Clinical trial NCT03545867: Energetic Response to Feeding and Exercise in SCI
Official title: Effect of Various Forms of Upper Body Exercise on the Energetic Response to a Meal in Persons With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: postprandial
glycemia
lipemia
macronutrient metabolism
physical activity
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Static first arm with randomized remaining three arms.
Primary purpose: PREVENTION

Brief 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 interval arm cycling (HIIT), and circuit resistance exercise (CRT) matched for exercise energy expenditure.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Postprandial insulin sensitivity
timeFrame: 2.5 hr
measure: Postprandial insulin sensitivity
timeFrame: 2.5 hr
Secondary outcomes:
measure: Lipemia
timeFrame: 2.5 hr
measure: Carbohydrate use
timeFrame: 2.5 hr
measure: Fat use
timeFrame: 2.5 hr
measure: Fasted insulin sensitivity
timeFrame: Baseline
Other outcomes:
Locations:
city: Miami
country: United States
facility: Lois Pope Life Center
state: Florida
Study officials:
affiliation: University of Miami
name: Mark S Nash, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: McMillan 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.