Development of Clinical Methods to Evaluate Neural Function in Aging (MIND)
2018년 4월 4일 업데이트: University of Florida
A primary focus of the University of Florida (UF) Claude D. Pepper Older Americans Independence Center (OAIC) is to build a comprehensive understanding of the causes and consequences of declining physical function and disability development among older adults.
To date investigators have largely focused on sarcopenia, the age-related decline in skeletal muscle mass and strength, as the primary contributor to physical decline.
However, recent findings indicate that changes in the central and/or peripheral nervous systems may play a larger role than previously thought in the development of functional limitations.
These fields hold extensive promise for identifying novel contributors to age-related functional decline.
Therefore, the overarching aim of this project is to develop the ability of RC1 to assess novel neural contributors to mobility and overall physical function.
Importantly, the development of these techniques will provide the RC1 with the tools to evaluate the potential involvement of the central and peripheral nervous systems in age-related functional decline and disablement.
The primary aim of this project is to develop techniques for quantifying peripheral motor unit number and size as well as spinal cord integrity.
연구 개요
상태
완전한
정황
상세 설명
As part of participation, the subjects will attend up to 4 visits. During the visits the following testing may occur:
- Vital signs (heart rate, blood pressure), height and weight will be measured.
Tests that assess your mobility and questions about physical function. These tests are listed below and will not be conducted in a particular order, and will take approximately 1.5 hours to complete.
- Walking tests,
Tests of physical ability that include:
- Standing up from chairs of different height
- Lying on the floor and rising to a standing position
- Kneeling on the floor and rising to standing position
- Climbing a flight of stairs
- Lift a weighted laundry basket and placing it on a shelf
- Muscle strength tests will be performed on the legs and arms.
- Questionnaires that address physical function.
- Muscle and nerve testing will be done.
- During the above testing, sensors will be worn on the forehead that use invisible light to indirectly measure blood flow and blood oxygen content of the brain. In addition, sensors may be worn the fingers that measure how the skin conducts electricity. A chest strap that measures heart beats will also be worn. These measures are safe and provide information about the nervous system responds to physical and/or mental challenges.
- Tests will be done that measure memory, attention, vocabulary, problem solving, and planning skills.
- A bone density and body composition measured (scanned) by the machine called DEXA. DEXA scans, like x-rays, are painless, and involve exposure to very small amounts of radiation.
- Images of the brain will be taken using magnetic resonance imaging (MRI). Magnetic resonance imaging (MRI) is a procedure that allows doctors to look inside the body by using a scanner that sends out a strong magnetic field and radio waves.
All of these test are done for this study and will not be used to diagnose or treat any medical problems.
The expected length of participation is approximately six hours total, over the course of 4 separate visits.
연구 유형
관찰
등록 (실제)
27
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Florida
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Gainesville, Florida, 미국, 32611
- UF Clinical Translational Research Building
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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
20년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
We propose to recruit 30 persons over 60 years of age who are classified as either high- or low functioning based on performance on the Short Physical Performance Battery (SPPB).
Participants with a SPPB score ≥ 11 will be categorized as high-functioning, while the low-functioning group will include participants with a SPPB score ≤ 8.
We will also recruit 15 persons between 20-30 years of age.
We will target cognitively intact (3MSE > 80) older adults who are free of overt neuromuscular impairments (no dementias, brain tumors, major depression, history of stroke, etc.).
