Unraveling the Mechanisms of a Novel Music Intervention for Physical Activity Promotion in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- Ecological Momentary Assessment (EMA): Physical Activity setting
研究概览
简要总结
The goal of this clinical trial is to test the benefits of beat-accented music stimulation (BMS) for behavioral changes of physical activity (PA) in older adults. Specific Aims are to determine (1) whether BMS beneficially influences PA behaviors and psychological responses to PA in older adults for 6 months, and (2) whether exercising with BMS differently influences physical and cognitive functioning as well as quality of life in older adults.
To test the effects of BMS on PA, participants will be randomly assigned to an exercise intervention that either includes BMS or does not include BMS. Participants will attend a supervised group strength training (ST) (30 min/day) and aerobic exercise (AE) (30-50 min/day) session for 3 days/week for the first 2 months, 1 day/week for the next 2 months (while encouraging participants to independently perform both AE and ST on other days), and independently for the final 2 months (always with a goal of performing >150min/week AE and 3 days/week of ST for 30 min/day.
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 (Outcomes Assessor)
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
- •At least 65 years old.
- •Ambulatory/capable of walking for 6 minutes without pain or aid such as a walker/cane.
- •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 (6 months).
- •Having a reliable means of transportation.
- •Having a safe place (at least 6 feet by 6 feet of open space) at home for unsupervised exercise training.
- •Having no diagnosis or symptoms of cognitive impairment.
- •Having no symptoms of suicidal ideation and not meeting criteria for depressive disorder.
- •Physically low-active by doing < 60 min/week of moderate-intensity aerobic exercise and no strength training for the last 3 months.
排除标准
- •Diagnosis of neurological disorder or spinal cord disorder.
- •Known exercise contraindications.
- •Current cancer treatment.
- •Stroke or neural impairment in the past 6 months.
- •Hip/knee/spinal fracture or surgery in the past 6 month.
- •Unable or unwilling to attend intervention classes 3x/week in Months 1-2 and 1x/week in Months 3-
- •Currently participating in any other physical activity or fitness-related research study.
- •Use of medication for Alzheimer's disease.
- •Change in dosage of medications prescribed for anxiety or depression within the previous 6 months.
- •Regularly drink > 14 alcoholic beverages a week or current illicit drug use.
- •Having no diagnosis or symptoms of cognitive impairment.
- •Meet the threshold for clinical depression.
- •Uncorrected hearing or visual impairments.
- •Unable to understand the study procedures.
- •One of the household members is participating in this study.
结局指标
主要结局
Ecological Momentary Assessment (EMA): Physical Activity setting
时间窗: Will be collected using EMA for 4 days at baseline and months 1, 2, 3, 4, 5, and 6.
Assessed the physical and social setting in which a participant engages in physical activity.
Ecological Momentary Assessment (EMA): Behavioral intention
时间窗: Will be collected using EMA for 4 days at baseline and months 1, 2, 3, 4, 5, and 6.
Assesses degree to which participant intends to engage in PA.
Physical activity (self-report)
时间窗: Will be reported daily from the first day of the intervention to the last day of the intervention (6 months)
Aerobic exercise and strength training self-reported
Ecological Momentary Assessment (EMA): Perceived autonomy
时间窗: Will be collected using EMA for 4 days at baseline and months 1, 2, 3, 4, 5, and 6.
Assesses participant's perceived autonomy over exercise behavior.
Ecological Momentary Assessment (EMA): Perceived exertion
时间窗: Will be collected using EMA for 4 days at baseline and months 1, 2, 3, 4, 5, and 6.
Assesses participant's perceived exertion during PA.
Physical activity (objective)
时间窗: Accelerometers will be worn for 4 days at baseline and months 1, 2, 3, 4, 5, and 6.
Physical activity behavior assessed using accelerometry
Ecological Momentary Assessment (EMA): Affective response to PA
时间窗: Will be collected using EMA for 4 days at baseline and months 1, 2, 3, 4, 5, and 6.
Captures the shift in core affective valence (feeling good vs bad) from pre-PA to during-PA.
Ecological Momentary Assessment (EMA): Anticipated, remembered, and incidental affect
时间窗: Will be collected using EMA for 4 days at baseline and months 1, 2, 3, 4, 5, and 6.
Will assess how participant expects to feel after engaging in PA, how participant remembers feeling after engaging in PA, and how participant currently feels.
Ecological Momentary Assessment (EMA): Social Support for Exercise
时间窗: Will be collected using EMA for 4 days at baseline and months 1, 2, 3, 4, 5, and 6.
Measures with whom a person is exercising
次要结局
- Cognitive performance - Tower of London(At pre-test and following study completion (approximately 6 months after pre-test))
- Cognitive performance - NIH Toolbox Picture Sequence Test(At pre-test and following study completion (approximately 6 months after pre-test))
- Cognitive performance - NIH Toolbox Flanker Inhibitory Control and Attention Test(At pre-test and following study completion (approximately 6 months after pre-test))
- Cognitive performance - NIH Toolbox Oral Reading Recognition Test(At pre-test and following study completion (approximately 6 months after pre-test))
- Cognitive performance - NIH Toolbox List Sort Working Memory Test(At pre-test and following study completion (approximately 6 months after pre-test))
- Cognitive performance - General(At pre-test and following study completion (approximately 6 months after pre-test))
- Cognitive performance - NIH Toolbox Dimensional Change Card Sort Test(At pre-test and following study completion (approximately 6 months after pre-test))
- Physical activity (subjective)(At pre-test and following study completion (approximately 6 months after pre-test))
- Music Reward Experience(At pre-test and following study completion (approximately 6 months after pre-test))
- Treatment Satisfaction(At pre-test and following study completion (approximately 6 months after pre-test))
- 4-Stage Balance Test(At pre-test and following study completion (approximately 6 months after pre-test))
- Cognitive performance - Mnemonic Similarity Task(At pre-test and following study completion (approximately 6 months after pre-test))
- Cognitive performance - Perceptual Discrimination Task(At pre-test and following study completion (approximately 6 months after pre-test))
- Health Related Quality of Life(At pre-test and following study completion (approximately 6 months after pre-test))
- 6-Minute Walk Test (6MWT)(At pre-test and following study completion (approximately 6 months after pre-test))
- Body Mass Index(At pre-test and following study completion (approximately 6 months after pre-test))
- Waist/Hip/Leg Circumference(At pre-test and following study completion (approximately 6 months after pre-test))
- Sagittal Diameter(At pre-test and following study completion (approximately 6 months after pre-test))
- Blood Pressure(At pre-test and following study completion (approximately 6 months after pre-test))
- Timed Up and Go (TUG)(At pre-test and following study completion (approximately 6 months after pre-test))
- Handgrip Strength(At pre-test and following study completion (approximately 6 months after pre-test))
- 10-Meter Walk(At pre-test and following study completion (approximately 6 months after pre-test))
- 30-second Chair Stand(At pre-test and following study completion (approximately 6 months after pre-test))
研究者
Jennifer L. Etnier
Distinguished Professor
University of North Carolina, Greensboro