Effect of Exercise and Surgical Weight Loss on Polyneuropathy
Study Details
Study Description
Brief Summary
The purpose of this research study is to evaluate how exercise and surgical weight loss affect how likely an individual is to develop peripheral neuropathy and other neurologic complications.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The length of this study, including screening is approximately 24 months. Patients at Bariatric Surgery Clinics will be recruited for this study. Both patients that decide to undergo bariatric surgery, and those that do not undergo surgery will be enrolled. Patients will be randomized to either a high intensity interval training (HIIT) or standard exercise regimen after eligibility is confirmed and the baseline visit is complete. All patients will complete follow-up appointments at 3 month, 12 months and 24 months. Patients that are randomized to the HIIT program will compete 2 supervised and 1 unsupervised training sessions a week for 24 months.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Bariatric Surgery/HIIT Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week. |
Other: High Intensity Interval Training (HIIT)
Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Procedure: Bariatric surgery
Patients will undergo bariatric surgery as part of their routine care
|
| Active Comparator: Bariatric Surgery/Routine Exercise Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months. |
Other: Routine Exercise
Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Procedure: Bariatric surgery
Patients will undergo bariatric surgery as part of their routine care
|
| Active Comparator: No Bariatric Surgery/HIIT Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week. |
Other: High Intensity Interval Training (HIIT)
Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
| Active Comparator: No Bariatric Surgery/Routine Exercise Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months. |
Other: Routine Exercise
Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
Outcome Measures
Primary Outcome Measures
- Change in Intraepidermal Nerve Fiber Density (IENFD) at the proximal thigh [Baseline, 3 months, 12 months and 24 months]
As assessed by 3mm skin biopsies.Linear mixed effects regression modeling will account for multiple time points of the same measure.
Secondary Outcome Measures
- Change in Intraepidermal Nerve Fiber Density (IENFD) at distal leg. [Baseline, 3 months, 12 months and 24 months]
As assessed by 3mm skin biopsies. Linear mixed effects regression modeling will account for multiple time points of the same measure.
- Corneal Confocal Microscopy (CCM) [Baseline, 3 month, 12 months and 24 months]
- 24-2 Frequency Doubling Technology (FDT) [Baseline, 3 month, 12 months and 24 months]
- Retinal Fundus Photography [Baseline, 3 month, 12 months and 24 months]
- Nerve Conduction Study (NCS) [Baseline and 24 months]
Sural, peroneal, and tibial nerves.
- Cardiac Autonomic Neuropathy Testing [Baseline and 24 months]
Deep breathing-E:I ratio
- Cardiac Autonomic Neuropathy Testing [Baseline and 24 months]
Postural change-30:15 ratio
- Cardiac Autonomic Neuropathy Testing [Baseline and 24 months]
Valsalva- Valsalva ratio
- Incidence of polyneuropathy as defined by the Toronto definition of probable neuropathy [24 months]
Toronto definition of probable neuropathy-2 out of 3 of abnormal sensory examination, reflexes, and symptoms.
- Michigan Neuropathy Screening Instrument (MNSI) [Baseline, 3 month, 12 months and 24 months]
- Utah Early Neuropathy Score [Baseline, 3 month, 12 months and 24 months]
Scale 0-48, higher is more severe polyneuropathy
- Modified Toronto Neuropathy Score (mTNS) [Baseline, 3 month, 12 months and 24 months]
Range 0-33, higher is more severe polyneuropathy
- Survey of Autonomic Symptoms (SAS) [Baseline, 3 month, 12 months and 24 months]
- Diabetic Neuropathy Score (DNS) [Baseline, 3 month, 12 months and 24 months]
Range 0-4, >/=1 indicates polyneuropathy
- Short Form McGill Pain Questionnaire [Baseline, 3 months, 12 months, 24 months]
- Numerical Rating Scale for pain [Baseline, 3 months, 12 months, 24 months]
Range 0-10, higher score indicates more pain
- Neuropathy Quality of Life (NeuroQOL) [Baseline, 3 months, 12 months, and 24 months]
- Berg Balance Scale [Baseline, 3 months, 12 months, and 24 months]
Range 0-56, higher score indicates less likely to fall
- 8 Foot Get Up and Go Test [Baseline, 3 months, 12 months, and 24 months]
- Modified Falls Efficacy Scale [Baseline, 3 months, 12 months, and 24 months]
Range 0-140, higher score indicates less likely to fall
- Neurothesiometer [Baseline, 3 months, 12 months, and 24 months]
- NIH Toolbox Cognitive Battery [Baseline and at 24 months]
- Rey Auditory Verbal Learning Test [Baseline and at 24 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Attending a bariatric surgery clinic
-
BMI > 35 with one comorbid condition present or BMI > 40 without comorbid conditions present
-
Willing and capable to sign the Institutional Review Board (IRB) approved consent form and cooperate with the medical procedures for the study duration
-
Willing to accept random treatment assignment to HIIT or routine exercise counseling
Exclusion Criteria:
-
History of distal symmetric polyneuropathy (DSP) from causes other than diabetes and/or the metabolic syndrome as determined through medical history, family history, history of medications, occupational history, history of exposure to toxins, physical and neurological examinations;
-
Use of warfarin, heparin, or other anticoagulants, which would increase the risk of complications from skin biopsy
-
Contraindication to HIIT participation including a failed exercise stress test
-
Participation in an experimental medication trial within 3 months of starting the study
-
Undergoing therapy for malignant disease other than basal-cell or squamous-cell skin cancer
-
Medical or psychiatric reason for not being a surgical candidate
-
Requiring a walking assist device;
-
Currently smoking
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
- Principal Investigator: Brian C Callaghan, MD, MS, University of Michigan, Department of Neurology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00143541
- 1R01DK115687-01A1