Spinal Cord InjuriesCRITNCT03545867
Energetic Response to Feeding and Exercise in SCI
A study testing Moderate intensity continuous (MICT), High intensity interval training (HIIT) and Circuit resistance training (CRT) in people with Spinal Cord Injuries, run by University of Miami at 1 site in United States.
Trial summary
This study investigates the effect of various forms of upper extremity exercise on postprandial glycemia and lipemia in persons with spinal cord injury (SCI). Participants are measured at rest and fed a standardized meal following seated rest (CON), moderate intensity continuous arm cycling (MICT), high intensity… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Moderate intensity continuous (MICT), High intensity interval training (HIIT) and Circuit resistance training (CRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2018to 30 Sep 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (>/=18 years of age)
- Neurologically stable chronic (>/= 1year) spinal cord injury (SCI)
- American Spinal Injury Association Impairment Scale (AIS) grade A, B, or C
- SCI at level </= the first thoracic vertebrae (T1)
Who cannot join
- Being of ≤ 18 years of age.
- Contraindication to exercise (ACSM Guideline, 10th edition)
- Lower extremity fracture or dislocation within 6 months of participation,
- History head injury or seizures.
- Inability to consent.
- Restrictions in upper extremity range of motion that would prevent an individual from achieving an unhindered arm cycling motion or moving throughout a range needed to perform resistance maneuvers.
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- A pressure ulcer at ischial/gluteus, trochanteric, sacral, or heel sites within the last 3 months.
- Pregnancy determined by urine testing in sexually active females.
- Imprisonment in state or federal jail or prison.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Various Forms of Upper Body Exercise on the Energetic Response to a Meal in Persons With Spinal Cord Injury
This study investigates the effect of various forms of upper extremity exercise on postprandial glycemia and lipemia in persons with spinal cord injury (SCI). Participants are measured at rest and fed a standardized meal following seated rest (CON), moderate intensity continuous arm cycling (MICT), high intensity interval arm cycling (HIIT), and circuit resistance exercise (CRT) matched for exercise energy expenditure.
- Conditions
- Spinal Cord Injuries
- Being tested
- Seated control (CON), Moderate intensity continuous (MICT), High intensity interval training (HIIT), Circuit resistance training (CRT), Liquid Meal
- Keywords
- postprandial, glycemia, lipemia, macronutrient metabolism, physical activity
- Medical subject headings
- Spinal Cord Injuries, Hyperlipidemias, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seated control (CON)Behavioural
Seated rest
Moderate intensity continuous (MICT)Behavioural
Arm cycling at a continuous power output
High intensity interval training (HIIT)Behavioural
Arm cycling at power outputs that vary between high and low intensity intervals
Circuit resistance training (CRT)Behavioural
Alternating between six upper extremity resistance maneuvers interspersed with low-resistance/high-speed arm cycling.
Liquid MealOther
A liquid meal consisting of 600 kcal comprised of 50% carbohydrate, 35% fat, and 15% protein (by kcal).
| Study group | Role | What they receive |
|---|---|---|
| Seated control (CON) | Experimental | Participants remain seated in their habitual wheel chair for ~45 min (duration of exercise performed in other arms). Following the intervention they are fed. Receives: Behavioral: Seated control (CON); Other: Liquid Meal |
| Circuit resistance training (CRT) | Experimental | Participants complete upper extremity resistance maneuvers (lifts) interspersed with low-load/high-speed arm cycling for a combined 30 repetitions of 6 lifts and ~20 min of arm cycling. During this time energy expenditure is measured via open-circuit indirect calorimetry. Following the intervention they are fed. Receives: Behavioral: Circuit resistance training (CRT); Other: Liquid Meal |
| Moderate intensity continuous (MICT) | Experimental | Participants complete continous arm cycling at a steady-state power output (intensity) matched to the energy expenditure (kcal/min) and duration of exercise (min) response during CRT. Following the intervention they are fed. Receives: Behavioral: Moderate intensity continuous (MICT); Other: Liquid Meal |
| High intensity interval training (HIIT) | Experimental | Participants complete interval arm cycling at power output that varies between 2 min "active" and two min "recovery" periods. This interval exercise is matched to the total energy expenditure (accumulated kcals) response during CRT. Following the intervention they are fed. Receives: Behavioral: High intensity interval training (HIIT); Other: Liquid Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial insulin sensitivity
Measured by insulin incremental area under the curve (iAUC).
Measured: 2.5 hr
Postprandial insulin sensitivity
Measured by "ISIMatsuada" insulin sensitivity index. This index is calculated based on the ratio of blood glucose and insulin.
Measured: 2.5 hr
Secondary outcomes (4)
Lipemia
Measured by blood concentrations of triglycerides.
Measured: 2.5 hr
Carbohydrate use
Whole-body rates of carbohydrate oxidation, as determined by open-circuit indirect calorimetry.
Measured: 2.5 hr
Fat use
Whole-body rates of fat oxidation, as determined by open-circuit indirect calorimetry.
Measured: 2.5 hr
Fasted insulin sensitivity
Measured by "HOMA-2" model. This model is calculated based on the ratio of blood glucose and insulin.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start28 Feb 2018
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Static first arm with randomized remaining three arms.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark S. Nash, Ph.D., FACSM, University of Miami
- Investigators
- Mark S Nash, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545867
- Sponsor's protocol ID
- 20171114
- Acronym
- CRIT
- Status last verified
- Oct 2018
- First submitted
- 22 May 2018
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McMillan DW, Maher JL, Jacobs KA, Mendez AJ, Nash MS, Bilzon JLJ. Effects of Exercise Mode on Postprandial Metabolism in Humans with Chronic Paraplegia. Med Sci Sports Exerc. 2021 Jul 1;53(7):1495-1504. doi: 10.1249/MSS.0000000000002593.
