Effect of Exercise and Surgical Weight Loss on Polyneuropathy

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT03617185
Status
Completed

Conditions

  • Bariatric Surgery Candidate
  • Obesity
  • Polyneuropathies

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • High Intensity Interval Training (HIIT) — OTHER
    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.
  • Routine Exercise — OTHER
    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).
  • Bariatric surgery — PROCEDURE
    Patients will undergo bariatric surgery as part of their routine care

Study Details

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.

Key Dates

Start date
Jul 27, 2018
Status verified
Feb 2026
Primary completion
Aug 1, 2024
Completion
Aug 1, 2024

Study Design

Enrollment
140 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh [ Time Frame: Baseline, 3 months, 12 months and 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University Of MichiganAnn ArborMichigan48109-

Find similar trials in Ann Arbor, MI

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University Of Michigan· Ann Arbor, MI

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