NCT04011137

Brief Summary

Persons with chronic paraplegia at an increased risk of developing cardiovascular disease and type-2 diabetes compared to the able-bodied population. There is mounting evidence from the able-bodied literature that high-intensity interval training (HIIT) is more effective than moderate-intensity continuous training (MICT) at improving markers of cardiometabolic health. Before we can understand the long-term training effects of HIIT in this population, it is important to compare the acute metabolic responses to a typical mixed-macronutrient meal following both exercise modalities. This study is recruiting adults (aged 18-65 years) with paraplegia (T2 or below) who sustained their spinal cord injury more than one-year ago. Participants will need to attend the laboratory at the University of Bath on four separate occasions, once for preliminary testing, and three times for study trials.

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 Apr 2018

Typical duration 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

April 1, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

July 29, 2022

Status Verified

July 1, 2022

Enrollment Period

2 years

First QC Date

July 3, 2019

Last Update Submit

July 26, 2022

Conditions

Paraplegia

Keywords

high-intensity interval trainingpostprandial metabolism

Outcome Measures

Primary Outcomes (1)

  • Postprandial triglyceride concentrations

    Postprandial triglyceride concentrations in serum samples

    6 hours

Secondary Outcomes (9)

  • Postprandial glucose concentrations

    6 hours

  • Postprandial insulin concentrations

    6 hours

  • Postprandial non-esterified fatty acid concentrations

    6 hours

  • Postprandial substrate oxidation

    6 hours

  • Rating of Perceived Exertion

    MICT: End of Warm-Up, 6 minutes 15 seconds, 12 minutes 30 seconds, 18 minutes 45 seconds, End of Exercise. HIIT: End of Warm-Up, 8 minutes, 12 minutes, 16 minutes, 20 minutes)

  • +4 more secondary outcomes

Study Arms (3)

Control

NO INTERVENTION

No exercise - 30-min of rest

High-intensity interval training

EXPERIMENTAL

8 x 60 s intervals at 70% peak power output (intersperesed with 60 s recovery intervals at 10% peak power output)

Other: Exercise

Moderate-intensity continous training

EXPERIMENTAL

25 min at 45% peak power output

Other: Exercise

Interventions

ExerciseOTHER

Arm-cranking exercise

High-intensity interval trainingModerate-intensity continous training

Eligibility Criteria

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

You may qualify if:

  • Individuals with a chronic (\>12 months post-injury) SCI below T2
  • Individuals who spend \>75% of their waking day in a wheelchair
  • Weight stable (weight not changed by \>3% over the last 3 months)

You may not qualify if:

  • Individuals who an acute (\<12 months post-injury) SCI
  • Individuals who spend \<75% of their waking day in a wheelchair
  • Individuals on type-2 diabetes medication
  • Individuals with a peanut allergy
  • Individuals who self-report use of lipid-lowering agents
  • Individuals self-reporting active medical issues (pressure sores, urinary tract infections, cardiac disorders, musculoskeletal complaints of the upper extremities, or cardiovascular contraindications to exercise testing)
  • Individuals who report uncontrolled or regular autonomic dysreflexia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for Health

Bath, BA2 7AY, United Kingdom

Location

Related Publications (1)

  • Farrow MT, Maher JL, Nightingale TE, Thompson D, Bilzon JLJ. A Single Bout of Upper-Body Exercise Has No Effect on Postprandial Metabolism in Persons with Chronic Paraplegia. Med Sci Sports Exerc. 2021 May 1;53(5):1041-1049. doi: 10.1249/MSS.0000000000002561.

    PMID: 33560775DERIVED

MeSH Terms

Conditions

Paraplegia

Interventions

Exercise

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • James Bizon

    University of Bath

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 3, 2019

First Posted

July 8, 2019

Study Start

April 1, 2018

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

July 29, 2022

Record last verified: 2022-07

Locations

GB(1)