Diabetic NeuropathiesNCT00270842
Effect of Exercise on Gait and Balance in Peripheral Neuropathy
A study testing Tai Chi and Functional Balance in people with Diabetic Neuropathies and Peripheral Nerve Diseases, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to find out if participation in one of the study groups: functional balance training, Tai Chi, or education, results in better outcomes overall. The outcomes that we are primarily interested in are related to walking ability and balance. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Neuropathies, Peripheral Nerve Diseases, Peripheral Nervous System Diseases
- What is being tested?
- Tai Chi and Functional Balance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Sep 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Corrected vision not worse than 20/50 to have visual acuity to read and follow instructions.
- Ability to ambulate household distances with or without an assistive device. This reflects a minimum functional status for ambulation as primary mode of mobility.
- Symptoms and Signs consistent with LLPN as determined by the Michigan Diabetic Neuropathy Scale (Score greater than 6, presence of mild PN). The Michigan Diabetic Neuropathy Score quantifies sensory impairment, muscle strength, and reflexes, using vibration, filament, pin prick, and physical touch. Scale ranges from 0-46, with higher score indicating great severity of PN. The score is used to stratify severity of PN, and takes approximately 10-15 minutes to complete. Testing aspects elicit sensation from small and moderate nerve fibers, and is more sensitive to mild to moderate sensory neuropathy. This test was selected rather than the gold standard EMG in order to screen for study subjects, is less invasive, and reduces the burden of subject screening for inclusion into this study.
Who cannot join
- Cognitive impairment with MMSE score less than 24, level 24 and below scores indicated cognitive impairments, limiting ability to remember instructions.
- Metastatic cancer, limits ability to complete the intensity and duration of the study.
- Central neurological dysfunction e.g. diagnosis of hemiparesis, cerebellar dysfunction, Parkinson's disease as determined by medical record review. These neurological impairments impair gait and balance, and would jeopardize safety if randomized to an intervention group.
- Lower extremity amputation, a physical disability that results in altered postural balance.
- Lower extremity abnormality other than peripheral neuropathy, such as foot drop, as participation in class would compromise patient safety.
- Mobility limitations due to altered lower extremity skin integrity/ulcer, where pain would limit gait and weight-bearing would be contraindicated such as stasis and foot ulcers or claudication.
- Medically unstable upon exam, i.e. poorly controlled blood pressure and blood sugar, coronary artery disease, where group participation would compromise medical status.
Trial locations and contacts
1 site in 1 country.
United States1 site
James A. Haley Veterans Hospital
Tampa, Florida, 33637-1022
About this study
The purpose of this study is to find out if participation in one of the study groups: functional balance training, Tai Chi, or education, results in better outcomes overall. The outcomes that we are primarily interested in are related to walking ability and balance.
Read the detailed description
Since the 1970's, researchers and epidemiologists have documented that patient falls are a high-risk, high volume, high cost adverse events contributing to morbidity, mortality, decreased quality of life, and premature nursing home placement. Despite thousands of research studies published on patient falls, few studies have focused on the effectiveness of interventions , and fall rates and associated injuries among the elderly continue to rise. Impaired gait and balance (referred to as impaired stability) is one of the most significant causes and consequences of falls. Persons with peripheral neuropathy represent one of the largest patient populations with impaired stability. Lower limb peripheral neuropathy (LLPN) includes sensory and motor impairments that result in impaired gait and balance, jeopardizing safe mobility. Emerging evidence suggests that exercise programs can be effective in improving gait and balance in general fall risk populations, as well as reducing falls and fall-related injuries. Exercise interventions have been designed to reduce fall risk and promote successful aging. These interventions come in many forms, but the most common interventions are exercise training and Tai Chi, offered individually and in small group formats. Further research is needed to gain insight into the underlying mechanisms of different type of exercises and their impact on stability in veterans with LLPN. Research is needed to determine the type or combination of types of exercise to produce a more normal and/or stable gait in this high-risk patient population. Researchers are beginning to document that exercise interventions positively influence a person's fall self efficacy, i.e. self confidence for avoiding a fall, an important factor in understanding and examining a persons' behaviors related to fall risks. The emphasis on functionally based interventions has led to inappropriate broad groupings of older persons with mobility disorders. A weakness of previous studies was that they aggregated heterogeneous patient populations, resulting in neurological and musculoskeletal diagnostic heterogeneity and the confounding of results. Focusing on a homogeneous patient population is necessary to distinguish unique sensory, gait and balance deficits that contribute to impaired stability and mobility risk, as well as to better understand unique responses to treatment that are clouded when diverse patients are aggregated. We will target veterans with LLPN--one of the largest groups of patients referred to our Falls Clinic, and an understudied population with respect to safe patient mobility. This will allow us to design targeted interventions likely to be more effective than those tested on heterogeneous elderly populations, where visual and vestibular input to compensate for impaired proprioception were not taken into account.
