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Completed

NCT Number: NCT03545867

Energetic Response to Feeding and Exercise in SCI

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.

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Key information

Conditions

Spinal Cord Injuries Behavior Central Nervous System Diseases Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Motor Activity Nervous System Diseases Nutritional and Metabolic Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lois Pope Life Center

Miami, Florida, 33143, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Seated control (CON)

Behavioral

Seated rest

Moderate intensity continuous (MICT)

Behavioral

Arm cycling at a continuous power output

High Intensity Interval Training (HIIT)

Behavioral

Arm cycling at power outputs that vary between high and low intensity intervals

Circuit resistance training (CRT)

Behavioral

Alternating between six upper extremity resistance maneuvers interspersed with low-resistance/high-speed arm cycling.

liquid meal

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Effect of Various Forms of Upper Body Exercise on the Energetic Response to a Meal in Persons With Spinal Cord Injury

Acronym: CRIT

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 4, 2018
Registry last updated
Jun 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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