Back to resultsExercise Induced Hypoalgesia Diabetes (EIHDM)
Primary Purpose
Diabetic Peripheral Neuropathy, Diabetic Peripheral Neuropathic Pain
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Moderate Cycling
Personalized Tourniquet System
Sponsored by
About this trial
This is an interventional diagnostic trial for Diabetic Peripheral Neuropathy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- University of Miami Miller School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cycling at a Moderate Intensity Aerobic Exercise (AE) group
Blood Flow restriction training with cycling at a moderate intensity (BFR+AE) group
Arm Description
All participants will be asked to cycle during the first phase at a moderate intensity for 20 minutes.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Heat Pain Threshold (HPT)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05296642
Brief Title
Exercise Induced Hypoalgesia Diabetes
Acronym
EIHDM
Official Title
Exploring the Use of Blood Flow Restriction in Addition to Aerobic Exercise as a Modality to Produce Exercise Induced Hypoalgesia in Participants With Painful Diabetic Peripheral Neuropathy.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Principal investigator decision
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy, Diabetic Peripheral Neuropathic Pain
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cycling at a Moderate Intensity Aerobic Exercise (AE) group
Arm Type
Experimental
Arm Description
All participants will be asked to cycle during the first phase at a moderate intensity for 20 minutes.
Arm Title
Blood Flow restriction training with cycling at a moderate intensity (BFR+AE) group
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Moderate Cycling
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Personalized Tourniquet System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Pain Pressure Threshold (PPT)
Description
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.
Time Frame
Baseline, 20 minutes
Secondary Outcome Measure Information:
Title
Change in Heat Pain Threshold (HPT)
Description
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.
Time Frame
Baseline, 20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marlon L. Wong, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exercise Induced Hypoalgesia Diabetes
We'll reach out to this number within 24 hrs