Diabetes MellitusNCT00763087
Effect of Weight-Bearing Exercise on People With Diabetes and Neuropathic Feet
A study testing weightbearing exercise and nonweightbearing exercise in people with Diabetes Mellitus and Peripheral Neuropathy, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Diabetes Mellitus, Peripheral Neuropathy
- What is being tested?
- weightbearing exercise and nonweightbearing exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Program in Physical Therapy, Washington University in St. Louis
St Louis, Missouri, 63108
About this study
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.
Read the 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Diabetes Mellitus, Peripheral Neuropathy
- Being tested
- weightbearing exercise, nonweightbearing exercise, nonexercising control
- Keywords
- diabetes mellitus, peripheral neuropathy, exercise
- Medical subject headings
- Diabetes Mellitus, Peripheral Nervous System Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weightbearing exerciseBehavioural
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.
nonweightbearing exerciseBehavioural
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.
nonexercising controlBehavioural
All subjects will be instructed, verbally and with written documents, regarding appropriate foot and skin care twice per month.
| Study group | Role | What they receive |
|---|---|---|
| nonweightbearing exercise | Active comparator | Not described Receives: Behavioral: nonweightbearing exercise |
| nonexercising control | Placebo comparator | Not described Receives: Behavioral: nonexercising control |
| weightbearing exercise | Experimental | Not described Receives: Behavioral: weightbearing exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
daily step count
Measured: 3 months
Secondary outcomes (1)
skin breakdown
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael J Mueller, PT, PhD, Principal investigator, Washington University in St. Louis, Program in Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763087
- Sponsor's protocol ID
- 06-0953
- Status last verified
- Nov 2017
- First submitted
- 26 Sep 2008
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Weight-Bearing Exercise on People With Diabetes and Neuropathic Feet
- ClinicalTrials.gov ID
- NCT00763087
- Acronym / sponsor ID
- 06-0953
- Conditions
- Diabetes Mellitus, Peripheral Neuropathy
- Keywords
- diabetes mellitus, peripheral neuropathy, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
- 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.
- 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.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| nonweightbearing exercise | Active comparator | Behavioral: nonweightbearing exercise |
| nonexercising control | Placebo comparator | Behavioral: nonexercising control |
| weightbearing exercise | Experimental | Behavioral: weightbearing exercise |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| weightbearing exerciseAll 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. | Behavioural | weightbearing exercise |
| nonweightbearing exerciseAll 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. | Behavioural | nonweightbearing exercise |
| nonexercising controlAll subjects will be instructed, verbally and with written documents, regarding appropriate foot and skin care twice per month. | Behavioural | nonexercising control |
Primary outcome
daily step count
Time frame: 3 months
1 secondary outcome
skin breakdown
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Mueller, PT, PhD principal investigator
Washington University in St. Louis, Program in Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing weightbearing exercise and nonweightbearing exercise in people with Diabetes Mellitus and Peripheral Neuropathy, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
daily step count (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.