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Principal investigator decision
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 20 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marlon L. Wong, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
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| 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. |
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