Effect of Weight-Bearing Exercise on People With Diabetes and Neuropathic Feet

NCT00763087 | Completed DMC

• 1 other identifier: 06-0953
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if people with Diabetes Mellitus and peripheral neuropathy can increase their activity (i.e. walking or stationary biking) and leg strength without having an increase in foot problems compared to a group of people with diabetes and peripheral neuropathy that do no exercise. Our hypothesis is that the weight-bearing exercise group will achieve greater increases in weight-bearing activity (i.e., increased steps/day and cumulative load) and leg strength compared to the non-weight bearing exercise group and the non-exercising control group; and there will be no clinically meaningful difference in incidence or indicators of foot lesions between groups.

Conditions

Diabetes Mellitus; Peripheral Neuropathy

Keywords

diabetes mellitus; peripheral neuropathy; exercise

Outcome Measures

Primary Outcomes (1)

• daily step count

  3 months

Secondary Outcomes (1)

• skin breakdown

  3 months

Study Arms (3)

nonweightbearing exercise

ACTIVE COMPARATOR

Behavioral: nonweightbearing exercise

nonexercising control

PLACEBO COMPARATOR

Behavioral: nonexercising control

weightbearing exercise

EXPERIMENTAL

Behavioral: weightbearing exercise

Interventions

weightbearing exercise BEHAVIORAL

All subjects in the exercise group will participate, as able, in 3 supervised 1 hour exercise sessions per week for the first month and 2 supervised and 1 unsupervised exercise session per week for the remaining 2 months. Subjects in each exercise group will be seen on alternating times to avoid cross contamination of treatment intervention. Walking intensity for all subjects will be applied with the intent to exceed their routine physical stress level, and therefore incur positive adaptations to physical stress, but not exceed their threshold for injury.

weightbearing exercise

nonweightbearing exercise BEHAVIORAL

All subjects in the 2 exercise groups will participate, as able, in 3 supervised 1 hour exercise sessions per week for the first month and 2 supervised and 1 unsupervised exercise session per week for the remaining 2 months. Subjects in each exercise group will be seen on alternating times to avoid cross contamination of treatment intervention. Biking intensity for all subjects will be applied with the intent to exceed their routine physical stress level, and therefore incur positive adaptations to physical stress, but not exceed their threshold for injury.

nonweightbearing exercise

nonexercising control BEHAVIORAL

All subjects will be instructed, verbally and with written documents, regarding appropriate foot and skin care twice per month.

nonexercising control

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 or Type 2 DM and PN
• biothesiometer \> 25mV and
• unable to sense the 5.07 Semmes Weinstein monofilament on at least one spot on the plantar foot
• Relatively sedentary
• step count of 2-9,000 steps per day
• exercising less than 3 times per week (\<20 min/session).
• Have the approval of his/her primary care physician to participate in the study.

You may not qualify if:

• Subjects who weigh greater than 300 pounds (DXA scanner's weight limit).
• A history of severe foot deformity, such as Charcot neuroarthropathy or partial foot amputation that would require custom therapeutic footwear.
• Any co-morbidity or medication that would interfere with ability to exercise according to ADA and ACSM guidelines.
• People with severe depression as determined by the Beck Depression Inventory II with a score of 29 or greater.
• People who are physically incapable of tolerating one hour of activity.
• Women of child bearing age due to risk of exposure from radiation in DXA testing.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Program in Physical Therapy, Washington University in St. Louis

St Louis, Missouri, 63108, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Peripheral Nervous System Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior

Study Officials

• Michael J Mueller, PT, PhD

  Washington University in St. Louis, Program in Physical Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: September 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: November 7, 2017

Record last verified: 2017-11

Locations

US (1)