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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00763087
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE September 26, 2008
First Posted Date  ICMJE September 30, 2008
Last Update Posted Date November 7, 2017
Study Start Date  ICMJE September 2008
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2008)
daily step count [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2008)
skin breakdown [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Weight-Bearing Exercise on People With Diabetes and Neuropathic Feet
Official Title  ICMJE Effect of Weight-Bearing Exercise on People With Diabetes and Neuropathic Feet
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.

Detailed Description

People with diabetes and peripheral neuropathy (DM+PN) have substantial lower extremity impairments, functional limitations and disability. In addition to muscle weakness and poor balance, they also are at high risk for foot ulcerations, especially if they have a history of ulceration. Although there is a large and growing body of knowledge about the effect of exercise on people with DM, there is little evidence about the effect of exercise in people with DM+PN. Exercise is an important treatment component to help control the complications of DM. The American Diabetes Association (ADA), and the American College of Sports Medicine (ACSM)4 recommend that adults with DM participate in at least 30 minutes a day of moderate-intensity physical activity that is consistent with a brisk walk. The ADA and ACSM, however, discourage weight-bearing exercise for people with DM+PN due to risk of exercise-induced foot injury. No data support this guideline to restrict those with DM+PN from weight-bearing activity, and in fact, some evidence suggests that those with DM+PN who are most active are least likely to develop skin breakdown. The Primary Goal of this proposal is to conduct a pilot randomized prospective controlled clinical trial to determine if people with DM+PN can benefit from a progressive weight-bearing exercise program to improve impairments, functional limitations, disability, and pathophysiology without an increase in skin breakdown or foot lesions. The benefits of a weight bearing program will be compared to the benefits of a non weight bearing exercise program and to a non-exercising control group. The results of this study also will help to determine if neuropathic skin and muscle can adapt to increasing physical stress levels without injury which could have important implications for weight-bearing and exercise guidelines for people with DM+PN.

A. SPECIFIC AIMS

Aim 1. Determine the effect of a weight-bearing exercise program compared to a non-weight bearing exercise program and to a non-exercising control group on indicators of impairments, functional limitations, disability, and pathophysiology in patients with DM+PN.

  1. Measures of Impairment: Ankle joint range of motion, ankle plantar flexor and dorsiflexor muscle strength (peak torque), muscle volume (magnetic resonance imaging), and standing balance.

    H1: Both exercise groups will show an improvement in ankle joint range of motion and ankle plantar flexor / dorsiflexor muscle strength / volume compared to the non-exercising control group, but only the weight-bearing exercise group will show an improvement in standing balance because of exposure to challenging weight-bearing activities.

  2. Measures of Functional Limitations: Physical Performance Test, Foot & Ankle Ability Measure.

    H2: Both exercise groups will show improvement in the Physical Performance Test and Foot & Ankle Ability Measure compared to the non-exercising control group, and the weight-bearing exercise group will show greater improvements than the non-weight bearing exercise group because of improved balance and exposure to challenging weight-bearing activities.

  3. Measures of Disability / Participation: Diabetes Symptom Checklist, Beck Depression Inventory.

    H3: Both exercise groups will show improved measures of disability compared to the non-exercising control group, and the weight-bearing exercise group will show greater improvements than the non-weight bearing exercise group because of improved ability to participate in community activities which require weight-bearing and walking ability.

  4. Measures of Pathophysiology: HbA1c, serum lipids, DXA (body composition), and body mass index.

H4: Both exercise groups will show modest but statistically significant improvements compared to the non-exercising control group in the above measures of pathophysiology.

Aim 2: Determine the effect of weight-bearing exercise program and non-weight bearing exercise program compared to a control group on 1) daily step count (steps/day), 2) an estimate of cumulative load (step count * plantar pressure integral), 3) unilateral increase in surface foot temperature, and 4) incidence of foot lesions (digital photograph).

H5: The weight-bearing exercise group will achieve greater increases in weight-bearing activity (i.e., increased steps/day and cumulative load) 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Diabetes Mellitus
  • Peripheral Neuropathy
Intervention  ICMJE
  • Behavioral: weightbearing exercise
    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.
  • Behavioral: nonweightbearing exercise
    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.
  • Behavioral: nonexercising control
    All subjects will be instructed, verbally and with written documents, regarding appropriate foot and skin care twice per month.
Study Arms  ICMJE
  • Active Comparator: nonweightbearing exercise
    Intervention: Behavioral: nonweightbearing exercise
  • Placebo Comparator: nonexercising control
    Intervention: Behavioral: nonexercising control
  • Experimental: weightbearing exercise
    Intervention: Behavioral: weightbearing exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 10, 2011)
43
Original Estimated Enrollment  ICMJE
 (submitted: September 26, 2008)
96
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00763087
Other Study ID Numbers  ICMJE 06-0953
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael J Mueller, PT, PhD Washington University in St. Louis, Program in Physical Therapy
PRS Account Washington University School of Medicine
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP