Metabolic SyndromeNCT02633891
Metabolic Syndrome and Fall Risk
A study testing Balance exercise in people with Metabolic Syndrome and Autonomic Neuropathy, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Obesity and the metabolic syndrome (MetS) are rapidly growing problems. Individuals with the MetS are at risk for not only future chronic diseases, but they have a higher prevalence of neuropathy, including cardiac autonomic neuropathy, and have a higher incidence of falls. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Metabolic Syndrome, Autonomic Neuropathy
- What is being tested?
- Balance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2017to 28 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MetS at the time of screening based on the International Diabetes Federation definition
- No risk factors for other causes of neuropathy
- Autonomic neuropathy as defined by the Toronto Diabetic Neuropathy Expert Group 2010/11 consensus criteria
- Age 45-75 years inclusive at the time of screening
- Medically stable at the time of enrollment
- Able to participate in a standing balance exercise program without constant standby monitoring
Show all 9Show fewer
- Women of childbearing potential must be using an acceptable method of contraception for the duration of their participation in the study
- Willing to accept assignment to either training group
- Willing and able to participate in the assigned intervention program
Who cannot join
- Pregnant women, prisoners, institutionalized subjects and other at risk subjects
- Etiology of neuropathy other than the MetS
- History of severe medical conditions likely to shorten lifespan or alter ability to participate in the trial
- Severe autonomic neuropathy that restricts daily function and the ability to participate in study interventions
- An inability to understand or cooperate with the procedures of the trial or refusal to sign the informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
About this study
Obesity and the metabolic syndrome (MetS) are rapidly growing problems. Individuals with the MetS are at risk for not only future chronic diseases, but they have a higher prevalence of neuropathy, including cardiac autonomic neuropathy, and have a higher incidence of falls. Currently there are no effective therapies to prevent or reverse the neuropathy seen in the MetS or to reduced the fall risk in this population. This research project will determine if a tailored balance exercise program will have functional benefits and result in a reduced fall risk in the growing population of patients with the MetS and neuropathy.
Read the detailed description
Completed
55 participants with evidence of the MetS and autonomic neuropathy will be assessed for fall risk with the Four Square Step Test (FSST), which is a measure of dynamic standing balance. Additional endpoints include the dynamic gait index. Measures of height, weight, and waist circumference will be taken and an oral glucose tolerance test as well as lipids and blood pressure will also be measured. Autonomic function will be measured using cardiac autonomic testing, quantitative sudomotor axon reflex test and tilt table testing. Participants will be randomized into either a standard care group that will receive fall risk education or a targeted balance exercise intervention group. Both groups will meet once a week. The intervention group will receive a 12 week balance program with personalized incremental increases in the amount and difficulty of each maneuver.
- Conditions
- Metabolic Syndrome, Autonomic Neuropathy
- Being tested
- Balance exercise, Standard care
- Keywords
- neuropathies, metabolic diseases, nervous system diseases, peripheral nervous system diseases
- Medical subject headings
- Metabolic Syndrome, Metabolic Diseases, Nervous System Diseases, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance exerciseBehavioural
tailored balance exercise program
Standard careBehavioural
general health education and fall prevention classes
| Study group | Role | What they receive |
|---|---|---|
| Balance exercise program | Experimental | Participants will attend weekly group training sessions and will keep an exercise log of home activity during a three month exercise program designed to improve balance. Balance exercises will be performed three times per week in a home-based training program. Receives: Behavioral: Balance exercise |
| standard care | Active comparator | Participants will meet in person on a weekly basis for a general education class regarding health and fall prevention but will not participate in an exercise class. Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Four Square Step Test (FSST)
A measure of proactive dynamic standing balance. A participant steps over four canes that are laid on the ground at 90 degree angles to each other. The participants stands in one of the squares formed by the canes and they are instructed to step as quickly as possible into each square in a specified sequence.
Measured: 12 weeks
Secondary outcomes (1)
Dynamic Gait Index (DGI)
An instrumented DGI will be performed on an instrumented gait mat. The DGI is a measure of functional balance during walking and it assesses an individual's ability to modify balance while walking in the presence of external demands (walking while changing speeds, head turns, stepping over and around obstacles, pivoting, and stair climbing).
