Diabetes ComplicationsDPNNCT02541838
Enhance Balance and Mobility in People With Type 2 Diabetic Peripheral Neuropathy
A study testing Muscle power, balance perturbation and aerobic exercise in people with Diabetes Complications and Diabetic Neuropathies, run by University of Maryland, Baltimore at 2 sites in United States.
Trial summary
Type 2 diabetes results in a host of neuromuscular, muscular, and autonomic system impairments that accelerate age-associated limitations in functional independence and the risk of falls. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Diabetes Complications, Diabetic Neuropathies
- What is being tested?
- Muscle power, balance perturbation and aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2016to Dec 2017
- 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HbA1C of 5.7% to 9.0% or a fasting blood glucose of greater than or equal to 100
- Participants that are diabetic should be stable on medications for at least 3 months prior to entering the study
- Neuropathy is most likely caused by impaired glucose regulation determined by medical or family history
- Autonomic neuropathy as defined by Toronto Neuropathy Expert Group 2010/2011 consensus criteria
- Medically stable at time of enrollment as determined by screening process
Who cannot join
- Neuropathy due to factors other than impaired glucose regulation determined by screening process
- Other severe medical illness or condition that would preclude safe participation in the study as determined by the study team
- Severe Autonomic Neuropathy that would limit study participation
- Musculoskeletal limitations that would preclude participation in balance assessment of protective stepping
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland School of Medicine
Baltimore, Maryland, 21201-1082
VA Maryland Health Care System
Baltimore, Maryland, 21201
About this study
Official title: High Intensity Muscle Power and Balance Perturbation Training to Enhance Balance and Mobility in People With Type 2 Diabetic Peripheral Neuropathy
Type 2 diabetes results in a host of neuromuscular, muscular, and autonomic system impairments that accelerate age-associated limitations in functional independence and the risk of falls. Diabetic peripheral neuropathy (DPN) contributes to functional declines in balance and mobility because of limitations metabolic abnormalities. The constellation of impairments accompanying type 2 diabetes diminishes muscle function and performance including strength and power. Loss of strength at higher speeds of movement (deficit in power) occurs in neural activation of muscles, changes in muscle properties, and through in older individuals with DPN compared to older controls. Consequently, this deficit in speed dependent muscle power production leads to limitations in rapidly responding to sudden loss of balance stability to prevent falling. The goal of this pilot research program is to determine the feasibility and effectiveness of a mechanism-based therapeutic intervention fro improving balance and mobility functions and preventing falls in older adults with DPN. The investigators pan to use the results from this pilot study to design and implement a larger randomized control trial.
Read the detailed description
The long-term goal of this research is to establish the effectiveness of a mechanism-based therapeutic intervention for improving balance and mobility functions and preventing falls in older adults with type 2 diabetic peripheral neuropathy (DPN).
Specific Aim 1 will determine if combined high intensity isolated leg muscle power exercise with balance perturbation training (ActiveStep) and aerobic exercise achieves greater improvements in balance stabilization (protective stepping behavior and kinematics) and mobility function (gait parameters and timed functional measures) than a lifestyle based intervention that primarily focuses on aerobic exercise through underlying mechanisms of improved neuromuscular activation (rate and magnitude) and sensorimotor control, improved muscle quality, and increased blood flow to enhance neuromuscular and sensorimotor performance in people with DPN.
Specific Aim #2: To determine if a neuromotor balance training program combined with muscle power exercise training and aerobic exercise, leading to improved neuromuscular and sensorimotor mechanisms, is more effective in improving clinical tests of balance and mobility functions in those with DPN compared with a traditional exercise intervention.
- Conditions
- Diabetes Complications, Diabetic Neuropathies
- Being tested
- Muscle power, balance perturbation, aerobic exercise
- Keywords
- Autonomic Neuropathy, diabetes, balance control
- Medical subject headings
- Diabetes Complications, Diabetic Neuropathies, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle powerOther
balance perturbationOther
aerobic exerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Muscle, Balance, and aerobic exercise | Experimental | This trial will have a single experimental arm that will include the following interventions: Leg muscle strengthening, balance training using balance perturbations, and aerobic exercise. All individuals in this trial will receive all interventions listed. Receives: Other: Muscle power; Other: balance perturbation; Other: aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Muscle size as determined with a CT Scan from baseline to 3 months and baseline to 6 months
A Computed Tomography Scan will be used to measure the cross sectional area of the leg muscles in cm. Changes from baseline to 3 and 6 months will be examined.
Measured: baseline, 3 months, and 6 months
Change in leg muscle strength as determined with a physiological test from baseline to 3 months and baseline to 6 months
A strength testing machine will be used to test the strength of the legs in newton meters. Changes from baseline to 3 and 6 months will be examined.
Measured: baseline, 3 months, and 6 months
Change in cardiac autonomic neuropathy as determined by heart rate variability from baseline to 3 months and baseline to 6 months
heart rate variability will be measured by placing electrodes near the heart similar to an EKG. Changes in heart rate variability from baseline to 3 and 6 months will be examined.
Measured: baseline, 3 months, and 6 months
Change in protective stepping as determined by the number of steps it take to recover from a balance perturbation from baseline to 3 months and baseline to 6 months
A machine that pulls individuals side to side will be used to measure the number of steps required to recover balance after a pull. Changes from baseline to 3 and 6 months will be examined.
Measured: baseline, 3 months, and 6 months
Secondary outcomes (2)
Change in clinical balance as measured by the Four Square Step Test
The Four Square Step Test (FSST) will be used to evaluate changes in clinical balance. The FSST is a single item, evaluator-administered tool that assesses the ability to change directions while stepping. It requires the individuals to move in the anterior-posterior and medial-lateral directions while stepping. Changes from baseline to 3 and 6 months will be examined.
Measured: baseline, 3 months, and 6 months
Change in mobility as measured by the modified physical performance test
The modified physical performance test will be used to evaluate changes in mobility. This test requires individuals to perform a variety of every day tests such as going up and down the stairs, standing from a chair, and putting on a coat. Changes from baseline to 3 and 6 months will be examined.
Measured: baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startMay 2016
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes ComplicationsStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- VA Maryland Health Care System
- Responsible party
- Principal investigator, Odessa Addison, DPT, PhD, University of Maryland, Baltimore
- Investigators
- Odessa Addison, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541838
- Sponsor's protocol ID
- HP-00064233
- Acronym
- DPN
- Status last verified
- Jan 2022
- First submitted
- 1 Sep 2015
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Muscle Power and Balance Perturbation Training to Enhance Balance and Mobility in People With Type 2 Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT02541838
- Acronym / sponsor ID
- DPN / HP-00064233
- Conditions
- Diabetes Complications, Diabetic Neuropathies
- Keywords
- Autonomic Neuropathy, diabetes, balance control
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- VA Maryland Health Care System
- Study start
- May 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 4 Sep 2015 (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.
Type 2 diabetes results in a host of neuromuscular, muscular, and autonomic system impairments that accelerate age-associated limitations in functional independence and the risk of falls. Diabetic peripheral neuropathy (DPN) contributes to functional declines in balance and mobility because of limitations metabolic abnormalities. The constellation of impairments accompanying type 2 diabetes diminishes muscle function and performance including strength and power. Loss of strength at higher speeds of movement (deficit in power) occurs in neural activation of muscles, changes in muscle properties, and through in older individuals with DPN compared to older controls. Consequently, this deficit in speed dependent muscle power production leads to limitations in rapidly responding to sudden loss of balance stability to prevent falling. The goal of this pilot research program is to determine the feasibility and effectiveness of a mechanism-based therapeutic intervention fro improving balance and mobility functions and preventing falls in older adults with DPN. The investigators pan to use the results from this pilot study to design and implement a larger randomized control trial.
Detailed description
The long-term goal of this research is to establish the effectiveness of a mechanism-based therapeutic intervention for improving balance and mobility functions and preventing falls in older adults with type 2 diabetic peripheral neuropathy (DPN).
Specific Aim 1 will determine if combined high intensity isolated leg muscle power exercise with balance perturbation training (ActiveStep) and aerobic exercise achieves greater improvements in balance stabilization (protective stepping behavior and kinematics) and mobility function (gait parameters and timed functional measures) than a lifestyle based intervention that primarily focuses on aerobic exercise through underlying mechanisms of improved neuromuscular activation (rate and magnitude) and sensorimotor control, improved muscle quality, and increased blood flow to enhance neuromuscular and sensorimotor performance in people with DPN.
Specific Aim #2: To determine if a neuromotor balance training program combined with muscle power exercise training and aerobic exercise, leading to improved neuromuscular and sensorimotor mechanisms, is more effective in improving clinical tests of balance and mobility functions in those with DPN compared with a traditional exercise intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Muscle, Balance, and aerobic exercise | Experimental | Other: Muscle power, Other: balance perturbation, Other: aerobic exerciseThis trial will have a single experimental arm that will include the following interventions: Leg muscle strengthening, balance training using balance perturbations, and aerobic exercise. All individuals in this trial will receive all interventions listed. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HbA1C of 5.7% to 9.0% or a fasting blood glucose of greater than or equal to 100
- Participants that are diabetic should be stable on medications for at least 3 months prior to entering the study
- Neuropathy is most likely caused by impaired glucose regulation determined by medical or family history
- Autonomic neuropathy as defined by Toronto Neuropathy Expert Group 2010/2011 consensus criteria
- Medically stable at time of enrollment as determined by screening process
Key exclusion criteria (4 listed)
- Neuropathy due to factors other than impaired glucose regulation determined by screening process
- Other severe medical illness or condition that would preclude safe participation in the study as determined by the study team
- Severe Autonomic Neuropathy that would limit study participation
- Musculoskeletal limitations that would preclude participation in balance assessment of protective stepping
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 |
|---|---|---|
| Muscle power | Other | Muscle, Balance, and aerobic exercise |
| balance perturbation | Other | Muscle, Balance, and aerobic exercise |
| aerobic exercise | Other | Muscle, Balance, and aerobic exercise |
Primary outcome
Change in Muscle size as determined with a CT Scan from baseline to 3 months and baseline to 6 months
Time frame: baseline, 3 months, and 6 months
A Computed Tomography Scan will be used to measure the cross sectional area of the leg muscles in cm. Changes from baseline to 3 and 6 months will be examined.
Change in leg muscle strength as determined with a physiological test from baseline to 3 months and baseline to 6 months
Time frame: baseline, 3 months, and 6 months
A strength testing machine will be used to test the strength of the legs in newton meters. Changes from baseline to 3 and 6 months will be examined.
Change in cardiac autonomic neuropathy as determined by heart rate variability from baseline to 3 months and baseline to 6 months
Time frame: baseline, 3 months, and 6 months
heart rate variability will be measured by placing electrodes near the heart similar to an EKG. Changes in heart rate variability from baseline to 3 and 6 months will be examined.
Change in protective stepping as determined by the number of steps it take to recover from a balance perturbation from baseline to 3 months and baseline to 6 months
Time frame: baseline, 3 months, and 6 months
A machine that pulls individuals side to side will be used to measure the number of steps required to recover balance after a pull. Changes from baseline to 3 and 6 months will be examined.
2 secondary outcomes
Change in clinical balance as measured by the Four Square Step Test
Time frame: baseline, 3 months, and 6 months
Change in mobility as measured by the modified physical performance test
Time frame: baseline, 3 months, and 6 months
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
- 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.
Odessa Addison, PhD principal investigator
University of Maryland, Baltimore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle power, balance perturbation and aerobic exercise in people with Diabetes Complications and Diabetic Neuropathies, run by University of Maryland, Baltimore at 2 sites 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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
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 Muscle size as determined with a CT Scan from baseline to 3 months and baseline to 6 months (time frame: baseline, 3 months, and 6 months). The study lists 4 primary outcomes in all. 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 31 Jan 2022.