INCOMPLETE SPINAL CORD INJURY (ASIA D)NCT03837834
Effects of 6 Weeks High-intensity Interval Training Among Spinal Cord Injury
A study testing Functional Electrical Stimulation Leg Cycling Exercise in people with INCOMPLETE SPINAL CORD INJURY (ASIA D), run by Universiti Teknologi Mara at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- INCOMPLETE SPINAL CORD INJURY (ASIA D)
- What is being tested?
- Functional Electrical Stimulation Leg Cycling Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteMalaysia
- Study dates
- 15 Feb 2019to 5 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Unhealed decubiti at electrode placement area.
- Recurrent autonomic dysreflexia.
- Active heterotopic ossification.
- Other peripheral or central neurologic injury.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of 6 Weeks High-intensity Interval Training on Muscle Strength and Cardiorespiratory Response 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.
- Conditions
- INCOMPLETE SPINAL CORD INJURY (ASIA D)
- Being tested
- Functional Electrical Stimulation Leg Cycling Exercise
- Keywords
- HIGH INTENSITY INTERVAL TRAINING, INCOMPLETE SPINAL CORD INJURY, MUSCLE STRENGTH, CARDIO-RESPIRATORY FITNESS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Electrical Stimulation Leg Cycling ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Functional Electrical Stimulation Leg Cycling Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of peak torque of Quadriceps and Hamstring
Isometric peak torque for quadriceps and hamstring will be measured using Biodex isokinetic machine.
Measured: Changes of peak torque at 6 week
Secondary outcomes (1)
Changes of peak VO2
Peak VO2 will be measured using Cosmed Quark CPET system apparatus
Measured: Changes of peak VO2 at 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start15 Feb 2019
- Primary completion5 Sep 2019
- Study completion5 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for INCOMPLETE SPINAL CORD INJURY (ASIA D)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Teknologi Mara
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malaya
- Responsible party
- Principal investigator, MOHD KHAIRUL AZHAR BIN ARIFFIN, Universiti Teknologi Mara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837834
- Sponsor's protocol ID
- 201682-4100
- Status last verified
- Sep 2019
- First submitted
- 7 Feb 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 6 Weeks High-intensity Interval Training on Muscle Strength and Cardiorespiratory Response Among Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03837834
- Acronym / sponsor ID
- 201682-4100
- Conditions
- INCOMPLETE SPINAL CORD INJURY (ASIA D)
- Keywords
- HIGH INTENSITY INTERVAL TRAINING, INCOMPLETE SPINAL CORD INJURY, MUSCLE STRENGTH, CARDIO-RESPIRATORY FITNESS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Universiti Teknologi MaraUniversity, hospital or other
- Collaborators
- University of Malaya
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 5 Sep 2019 (actual)
- First posted
- 12 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4 MIN X 4 MIN HIIT of FES-LCE | Experimental | Other: Functional Electrical Stimulation Leg Cycling Exercise4 min of high-intensity phase intersperses with 4 min of low-intensity phase for a total of 5 bouts. |
| 2 MIN X 2 MIN HIIT of FES-LCE | Experimental | Other: Functional Electrical Stimulation Leg Cycling Exercise2 min of high-intensity phase intersperses with 2 min of low-intensity phase for a total of 10 bouts. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Electrical Stimulation Leg Cycling ExerciseFES- 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. | Other | 2 MIN X 2 MIN HIIT of FES-LCE, 4 MIN X 4 MIN HIIT of FES-LCE |
Primary outcome
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.
1 secondary outcome
Changes of peak VO2
Time frame: Changes of peak VO2 at 6 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Individual participant dataSharing planned: No
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Enrolling by invitation
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INCOMPLETE SPINAL CORD INJURY (ASIA D), Able Bodied
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Electrical Stimulation Leg Cycling Exercise in people with INCOMPLETE SPINAL CORD INJURY (ASIA D), run by Universiti Teknologi Mara at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of peak torque of Quadriceps and Hamstring (time frame: Changes of peak torque at 6 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.