interventions

Cycling with functional electrical stimulationOTHER

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).

High cadence, low resistanceLow cadence, high resistance

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Magee Rehabilitation Hospital

Philadelphia, Pennsylvania, 19102, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

  • Johnston TE, Marino RJ, Oleson CV, Schmidt-Read M, Leiby BE, Sendecki J, Singh H, Modlesky CM. Musculoskeletal Effects of 2 Functional Electrical Stimulation Cycling Paradigms Conducted at Different Cadences for People With Spinal Cord Injury: A Pilot Study. Arch Phys Med Rehabil. 2016 Sep;97(9):1413-1422. doi: 10.1016/j.apmr.2015.11.014. Epub 2015 Dec 17.

    PMID: 26705884DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Therese E Johnston, PT, PhD, MBA

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2010

First Posted

November 19, 2010

Study Start

July 1, 2010

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

January 8, 2014

Record last verified: 2014-01

Locations

US(3)