The short form DGI is scored 0-12, with higher number indicating better performance.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study start2 Jan 2017
- Primary completion28 Mar 2022
- Study completion28 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel treatments
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Maryland
- Responsible party
- Sponsor
- Investigators
- Lindsay A Zilliox, MD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633891
- Sponsor's protocol ID
- F1651-W
- Other IDs
- 1IK2RX001651-01A2
- Status last verified
- Mar 2024
- First submitted
- 15 Dec 2015
- Last updated
- 28 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Syndrome and Fall Risk
- ClinicalTrials.gov ID
- NCT02633891
- Acronym / sponsor ID
- F1651-W
- Conditions
- Metabolic Syndrome, Autonomic Neuropathy
- Keywords
- neuropathies, metabolic diseases, nervous system diseases, peripheral nervous system diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Maryland
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Posted 28 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity and the metabolic syndrome (MetS) are rapidly growing problems. Individuals with the MetS are at risk for not only future chronic diseases, but they have a higher prevalence of neuropathy, including cardiac autonomic neuropathy, and have a higher incidence of falls. Currently there are no effective therapies to prevent or reverse the neuropathy seen in the MetS or to reduced the fall risk in this population. This research project will determine if a tailored balance exercise program will have functional benefits and result in a reduced fall risk in the growing population of patients with the MetS and neuropathy.
Detailed description
Completed
55 participants with evidence of the MetS and autonomic neuropathy will be assessed for fall risk with the Four Square Step Test (FSST), which is a measure of dynamic standing balance. Additional endpoints include the dynamic gait index. Measures of height, weight, and waist circumference will be taken and an oral glucose tolerance test as well as lipids and blood pressure will also be measured. Autonomic function will be measured using cardiac autonomic testing, quantitative sudomotor axon reflex test and tilt table testing. Participants will be randomized into either a standard care group that will receive fall risk education or a targeted balance exercise intervention group. Both groups will meet once a week. The intervention group will receive a 12 week balance program with personalized incremental increases in the amount and difficulty of each maneuver.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- parallel treatments
| Arm | Type | Receives |
|---|---|---|
| Balance exercise program | Experimental | Behavioral: Balance exerciseParticipants will attend weekly group training sessions and will keep an exercise log of home activity during a three month exercise program designed to improve balance. Balance exercises will be performed three times per week in a home-based training program. |
| standard care | Active comparator | Behavioral: Standard careParticipants will meet in person on a weekly basis for a general education class regarding health and fall prevention but will not participate in an exercise class. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- MetS at the time of screening based on the International Diabetes Federation definition
- No risk factors for other causes of neuropathy
- Autonomic neuropathy as defined by the Toronto Diabetic Neuropathy Expert Group 2010/11 consensus criteria
- Age 45-75 years inclusive at the time of screening
- Medically stable at the time of enrollment
Key exclusion criteria (5 listed)
- Pregnant women, prisoners, institutionalized subjects and other at risk subjects
- Etiology of neuropathy other than the MetS
- History of severe medical conditions likely to shorten lifespan or alter ability to participate in the trial
- Severe autonomic neuropathy that restricts daily function and the ability to participate in study interventions
- An inability to understand or cooperate with the procedures of the trial or refusal to sign the informed consent
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 |
|---|---|---|
| Balance exercisetailored balance exercise program | Behavioural | Balance exercise program |
| Standard caregeneral health education and fall prevention classes | Behavioural | standard care |
Primary outcome
Four Square Step Test (FSST)
Time frame: 12 weeks
A measure of proactive dynamic standing balance. A participant steps over four canes that are laid on the ground at 90 degree angles to each other. The participants stands in one of the squares formed by the canes and they are instructed to step as quickly as possible into each square in a specified sequence.
1 secondary outcome
Dynamic Gait Index (DGI)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Lindsay A Zilliox, MD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance exercise in people with Metabolic Syndrome and Autonomic Neuropathy, run by VA Office of Research and Development 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 9 inclusion and 5 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 28 Jun 2024. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Four Square Step Test (FSST) (time frame: 12 weeks). 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 28 Jun 2024; AzTrials last refreshed its copy on 1 Nov 2026.