Inspiring Seniors Towards Exercise Promotion to Protect Cognition
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Changes of physical activity behaviors as assessed by ActiGraph wGT3X-BT
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 with subjective memory complaints. 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 minutes per day) and aerobic exercise (AE) (30-50 minutes per day) session for 3 days per week for the first 2 months, 1 day per 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 >150minutes per week AE and 3 days per week of ST for 30 minutes per day).
详细描述
Regular physical activity (PA) is associated with numerous health benefits including improved muscular and cardiorespiratory fitness, cognitive functioning, and quality of life (QoL). Hence, national PA guidelines (PAG) have been disseminated to recommend regularly engaging in moderate-to-vigorous aerobic exercise (AE) and muscle-strengthening training (ST). However, adherence to the PAG steeply declines after ages 60-65,1-5 at the time when health benefits of PA become pronounced. Fewer than 20% of US older adults adhere to the national guidelines for both AE and ST.
PA promotion is particularly urgent in older adults who are experiencing subjective cognitive complaints (SCC) and thereby have a heightened risk of Alzheimer's disease. SCC refers to self-perceived worsening of memory or other cognitive capacities in the previous year, independent of cognitive testing or clinical diagnosis, and is known to be an important prognostic symptom of Alzheimer's Disease (AD). According to the latest national survey, ~10% of US adults aged > 45 years reported SCC and, of those with SCC, 43.6% do not engage in any PA outside of work.
A major challenge to promoting multicomponent PA is that many sedentary people have a negative affective attitude toward moderate AE and ST. This negative affective response is a critical barrier to the maintenance of regular PA because, in general, people are unlikely to continue a behavior that results in immediate displeasure. Listening to music during acute bouts of PA increases positive effects and reduces perceived exertion. However, for these benefits to translate to long-term adherence, music alone is not sufficient. Beat-accented music stimulation (BMS) is an application of pulsed, tempo-synchronous music stimuli for the facilitation of rhythmic body movements. BMS has shown effects on increasing the weekly volume of PA in midlife-to-older adults undergoing cardiac rehabilitation whereas beat-unaccented music had little effect on PA outcomes. This proof-of-concept has not been tested in low-active older adults and the psychological mechanisms of PA behavior change remain unknown.
Participants will be randomized to an exercise intervention with or without BMS (MEX vs. EX), both offering the same exercise prescription to foster independent adherence to the PAG through the gradual withdrawal of supervised training. The exercise intervention lasts for 6 months.
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
- •Adults at least 65 years old.
- •Ambulatory/capable of walking 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.
- •Having a reliable means of transportation.
- •Having a safe place at home or a residential area (at least 6 feet by 6 feet of open space) for unsupervised exercise training.
- •Being low-active (< 60 min/week of moderate-intensity aerobic exercise and no strength training for the last 3 months).
- •Having SCC, defined by the Cognitive Change Index (CCI) ≥ 15.
排除标准
- •Concurrent diagnosis of neurological disorder (e.g., dementia, Parkinson's disease, multiple sclerosis, stroke, etc.).
- •Known exercise contraindications (uncontrolled hypertension, joint problems, diabetes, metabolic conditions etc.).
- •Current cancer treatment.
- •Stroke or neural impairment in the past 6 months.
- •Hip/knee/spinal fracture or surgery in the past 6 months.
- •Unable or unwilling to attend intervention classes.
- •Currently participating in any other physical activity or fitness-related research study.
- •Use of medication for cognitive impairment.
- •Regularly drink > 14 alcoholic beverages a week or current illicit drug use.
- •Meet the threshold for 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.
研究组 & 干预措施
Exercise intervention with beat-accentuated, personalized music stimulation (BMS)
Cognitively unimpaired, physically low-active older adults with subjective cognitive complaints are provided with a 6-month exercise intervention with beat-accentuated, personalized music stimulation (BMS).
干预措施: Strength Training (ST) (Behavioral)
Exercise intervention with beat-accentuated, personalized music stimulation (BMS)
Cognitively unimpaired, physically low-active older adults with subjective cognitive complaints are provided with a 6-month exercise intervention with beat-accentuated, personalized music stimulation (BMS).
干预措施: Aerobic exercise (AE) (Behavioral)
Exercise intervention with beat-accentuated, personalized music stimulation (BMS)
Cognitively unimpaired, physically low-active older adults with subjective cognitive complaints are provided with a 6-month exercise intervention with beat-accentuated, personalized music stimulation (BMS).
干预措施: Beat-accentuated, personalized music stimulation (BMS) (Behavioral)
Exercise intervention without BMS
Cognitively unimpaired, physically low-active older adults with subjective cognitive complaints are provided with a 6-month exercise intervention without beat-accentuated, personalized music stimulation (BMS).
干预措施: Strength Training (ST) (Behavioral)
Exercise intervention without BMS
Cognitively unimpaired, physically low-active older adults with subjective cognitive complaints are provided with a 6-month exercise intervention without beat-accentuated, personalized music stimulation (BMS).
干预措施: Aerobic exercise (AE) (Behavioral)
结局指标
主要结局
Changes of physical activity behaviors as assessed by ActiGraph wGT3X-BT
时间窗: 7 consecutive days at Baseline (before the intervention) and during month 1, 2, 3, 4, 5, and 6
Duration, intensity, and frequency of physical activity assessed using a waist-worn accelerometer.
Adherence to the physical activity program
时间窗: A daily exercise log for the entire 6-month period
Daily duration of aerobic exercise and strength training is self-reported on an exercise log.
Affective responses to physical activity as assessed by Physical Activity Enjoyment Scale (PACES)
时间窗: At baseline (before the intervention), month 3 and month 5 during the intervention, and post-test (within 4 weeks after the intervention)
Self-reported affective states relative to physical activity. Physical Activity Enjoyment Scale has 18 items based on a 7-point Likert scale and the total score ranges from 18 to 126.
Affective attitude toward physical activity, perceived exertion, planned and actual physical activity, and physical activity settings
时间窗: 4 days at baseline and months 1, 2, 3, 4, 5, and 6
Concurrent, prospective, and retrospective affective attitude toward physical activity, perceived exertion, planned and actual physical activity, and physical activity settings as assessed by Ecological Momentary Assessment.
次要结局
- General cognition as assessed using the Montreal Cognitive Assessment (MoCA)(At pre-test (before the intervention) and post-test (within 4 weeks after the intervention))
- Executive function as assessed using the Tower of London - Freiburg version(At pre-test (before the intervention) and post-test (within 4 weeks after the intervention))
- Executive function as assessed using the NIH Toolbox Flanker Inhibitory Control and Attention test(At pre-test (before the intervention) and post-test (within 4 weeks after the intervention))
- Executive function as assessed using the NIH Toolbox Dimensional Change Card Sort test(At pre-test (before the intervention) and post-test (within 4 weeks after the intervention))
- Executive function as assessed using the NIH Toolbox List Sorting Working Memory test(At pre-test (before the intervention) and post-test (within 4 weeks after the intervention))
- Episodic memory as assessed using the NIH Toolbox Picture Sequence Memory test(At pre-test (before the intervention) and post-test (within 4 weeks after the intervention))
- Episodic memory as assessed using the Mnemonic Similarity Task(At pre-test (before the intervention) and post-test (within 4 weeks after the intervention))
- Health-related quality of life as assessed using the RAND 36-Item Short-Form Health Survey (SF-36)(At pre-test (before the intervention) and post-test (within 4 weeks after the intervention))
- Physical activity behaviors as assessed by physical activity and sedentary behavior questionnaire(At pre-test (before the intervention) and post-test (within 4 weeks after the intervention))
- The progress of aerobic capacity and endurance as assessed by 6-minute walk test(At pre-test (before the intervention) and post-test (within 4 weeks after the intervention))
- The progress of balance, sit-to-stand, and walking as assessed by Timed Up and Go test(At pre-test (before the intervention) and post-test (within 4 weeks after the intervention))
- The progress of lower-body strength as assessed by 30-Second Sit-to-Stand test(At pre-test (before the intervention) and post-test (within 4 weeks after the intervention))
- The progress of upper-body strength as assessed by Grip Strength test(At pre-test (before the intervention) and post-test (within 4 weeks after the intervention))
- The progress of balance as assessed by 4-Stage Balance Test(At pre-test (before the intervention) and post-test (within 4 weeks after the intervention))
- Individual differences in music-related reward experiences as assessed by the Barcelona Music Reward Questionnaire (BMRQ)(At pre-test (before the intervention) and post-test (within 4 weeks after the intervention))
- Treatment satisfaction as assessed by the iSTEP Satisfaction Survey (iSTEP-SS)(At post-test (within 4 weeks after the intervention))
研究者
Kyoung Shin Park, PhD
Assistant Professor
Emory University