Functional Electrical Stimulation With Rowing as Exercise After Spinal Cord Injury

Spinal Cord Injury Clinical Trial

— FES  

Official title:

Development of a Spinal Cord Injury-specific Exercise-based Capacity

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02602639
• Other study ID #: H2014:174
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 2015
• Est. completion date: September 2022

Study information

• Verified date: June 2020
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Currently, those with spinal cord injury (SCI) demonstrate increased prevalence of obesity (75%) cardiovascular disease (30 - 50%), type II diabetes (21%) and osteoporosis in the legs (100%) when compared to the general population. It is important to identify the modes and intensities of exercise most likely to generate a reduction in these inactivity-related diseases in this population.

Therefore, the main purpose of this pilot research project is to implement and test a form of a spinal cord injury-specific exercise, known as FES rowing (FES: functional electrical stimulation).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 6
• Est. completion date: September 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Have a spinal cord injury, C5-T12 (level), AIS A-D (severity)

• Be aged 18-75 for duration of study

• Medically stable and healthy enough to complete exercise requirements

• Willing and able to complete the at-home training requirements as prescribed

• Willing and able to complete the exercise sessions as prescribed

• Willing and able to complete the VO2 testing throughout the study

• Willing and able to complete the DEXA (Dual-energy X-ray absorptiometry) scans during the study

• Able to understand and follow written or verbal instructions from study staff

Exclusion Criteria:

• Current pressure ulcer(s) at sites of electrical stimulation

• Previous spontaneous or low-impact leg fracture

• Previous diagnosis of cardiovascular disease (ie enlarged heart, heart murmur)

• Unsatisfactory results of EKG (electrocardiogram) screening test

• Known thyroid dysfunction

• Kidney disease

• Cancer

• Blood pressure > 140/90 mmHg

• Currently taking blood pressure medication

• History of epilepsy

• Current hand, arm or shoulder injury

• Current deep vein thrombosis

• Implanted electronic cardiac device (pace maker, defibrillator, etc)

• Ventilator-dependent

• Unable to follow written and verbal instructions

Related Conditions & MeSH terms

• Paraplegia
• Quadriplegia
• Spinal Cord Injuries
• Spinal Cord Injury
• Tetraplegia
• Wounds and Injuries

Intervention

Device:
• Functional electrical stimulation rowing (Odstock 4 channel neuromuscular stimulator with Concept 2 Rower)
Participants will strengthen their quadriceps and hamstrings using electrical stimulation for up to 12 weeks (using an Odstock 4 channel neuromuscular stimulator). Then participants will use a seated rower (Concept 2 Rower, fitted with a backrest that allows those with spinal cord injury to engage in rowing) in conjunction with the electrical stimulation for 12-24 weeks.

Locations

Country	Name	City	State
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak VO2 (volume oxygen) output during exercise	Peak VO2 testing will be performed before beginning rower training and again at the end of the 24 weeks of training. Testing will be performed with an arm ergometer, rowing without electrical stimulation, and rowing with electrical stimulation. This will assess energy use, time to fatigue, and perceived exertion.	24 weeks compared to baseline
Secondary	Body composition	Participants will have their body composition (specifically leg percent fat and muscle, and bone mineral density) measured before beginning training and at the end of the 24 weeks of training.	24 weeks compared to baseline
Secondary	Leg EMG (electromyogram) while rowing	Participants will perform the rowing exercise while having EMG of multiple leg muscles.	Throughout study (up to 36 weeks)