설명
Inclusion Criteria:
- Age 60 years and older OR 20-30 years
- Higher functioning older adults: Score ≥ 11 on the Short Physical Performance Battery (SPPB)
- Lower functioning older adults: Score ≤ 8 on the SPPB
- Body mass index: 20-35 kg/m2 to ensure homogeneity and strength of signal for EMG and MRI analyses
- Willingness to participate in all study procedures
Exclusion Criteria:
- Failure to provide informed consent;
- Contraindications to MRI, such as claustrophobia, heart pacemaker / defibrillator, heart valve prosthesis, aneurysm clip, metallic stent, neurostimulation system, cochlear implants or inner ear prosthesis, insulin pump or other infusion pump, metal slivers in the orbital area/eye socket
- active treatment for cancer or history of cancer in the past year
- Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest or stroke, use of a cardiac defibrillator, or uncontrolled angina;
- previous stroke with upper and/or lower extremities involvement within the last 6 months
- history of life-threatening cardiac arrhythmias, stroke, severe Parkinson's disease or severe neurological disorders likely to interfere with physical function
- renal disease requiring dialysis
- lung disease requiring steroids
- lower extremity amputation
- severe osteoarthritis or rheumatoid arthritis that interferes with physical function
- complicated diabetes requiring insulin
- A known diagnosis of dementia
- Unable to communicate because of severe hearing loss or speech disorder;
- Severe visual impairment, which would preclude completion of the assessments and/or intervention;
- Simultaneous participation in another intervention trial
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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High-functioning older adults
Participants with a SPPB score ≥ 11 will be categorized as high-functioning.
The following test will be performed: Health and Quality of Life questionnaires, Mobility Assessments, Accelerometry, Body Composition (DEXA scan), Strength assessments, Neuromuscular stimulation, and Magnetic resonance imaging (MRI).
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Participants with a SPPB score ≥ 11 will be categorized as high-functioning.
The following test will be performed: Health and Quality of Life questionnaires, Mobility Assessments, Accelerometry, Body Composition (DEXA scan), Strength assessments, Neuromuscular stimulation, and Magnetic resonance imaging (MRI).
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Lower-functioning older adults
Participants with a SPPB score ≤ 8 will be categorized as lower-functioning.
The following test will be performed: Health and Quality of Life questionnaires, Mobility Assessments, Accelerometry, Body Composition (DEXA scan), Strength assessments, Neuromuscular stimulation, and Magnetic resonance imaging (MRI).
|
Participants with a SPPB score ≤ 8 will be categorized as lower-functioning.
The following test will be performed: Health and Quality of Life questionnaires, Mobility Assessments, Accelerometry, Body Composition (DEXA scan), Strength assessments, Neuromuscular stimulation, and Magnetic resonance imaging (MRI).
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Young adults
Participants between the 20 - 30 years of age.
The following test will be performed: Health and Quality of Life questionnaires, Mobility Assessments, Accelerometry, Body Composition (DEXA scan), Strength assessments, Neuromuscular stimulation, and Magnetic resonance imaging (MRI).
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Participants between the 20 - 30 years of age.
The following test will be performed: Health and Quality of Life questionnaires, Mobility Assessments, Accelerometry, Body Composition (DEXA scan), Strength assessments, Neuromuscular stimulation, and Magnetic resonance imaging (MRI).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Neuromuscular integrity by motor unit function
기간: Baseline
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Tasks that require prolonged muscle force are carried out by slow, fatigue-resistant motor units, while tasks that require a quick but short increase in muscle force are mostly performed by fast motor units.
Many of the postural muscles have a large proportion of S motor units.
On the other hand, muscles that participate in quick limb movements such as kicking, hitting, or catching typically have a large proportion of FR and FF motor units.
Most muscles, however, have a relatively wide range of the various motor units, reflecting their participation in a variety of motor tasks.
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Baseline
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Structural integrity of the brain and spinal cord
기간: Baseline
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Magnetic resonance (MR)-based
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Baseline
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Thomas Buford, PhD, University of Florida
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)
2015년 9월 1일
기본 완료 (실제)
2016년 12월 1일
연구 완료 (실제)
2017년 6월 2일
연구 등록 날짜
최초 제출
2014년 2월 25일
QC 기준을 충족하는 최초 제출
2014년 2월 25일
처음 게시됨 (추정)
2014년 2월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 4월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 4월 4일
마지막으로 확인됨
2018년 4월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- IRB201300835-N
- 2P30AG028740 (미국 NIH 보조금/계약)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .