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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Electrical stimulation exercise, Low glycemic load for low blood pressure?

Research shows that combining diet and exercise can lower blood pressure, as seen in a study where a specific diet and increased walking reduced blood pressure in people with diabetes and hypertension. Additionally, low-intensity exercise has been shown to reduce blood pressure and improve heart function in women with hypertension. ^{1 2 3 4 5}

Is the combination of diet and exercise generally safe for humans?

Research suggests that a low-glycemic diet combined with exercise is generally safe and can improve blood sugar control and cardiovascular health in various populations, including pregnant women and individuals with type 2 diabetes. ^{6 7 8 9 10}

How does the treatment of electrical stimulation exercise and low glycemic load diet for low blood pressure differ from other treatments?

This treatment is unique because it combines electrical stimulation exercise, which mimics the effects of physical activity by inducing muscle contractions, with a low glycemic load diet that helps manage blood sugar levels without causing spikes. Unlike traditional treatments that may focus solely on medication, this approach uses non-invasive methods to potentially improve blood pressure and overall cardiovascular health. ^{6 11 12 13 14}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of the DASH Diet and Walking on Blood Pressure in Patients With Type 2 Diabetes and Uncontrolled Hypertension: A Randomized Controlled Trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Synergistic effects of low-intensity exercise conditioning and β-blockade on cardiovascular and autonomic adaptation in pre- and postmenopausal women with hypertension. [2013]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Interrupting prolonged sitting with brief bouts of light walking or simple resistance activities reduces resting blood pressure and plasma noradrenaline in type 2 diabetes. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Profile of blood pressure and glycemic responses after interval exercise in older women attending (in) a public health physical activity program. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Significance of physical activity for prevention and control of hypertension. [2007]

6. United States pubmed.ncbi.nlm.nih.gov

High-glycemic index meal acutely potentiates blood pressure response to static handgrip exercise in healthy humans. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of Low-Energy Diet or Exercise on Cardiovascular Function in Working-Age Adults With Type 2 Diabetes: A Prospective, Randomized, Open-Label, Blinded End Point Trial. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Impact of leisure-time physical activity on glycemic control and cardiovascular risk factors in Japanese patients with type 2 diabetes mellitus: the Fukuoka Diabetes Registry. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. England pubmed.ncbi.nlm.nih.gov

Additional effects of exercise to hypocaloric diet on body weight, body composition, glycaemic control and cardio-respiratory fitness in adults with overweight or obesity and type 2 diabetes: A systematic review and meta-analysis. [2023]

11. Germany pubmed.ncbi.nlm.nih.gov

Treatment of Patients with Obese Type 2 Diabetes with Tantalus-DIAMOND® Gastric Electrical Stimulation: Normal Triglycerides Predict Durable Effects for at Least 3 Years. [2015]

12. United States pubmed.ncbi.nlm.nih.gov

Blood flow restriction and stimulated muscle contractions do not improve metabolic or vascular outcomes following glucose ingestion in young, active individuals. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Fasting plasma triglycerides predict the glycaemic response to treatment of type 2 diabetes by gastric electrical stimulation. A novel lipotoxicity paradigm. [2022]

14. Canada pubmed.ncbi.nlm.nih.gov

Effect of neuromuscular electrical stimulation frequency on postprandial glycemia, current-related discomfort, and muscle soreness. A crossover study. [2020]