PubMed 33433151McMillan DW, Maher JL, Jacobs KA, Mendez AJ, Nash MS, Bilzon JLJ. Influence of upper-body continuous, resistance or high-intensity interval training (CRIT) on postprandial responses in persons with spinal cord injury: study protocol for a randomised controlled trial. Trials. 2019 Aug 13;20(1):497. doi: 10.1186/s13063-019-3583-1.
PubMed 31409383
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Various Forms of Upper Body Exercise on the Energetic Response to a Meal in Persons With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03545867
- Acronym / sponsor ID
- CRIT / 20171114
- Conditions
- Spinal Cord Injuries
- Keywords
- postprandial, glycemia, lipemia, macronutrient metabolism, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 4 Jun 2018 (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.
This study investigates the effect of various forms of upper extremity exercise on postprandial glycemia and lipemia in persons with spinal cord injury (SCI). Participants are measured at rest and fed a standardized meal following seated rest (CON), moderate intensity continuous arm cycling (MICT), high intensity interval arm cycling (HIIT), and circuit resistance exercise (CRT) matched for exercise energy expenditure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Static first arm with randomized remaining three arms.
| Arm | Type | Receives |
|---|---|---|
| Seated control (CON) | Experimental | Behavioral: Seated control (CON), Other: Liquid MealParticipants remain seated in their habitual wheel chair for ~45 min (duration of exercise performed in other arms). Following the intervention they are fed. |
| Circuit resistance training (CRT) | Experimental | Behavioral: Circuit resistance training (CRT), Other: Liquid MealParticipants complete upper extremity resistance maneuvers (lifts) interspersed with low-load/high-speed arm cycling for a combined 30 repetitions of 6 lifts and ~20 min of arm cycling. During this time energy expenditure is measured via open-circuit indirect calorimetry. Following the intervention they are fed. |
| Moderate intensity continuous (MICT) | Experimental | Behavioral: Moderate intensity continuous (MICT), Other: Liquid MealParticipants complete continous arm cycling at a steady-state power output (intensity) matched to the energy expenditure (kcal/min) and duration of exercise (min) response during CRT. Following the intervention they are fed. |
| High intensity interval training (HIIT) | Experimental | Behavioral: High intensity interval training (HIIT), Other: Liquid MealParticipants complete interval arm cycling at power output that varies between 2 min "active" and two min "recovery" periods. This interval exercise is matched to the total energy expenditure (accumulated kcals) response during CRT. Following the intervention they are fed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (>/=18 years of age)
- Neurologically stable chronic (>/= 1year) spinal cord injury (SCI)
- American Spinal Injury Association Impairment Scale (AIS) grade A, B, or C
- SCI at level </= the first thoracic vertebrae (T1)
Key exclusion criteria (9 listed)
- Being of ≤ 18 years of age.
- Contraindication to exercise (ACSM Guideline, 10th edition)
- Lower extremity fracture or dislocation within 6 months of participation,
- History head injury or seizures.
- Inability to consent.
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 |
|---|---|---|
| Seated control (CON)Seated rest | Behavioural | Seated control (CON) |
| Moderate intensity continuous (MICT)Arm cycling at a continuous power output | Behavioural | Moderate intensity continuous (MICT) |
| High intensity interval training (HIIT)Arm cycling at power outputs that vary between high and low intensity intervals | Behavioural | High intensity interval training (HIIT) |
| Circuit resistance training (CRT)Alternating between six upper extremity resistance maneuvers interspersed with low-resistance/high-speed arm cycling. | Behavioural | Circuit resistance training (CRT) |
| Liquid MealA liquid meal consisting of 600 kcal comprised of 50% carbohydrate, 35% fat, and 15% protein (by kcal). | Other | Circuit resistance training (CRT), High intensity interval training (HIIT), Moderate intensity continuous (MICT), Seated control (CON) |
Primary outcome
Postprandial insulin sensitivity
Time frame: 2.5 hr
Measured by insulin incremental area under the curve (iAUC).
Postprandial insulin sensitivity
Time frame: 2.5 hr
Measured by "ISIMatsuada" insulin sensitivity index. This index is calculated based on the ratio of blood glucose and insulin.
4 secondary outcomes
Lipemia
Time frame: 2.5 hr
Carbohydrate use
Time frame: 2.5 hr
Fat use
Time frame: 2.5 hr
Fasted insulin sensitivity
Time frame: Baseline
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 19 Jun 2020.
- Derived from this study: PubMed 33433151McMillan DW, Maher JL, Jacobs KA, Mendez AJ, Nash MS, Bilzon JLJ. Effects of Exercise Mode on Postprandial Metabolism in Humans with Chronic Paraplegia. Med Sci Sports Exerc. 2021 Jul 1;53(7):1495-1504. doi: 10.1249/MSS.0000000000002593.
- Derived from this study: PubMed 31409383McMillan DW, Maher JL, Jacobs KA, Mendez AJ, Nash MS, Bilzon JLJ. Influence of upper-body continuous, resistance or high-intensity interval training (CRIT) on postprandial responses in persons with spinal cord injury: study protocol for a randomised controlled trial. Trials. 2019 Aug 13;20(1):497. doi: 10.1186/s13063-019-3583-1.
- Individual participant dataSharing planned: No
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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.
Mark S Nash, Ph.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate intensity continuous (MICT), High intensity interval training (HIIT) and Circuit resistance training (CRT) in people with Spinal Cord Injuries, run by University of Miami at 1 site in United States.
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 4 inclusion and 9 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 19 Jun 2020. 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 United States. 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?
Postprandial insulin sensitivity (time frame: 2.5 hr). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03545867, which also lists 2 linked publications.
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 19 Jun 2020.