The Effect of High Intensity Interval Training and Surgical Weight Loss on Distal Symmetric Polyneuropathy Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The neuropathy outcomes assessors will be blinded to the exercise protocol that the patients are randomized to and the surgical status for the duration of the study.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: High Intensity Interval Training (HIIT) (Other)
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.
干预措施: Bariatric surgery (Procedure)
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.
干预措施: Routine Exercise (Other)
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.
干预措施: Bariatric surgery (Procedure)
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.
干预措施: High Intensity Interval Training (HIIT) (Other)
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.
干预措施: Routine Exercise (Other)
结局指标
主要结局
Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh
时间窗: Baseline, 3 months, 12 months and 24 months
Intraepidermal Nerve Fiber Density (IENFD) as assessed by 3mm skin biopsies at the proximal thigh.
次要结局
- Intraepidermal Nerve Fiber Density (IENFD) at Distal Leg.(Baseline, 3 months, 12 months and 24 months)
- Corneal Confocal Microscopy (CCM) - Fiber Density(Baseline, 3 month, 12 months and 24 months)
- Corneal Confocal Microscopy (CCM) - Branch Density(Baseline, 3 month, 12 months and 24 months)
- Corneal Confocal Microscopy (CCM) - Fiber Length(Baseline, 3 month, 12 months and 24 months)
- Corneal Confocal Microscopy (CCM) - Tortuosity Coefficient(Baseline, 3 month, 12 months and 24 months)
- 24-2 Frequency Doubling Technology (FDT) - Mean Deviation(Baseline, 3 month, 12 months and 24 months)
- 24-2 Frequency Doubling Technology (FDT) - Foveal Sensitivity dB(Baseline, 3 month, 12 months and 24 months)
- 24-2 Frequency Doubling Technology (FDT) - Pattern SD(Baseline, 3 month, 12 months and 24 months)
- Retinal Fundus Photography(Baseline, 3 month, 12 months and 24 months)
- Nerve Conduction Study (NCS) - CV(Baseline and 24 months)
- Nerve Conduction Study (NCS) - Latency(Baseline and 24 months)
- Michigan Neuropathy Screening Instrument (MNSI)(Baseline, 3 month, 12 months and 24 months)
- Michigan Neuropathy Screening Instrument (MNSI) - Exam(Baseline, 3 month, 12 months and 24 months)
- Nerve Conduction Study (NCS) - Motor Amplitude(Baseline and 24 months)
- Nerve Conduction Study (NCS) - F Wave Index(Baseline and 24 months)
- Nerve Conduction Study (NCS) - Sensory Amplitude(Baseline and 24 months)
- Cardiac Autonomic Neuropathy Testing-Deep Breathing/Exhalation to Inhalation (E:I) Ratio(Baseline and 24 months)
- Cardiac Autonomic Neuropathy Testing (30:15 Ratio)(Baseline and 24 months)
- Cardiac Autonomic Neuropathy Testing (Valsalva Ratio)(Baseline and 24 months)
- Numerical Rating Scale for Pain(Baseline, 3 months, 12 months, 24 months)
- Participants With Probable Polyneuropathy as Defined by the Toronto Definition of Probable Neuropathy(24 months)
- Michigan Neuropathy Screening Instrument (MNSI) - Index(Baseline, 3 month, 12 months and 24 months)
- Utah Early Neuropathy Score (UENS)(Baseline, 3 month, 12 months and 24 months)
- Modified Toronto Neuropathy Score (mTNS)(Baseline, 3 month, 12 months and 24 months)
- 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)
- Short Form McGill Pain Questionnaire(Baseline, 3 months, 12 months, 24 months)
- Neuropathy Quality of Life (NeuroQOL)(Baseline, 3 months, 12 months, and 24 months)
- 8 Foot Get Up and Go Test(Baseline, 3 months, 12 months, and 24 months)
- Berg Balance Scale(Baseline, 3 months, 12 months, and 24 months)
- Modified Falls Efficacy Scale - Fall Evaluation(Baseline, 3 months, 12 months, and 24 months)
- 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)
研究者
Brian Callaghan
Fovette E Dush Early Career Professor and Assistant Professor of Neurology
University of Michigan