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

NCT ID: NCT03837834

Last Updated: 2019-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-15
• Study Completion Date: 2019-09-05

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)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Functional Electrical Stimulation Leg Cycling Exercise

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Functional Electrical Stimulation Leg Cycling Exercise

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaya

OTHER

Sponsor Role: collaborator

Universiti Teknologi Mara

OTHER

Sponsor Role: lead

Responsible Party

MOHD KHAIRUL AZHAR BIN ARIFFIN

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Malaya Medical Center

Kuala Lumpur, , Malaysia

Countries

Malaysia

Other Identifiers

201682-4100

Identifier Type: -

Identifier Source: org_study_id