The goal of this study is to improve successful adaptation to aging and quality of life in veterans with lower limb peripheral neuropathy (LLPN). Functional Balance Training and Tai Chi, the two exercise interventions tested in this study, have been documented to improve gait and balance, and decrease falls and associated fall-related injuries in the general elderly population. We are interested in whether one or both of these exercise interventions (successful in general elderly populations) would be effective in a special subpopulation of elderly, namely persons with LLPN.
The purpose of this study is to compare the effectiveness of these two exercise interventions and an education control group. Effectiveness will be assessed by studying the impact of interventions on (1) composite measures of stability (gait and balance), (2) fall self-efficacy, and (3) patient acceptance. Given the well-documented links between falls and fall-related injuries (ultimate outcomes) our study will focus on stability (intermediate outcome). Because falls and fall-related injuries are relatively rare events, examining stability as an outcome will allow us to have sufficient power to test our hypotheses with a relatively small sample size thereby decreasing the cost and duration of the study without sacrificing the rigor of the research design.
- Being tested
- Tai Chi, Functional Balance, Education Control group
- Keywords
- Education, Exercise, Gait, Peripheral Nervous System, Postural Balance, Self Efficacy, Tai Chi Chuan
- Medical subject headings
- Diabetic Neuropathies, 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.
Tai ChiBehavioural
This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet.
Functional BalanceBehavioural
This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet.
Education Control groupBehavioural
This control group participated in 10 weeks of general health education classes.
| Study group | Role | What they receive |
|---|---|---|
| Education Control Group | Placebo comparator | Education group that is the control group for the study. Is a 10 week course with diverse health education topics. Receives: Behavioral: Education Control group |
| Functional Balance Training | Experimental | Exercise group that participated in functional balance training Receives: Behavioral: Functional Balance |
| Tai chi | Experimental | Exercise Group that participated in tai chi training classes Receives: Behavioral: Tai Chi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait and Balance Measures
The Berg Balance Scale is a commonly used clinical, performance-based measure designed to evaluate performance during various balance activities in community dwelling and institutionalized older adults. The scale consists of 14 common daily balance tasks. Administration requires only minimal basic equipment and takes approximately 15 minutes. All 14 sub-tests are scored on a 5-point ordinal scale based on the subject's ability to perform the requested task safely and in a timely manner. Sub-test scores are summed to achieve a total score ranging from 0 to 56 with higher scores indicating better performance.
Measured: 10 weeks
Secondary outcomes (1)
Fall Self Efficacy
Fall Self Efficacy is operationalized as perceived self efficacy (i.e. self confidence) for avoiding a fall during 10 global, relatively non-hazardous activities of daily living (getting dressed and undressed, for example). Fall self efficacy manifests itself with different degrees of fear of falling, each with a unique associated risk level. The MFES is simple, quick, easy-to-administer scale that assesses a patient's self-reported ability to perform, without falling, each of 14 common activities of daily living in a Likert scale format. Total scale ranges from 0 to 140, the higher score indicated more confidence in ability to manage a fall.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2005 (estimated)
- Study startJan 2006
- Primary completionJan 2009
- Study completionSep 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Patricia A Quigley, PhD MPH, Principal investigator, James A. Haley Veterans Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00270842
- Sponsor's protocol ID
- O4006-R
- Status last verified
- Apr 2015
- First submitted
- 23 Dec 2005
- Last updated
- 8 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Quigley PA, Bulat T, Schulz B, Friedman Y, Hart-Hughes S, Richardson JK, Barnett S. Exercise interventions, gait, and balance in older subjects with distal symmetric polyneuropathy: a three-group randomized clinical trial. Am J Phys Med Rehabil. 2014 Jan;93(1):1-12; quiz 13-6. doi: 10.1097/PHM.0000000000000052.
