Energetic Response to Feeding and Exercise in SCI
CRIT
Effect of Various Forms of Upper Body Exercise on the Energetic Response to a Meal in Persons With Spinal Cord Injury
1 other identifier
interventional
10
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 28, 2018
CompletedFirst Submitted
Initial submission to the registry
May 22, 2018
CompletedFirst Posted
Study publicly available on registry
June 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedJune 19, 2020
October 1, 2018
7 months
May 22, 2018
June 17, 2020
Conditions
Keywords
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)
EXPERIMENTALParticipants remain seated in their habitual wheel chair for \~45 min (duration of exercise performed in other arms). Following the intervention they are fed.
Circuit resistance training (CRT)
EXPERIMENTALParticipants 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.
Moderate intensity continuous (MICT)
EXPERIMENTALParticipants 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.
High intensity interval training (HIIT)
EXPERIMENTALParticipants 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.
Interventions
Arm cycling at a continuous power output
Arm cycling at power outputs that vary between high and low intensity intervals
Alternating between six upper extremity resistance maneuvers interspersed with low-resistance/high-speed arm cycling.
A liquid meal consisting of 600 kcal comprised of 50% carbohydrate, 35% fat, and 15% protein (by kcal).
Eligibility Criteria
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
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.
PMID: 33433151DERIVEDMcMillan 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.
PMID: 31409383DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark S Nash, Ph.D.
University of Miami
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- 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