Enhance Balance and Mobility in People With Type 2 Diabetic Peripheral Neuropathy (DPN)
2022년 1월 14일 업데이트: Odessa Addison, DPT, PhD, University of Maryland, Baltimore
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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
3
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Maryland
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Baltimore, Maryland, 미국, 21201
- VA Maryland Health Care System
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Baltimore, Maryland, 미국, 21201-1082
- University of Maryland School of Medicine
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
55년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Muscle, Balance, and aerobic exercise
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Muscle size as determined with a CT Scan from baseline to 3 months and baseline to 6 months
기간: baseline, 3 months, and 6 months
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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.
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baseline, 3 months, and 6 months
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Change in leg muscle strength as determined with a physiological test from baseline to 3 months and baseline to 6 months
기간: baseline, 3 months, and 6 months
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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.
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baseline, 3 months, and 6 months
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Change in cardiac autonomic neuropathy as determined by heart rate variability from baseline to 3 months and baseline to 6 months
기간: baseline, 3 months, and 6 months
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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.
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baseline, 3 months, and 6 months
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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
기간: baseline, 3 months, and 6 months
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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.
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baseline, 3 months, and 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in clinical balance as measured by the Four Square Step Test
기간: baseline, 3 months, and 6 months
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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.
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baseline, 3 months, and 6 months
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Change in mobility as measured by the modified physical performance test
기간: baseline, 3 months, and 6 months
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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.
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baseline, 3 months, and 6 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Odessa Addison, PhD, University of Maryland, Baltimore
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 5월 1일
기본 완료 (실제)
2017년 12월 1일
연구 완료 (실제)
2017년 12월 1일
연구 등록 날짜
최초 제출
2015년 9월 1일
QC 기준을 충족하는 최초 제출
2015년 9월 2일
처음 게시됨 (추정)
2015년 9월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 1월 31일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 1월 14일
마지막으로 확인됨
2022년 1월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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