Inspiring Seniors Towards Exercise Promotion to Protect Cognition

Обзор

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).

Подробное описание

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.

Вмешательства

• Поведенческое Beat-accentuated, personalized music stimulation (BMS)
  Participants receive pre-recorded music playlists to use during exercise. During the strength training (ST), participants are asked to sync their concentric and eccentric muscle contractions to the beats of the music at a specific tempo. During aerobic exercise (AE), the tempo is adjusted to match individual walking cadence for participants to step in sync with the playlists.
• Поведенческое Strength Training (ST)
  Most exercises for the ST are chair- or wall-assisted to be safely performed by older adults on their own and adaptable across fitness levels by using different resistance bands. ST are taught at in-person and virtual sessions. Repetitions are increased by 1 repetition every 2 to 3 weeks up to 1 set of 12 repetitions. Participants start the program using no band or the lowest-resistance band. Band level is increased gradually, individually for each participant, to help reduce the risk of injury
• Поведенческое Aerobic exercise (AE)
  At the beginning of the program, participants are asked to exercise 45 minutes per week spread over 3 sessions (15 minutes per session). Beginning at Week 4, a 5-minute increase in walking time per session occurs every 2 weeks until 30 minutes of walking is reached per session. Beginning at Week 10 the number of sessions per week increases until participants walk for 30 minutes 5 times per week, for a total of 150 minutes per week. Minutes per session and total minutes per week are guidelines. P

Первичные конечные точки

• Changes of physical activity behaviors as assessed by ActiGraph wGT3X-BT [Срок оценки: 7 consecutive days at Baseline (before the intervention) and during month 1, 2, 3, 4, 5, and 6]
• Affective responses to physical activity as assessed by Physical Activity Enjoyment Scale (PACES) [Срок оценки: At baseline (before the intervention), month 3 and month 5 during the intervention, and post-test (within 4 weeks after the intervention)]
• Affective attitude toward physical activity, perceived exertion, planned and actual physical activity, and physical activity settings [Срок оценки: 4 days at baseline and months 1, 2, 3, 4, 5, and 6]
• Adherence to the physical activity program [Срок оценки: A daily exercise log for the entire 6-month period]

Вторичные конечные точки (12)

• General cognition as assessed using the Montreal Cognitive Assessment (MoCA) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention)]
• Episodic memory as assessed using the Mnemonic Similarity Task [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 2 центра

• Emory University — Atlanta
• UNC Greensboro — Greensboro

Публикации

• Park KS, Williams DM, Etnier JL. Exploring the use of music to promote physical activity: From the viewpoint of psychological hedonism. Front Psychol. 2023 Jan 25;14:1021825. doi: 10.3389/fpsyg.2023.1021825. eCollection 2023. PMID 36760458

Идентификаторы

NCT: NCT06496425 · STUDY00008531 · AARF-23-1145107 · 2025P013046

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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