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

NCT03837834 | Completed

• 1 other identifier: 201682-4100
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

INCOMPLETE SPINAL CORD INJURY (ASIA D)

Keywords

HIGH INTENSITY INTERVAL TRAINING; INCOMPLETE SPINAL CORD INJURY; MUSCLE STRENGTH; CARDIO-RESPIRATORY FITNESS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes of peak VO2

  Changes of peak VO2 at 6 week

Study Arms (2)

4 MIN X 4 MIN HIIT of FES-LCE

EXPERIMENTAL

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

2 MIN X 2 MIN HIIT of FES-LCE

EXPERIMENTAL

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

Interventions

Functional Electrical Stimulation Leg Cycling Exercise OTHER

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.

2 MIN X 2 MIN HIIT of FES-LCE; 4 MIN X 4 MIN HIIT of FES-LCE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Teknologi Mara: lead
• University of Malaya: collaborator

Study Sites (1)

University Malaya Medical Center

Kuala Lumpur, 59100, Malaysia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 12, 2019
• Study Start: February 15, 2019
• Primary Completion: September 5, 2019
• Study Completion: September 5, 2019
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)