PubMed 24355993
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise on Gait and Balance in Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT00270842
- Acronym / sponsor ID
- O4006-R
- Keywords
- Education, Exercise, Gait, Peripheral Nervous System, Postural Balance, Self Efficacy, Tai Chi Chuan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jan 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 28 Dec 2005 (estimated)
- Results
- Posted 8 Apr 2015
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 find out if participation in one of the study groups: functional balance training, Tai Chi, or education, results in better outcomes overall. The outcomes that we are primarily interested in are related to walking ability and balance.
Detailed description
Since the 1970's, researchers and epidemiologists have documented that patient falls are a high-risk, high volume, high cost adverse events contributing to morbidity, mortality, decreased quality of life, and premature nursing home placement. Despite thousands of research studies published on patient falls, few studies have focused on the effectiveness of interventions , and fall rates and associated injuries among the elderly continue to rise. Impaired gait and balance (referred to as impaired stability) is one of the most significant causes and consequences of falls. Persons with peripheral neuropathy represent one of the largest patient populations with impaired stability. Lower limb peripheral neuropathy (LLPN) includes sensory and motor impairments that result in impaired gait and balance, jeopardizing safe mobility. Emerging evidence suggests that exercise programs can be effective in improving gait and balance in general fall risk populations, as well as reducing falls and fall-related injuries. Exercise interventions have been designed to reduce fall risk and promote successful aging. These interventions come in many forms, but the most common interventions are exercise training and Tai Chi, offered individually and in small group formats. Further research is needed to gain insight into the underlying mechanisms of different type of exercises and their impact on stability in veterans with LLPN. Research is needed to determine the type or combination of types of exercise to produce a more normal and/or stable gait in this high-risk patient population. Researchers are beginning to document that exercise interventions positively influence a person's fall self efficacy, i.e. self confidence for avoiding a fall, an important factor in understanding and examining a persons' behaviors related to fall risks. The emphasis on functionally based interventions has led to inappropriate broad groupings of older persons with mobility disorders. A weakness of previous studies was that they aggregated heterogeneous patient populations, resulting in neurological and musculoskeletal diagnostic heterogeneity and the confounding of results. Focusing on a homogeneous patient population is necessary to distinguish unique sensory, gait and balance deficits that contribute to impaired stability and mobility risk, as well as to better understand unique responses to treatment that are clouded when diverse patients are aggregated. We will target veterans with LLPN--one of the largest groups of patients referred to our Falls Clinic, and an understudied population with respect to safe patient mobility. This will allow us to design targeted interventions likely to be more effective than those tested on heterogeneous elderly populations, where visual and vestibular input to compensate for impaired proprioception were not taken into account.
The goal of this study is to improve successful adaptation to aging and quality of life in veterans with lower limb peripheral neuropathy (LLPN). Functional Balance Training and Tai Chi, the two exercise interventions tested in this study, have been documented to improve gait and balance, and decrease falls and associated fall-related injuries in the general elderly population. We are interested in whether one or both of these exercise interventions (successful in general elderly populations) would be effective in a special subpopulation of elderly, namely persons with LLPN.
