NCT03545867

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 4, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

June 19, 2020

Status Verified

October 1, 2018

Enrollment Period

7 months

First QC Date

May 22, 2018

Last Update Submit

June 17, 2020

Conditions

Keywords

postprandialglycemialipemiamacronutrient metabolismphysical activity

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Lipemia

    2.5 hr

  • Carbohydrate use

    2.5 hr

  • Fat use

    2.5 hr

  • Fasted insulin sensitivity

    Baseline

Study Arms (4)

Seated control (CON)

EXPERIMENTAL

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)Other: Liquid Meal

Circuit resistance training (CRT)

EXPERIMENTAL

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)Other: Liquid Meal

Moderate intensity continuous (MICT)

EXPERIMENTAL

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)Other: Liquid Meal

High intensity interval training (HIIT)

EXPERIMENTAL

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)Other: Liquid Meal

Interventions

Seated rest

Seated control (CON)

Arm cycling at a continuous power output

Moderate intensity continuous (MICT)

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

High intensity interval training (HIIT)

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

Circuit resistance training (CRT)

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

Circuit resistance training (CRT)High intensity interval training (HIIT)Moderate intensity continuous (MICT)Seated control (CON)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lois Pope Life Center

Miami, Florida, 33143, United States

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Spinal Cord InjuriesHyperlipidemiasMotor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mark S Nash, Ph.D.

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: Static first arm with randomized remaining three arms.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 22, 2018

First Posted

June 4, 2018

Study Start

February 28, 2018

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

June 19, 2020

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations