Inspiring Seniors Towards Exercise Promotion - 2

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Exercise intervention with RAS (EX+RAS)
  Supervised exercise sessions will be led by an exercise specialist at an open-floor gym. All participants will be asked to attend a supervised group exercise session for moderate aerobic training (MAT) for 15-40 minutes/day and muscle-strengthening training (ST) for 15-20 minutes/day for 2 days/week for the first 3 months, while being encouraged to independently perform MAT on up to 3 more days/week. Then, the same training session will be offered for 1 day/week for an additional 3 months while
• Поведенческое Exercise intervention without RAS (EX)
  Supervised exercise sessions will be led by an exercise specialist at an open-floor gym. All participants will be asked to attend a supervised group exercise session for moderate aerobic training (MAT) for 15-40 minutes/day and muscle-strengthening training (ST) for 15-20 minutes/day for 2 days/week for the first 3 months, while being encouraged to independently perform MAT on up to 3 more days/week. Then, the same training session will be offered for 1 day/week for an additional 3 months while

Первичные конечные точки

• Weekly volume of light, moderate, and vigorous physical activity as assessed by ActiGraph [Срок оценки: 7 consecutive days at Baseline (before the intervention) and during month 1, 2, 3, 4, 5, and 6 (during intervention) and month 8 (2 months post-intervention)]
• Daily duration of aerobic and strenght training as recorded on an Exercise Log [Срок оценки: During month 1, 2, 3, 4, 5, 6, 7 (during the intervention) and month 8 (2 months post - intervention until 2-month post-intervention)]
• Affective response to exercise measured by the single-item Feeling Scale (FS) [Срок оценки: 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)]

Вторичные конечные точки (12)

• Perceived exertion measured by the Borg's Rating of Perceived Exertion (RPE) scale [Срок оценки: 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) [Срок оценки: At pre-test (before the intervention) and 6 weeks post-intervention]
• Exercise motivation measured by the Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Pre-test (before the intervention) and post-test within 6 weeks after the intervention]
• Sleep disturbance measured by the Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: 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) [Срок оценки: 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). [Срок оценки: 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 [Срок оценки: Pre-test (before the intervention) and post-test within 6 weeks after the intervention]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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 < 17.
• 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.

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 · 1 центр

• Emory University — Atlanta

Идентификаторы

NCT: NCT07629739 · 2025P011936 · R33AG084479

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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