Effects of 6 Weeks High-intensity Interval Training Among Spinal Cord Injury

Not Applicable

Completed

• Conditions: INCOMPLETE SPINAL CORD INJURY (ASIA D)
• Interventions: Other: Functional Electrical Stimulation Leg Cycling Exercise

• Registration Number: NCT03837834
• Lead Sponsor: Universiti Teknologi Mara

Brief Summary

The training consists of 6 weeks of functional electrical stimulation leg cycling exercise (FES-LCE) program. The training program comprises of 2 visits per week. Each visit consists of FES-LCE for 45 minutes. Throughout the 6 weeks program, there will be testing/assessment sessions on week 1, week 3 and week 6. The FES will be applied via surface electrodes and the stimulation intensity based on the participant's tolerance level.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-07
• Study First Submitted QC: 2019-02-08
• Study First Posted: 2019-02-12
• Study Start: 2019-02-15
• Status Verified: 2019-09
• Primary Completion: 2019-09-05
• Study Completion: 2019-09-05
• Last Update Submitted: 2019-09-05
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Participants were diagnosed with incomplete spinal cord injury (SCI) at least one year prior to participation.
• Age between 18-75 years old.
• Both male and female.
• Have at least 90º bilateral knee flexion.
• Moderate neurological induce weakness in quadriceps muscle of 1 leg that is responsive to electrical stimulation (moderate weakness was defined as 3/5 or 4/5 on manual muscle testing).
• Able to perform cycling activity.
• Normal upper limb function.
• Able to follow command.

Exclusion Criteria

• Had a recent history of trauma to the lower limb.
• Severely infected skin pressure sore on weight-bearing skin areas.
• Illness caused by acute urinary tract infection.
• Uncontrolled spasticity or pain.
• History of cardiovascular/cardiorespiratory problem.
• Orthostatic hypotension.
• Unhealed decubiti at electrode placement area.
• Recurrent autonomic dysreflexia.
• Active heterotopic ossification.
• Other peripheral or central neurologic injury.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
4 MIN X 4 MIN HIIT of FES-LCE	Functional Electrical Stimulation Leg Cycling Exercise	4 min of high-intensity phase intersperses with 4 min of low-intensity phase for a total of 5 bouts.
2 MIN X 2 MIN HIIT of FES-LCE	Functional Electrical Stimulation Leg Cycling Exercise	2 min of high-intensity phase intersperses with 2 min of low-intensity phase for a total of 10 bouts.

Primary Outcome Measures

Name	Time	Method
Changes of peak torque of Quadriceps and Hamstring	Changes of peak torque at 6 week	Isometric peak torque for quadriceps and hamstring will be measured using Biodex isokinetic machine.

Secondary Outcome Measures

Name	Time	Method
Changes of peak VO2	Changes of peak VO2 at 6 week	Peak VO2 will be measured using Cosmed Quark CPET system apparatus

Trial Locations

Locations (1)

University Malaya Medical Center; 🇲🇾 Kuala Lumpur, Malaysia