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

Effects of 6 Weeks High-intensity Interval Training on Muscle Strength and Cardiorespiratory Response Among Spinal Cord Injury

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.

Study Overview

• Status: Completed
• Conditions: INCOMPLETE SPINAL CORD INJURY (ASIA D)
• Intervention / Treatment: Other: Functional Electrical Stimulation Leg Cycling Exercise

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4 MIN X 4 MIN HIIT of FES-LCE; 4 min of high-intensity phase intersperses with 4 min of low-intensity phase for a total of 5 bouts.	Other: Functional Electrical Stimulation Leg Cycling Exercise; FES- leg cycling for 45 minutes (3 min warm up + 40 min HIIT + 2 min cooldown). The FES will be applied via surface electrodes and the stimulation intensity based on your tolerance level.
Experimental: 2 MIN X 2 MIN HIIT of FES-LCE; 2 min of high-intensity phase intersperses with 2 min of low-intensity phase for a total of 10 bouts.	Other: Functional Electrical Stimulation Leg Cycling Exercise; FES- leg cycling for 45 minutes (3 min warm up + 40 min HIIT + 2 min cooldown). The FES will be applied via surface electrodes and the stimulation intensity based on your tolerance level.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of peak torque of Quadriceps and Hamstring	Isometric peak torque for quadriceps and hamstring will be measured using Biodex isokinetic machine.	Changes of peak torque at 6 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of peak VO2	Peak VO2 will be measured using Cosmed Quark CPET system apparatus	Changes of peak VO2 at 6 week

Collaborators and Investigators

• Sponsor: Universiti Teknologi Mara
• Collaborators: University of Malaya

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2019
• Primary Completion (Actual): September 5, 2019
• Study Completion (Actual): September 5, 2019

Study Registration Dates

• First Submitted: February 7, 2019
• First Submitted That Met QC Criteria: February 8, 2019
• First Posted (Actual): February 12, 2019

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 5, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: HIGH INTENSITY INTERVAL TRAINING; INCOMPLETE SPINAL CORD INJURY; MUSCLE STRENGTH; CARDIO-RESPIRATORY FITNESS
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 201682-4100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No