Inspiring Seniors Toward Exercise Promotion to Prevent Alzheimer's Disease
NCT Number: NCT06496425
Acronym: iSTEP+
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Alzheimer Disease
Interventions: BEHAVIORAL: Music
Sponsor: University of North Carolina, Greensboro
Collaborators: Alzheimer's Association
Sex: ALL
Age: OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-05-15
Completion Date: 2026-03
Locations: UNC Greensboro, Greensboro, North Carolina, 27412, United States

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 min/day) and and aerobic exercise (AE) (30-50 min/day) session for 3 days/week for the first 2 months, 1 day/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 \>150min/week AE and 3 days/week of ST for 30 min/day).

Primary Outcome Measures: Changes of physical activity behaviors as assessed by ActiGraph wGT3X-BT, Duration, intensity, and frequency of physical activity assessed using an 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, 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 is ranged 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)|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
Secondary Outcome Measures: General cognition as assessed using the Montreal Cognitive Assessment, Montreal Cognitive Assessment takes approximately 10 minutes for completion and the total score is ranged 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, 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, 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 behaviour questionnaire., The physical activity and sedentary behaviour 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 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 Client Satisfaction Questionnaire (CSQ-8), CSQ has 8 items and takes approximately 3 minutes to complete and measures self-reported satisfaction with the program with a score ranging from 0 to 32., At post-test (within 4 weeks after the intervention).