NCT06496425

Inspiring Seniors Towards Exercise Promotion to Protect Cognition

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Alzheimer Disease
• Physical Activity

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	Muscle-strengthening 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 and prevent excessive fatigue.
BEHAVIORAL	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. Participants may choose to increase or decrease daily or weekly exercise time based on their individual needs. Participants may choose to perform AE more than 150 minutes per week.

Timeline

• Start date: 2024-05-15
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2024-07-11
• Last updated: 2026-03-27

Locations

2 sites across 1 country: United States