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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03837834
Recruitment Status : Completed
First Posted : February 12, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
University of Malaya
Information provided by (Responsible Party):
MOHD KHAIRUL AZHAR BIN ARIFFIN, Universiti Teknologi Mara

Study Description
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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.

Condition or disease Intervention/treatment Phase
INCOMPLETE SPINAL CORD INJURY (ASIA D) Other: Functional Electrical Stimulation Leg Cycling Exercise Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of 6 Weeks High-intensity Interval Training on Muscle Strength and Cardiorespiratory Response Among Spinal Cord Injury
Actual Study Start Date : February 15, 2019
Actual Primary Completion Date : September 5, 2019
Actual Study Completion Date : September 5, 2019

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837834


Locations
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Malaysia
University Malaya Medical Center
Kuala Lumpur, Malaysia, 59100
Sponsors and Collaborators
Universiti Teknologi Mara
University of Malaya
More Information
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Responsible Party: MOHD KHAIRUL AZHAR BIN ARIFFIN, Principal Investigator, Universiti Teknologi Mara
ClinicalTrials.gov Identifier: NCT03837834    
Other Study ID Numbers: 201682-4100
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MOHD KHAIRUL AZHAR BIN ARIFFIN, Universiti Teknologi Mara:
HIGH INTENSITY INTERVAL TRAINING
INCOMPLETE SPINAL CORD INJURY
MUSCLE STRENGTH
CARDIO-RESPIRATORY FITNESS
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System