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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
140
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.
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).
University Of Michigan
Ann Arbor, Michigan, United States
Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh
Intraepidermal Nerve Fiber Density (IENFD) as assessed by 3mm skin biopsies at the proximal thigh.
Time frame: Baseline, 3 months, 12 months and 24 months
Intraepidermal Nerve Fiber Density (IENFD) at Distal Leg.
Intraepidermal Nerve Fiber Density (IENFD) as assessed by 3mm skin biopsies at the distal leg.
Time frame: Baseline, 3 months, 12 months and 24 months
Corneal Confocal Microscopy (CCM) - Fiber Density
Non-invasive imaging technique of the corneal nerves to quantify nerve density and morphology. Corneal Nerve Fiber Density are quantified by fibers/mm2, a higher number represents a higher density of fibers. Lower numbers indicate worse neuropathy.
Time frame: Baseline, 3 month, 12 months and 24 months
Corneal Confocal Microscopy (CCM) - Branch Density
Non-invasive imaging technique of the corneal nerves to quantify nerve density and morphology. Corneal Nerve Branch Density are quantified by branches/mm2, a higher number represents a higher density of branches. Lower numbers indicate worse neuropathy.
Time frame: Baseline, 3 month, 12 months and 24 months
Corneal Confocal Microscopy (CCM) - Fiber Length
Non-invasive imaging technique of the corneal nerves to quantify nerve density and morphology. Corneal Nerve Fiber Length are quantified by mm/mm2, a higher number represents a higher total length of fibers. Lower numbers indicate worse neuropathy .
Time frame: Baseline, 3 month, 12 months and 24 months
Corneal Confocal Microscopy (CCM) - Tortuosity Coefficient
Non-invasive imaging technique of the corneal nerves to quantify nerve density and morphology. Tortuosity Coefficient represents the total tortuosity (twisting/bending of nerves). As a coefficient the value is unitless, a higher value represents greater tortuosity. Lower numbers indicate worse neuropathy.
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Patients will undergo bariatric surgery as part of their routine care
Time frame: Baseline, 3 month, 12 months and 24 months
24-2 Frequency Doubling Technology (FDT) - Mean Deviation
24-2 FDT was used to evaluate retinopathy using visual field deficits. Mean Deviation is presented below. Mean deviation is the average difference from normal expected value in the patients' particular age group. Lower values indicate more visual deficit. Higher values indicate fewer visual deficit.
Time frame: Baseline, 3 month, 12 months and 24 months
24-2 Frequency Doubling Technology (FDT) - Foveal Sensitivity dB
24-2 FDT was used to evaluate retinopathy using visual field deficits. Foveal sensitivity is presented below. Foveal sensitivity is the measurement of the fovea's light detection ability. Lower values suggest visual field deficits.
Time frame: Baseline, 3 month, 12 months and 24 months
24-2 Frequency Doubling Technology (FDT) - Pattern SD
24-2 FDT was used to evaluate retinopathy using visual field deficits. Pattern SD (PSD) is presented below. PSD provides information about localized loss. A higher PSD indicates a non-uniform sensitivity loss and visual field deficit.
Time frame: Baseline, 3 month, 12 months and 24 months
Retinal Fundus Photography
As assessed by fundus photographs, participants were identified as either having retinopathy or not having retinopathy. Data is shown as number of people with retinopathy at a particular study visit.
