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Recruiting NCT06882460

Diet and Exercise Solutions to Postprandial Hypotension

No phase Interventional Spinal Cord Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low glycemic load, Electrical stimulation exercise, High glycemic load diet.
Who it may be relevant to
Registry conditions: Spinal Cord Injuries. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Lifestyle Solutions to Postprandial Hypotension in Spinal Cord Injury

Overview

The purpose of this study is to determine if a low glycemic diet and lower-body electrical stimulation can reduce postprandial hypotension in individuals with chronic spinal cord injury.

Interventions

  • Other Low glycemic load
    Low glycemic load diet
  • Other Electrical stimulation exercise
    Lower-body electrical stimulation exercise for 1-h after eating
  • Other High glycemic load diet
    High glycemic load diet

Primary outcome measures

  • Magnitude of systolic blood pressure decrease (in-lab) [Time frame: Visit 2-4, Day 1]
Secondary outcome measures (5)
  • Magnitude of systolic blood pressure decrease (at-home) [Time frame: Visits 2-4, Days 1-3]
  • Postprandial glucose (in-lab) [Time frame: Visits 2-4, Day 1]
  • Postprandial insulin (in-lab) [Time frame: Visits 2-4, Day 1]
  • Postprandial glucose (at-home) [Time frame: Visits 2-4, Day 1-3]
  • Blood flow (in-lab) [Time frame: Visits 2-4, Day 1]

Eligibility criteria

Inclusion criteria

  • Spinal cord injury (SCI) between C4 and T12 who require use of wheelchair for daily mobility
  • AIS A or B
  • >1-year post-injury

Exclusion criteria

  • Currently pregnant of breast-feeding
  • Type 1 or 2 diabetes
  • Previous gut augmentation bariatric surgery
  • Neurological impairment other than SCI
  • History of uncontrolled autonomic dysreflexia
  • History of bone fractures
  • Use of abdominal binder or anti-hypotensive drugs
  • Fitted with pacemaker or defibrillator
  • Currently receiving electrical stimulation training or in the previous year

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Dodd Rehabilitation Hospital — Columbus

Identifiers

NCT: NCT06882460 · 2024H0147

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