Diet and Exercise for Low Blood Pressure

Overseen By Ceren Yarar-Fisher, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Must not be taking: Anti-hypotensive drugs

Disqualifiers: Pregnancy, Diabetes, Bariatric surgery, others

Compensation: Varies

Number of Visits: 2

Duration: 3 days

13 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a low glycemic diet and lower-body electrical stimulation exercise can help manage low blood pressure after meals in individuals with long-term spinal cord injuries. The study tests three approaches: a high glycemic diet as a comparison, a low glycemic diet, and electrical stimulation exercises. Individuals with a spinal cord injury between the neck and mid-back, who use a wheelchair, and have lived with the injury for more than a year may be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance the quality of life for those with spinal cord injuries.

Will I have to stop taking my current medications?

The trial excludes participants who use anti-hypotensive drugs, so if you are taking these medications, you would not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that electrical stimulation is safe for people. In healthy individuals, it does not significantly affect blood pressure or heart rate, indicating it is generally well-tolerated. For those with spinal cord injuries, electrical stimulation has helped manage symptoms like fainting without causing major side effects.

Studies on low glycemic load diets indicate they can help lower blood pressure, particularly in individuals with high blood pressure. These diets are also linked to better heart health without serious risks. Overall, past research suggests both treatments are safe. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for low blood pressure because they take a novel approach. Unlike traditional medications that primarily involve drugs to increase blood pressure, these interventions focus on lifestyle changes and innovative methods. The low glycemic load diet is designed to stabilize blood sugar levels, which can indirectly support blood pressure regulation, offering a natural alternative to medication. Meanwhile, electrical stimulation exercise provides a way to enhance muscle activity and circulation without the need for intense physical exertion, making it accessible to those who may struggle with conventional exercise. Together, these treatments offer potentially safer and more holistic options for managing low blood pressure.

What evidence suggests that this trial's treatments could be effective for reducing postprandial hypotension in individuals with chronic spinal cord injury?

Studies have shown that electrical stimulation, one of the treatments tested in this trial, can help manage blood pressure. It can sometimes prevent the drop in blood pressure that occurs when standing up, which is crucial for people with spinal cord injuries. Research also shows that electrical stimulation can raise overall blood pressure during use.

For low glycemic diets, another treatment option in this trial, research suggests they can improve blood pressure and help control blood sugar levels. In people with long-term spinal cord injuries, consuming low glycemic foods might prevent the drop in blood pressure after meals. These findings support the idea that both treatments studied in this trial could help manage blood pressure drops after eating in people with spinal cord injuries. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for people with a spinal cord injury between C4 and T12 levels, who use wheelchairs for daily movement, and are over one year post-injury. It's specifically aimed at those classified as AIS A or B, indicating severe SCI without or with some sensory function preserved.

Inclusion Criteria

My spinal cord injury is classified as complete or sensory incomplete.

It has been over a year since my injury.

I have a spinal cord injury between C4 and T12 and use a wheelchair.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a low glycemic diet and lower-body electrical stimulation to reduce postprandial hypotension

3 days

Visits 2-4, Day 1-3

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Electrical stimulation exercise
• Low glycemic load

Trial Overview The study is testing whether eating foods that cause a slow rise in blood sugar (low glycemic load) combined with lower-body workouts using electrical stimulation can help manage low blood pressure after meals in chronic spinal cord injury patients.

How Is the Trial Designed?

Group I: Low glycemic load Experimental Treatment 1 Intervention

Group II: Electrical Stimulation Experimental Treatment 2 Interventions

Group III: High glycemic load Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

A low-glycemic diet combined with low-volume exercise during pregnancy can significantly reduce insulin resistance, leading to lower blood glucose levels and decreased maternal weight gain, which may help prevent gestational diabetes.

Regular weight-bearing exercise alone also lowers insulin resistance and blood glucose levels during pregnancy, suggesting that both dietary and physical activity interventions are beneficial for at-risk women and those with gestational diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Diet and Exercise on Insulin Resistance during Pregnancy. Clapp, JF.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11756561/

Efficacy of Neuro-muscular Electrical Stimulation for ... After approximately 3 days of NMES, BP decreased slowly, presyncopic symptoms disappeared, and he could leave bed more frequently and for longer periods. The ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2936915/

Postexercise Hypotension: Central Mechanisms - PMC A single bout of exercise can lead to a postexercise decrease in blood pressure in hypertensive individuals, called postexercise hypotension.

3. nature.com nature.com/articles/sc2014187

Electrical stimulation-evoked contractions blunt orthostatic ... Electrical stimulation-evoked contractions blunt orthostatic hypotension in sub-acute spinal cord-injured individuals: two clinical case ...

4. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.121.18580?doi=10.1161/HYPERTENSIONAHA.121.18580

Mitigating Initial Orthostatic Hypotension The drop in SBP from INTV to BPnadir following ES was significantly reduced compared with CONT (−28±12 versus −34±11 mm Hg; P=0.002), as was the ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0272638608006045

Effect of Transcutaneous Electrical Muscle Stimulation and ... Mean blood pressure increased from 121/64 ± 21/15 mm Hg with NI to 132/69 ± 21/15 mm Hg (P < 0.001) during sessions with PCMs and 125/66 ± 22/16 mm Hg (P < 0.05) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6937082/

Side effects of and contraindications for whole-body electro ... In healthy subjects, WB-EMS does not seem to affect blood pressure, heart rate and oxygen uptake.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1878747925000066

Cardiovascular safety of transcutaneous spinal cord ... Sessions of tSCS ​+ ​rehab did not cause significant changes in blood pressure or heart rate compared to Rehab alone (p ​> ​0.05). Further, blood pressure ...

8. frontiersin.org frontiersin.org/journals/physiology/articles/10.3389/fphys.2022.828670/full

Acute Effects of Low-Intensity Electrical Stimulation on ... These findings suggest that low-intensity EMS of the lower limbs reduces arterial stiffness, but only in sites that received EMS.