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Completed

NCT Number: NCT03837834

Effects of 6 Weeks High-intensity Interval Training 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.

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Key information

Conditions

INCOMPLETE SPINAL CORD INJURY (ASIA D)

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Malaya Medical Center

Kuala Lumpur, 59100, Malaysia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Changes of peak torque of Quadriceps and Hamstring

    Time frame: Changes of peak torque at 6 week

    Isometric peak torque for quadriceps and hamstring will be measured using Biodex isokinetic machine.

Secondary outcomes

  1. Changes of peak VO2

    Time frame: Changes of peak VO2 at 6 week

    Peak VO2 will be measured using Cosmed Quark CPET system apparatus

Sponsors and collaborators

Lead sponsor

Universiti Teknologi Mara

Other

Collaborators

  • University of Malaya

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 12, 2019
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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