Time frame: Baseline, 3 month, 12 months and 24 months
Nerve Conduction Study (NCS) - Latency
Latency measures the time in millisecond between stimulation and the recording electrode. Was performed on sural, peroneal, and tibial nerves. No response and abnormal values indicate neuropathy. * Peroneal: 0 - No response, \>6.5 - Abnormal * Sural: 0 - No response, \>4.5 - Abnormal * Tibial: 0 - No response, \>6.1 - Abnormal
Time frame: Baseline and 24 months
Nerve Conduction Study (NCS) - Motor Amplitude
Amplitude measures the height of electrical signal (waveform) in millivolts produced by the stimulated motor nerve. Was performed on peroneal, and tibial nerves. No response and abnormal values indicate neuropathy. * Peroneal: 0 - No response, \< 1.1 - Abnormal * Tibial: 0 - No response, \<1.1 - Abnormal
Time frame: Baseline and 24 months
Nerve Conduction Study (NCS) - Sensory Amplitude
Amplitude measures the height of electrical signal (waveform) in microvolts produced by the stimulated sensory nerve. Was performed on sural nerve. No response and abnormal values indicate neuropathy. \* Sural: 0 - No response, \<4 - Abnormal
Time frame: Baseline and 24 months
Nerve Conduction Study (NCS) - CV
Conduction velocity (V) measures the speed (m/s) at which the electrical impulse travels along the nerve. Was performed on peroneal nerves. No response and abnormal values indicate neuropathy. Abnormal values are \<36 or 39, depending on whether certain criteria applied to the participant. Data was not analyzed separately.
Time frame: Baseline and 24 months
Nerve Conduction Study (NCS) - F Wave Index
F wave index measures the time in millisecond between stimulation at a distal (near the muscle) point and for the stimulus to travel to the spinal cord and back, allowing to assess the entire length of the nerve. Was performed on peroneal, and tibial nerves. No response and abnormal values indicate neuropathy. * Peroneal: 0 - No response, \>55 - Abnormal * Tibial: 0 - No response, \>55 - Abnormal
Time frame: Baseline and 24 months
Cardiac Autonomic Neuropathy Testing-Deep Breathing/Exhalation to Inhalation (E:I) Ratio
Deep breathing/exhalation to inhalation (E:I) ratio were evaluated using PS monitor software. Values \< 1 are abnormal, indicative of cardiovascular autonomic neuropathy
Time frame: Baseline and 24 months
Cardiac Autonomic Neuropathy Testing (30:15 Ratio)
Postural change-30:15 ratio was evaluated using PS monitor software. Values \< 1 are abnormal, indicative of cardiovascular autonomic neuropathy
Time frame: Baseline and 24 months
Cardiac Autonomic Neuropathy Testing (Valsalva Ratio)
Valsalva ratio was evaluated using PS monitor software. Values \<= 1.10 are abnormal, indicative of cardiovascular autonomic neuropathy
Time frame: Baseline and 24 months
Participants With Probable Polyneuropathy as Defined by the Toronto Definition of Probable Neuropathy
Toronto definition of probable neuropathy is having at least 2 out of 3 of the following: abnormal sensory examination, reflexes, and patient-reported symptoms. Data is reported as number of participants who, under the Toronto definition, were identified as having probable polyneuropathy.
Time frame: 24 months
Michigan Neuropathy Screening Instrument (MNSI)
MNSI questionnaire is scored from 0-15, score \> 4 indicate neuropathy, higher scores indicate worse neuropathy. A score of 1 point is given for answers of "yes" for questions 1-6, 8-12, 14, and 15 and "no" for questions 7 and 13.
Time frame: Baseline, 3 month, 12 months and 24 months
Michigan Neuropathy Screening Instrument (MNSI) - Exam
MNSI exam is scored from 0-8, score \>= 2.5 indicate neuropathy. Higher scores indicate worse neuropathy.
Time frame: Baseline, 3 month, 12 months and 24 months
Michigan Neuropathy Screening Instrument (MNSI) - Index
The Michigan Neuropathy Screening Instrument (MNSI) index is a weighted composite score computed using the sum of the b-coefficients for all items within the MNSI questionnaire (15 questions) and MNSI exam (4 physical/visual exam). Range: -0.93, 7.39 Values \> 2.5407 are indicative of clinical neuropathy
Time frame: Baseline, 3 month, 12 months and 24 months
Utah Early Neuropathy Score (UENS)
UENS is a composite score with five sections measuring multiple clinical measures of nerve injury. Sections are scored separately for each side (Right vs Left), and the total score is the sum across everything. Range: 0-42, higher score represents more severe polyneuropathy.
Time frame: Baseline, 3 month, 12 months and 24 months
Modified Toronto Neuropathy Score (mTNS)
mTNS is a scale of 0-33 that measures neuropathy symptoms and exam findings. Higher scores indicate more severe polyneuropathy.
