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Energetic Response to Feeding and Exercise in SCI (CRIT)

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ClinicalTrials.gov Identifier: NCT03545867
Recruitment Status : Completed
First Posted : June 4, 2018
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Mark S. Nash, Ph.D., FACSM, University of Miami

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Behavioral: Seated control (CON) Behavioral: Moderate intensity continuous (MICT) Behavioral: High intensity interval training (HIIT) Behavioral: Circuit resistance training (CRT) Other: Liquid Meal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Static first arm with randomized remaining three arms.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Various Forms of Upper Body Exercise on the Energetic Response to a Meal in Persons With Spinal Cord Injury
Actual Study Start Date : February 28, 2018
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


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.
Behavioral: Circuit resistance training (CRT)
Alternating between six upper extremity resistance maneuvers interspersed with low-resistance/high-speed arm cycling.

Other: Liquid Meal
A liquid meal consisting of 600 kcal comprised of 50% carbohydrate, 35% fat, and 15% protein (by kcal).

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.
Behavioral: Moderate intensity continuous (MICT)
Arm cycling at a continuous power output

Other: Liquid Meal
A liquid meal consisting of 600 kcal comprised of 50% carbohydrate, 35% fat, and 15% protein (by kcal).

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.
Behavioral: High intensity interval training (HIIT)
Arm cycling at power outputs that vary between high and low intensity intervals

Other: Liquid Meal
A liquid meal consisting of 600 kcal comprised of 50% carbohydrate, 35% fat, and 15% protein (by kcal).




Primary Outcome Measures :
  1. Postprandial insulin sensitivity [ Time Frame: 2.5 hr ]
    Measured by insulin incremental area under the curve (iAUC).

  2. 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.


Secondary Outcome Measures :
  1. Lipemia [ Time Frame: 2.5 hr ]
    Measured by blood concentrations of triglycerides.

  2. Carbohydrate use [ Time Frame: 2.5 hr ]
    Whole-body rates of carbohydrate oxidation, as determined by open-circuit indirect calorimetry.

  3. Fat use [ Time Frame: 2.5 hr ]
    Whole-body rates of fat oxidation, as determined by open-circuit indirect calorimetry.

  4. Fasted insulin sensitivity [ Time Frame: Baseline ]
    Measured by "HOMA-2" model. This model is calculated based on the ratio of blood glucose and insulin.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 sixth thoracic vertebrae (T6)

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03545867


Locations
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United States, Florida
Lois Pope Life Center
Miami, Florida, United States, 33143
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Mark S Nash, Ph.D. University of Miami

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mark S. Nash, Ph.D., FACSM, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03545867     History of Changes
Other Study ID Numbers: 20171114
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mark S. Nash, Ph.D., FACSM, University of Miami:
postprandial
glycemia
lipemia
macronutrient metabolism
physical activity

Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries