Lifestyle Interventions for Vitality and Empowerment in Seniors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Executive Functioning
研究概览
简要总结
The goal of this clinical trial is to test a newer type of high intensity interval resistance training in adults 65 years of age or older. The main aims of this study are:
- To develop study procedures in order to conduct a randomized controlled trial to test the impact of high intensity interval training on cognition in older adults. We will develop procedures for recruitment, screening, data collection, blinded randomization, HIIRT and EA interventions, safety monitoring, and data analyses.
- To determine the feasibility of using high intensity interval resistance training as an intervention. Feasibility will be shown by; 1) recruiting the target population and meeting our overall patient accrual goal of 30 participants over a 12-week period, 2) achieving an average attendance rate of ≥ 70% of the 24 scheduled sessions in the HIIRT group, 3) at least 80% retention of participants at the final follow-up assessment (week 12), and 4) successful completion of the MRI task (finishing the session with a behavioral accuracy greater than 70%) by at least 80% of participants. Acceptability will be assessed via participants' ratings on a standardized measure of treatment satisfaction and reasons for dropout. Acceptability will be indicated in 2 ways: 70% of the participants report treatment satisfaction on a standard questionnaire, and consistent collection of follow-up data across sites.
- To examine causal mechanisms and preliminary efficacy. We will examine the relationships among several proposed mediators of the expected treatment effect. We will also examine the mean change and variability of our primary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Lives within 20 miles of the school
- •Does not plan to travel outside the home geographic area for an extended period during the study participation
- •Willing to provide informed consent
- •Willing to be randomized to either lifestyle intervention group
- •Willing to complete all study procedures and assessments
- •No contraindications to exercise
- •Capacity to complete physical exercise
排除标准
- •Dependent on walking device
- •Claustrophobia
- •Performs 30 minutes of moderate intensity exercise three times per week for the previous three months
- •Joint replacement or orthopedic surgery in the previous 6-months or planning to have surgery in the next 6-months
- •Uncontrolled hypertension
- •Pathological neurological condition
- •Parkinson's disease
- •Unstable depression, anxiety, or schizophrenia (medication changes in the past 6 months)
- •Experienced a concussion within the last 6 months
- •Respiratory disease requiring oxygen
- •Cancer requiring treatment
- •Osteoarthritis
- •Osteopenia or Osteoporosis
- •Body mass index under 18
- •Muscle wasting disease
- •Hypertrophic or dilated cardiomyopathy significant cardiovascular disease (NIHA Class III/IV congestive heart failure, aortic stenosis, history of cardiac arrest, uncontrolled angina)
- •Currently receiving physical therapy or cardiopulmonary rehabilitation
- •Type I or insulin dependent Type II Diabetes
- •Any implanted medical devices that are not compatible with fMRI scans (cardiac pacemaker or implanted cardiac defibrillator (ICD))
- •Metal shavings in eyes
- •Ferromagnetic piercings that cannot be taken out
- •Transdermal patches that cannot be removed
- •Cerebral aneurysm clip
- •>14 alcoholic drinks in one week
- •Not receiving medical clearance after PARQ+
- •Evidence of cognitive impairment (Scoring below 32 points on the Telephone Interview of Cognitive Status)
- •Site PI/Study Clinician discretion regarding medical status, appropriateness of participation or concern about intervention adherence, clinical judgement
结局指标
主要结局
Executive Functioning
时间窗: Baseline and 12-weeks
Executive Functioning will be operationalized as an index of several computer-based tasks assessing aspects of executive functioning: Inhibition (Stroop Test), Updating (The 4-part continuous performance task), and Switching (Shifting attention task, Symbol Digit Coding).
Gradual Continuous Performance Test
时间窗: Baseline and 12-weeks
Participants will make continuous responses to target picture stimuli (images of cities among distractor images of mountains). Periodically, a colored border will appear around each location, cuing the participant to attend to either the left or right picture stream. If the currently cued stream differs from their previous focus of attention, the participant will make a saccadic eye movement. At the same time as the color onset, a number will appear at each location. Participants will then make an even/odd discrimination for stimuli appearing at the to-be-attended location.
Functional Magnetic Resonance Imagining
时间窗: Baseline and 12-weeks
Participants will complete a 60-minute magnetic resonance imagining session during which will acquire a high-resolution anatomical scan, an echo planar image while participants complete the Gradual Continuous Performance Test. This task is a cognitive task designed to measure the neural correlates of moment-by-moment fluctuations in the efficacy of sustained attention and attention shifting readiness, termed attentional flexibility, a resting state scan, and a diffusion tensor imaging to measure white matter tract integrity.
次要结局
- Four-Part Continuous Performance Test(Baseline and 12-weeks)
- The Physical Activity Enjoyment Scale(Baseline and 12-weeks)
- Community Health Activities Model Program for Seniors Activity Questionnaire for Older Adults(Baseline and 12-weeks)
- Brain Derived Neurotrophic Factor(Baseline and 12-weeks)
- Basic Psychological Need Satisfaction and Frustration Scales(Baseline and 12-weeks)
- SF-36 Health Questionnaire(Baseline and 12-weeks)
- 400 Meter Walk Test(Baseline and 12-weeks)
- Short Physical Performance Battery(Baseline and 12-weeks)
- Stroop Test(Baseline and 12-weeks)
- Shifting Attention Test(Baseline and 12-weeks)
- Symbol Digit Coding(Baseline and 12-weeks)
研究者
Jeff Katula
Professor
Wake Forest University