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| ID | Type | Description | Link |
|---|---|---|---|
| AARF-23-1145107 | Other Grant/Funding Number | Alzheimer's Association | |
| 2025P013046 | Other Identifier | Emory IRB |
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| Name | Class |
|---|---|
| Alzheimer's Association | OTHER |
| University of North Carolina, Greensboro | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise intervention with beat-accentuated, personalized music stimulation (BMS) | Experimental | 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). |
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| Exercise intervention without BMS | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beat-accentuated, personalized music stimulation (BMS) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of physical activity behaviors as assessed by ActiGraph wGT3X-BT | Duration, intensity, and frequency of physical activity assessed using a waist-worn accelerometer. | 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) | 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. | 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 | 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. | 4 days at baseline and months 1, 2, 3, 4, 5, and 6 |
| Adherence to the physical activity program | Daily duration of aerobic exercise and strength training is self-reported on an exercise log. | A daily exercise log for the entire 6-month period |
| Measure | Description | Time Frame |
|---|---|---|
| General cognition as assessed using the Montreal Cognitive Assessment (MoCA) | Montreal Cognitive Assessment takes approximately 10 minutes for completion and the total score ranges from 0 to 30. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Team | Contact | 404-727-8919 | istep@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kyoung Shin Park, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Recruiting | Atlanta | Georgia | 30324 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36760458 | Background | 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. |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Strength Training (ST) | Behavioral | 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. |
|
| Aerobic exercise (AE) | Behavioral | 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. |
|
Tower of London - Freiburg version takes approximately 14 minutes to complete and measures the total number of items solved in minimum number of moves in the range from 0 to 12. |
| 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 | The Flanker Inhibitory Control and Attention test takes approximately 5 minutes to complete and measures the accuracy and reaction time to create a composite score, ranging from 0 to 10. | 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 | The Dimensional Change Card Sort test takes approximately 5 minutes to complete and measures the accuracy and reaction time to create a composite score, ranging from 0 to 10. | 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 | The List Sorting Working Memory test takes approximately 10 minutes to complete and measures the total number of items correctly recalled and sequenced, ranging from 0 to 26. | 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 | The Picture Sequence Memory test takes approximately 7 minutes to complete and measures the total number of items correctly placed, ranging from 0 to 31, and the IRT-based theta score, ranging from 200 to 700. | At pre-test (before the intervention) and post-test (within 4 weeks after the intervention) |
| Episodic memory as assessed using the Mnemonic Similarity Task | This custom-developed test takes approximately 15 minutes to complete and measures mnemonic discrimination (a score ranging from 0-1) and visual recognition (a score ranging from 0-1). | 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) | The RAND 36-Item Short-Form Health Survey Scale has 36 items for self-report, takes 10-15 minutes to complete, and measures health-related quality of life with a score ranging from 0 - 100. | 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 | The physical activity and sedentary behavior questionnaire has 7 items and takes approximately 5 minutes for completion. | 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 | The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. | 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 | The time taken to complete a Timed Up and Go test is an indicator of fall risks. | 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 | The number of sit-to-stand maneuvers completed in 30 seconds. | 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 | The squeeze power in pounds measured by a handheld dynamometer. | 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 | The duration of maintaining 4 difference postures. | 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) | BMRQ has 24 items and takes 5-10 minutes to complete and measures music-related reward experiences with a score ranging from 0 to 100. | 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) | iSTEP-SS has 25 items and takes up to 5 minutes to complete and measure participants' perceived accessibility, social support, confidence, and satisfaction with the intervention. | At post-test (within 4 weeks after the intervention) |
| UNC Greensboro | Completed | Greensboro | North Carolina | 27412 | United States |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |