Exercise Induced Hypoalgesia Diabetes (EIHDM)

University of Miami

Status: Withdrawn

Conditions: Diabetic Peripheral Neuropathic Pain; Diabetic Peripheral Neuropathy

Treatments: Other: Personalized Tourniquet System; Other: Moderate Cycling

Study type: Interventional

Funder types: Other

Identifiers

NCT05296642

20220189

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Cycling at a Moderate Intensity Aerobic Exercise (AE) group

Experimental group

Description:

All participants will be asked to cycle during the first phase at a moderate intensity for 20 minutes.

Treatment:

Other: Moderate Cycling

Blood Flow restriction training with cycling at a moderate intensity (BFR+AE) group

Experimental group

Description:

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.

Treatment:

Other: Personalized Tourniquet System

Other: Moderate Cycling