Effect of Exercise and Surgical Weight Loss on Polyneuropathy

Not Applicable

Completed

• Conditions: Polyneuropathies; Obesity; Bariatric Surgery Candidate
• Interventions: Other: High Intensity Interval Training (HIIT); Other: Routine Exercise; Procedure: Bariatric surgery

• Registration Number: NCT03617185
• Lead Sponsor: University of Michigan

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.

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 Timeline

• Study Start: 2018-07-12
• Study First Submitted: 2018-07-14
• Study First Submitted QC: 2018-08-02
• Study First Posted: 2018-08-06
• Status Verified: 2024-08
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bariatric Surgery/HIIT	Bariatric surgery	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.
Bariatric Surgery/HIIT	High Intensity Interval Training (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.
Bariatric Surgery/Routine Exercise	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.
No Bariatric Surgery/HIIT	High Intensity Interval Training (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.
Bariatric Surgery/Routine Exercise	Bariatric surgery	Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
No Bariatric Surgery/Routine Exercise	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Utah Early Neuropathy Score	Baseline, 3 month, 12 months and 24 months	Scale 0-48, higher is more severe polyneuropathy
Survey of Autonomic Symptoms (SAS)	Baseline, 3 month, 12 months and 24 months
Corneal Confocal Microscopy (CCM)	Baseline, 3 month, 12 months and 24 months
Michigan Neuropathy Screening Instrument (MNSI)	Baseline, 3 month, 12 months and 24 months
Short Form McGill Pain Questionnaire	Baseline, 3 months, 12 months, 24 months
8 Foot Get Up and Go Test	Baseline, 3 months, 12 months, and 24 months
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.
Cardiac Autonomic Neuropathy Testing	Baseline and 24 months	Valsalva- Valsalva ratio
Neuropathy Quality of Life (NeuroQOL)	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
NIH Toolbox Cognitive Battery	Baseline and at 24 months
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.
Modified Toronto Neuropathy Score (mTNS)	Baseline, 3 month, 12 months and 24 months	Range 0-33, higher is more severe polyneuropathy
Numerical Rating Scale for pain	Baseline, 3 months, 12 months, 24 months	Range 0-10, higher score indicates more pain
Neurothesiometer	Baseline, 3 months, 12 months, and 24 months
Rey Auditory Verbal Learning Test	Baseline and at 24 months
Diabetic Neuropathy Score (DNS)	Baseline, 3 month, 12 months and 24 months	Range 0-4, \>/=1 indicates polyneuropathy
Berg Balance Scale	Baseline, 3 months, 12 months, and 24 months	Range 0-56, higher score indicates less likely to fall

Trial Locations

Locations (1)

University Of Michigan; 🇺🇸 Ann Arbor, Michigan, United States