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Energetic Response to Feeding and Exercise in SCI (CRIT)

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Seated control (CON)
Moderate intensity continuous (MICT)
High intensity interval training (HIIT)
Circuit resistance training (CRT)
Liquid Meal
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Cord Injuries focused on measuring postprandial, glycemia, lipemia, macronutrient metabolism, physical activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Lois Pope Life Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Seated control (CON)

Circuit resistance training (CRT)

Moderate intensity continuous (MICT)

High intensity interval training (HIIT)

Arm Description

Participants remain seated in their habitual wheel chair for ~45 min (duration of exercise performed in other arms). Following the intervention they are fed.

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.

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.

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.

Outcomes

Primary Outcome Measures

Postprandial insulin sensitivity
Measured by insulin incremental area under the curve (iAUC).
Postprandial insulin sensitivity
Measured by "ISIMatsuada" insulin sensitivity index. This index is calculated based on the ratio of blood glucose and insulin.

Secondary Outcome Measures

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

Full Information

First Posted
May 22, 2018
Last Updated
June 17, 2020
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT03545867
Brief Title
Energetic Response to Feeding and Exercise in SCI
Acronym
CRIT
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 28, 2018 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
postprandial, glycemia, lipemia, macronutrient metabolism, physical activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Static first arm with randomized remaining three arms.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Seated control (CON)
Arm Type
Experimental
Arm Description
Participants remain seated in their habitual wheel chair for ~45 min (duration of exercise performed in other arms). Following the intervention they are fed.
Arm Title
Circuit resistance training (CRT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Moderate intensity continuous (MICT)
Arm Type
Experimental
Arm Description
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.
Arm Title
High intensity interval training (HIIT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Seated control (CON)
Intervention Description
Seated rest
Intervention Type
Behavioral
Intervention Name(s)
Moderate intensity continuous (MICT)
Intervention Description
Arm cycling at a continuous power output
Intervention Type
Behavioral
Intervention Name(s)
High intensity interval training (HIIT)
Intervention Description
Arm cycling at power outputs that vary between high and low intensity intervals
Intervention Type
Behavioral
Intervention Name(s)
Circuit resistance training (CRT)
Intervention Description
Alternating between six upper extremity resistance maneuvers interspersed with low-resistance/high-speed arm cycling.
Intervention Type
Other
Intervention Name(s)
Liquid Meal
Intervention Description
A liquid meal consisting of 600 kcal comprised of 50% carbohydrate, 35% fat, and 15% protein (by kcal).
Primary Outcome Measure Information:
Title
Postprandial insulin sensitivity
Description
Measured by insulin incremental area under the curve (iAUC).
Time Frame
2.5 hr
Title
Postprandial insulin sensitivity
Description
Measured by "ISIMatsuada" insulin sensitivity index. This index is calculated based on the ratio of blood glucose and insulin.
Time Frame
2.5 hr
Secondary Outcome Measure Information:
Title
Lipemia
Description
Measured by blood concentrations of triglycerides.
Time Frame
2.5 hr
Title
Carbohydrate use
Description
Whole-body rates of carbohydrate oxidation, as determined by open-circuit indirect calorimetry.
Time Frame
2.5 hr
Title
Fat use
Description
Whole-body rates of fat oxidation, as determined by open-circuit indirect calorimetry.
Time Frame
2.5 hr
Title
Fasted insulin sensitivity
Description
Measured by "HOMA-2" model. This model is calculated based on the ratio of blood glucose and insulin.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark S Nash, Ph.D.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lois Pope Life Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33433151
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.
Results Reference
derived
PubMed Identifier
31409383
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.
Results Reference
derived

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Energetic Response to Feeding and Exercise in SCI

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