Diabetes MellitusPhase 1NCT00286598
Feet First: Promoting Physical Activity Among People With Diabetes Mellitus and Insensate Feet
A Phase 1 study testing Feet First in people with Diabetes Mellitus and Peripheral Neuropathies, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The role of weight-bearing physical activity in the development of diabetic foot ulcers remains poorly understood. Regular participation in moderately intense physical activity (e.g. brisk walking ) reduces 8-year cardiovascular mortality in those with diabetes mellitus by over 30%. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Diabetes Mellitus, Peripheral Neuropathies
- What is being tested?
- Feet First
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jun 2008
- Phase
- Phase 1
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed type 1 or 2 diabetes mellitus
- Age 50 years or older
- Absent 5.07 Semmes Weinstein monofilament sensation to > 1 point on both feet
- Residence within 50 miles of Columbia, MO
- Functioning telephone service
- Not currently participating in 20 or more minutes of moderately intense activity more than twice a week
Who cannot join
- Hospitalization in the last year for any of the following reasons:
- Proliferative diabetic retinopathy
- Accelerated hypertension (systolic BP >200 or diastolic BP > 120)
- Myocardial infarction or unstable angina
- New hemodynamically significant arrhythmia
- Acute congestive heart failure
Show all 13Show fewer
- Failure to attend 3 of the last 5 scheduled clinic visits
- Foot deformities requiring a custom shoe
- "Timed Up and Go" test 3 > 15 seconds Subjects unable to ambulate without assistance
- Severe cardiac autonomic neuropathy
- Lower extremity amputation > one digit
- Heart, kidney or other transplant
- Currently unhealed foot ulcer (or healed for less than 1 month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feet First: Increasing Activity Without Increasing the Risk of Foot Ulcers in People With Diabetes and Insensate Feet
The role of weight-bearing physical activity in the development of diabetic foot ulcers remains poorly understood. Regular participation in moderately intense physical activity (e.g. brisk walking ) reduces 8-year cardiovascular mortality in those with diabetes mellitus by over 30%. The American Diabetes Association (ADA) recommends at least 30 minutes of daily moderate intensity activity for people with diabetes. However, the ADA recommends that people with diabetes and insensate feet, which affects up to 40% of those with diabetes, should limit their walking because of concerns that walking could increase the risk of foot ulcers and amputation. Firm evidence is lacking to support these concerns; in fact, while a research fellow I conducted an observational study that showed daily weight-bearing activity may reduce the risk of foot ulceration among people with diabetic foot problems. A controlled clinical trial is needed to study these issues further.
The present study is a randomized controlled trial in 100 older adults with diabetes and insensate feet, 50 of whom will participate in an individually-tailored behavior-change intervention called "Feet First", and 50 of whom will be controls. The intervention is based on the extensively-tested CHAMPS model used by the Robert Wood Johnson Foundation's Active for Life Program. Feet First extends the target population beyond older adults generally to people with insensate feet due to diabetic peripheral neuropathy.
Read more
The specific aims of the study are:
- To determine whether Feet First intervention subjects achieve a greater increase in weight-bearing activity than control subjects, and
- To obtain preliminary evidence on intervention subjects' foot outcomes (foot function, foot-related self-care, and risk of foot ulcers), compared to control subjects.
Read the detailed description
Physical activity is a vital component of self-management for patients with diabetes mellitus, yet there are special problems in patients whose disease is complicated by insensate feet (i.e. loss of protective sensation caused by diabetic distal symmetric sensory peripheral neuropathy). Foot ulcers develop in 15% of the 17 million people in the United States with diabetes mellitus, and contribute to 84% of foot or toe amputations. Foot ulcer risk is very high among those with insensate feet. Although the roles of neuropathy, plantar foot pressure, and footwear in foot ulcers have been extensively studied, the independent role of physical activity has not. The overall goal of this study is to determine whether a "lifestyle" physical activity intervention, based on the Second Community Healthy Activities Model Program for Seniors (CHAMPS II), which we call FEET FIRST, can be used to safely increase moderate-intensity physical activity (achieving at least 40% of maximal oxygen consumption, as in walking briskly) among people with diabetes and insensate feet. "Lifestyle" physical activity interventions help participants to accumulate at least 30 minutes of self-selected activities in short bouts during the day. CHAMPS II effectively and safely increased physical activity in sedentary older adults with multiple chronic illnesses.
Substantial research has also found that people with diabetic peripheral neuropathy are also at increased risk of falls. Diabetic peripheral neuropathy also leads to postural instability, i.e. impairment in measures of functional dynamic balance. Moreover, this instability worsens with age. People with diabetic peripheral neuropathy in particular tend to have ankle instability due to decreased proprioception, making them less able to rapidly recover balance during sudden ankle dorsiflexion, inversion or eversion when walking on uneven surfaces.
There is ample evidence that promotion of an active lifestyle and specific exercises targeting endurance, strength and balance improves reduces functional decline in the elderly, and that home-based exercise programs effectively decrease fall risk in the elderly as well. One small, non-randomized trial found preliminary evidence that a 3-week intervention that focused on ankle strength improved balance measures in those with diabetic peripheral neuropathy. However, no randomized studies have investigated the effect of a physical activity intervention on fall risk in community-dwelling people with diabetic peripheral neuropathy, who may also be at increased risk of cutaneous injuries (i.e. foot lesions) during weight-bearing activity. Before we unequivocally recommend to people with diabetic peripheral neuropathy that they engage in exercise, we need to determine that this will be safe for their feet, and not increase fall risk.
- Conditions
- Diabetes Mellitus, Peripheral Neuropathies
- Being tested
- Feet First
- Keywords
- foot ulcer, diabetes mellitus, motor activity, randomized controlled trial, prevention
- Medical subject headings
- Diabetes Mellitus, Peripheral Nervous System Diseases, Foot Ulcer, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feet FirstBehavioural
Phase 1: (enrollment to 3 months) 8 sessions with a physical therapist learning leg strengthening and balance exercises, and initiating a walking program Phase 2: Motivational enhancement calls from a nurse every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Feet First | Experimental | Phase 1: (enrollment to 3 months) 8 sessions with a physical therapist learning leg strengthening and balance exercises, and initiating a walking program Phase 2: Motivational enhancement calls from a nurse every 2 weeks. Receives: Behavioral: Feet First |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight-bearing physical activity (steps/day)
Measured: Baseline, 3, 6 and 12 months post-enrollment
Secondary outcomes (4)
Partial or greater depth foot ulcer (Wagner Gr. 1 or deeper)
Measured: continuously post-enrollment for 12 months
Falls
Measured: continuously post-enrollment for 12 months
Self-reported foot disability
Measured: baseline, 6 and 12 months post enrollment
Foot-related self-care
Measured: baseline, 6 and 12 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2006 (estimated)
- Study startJan 2005
- Primary completionJun 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Sponsor
- Investigators
- Joseph W LeMaster, MD, MPH, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286598
- Sponsor's protocol ID
- UMHS IRB 1040047
- Status last verified
- Oct 2016
- First submitted
- 1 Feb 2006
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kruse RL, Lemaster JW, Madsen RW. Fall and balance outcomes after an intervention to promote leg strength, balance, and walking in people with diabetic peripheral neuropathy: "feet first" randomized controlled trial. Phys Ther. 2010 Nov;90(11):1568-79. doi: 10.2522/ptj.20090362. Epub 2010 Aug 26.
PubMed 20798179
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feet First: Increasing Activity Without Increasing the Risk of Foot Ulcers in People With Diabetes and Insensate Feet
- ClinicalTrials.gov ID
- NCT00286598
- Acronym / sponsor ID
- UMHS IRB 1040047
- Conditions
- Diabetes Mellitus, Peripheral Neuropathies
- Keywords
- foot ulcer, diabetes mellitus, motor activity, randomized controlled trial, prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Jan 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 3 Feb 2006 (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 role of weight-bearing physical activity in the development of diabetic foot ulcers remains poorly understood. Regular participation in moderately intense physical activity (e.g. brisk walking ) reduces 8-year cardiovascular mortality in those with diabetes mellitus by over 30%. The American Diabetes Association (ADA) recommends at least 30 minutes of daily moderate intensity activity for people with diabetes. However, the ADA recommends that people with diabetes and insensate feet, which affects up to 40% of those with diabetes, should limit their walking because of concerns that walking could increase the risk of foot ulcers and amputation. Firm evidence is lacking to support these concerns; in fact, while a research fellow I conducted an observational study that showed daily weight-bearing activity may reduce the risk of foot ulceration among people with diabetic foot problems. A controlled clinical trial is needed to study these issues further.
The present study is a randomized controlled trial in 100 older adults with diabetes and insensate feet, 50 of whom will participate in an individually-tailored behavior-change intervention called "Feet First", and 50 of whom will be controls. The intervention is based on the extensively-tested CHAMPS model used by the Robert Wood Johnson Foundation's Active for Life Program. Feet First extends the target population beyond older adults generally to people with insensate feet due to diabetic peripheral neuropathy.
The specific aims of the study are:
- To determine whether Feet First intervention subjects achieve a greater increase in weight-bearing activity than control subjects, and
- To obtain preliminary evidence on intervention subjects' foot outcomes (foot function, foot-related self-care, and risk of foot ulcers), compared to control subjects.
