Energetic Response to Feeding and Exercise in SCI

Spinal Cord Injuries Clinical Trial

— CRIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03545867
• Other study ID #: 20171114
• Status: Completed
• Phase: N/A
• Start date: February 28, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: October 2018
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Behavioral:
• Seated control (CON)
Seated rest
• Moderate intensity continuous (MICT)
Arm cycling at a continuous power output
• High intensity interval training (HIIT)
Arm cycling at power outputs that vary between high and low intensity intervals
• 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).

Locations

Country	Name	City	State
United States	Lois Pope Life Center	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial insulin sensitivity	Measured by insulin incremental area under the curve (iAUC).	2.5 hr
Primary	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	Lipemia	Measured by blood concentrations of triglycerides.	2.5 hr
Secondary	Carbohydrate use	Whole-body rates of carbohydrate oxidation, as determined by open-circuit indirect calorimetry.	2.5 hr
Secondary	Fat use	Whole-body rates of fat oxidation, as determined by open-circuit indirect calorimetry.	2.5 hr
Secondary	Fasted insulin sensitivity	Measured by "HOMA-2" model. This model is calculated based on the ratio of blood glucose and insulin.	Baseline