Exercise Induced Hypoalgesia Diabetes

Not Applicable

Withdrawn

• Conditions: Diabetic Peripheral Neuropathic Pain; Diabetic Peripheral Neuropathy
• Interventions: Other: Moderate Cycling; Other: Personalized Tourniquet System

• Registration Number: NCT05296642
• Lead Sponsor: University of Miami

Brief Summary

The purpose of this research study is to learn whether different forms of exercise can reduce pain experienced by individuals with painful diabetic peripheral neuropathy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-03-16
• Study First Posted: 2022-03-25
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-25
• Study Start: 2022-08-01
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Subjects between the ages of 18 - 65.
2. Subjects with confirmed Diabetes Mellitus as defined by the American Diabetes Association (ADA), a glycosylated hemoglobin (HbA1c) of 6.5%, a fasting blood glucose > 126 mg/dL, or an oral glucose tolerance test > 200 mg/dL.
3. Subjects who have stocking and/or glove distribution neuropathy symptoms as drawn on the painDETECT questionnaire.
4. Subjects who have neuropathic pain as defined by a minimum score of 4 or higher on the Douleur Neuropathique en 4 Questions (DN4). In addition, the location of pain must be present within the same region of neuropathy symptoms.
5. Subjects who have an ankle brachial index (ABI) between 0.7 and 1.4.

Exclusion Criteria

1. Subjects who have pain due to some other form of neuropathy (chemo-induced neuropathy, alcohol induced neuropathy, exposure to toxins/chemicals, vitamin b12 deficiency, etc.) assessed via a medical history.
2. Subjects with current or history of central nervous system disorders.
3. Subjects with resting hypertension (HTN) >/= 160/90 mmHg or known uncontrolled hypertension, coronary artery disease, heart failure, retinopathy, chronic obstructive pulmonary disease, end-stage renal disease, or current open foot ulcers.
4. Subjects who are unable to achieve walking a minimum distance of 400 meters in the six-minute walk test.
5. Subjects with Reynaud's disease or cold urticaria.
6. All vulnerable populations including adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners, individuals with cognitive impairment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cycling at a Moderate Intensity Aerobic Exercise (AE) group	Moderate Cycling	All participants will be asked to cycle during the first phase at a moderate intensity for 20 minutes.
Blood Flow restriction training with cycling at a moderate intensity (BFR+AE) group	Moderate Cycling	All participants will be asked to wear an automated personalize tourniquet system to restrict blood flow. Participants will be asked to lie in supine and a non-shedding stockinette protection sleeve will be placed at bilateral proximal thighs. Then, participants will be asked to cycle at a moderate intensity for 20 minutes during the second phase.
Blood Flow restriction training with cycling at a moderate intensity (BFR+AE) group	Personalized Tourniquet System	All participants will be asked to wear an automated personalize tourniquet system to restrict blood flow. Participants will be asked to lie in supine and a non-shedding stockinette protection sleeve will be placed at bilateral proximal thighs. Then, participants will be asked to cycle at a moderate intensity for 20 minutes during the second phase.

Primary Outcome Measures

Name	Time	Method
Change in Pain Pressure Threshold (PPT)	Baseline, 20 minutes	PPT will be measured both locally at the quadriceps and distally at the upper trapezius. The PPT will be determined with three series of ascending stimulus intensities at each point over 3 rounds. A positive change in PPT (PPT following exercise subtracted from PPT before exercise) will demonstrate an intact exercise induced hypoalgesic response.

Secondary Outcome Measures

Name	Time	Method
Change in Heat Pain Threshold (HPT)	Baseline, 20 minutes	HPT will be measured both locally at the quadriceps and distally at the upper trapezius. The HPT will be determined with three series of ascending stimulus intensities at each point over 3 rounds. A positive change in HPT (HPT following exercise subtracted from HPT before exercise) will demonstrate an intact exercise induced hypoalgesic response.

Trial Locations

Locations (1)

University of Miami Miller School of Medicine; 🇺🇸 Miami, Florida, United States