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

Primary Purpose

INCOMPLETE SPINAL CORD INJURY (ASIA D)

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Functional Electrical Stimulation Leg Cycling Exercise
Sponsored by
Universiti Teknologi Mara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for INCOMPLETE SPINAL CORD INJURY (ASIA D) focused on measuring HIGH INTENSITY INTERVAL TRAINING, INCOMPLETE SPINAL CORD INJURY, MUSCLE STRENGTH, CARDIO-RESPIRATORY FITNESS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Malaya Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

4 MIN X 4 MIN HIIT of FES-LCE

2 MIN X 2 MIN HIIT of FES-LCE

Arm Description

4 min of high-intensity phase intersperses with 4 min of low-intensity phase for a total of 5 bouts.

2 min of high-intensity phase intersperses with 2 min of low-intensity phase for a total of 10 bouts.

Outcomes

Primary Outcome Measures

Changes of peak torque of Quadriceps and Hamstring
Isometric peak torque for quadriceps and hamstring will be measured using Biodex isokinetic machine.

Secondary Outcome Measures

Changes of peak VO2
Peak VO2 will be measured using Cosmed Quark CPET system apparatus

Full Information

First Posted
February 7, 2019
Last Updated
September 5, 2019
Sponsor
Universiti Teknologi Mara
Collaborators
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT03837834
Brief Title
Effects of 6 Weeks High-intensity Interval Training Among Spinal Cord Injury
Official Title
Effects of 6 Weeks High-intensity Interval Training on Muscle Strength and Cardiorespiratory Response Among Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
September 5, 2019 (Actual)
Study Completion Date
September 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Teknologi Mara
Collaborators
University of Malaya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
INCOMPLETE SPINAL CORD INJURY (ASIA D)
Keywords
HIGH INTENSITY INTERVAL TRAINING, INCOMPLETE SPINAL CORD INJURY, MUSCLE STRENGTH, CARDIO-RESPIRATORY FITNESS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4 MIN X 4 MIN HIIT of FES-LCE
Arm Type
Experimental
Arm Description
4 min of high-intensity phase intersperses with 4 min of low-intensity phase for a total of 5 bouts.
Arm Title
2 MIN X 2 MIN HIIT of FES-LCE
Arm Type
Experimental
Arm Description
2 min of high-intensity phase intersperses with 2 min of low-intensity phase for a total of 10 bouts.
Intervention Type
Other
Intervention Name(s)
Functional Electrical Stimulation Leg Cycling Exercise
Intervention Description
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 Outcome Measure Information:
Title
Changes of peak torque of Quadriceps and Hamstring
Description
Isometric peak torque for quadriceps and hamstring will be measured using Biodex isokinetic machine.
Time Frame
Changes of peak torque at 6 week
Secondary Outcome Measure Information:
Title
Changes of peak VO2
Description
Peak VO2 will be measured using Cosmed Quark CPET system apparatus
Time Frame
Changes of peak VO2 at 6 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University Malaya Medical Center
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No

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

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