Inspiring Seniors Towards Exercise Promotion - 2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Daily duration of aerobic and strenght training as recorded on an Exercise Log
研究概览
简要总结
Older adults' low adherence to the national physical activity guidelines may stem from a failure to increase positive affective responses to exercise (e.g., enjoyment). Exercising with personalized, tempo-synchronous music playlists has shown promising effects on physical activity promotion in midlife-to-older adults during a cardiac rehab program. The purpose of this study is to determine how personalized, tempo-synchronous music playlists called rhythmic auditory stimulation (RAS) influence exercise behavior change and affective responses to exercise over 8 months among community-dwelling, sedentary older adults.
详细描述
Participants 65 years and older will be offered an exercise program for six months, either with or without RAS. The exercise program is based on the national physical activity guidelines for older adults and designed to train participants to independently engage in strength training and moderate-intensity aerobic training through the gradual withdrawal of supervised exercise classes (2 days/week for 3 months and 1 day/week for an additional 3 months). At baseline, every month during the 6-month intervention, and 2-month post-intervention follow-up, we assess weekly volume of physical activity (primary outcome) using a hip-worn activity tracker and affective attitude toward physical activity (mechanistic outcome) through text-message-based ecological momentary assessment (EMA). Before and after the 6-month intervention, participants will complete a lab visit for the assessment of cognitive, vascular, and physical functioning, fitness, anthropometry, and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Adults over 65 years old.
- •Ambulatory without pain or the use of assisted walking devices.
- •Able to speak and read English.
- •Healthy enough to exercise at moderate intensity with or without medical clearance by a primary care physician.
- •Living in the community for the duration of the study (9-10 months).
- •Having a reliable means of transportation.
- •Having a safe place at home or at a residential area (at least 6 feet by 6 feet of open space) for unsupervised exercise training.
- •Being low-active (< 90 min/week of MAT and < 2 days/week of ST for the last 3 months).
排除标准
- •Diagnosed progressive, neurodegenerative, or severe central nervous system disorders (e.g., Alzheimer's disease, Parkinson's disease, Multiple Sclerosis, or history of stroke with residual deficits) that significantly impair cognitive function, motor skills, or the ability to engage in independent exercise training over moderate intensity
- •Participants with a history of episodic or peripheral neurological conditions (such as neuralgia or migraines) or stable cardiovascular/metabolic conditions may be included if they receive formal written medical clearance from their primary care physician or treating specialist, confirming it is safe for them to engage in unsupervised exercise training at moderate intensity.
- •Known exercise contraindications (uncontrolled hypertension, joint problems, diabetes, metabolic conditions, etc.), determined by self-report on the PAR-Q+.
- •Current or upcoming cancer treatment, determined by self-report on the PAR-Q+.
- •Stroke or neural impairment in the past 6 months, as self-reported on the PAR-Q+.
- •Hip/knee/spinal fracture or surgery in the past 6 months, determined by self-report on the ACSM Health Screening Questionnaire.
- •Unable or unwilling to attend intervention classes, as determined by phone screening.
- •Currently participating in any other exercise or fitness-related research study, determined by phone screening.
- •Use of medications for cognitive impairment, as self-reported on the medication survey.
- •Initiation or change in dosage of psychiatric medications (e.g., antidepressants, anxiolytics) within the past 8 weeks; participants must be on a stable dose for at least 2 months before enrollment and intend to maintain this dose throughout the 8-month study period.
- •Self-report regularly drinking > 14 alcoholic beverages a week or current illicit drug use, determined by self-report to screening surveys.
- •Current regular or hazardous use of illicit substances, or misuse of prescription medications, that occurs on a weekly or more frequent basis, or any substance use that, in the judgment of the investigator, would systematically confound weekly affective assessments or compromise safety during unsupervised exercise training, determined by self-report to screening surveys
- •Cannot ambulate without a walker/cane, assessed in the American College of Sports Medicine (ACSM) Health Screening Questionnaire
- •Having cognitive impairment, determined by the Montreal Cognitive Assessment (MoCA) BLIND <
- •Meet the threshold for clinical depression, determined by the Center for Epidemiological Studies Depression Scale Revised (CESD-R).
- •Uncorrected hearing or visual impairments, self-reported on the Health History Questionnaire.
- •Unable to understand the study procedure.
- •One of the household members is participating in this study, as self-reported during phone screening.
研究组 & 干预措施
Exercise intervention with RAS (EX+RAS)
Participants will be randomized to an exercise intervention with RAS (EX+RAS) over 6 months, offering the exercise prescription to foster independent adherence to the Physical Activity guidelines (PAG) through the gradual withdrawal of supervised training. This group will be provided with RAS playlists and trained to use them for their exercise sessions.
干预措施: Exercise intervention with RAS (EX+RAS) (Behavioral)
Exercise intervention without RAS (EX)
Participants will be randomized to an exercise intervention (EX) over 6 months, offering the same exercise prescription as the experimental group, to foster independent adherence to the PAG through the gradual withdrawal of supervised training. This group will not be provided with any RAS playlists to accompany their exercise.
干预措施: Exercise intervention without RAS (EX) (Behavioral)
结局指标
主要结局
Daily duration of aerobic and strenght training as recorded on an Exercise Log
时间窗: During month 1, 2, 3, 4, 5, 6, 7 (during the intervention) and month 8 (2 months post - intervention until 2-month post-intervention)
Self-reported daily duration and types of physical activity will be self-reported on an exercise log.
Affective response to exercise measured by the single-item Feeling Scale (FS)
时间窗: For 3 days at Baseline (before the intervention), weekly during month 1, 2, 3, 4, 5, and 6 (during intervention), and for 3 days in month 8 (2 months post-intervention)
The single-item Feeling Scale (FS) will be used to measure affective responses to physical activity as assessed by Ecological Momentary Assessment (EMA). How are you feeling right now? with 11-point rating scale scores ranging from -5 to +5, with labels -5 = very bad, -3 = bad, -1 = somewhat bad, 0 = neutral, +1 = somewhat good, +3 = good, and +5 = very good.
次要结局
- Hand Grip Strength(Pre-test (before the intervention) and post-test within 6 weeks after the intervention)
- The progress of balance as assessed by 4-Stage Balance Test(Pre-test (before the intervention) and post-test within 6 weeks after the intervention)
- Perceived exertion measured by the Borg's Rating of Perceived Exertion (RPE) scale(For 3 days at Baseline (before the intervention), weekly during month 1, 2, 3, 4, 5, and 6 (during intervention), and for 3 days in month 8 (2 months post-intervention))
- Subjective cognitive decline measured by the Cognitive Change Index (CCI-12)(At pre-test (before the intervention) and 6 weeks post-intervention)
- Exercise motivation measured by the Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3)(Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention))
- Affective attitude toward physical activity measured by the Physical Activity Enjoyment Scale (PACES)(Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention))
- Individual confidence in regular exercise measured by the Self-Efficacy for Exercise Scale (SEE)(Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention))
- Individual barriers in regular exercise measured by Barriers to Being Active survey (BBA)(Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention))
- Physical activity and sedentary behaviors measured by Physical and Sedentary Behaviour Questionnaire (PASB-Q)(At pre-test (before the intervention) and post-test within 6 weeks after the intervention)
- Health-related quality of life measured by RAND 36-item Health Survey (RAND-36)(Pre-test (before the intervention) and post-test within 6 weeks after the intervention)
- Sleep disturbance measured by the Pittsburgh Sleep Quality Index (PSQI)(Pre-test (before the intervention) and post-test within 6 weeks after the intervention)
- Depression measured by the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R)(Pre-test (before the intervention) and post-test within 6 weeks after the intervention)
- Perceived stress measured by the NIH Toolbox Perceived Stress Scale (PSS).(Pre-test (before the intervention) and post-test within 6 weeks after the intervention)
- Arterial fitness (carotid-femoral pulse wave velocity) as measured by the SphygmoCor XCEL system(Pre-test (before the intervention) and post-test within 6 weeks after the intervention)
- Central aortic blood pressure (systolic and diastolic, mmHg) as measured by the SphygmoCor XCEL system(Pre-test (before the intervention) and post-test within 6 weeks after the intervention)
- Music-related reward experiences measured by the Barcelona Music Reward Questionnaire (BMRQ) to assess music-related reward experiences(Pre-test (before the intervention) and post-test within 6 weeks after the intervention)
- Waist circumference(Pre-test (before the intervention) and post-test within 6 weeks after the intervention)
- Hip circumference(Pre-test (before the intervention) and post-test within 6 weeks after the intervention)
- Leg circumference(Pre-test (before the intervention) and post-test within 6 weeks after the intervention)
- The auditory stimulation score(During month 3 and 6 (during intervention) and 8 months (2 months post-intervention))
- Gait speed at normal and brisk pace (meters/second) as assessed by the 10-Meter Walk Test (10MWT)(Pre-test (before the intervention) and post-test within 6 weeks after the intervention)
- Aerobic fitness as assessed by the total distance walked in 6-minute walk test(Pre-test (before the intervention) and post-test within 6 weeks after the intervention)
- Lower-body strength as assessed by 30-Second Sit-to-Stand test(At pre-test (before the intervention) and post-test, within 6 weeks after the intervention)
研究者
Kyoung Shin Park, PhD
Assistant Professor
Emory University