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Inspiring Seniors Towards Exercise Promotion to Protect Cognition

NCT06496425 · Emory University
In plain English

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About this study
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 effecte 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.
Eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 month. * 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.
Study design
Enrollment target: 80 participants
Allocation: randomized
Masking: single
Age groups: older_adult
Timeline
Starts: 2024-05-15
Estimated completion: 2026-10
Last updated: 2026-03-27
Interventions
Behavioral: Beat-accentuated, personalized music stimulation (BMS)Behavioral: Muscle-strengthening training (ST)Behavioral: Aerobic exercise (AE)
Primary outcomes
  • Changes of physical activity behaviors as assessed by ActiGraph wGT3X-BT (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) (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 (4 days at baseline and months 1, 2, 3, 4, 5, and 6)
Sponsor
Emory University · other
With: Alzheimer's Association, University of North Carolina, Greensboro
Contacts & investigators
ContactStudy Team · contact · istep@emory.edu · 404-727-8919
InvestigatorKyoung Shin Park, PhD · principal_investigator, Emory University
All locations (2)
Emory UniversityRecruiting
Atlanta, Georgia, United States
UNC GreensboroCompleted
Greensboro, North Carolina, United States
Inspiring Seniors Towards Exercise Promotion to Protect Cognition · TrialPath