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

This study has been completed.
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00763087
First received: September 26, 2008
Last updated: March 10, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus Peripheral Neuropathy Behavioral: weightbearing exercise Behavioral: nonweightbearing exercise Behavioral: nonexercising control Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Weight-Bearing Exercise on People With Diabetes and Neuropathic Feet

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • daily step count [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • skin breakdown [ Time Frame: 3 months ]

Enrollment: 43
Study Start Date: September 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: nonweightbearing exercise 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.
Placebo Comparator: nonexercising control Behavioral: nonexercising control
All subjects will be instructed, verbally and with written documents, regarding appropriate foot and skin care twice per month.
Experimental: weightbearing exercise 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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763087

Locations
United States, Missouri
Program in Physical Therapy, Washington University in St. Louis
St. Louis, Missouri, United States, 63108
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Michael J Mueller, PT, PhD Washington University in St. Louis, Program in Physical Therapy
  More Information

Responsible Party: Michael Mueller, PT, PhD, FAPTA, Washington University in St. Louis, Program in Physical Therapy
ClinicalTrials.gov Identifier: NCT00763087     History of Changes
Other Study ID Numbers: 06-0953
Study First Received: September 26, 2008
Last Updated: March 10, 2011

Keywords provided by Washington University School of Medicine:
diabetes mellitus
peripheral neuropathy
exercise

Additional relevant MeSH terms:
Diabetes Mellitus
Peripheral Nervous System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 21, 2017