Energetic Response to Feeding and Exercise in SCI (CRIT)

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Behavioral: Seated control (CON); Other: Liquid Meal; Behavioral: Circuit resistance training (CRT); Behavioral: Moderate intensity continuous (MICT); Behavioral: High intensity interval training (HIIT)

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33143
      • Lois Pope Life Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Seated control (CON); Participants remain seated in their habitual wheel chair for ~45 min (duration of exercise performed in other arms). Following the intervention they are fed.	Behavioral: Seated control (CON); Seated rest; Other: Liquid Meal; A liquid meal consisting of 600 kcal comprised of 50% carbohydrate, 35% fat, and 15% protein (by kcal).
Experimental: Circuit resistance training (CRT); 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.	Other: Liquid Meal; A liquid meal consisting of 600 kcal comprised of 50% carbohydrate, 35% fat, and 15% protein (by kcal).; Behavioral: Circuit resistance training (CRT); Alternating between six upper extremity resistance maneuvers interspersed with low-resistance/high-speed arm cycling.
Experimental: Moderate intensity continuous (MICT); 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.	Other: Liquid Meal; A liquid meal consisting of 600 kcal comprised of 50% carbohydrate, 35% fat, and 15% protein (by kcal).; Behavioral: Moderate intensity continuous (MICT); Arm cycling at a continuous power output
Experimental: High intensity interval training (HIIT); 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.	Other: Liquid Meal; A liquid meal consisting of 600 kcal comprised of 50% carbohydrate, 35% fat, and 15% protein (by kcal).; Behavioral: High intensity interval training (HIIT); Arm cycling at power outputs that vary between high and low intensity intervals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial insulin sensitivity	Measured by insulin incremental area under the curve (iAUC).	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.	2.5 hr

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipemia	Measured by blood concentrations of triglycerides.	2.5 hr
Carbohydrate use	Whole-body rates of carbohydrate oxidation, as determined by open-circuit indirect calorimetry.	2.5 hr
Fat use	Whole-body rates of fat oxidation, as determined by open-circuit indirect calorimetry.	2.5 hr
Fasted insulin sensitivity	Measured by "HOMA-2" model. This model is calculated based on the ratio of blood glucose and insulin.	Baseline

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Mark S Nash, Ph.D., University of Miami

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2018
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: May 22, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): June 4, 2018

Study Record Updates

• Last Update Posted (Actual): June 19, 2020
• Last Update Submitted That Met QC Criteria: June 17, 2020
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: physical activity; postprandial; glycemia; lipemia; macronutrient metabolism
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 20171114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No