Exercise Induced Hypoalgesia Diabetes

NCT05296642 | Withdrawn

• 1 other identifier: 20220189
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Peripheral Neuropathy; Diabetic Peripheral Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Change in Pain Pressure Threshold (PPT)

  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.

  Baseline, 20 minutes

Secondary Outcomes (1)

• Change in Heat Pain Threshold (HPT)

  Baseline, 20 minutes

Study Arms (2)

Cycling at a Moderate Intensity Aerobic Exercise (AE) group

EXPERIMENTAL

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

Other: Moderate Cycling

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

EXPERIMENTAL

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.

Other: Moderate Cycling; Other: Personalized Tourniquet System

Interventions

Moderate Cycling OTHER

Using the recumbent bicycle (95Ri, Life Fitness, Illinois) participants will be asked to sustain a moderate pace of 13 - 16 for 20 minutes of perceived exertion range using the Borg rate of perceived exertion scale (RPE).

Blood Flow restriction training with cycling at a moderate intensity (BFR+AE) group; Cycling at a Moderate Intensity Aerobic Exercise (AE) group

Personalized Tourniquet System OTHER

An automated personalize tourniquet system (Delfi Medical, Inc., Vancouver, BC, Canada) will be used to perform blood flow restriction during BFR+AE. This system has a dual-purpose tourniquet cuff (11.5 x 86 cm) connected by airtight hose tubing to a personalized tourniquet device. The device automatically measures LOP and regulated pressure during exercise within clinically acceptable limits. Participants will be asked to lie in supine and a non-shedding stockinette protection sleeve will be placed at bilateral proximal thighs. Following, a tourniquet cuff will be placed bilaterally around the protection material and connected to the airtight hose tube.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects between the ages of 18 - 65.
• 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.
• Subjects who have stocking and/or glove distribution neuropathy symptoms as drawn on the painDETECT questionnaire.
• 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.
• Subjects who have an ankle brachial index (ABI) between 0.7 and 1.4.

You may not qualify if:

• 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.
• Subjects with current or history of central nervous system disorders.
• 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.
• Subjects who are unable to achieve walking a minimum distance of 400 meters in the six-minute walk test.
• Subjects with Reynaud's disease or cold urticaria.
• All vulnerable populations including adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners, individuals with cognitive impairment.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Study Officials

• Marlon L. Wong, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 25, 2022
• Study Start: August 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)