Time frame: Baseline, 3 month, 12 months and 24 months
Survey of Autonomic Symptoms (SAS)
SAS evaluates the presence and magnitude of autonomic symptoms. Total impact score ranges from 0-60 (or up to 55 for participants to whom certain criteria did not apply). Higher score indicates worse autonomic neuropathy
Time frame: Baseline, 3 month, 12 months and 24 months
Diabetic Neuropathy Score (DNS)
DNS is a questionnaire of neuropathy symptoms. Score ranges 0-4, \>/=1 indicates polyneuropathy. 0 indicates no polyneuropathy.
Time frame: Baseline, 3 month, 12 months and 24 months
Short Form McGill Pain Questionnaire
Sum of the sensory score (0-30) and affective score (0-15) for a total score of 0-45. A higher score represents greater pain present.
Time frame: Baseline, 3 months, 12 months, 24 months
Numerical Rating Scale for Pain
Participant reported pain scale with range 0-10, higher score indicates more pain.
Time frame: Baseline, 3 months, 12 months, 24 months
Neuropathy Quality of Life (NeuroQOL)
Neuropathy Quality of Life (NeuroQOL) evaluates symptoms and function in regard to quality of life over the past four weeks. Range 1-15, higher score indicates neuropathy having a greater impact on quality of life.
Time frame: Baseline, 3 months, 12 months, and 24 months
8 Foot Get Up and Go Test
This test measures in seconds how long it takes the participant to stand up from a seated position, walk around a cone places 8 feet away, and return to the chair and sit down. Less time indicates better speed, agility, and balance when moving.
Time frame: Baseline, 3 months, 12 months, and 24 months
Berg Balance Scale
Berg Balance Scale measures participants' ability to balance and avoid falls. Scores range from 0-56, higher score indicates less likely to fall.
Time frame: Baseline, 3 months, 12 months, and 24 months
Modified Falls Efficacy Scale - Fall Evaluation
Patient response indicating if they have fallen in the last year. Data is shown as number of people who have fallen in the last year.
Time frame: Baseline, 3 months, 12 months, and 24 months
Neurothesiometer
Neurothesiometer is placed on the bottom of the great toe, and slowly increased until participant reports they can feel the vibration. The greater the microns, the less feeling the participant has, suggestive of worse sensory function. Value \> 25 Microns is indicative of neuropathy. There is no known maximum range. Lower values indicate better sensory function.
Time frame: Baseline, 3 months, 12 months, and 24 months
NIH Toolbox Cognitive Battery
NIH Toolbox Cognition Fluid (Range: 0-100) - Composite score derived as an average across five cognitive domains. It's a fully adjusted T-score comparing the participant to a nationally representative sample, stratified by age and other demographics. Individual domain scores are fully adjusted T score with range 0-100 and measures the following- * Inhibitory Control and Attention - executive function, attention . * Dimensional Change Card Sort - executive function * Picture Sequence Memory - episodic memory * List Sorting Working Memory - working memory * Pattern Comparison - processing speed A T-score of 50 represents the population mean. A score of 60 indicates that the participant is 1 SD above the national average for individuals with similar demographic characteristics Higher scores reflect better cognitive functionality. No set clinical threshold, scores above mean indicate above average cognition for a given age group.
Time frame: Baseline and at 24 months
Rey Auditory Verbal Learning Test
Used to evaluate verbal learning and memory using a list of 15 unrelated words presented to the participant over repeat trial. Includes 3 independent scales: * Auditory Learning (Total recall) - Measures memory and learning ability. Raw score range (0- 75) * Delayed Recall - Measures long term memory retention. Raw score range (0-15) * Recognition - Measures ability to recognize previously learned information. Raw score range (0-15). * Raw scores were converted to age-standardized Z-scores using 10-year age bands (e.g., 20-29, 30-39, 40-49, etc.), with a mean of 0 and standard deviation of 1. * A Z-score of 0 represents the population mean * For each scale, scores above 0 are better. Standard deviations above the mean indicates a better learning and memory ability for a given age group. No set clinical threshold, scores above mean indicate above average cognition for a given age group.
Time frame: Baseline and at 24 months