Detailed description
Physical activity is a vital component of self-management for patients with diabetes mellitus, yet there are special problems in patients whose disease is complicated by insensate feet (i.e. loss of protective sensation caused by diabetic distal symmetric sensory peripheral neuropathy). Foot ulcers develop in 15% of the 17 million people in the United States with diabetes mellitus, and contribute to 84% of foot or toe amputations. Foot ulcer risk is very high among those with insensate feet. Although the roles of neuropathy, plantar foot pressure, and footwear in foot ulcers have been extensively studied, the independent role of physical activity has not. The overall goal of this study is to determine whether a "lifestyle" physical activity intervention, based on the Second Community Healthy Activities Model Program for Seniors (CHAMPS II), which we call FEET FIRST, can be used to safely increase moderate-intensity physical activity (achieving at least 40% of maximal oxygen consumption, as in walking briskly) among people with diabetes and insensate feet. "Lifestyle" physical activity interventions help participants to accumulate at least 30 minutes of self-selected activities in short bouts during the day. CHAMPS II effectively and safely increased physical activity in sedentary older adults with multiple chronic illnesses.
Substantial research has also found that people with diabetic peripheral neuropathy are also at increased risk of falls. Diabetic peripheral neuropathy also leads to postural instability, i.e. impairment in measures of functional dynamic balance. Moreover, this instability worsens with age. People with diabetic peripheral neuropathy in particular tend to have ankle instability due to decreased proprioception, making them less able to rapidly recover balance during sudden ankle dorsiflexion, inversion or eversion when walking on uneven surfaces.
There is ample evidence that promotion of an active lifestyle and specific exercises targeting endurance, strength and balance improves reduces functional decline in the elderly, and that home-based exercise programs effectively decrease fall risk in the elderly as well. One small, non-randomized trial found preliminary evidence that a 3-week intervention that focused on ankle strength improved balance measures in those with diabetic peripheral neuropathy. However, no randomized studies have investigated the effect of a physical activity intervention on fall risk in community-dwelling people with diabetic peripheral neuropathy, who may also be at increased risk of cutaneous injuries (i.e. foot lesions) during weight-bearing activity. Before we unequivocally recommend to people with diabetic peripheral neuropathy that they engage in exercise, we need to determine that this will be safe for their feet, and not increase fall risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feet First | Experimental | Behavioral: Feet FirstPhase 1: (enrollment to 3 months) 8 sessions with a physical therapist learning leg strengthening and balance exercises, and initiating a walking program Phase 2: Motivational enhancement calls from a nurse every 2 weeks. |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed type 1 or 2 diabetes mellitus
- Age 50 years or older
- Absent 5.07 Semmes Weinstein monofilament sensation to > 1 point on both feet
- Residence within 50 miles of Columbia, MO
- Functioning telephone service
Key exclusion criteria (13 listed)
- Hospitalization in the last year for any of the following reasons:
- Proliferative diabetic retinopathy
- Accelerated hypertension (systolic BP >200 or diastolic BP > 120)
- Myocardial infarction or unstable angina
- New hemodynamically significant arrhythmia
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 |
|---|---|---|
| Feet FirstPhase 1: (enrollment to 3 months) 8 sessions with a physical therapist learning leg strengthening and balance exercises, and initiating a walking program Phase 2: Motivational enhancement calls from a nurse every 2 weeks. | Behavioural | Feet First |
Primary outcome
Change in weight-bearing physical activity (steps/day)
Time frame: Baseline, 3, 6 and 12 months post-enrollment
4 secondary outcomes
Partial or greater depth foot ulcer (Wagner Gr. 1 or deeper)
Time frame: continuously post-enrollment for 12 months
Falls
Time frame: continuously post-enrollment for 12 months
Self-reported foot disability
Time frame: baseline, 6 and 12 months post enrollment
Foot-related self-care
Time frame: baseline, 6 and 12 months post enrollment
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 5 Oct 2016.
- Derived from this study: PubMed 20798179Kruse RL, Lemaster JW, Madsen RW. Fall and balance outcomes after an intervention to promote leg strength, balance, and walking in people with diabetic peripheral neuropathy: "feet first" randomized controlled trial. Phys Ther. 2010 Nov;90(11):1568-79. doi: 10.2522/ptj.20090362. Epub 2010 Aug 26.
- Individual participant dataSharing planned: No
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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.
Joseph W LeMaster, MD, MPH principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Feet First in people with Diabetes Mellitus and Peripheral Neuropathies, run by University of Missouri-Columbia 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 6 inclusion and 13 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 5 Oct 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in weight-bearing physical activity (steps/day) (time frame: Baseline, 3, 6 and 12 months post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00286598, which also lists 1 linked publication.
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 5 Oct 2016.