The purpose of this study is to compare the effectiveness of these two exercise interventions and an education control group. Effectiveness will be assessed by studying the impact of interventions on (1) composite measures of stability (gait and balance), (2) fall self-efficacy, and (3) patient acceptance. Given the well-documented links between falls and fall-related injuries (ultimate outcomes) our study will focus on stability (intermediate outcome). Because falls and fall-related injuries are relatively rare events, examining stability as an outcome will allow us to have sufficient power to test our hypotheses with a relatively small sample size thereby decreasing the cost and duration of the study without sacrificing the rigor of the research design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Education Control Group | Placebo comparator | Behavioral: Education Control groupEducation group that is the control group for the study. Is a 10 week course with diverse health education topics. |
| Functional Balance Training | Experimental | Behavioral: Functional BalanceExercise group that participated in functional balance training |
| Tai chi | Experimental | Behavioral: Tai ChiExercise Group that participated in tai chi training classes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Corrected vision not worse than 20/50 to have visual acuity to read and follow instructions.
- Ability to ambulate household distances with or without an assistive device. This reflects a minimum functional status for ambulation as primary mode of mobility.
- Symptoms and Signs consistent with LLPN as determined by the Michigan Diabetic Neuropathy Scale (Score greater than 6, presence of mild PN). The Michigan Diabetic Neuropathy Score quantifies sensory impairment, muscle strength, and reflexes, using vibration, filament, pin prick, and physical touch. Scale ranges from 0-46, with higher score indicating great severity of PN. The score is used to stratify severity of PN, and takes approximately 10-15 minutes to complete. Testing aspects elicit sensation from small and moderate nerve fibers, and is more sensitive to mild to moderate sensory neuropathy. This test was selected rather than the gold standard EMG in order to screen for study subjects, is less invasive, and reduces the burden of subject screening for inclusion into this study.
Key exclusion criteria (7 listed)
- Cognitive impairment with MMSE score less than 24, level 24 and below scores indicated cognitive impairments, limiting ability to remember instructions.
- Metastatic cancer, limits ability to complete the intensity and duration of the study.
- Central neurological dysfunction e.g. diagnosis of hemiparesis, cerebellar dysfunction, Parkinson's disease as determined by medical record review. These neurological impairments impair gait and balance, and would jeopardize safety if randomized to an intervention group.
- Lower extremity amputation, a physical disability that results in altered postural balance.
- Lower extremity abnormality other than peripheral neuropathy, such as foot drop, as participation in class would compromise patient safety.
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 |
|---|---|---|
| Tai ChiThis intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet. | Behavioural | Tai chi |
| Functional BalanceThis intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet. | Behavioural | Functional Balance Training |
| Education Control groupThis control group participated in 10 weeks of general health education classes. | Behavioural | Education Control Group |
Primary outcome
Gait and Balance Measures
Time frame: 10 weeks
The Berg Balance Scale is a commonly used clinical, performance-based measure designed to evaluate performance during various balance activities in community dwelling and institutionalized older adults. The scale consists of 14 common daily balance tasks. Administration requires only minimal basic equipment and takes approximately 15 minutes. All 14 sub-tests are scored on a 5-point ordinal scale based on the subject's ability to perform the requested task safely and in a timely manner. Sub-test scores are summed to achieve a total score ranging from 0 to 56 with higher scores indicating better performance.
1 secondary outcome
Fall Self Efficacy
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24355993Quigley PA, Bulat T, Schulz B, Friedman Y, Hart-Hughes S, Richardson JK, Barnett S. Exercise interventions, gait, and balance in older subjects with distal symmetric polyneuropathy: a three-group randomized clinical trial. Am J Phys Med Rehabil. 2014 Jan;93(1):1-12; quiz 13-6. doi: 10.1097/PHM.0000000000000052.
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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.
Patricia A Quigley, PhD MPH principal investigator
James A. Haley Veterans Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi and Functional Balance in people with Diabetic Neuropathies and Peripheral Nerve Diseases, run by US Department of Veterans Affairs 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 3 inclusion and 7 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 8 Apr 2015. 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?
Yes. Results are posted in the registry (first posted 8 Apr 2015). 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?
Gait and Balance Measures (time frame: 10 weeks). 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 NCT00270842, 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 8 Apr 2015.