Inspiring Seniors Towards Exercise Promotion to Protect Cognition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorEmory University
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Beat-accentuated, personalized music stimulation (BMS)
BehavioralParticipants 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.
Strength Training (ST)
BehavioralMost 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)
BehavioralAt 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Exercise intervention with beat-accentuated, personalized music stimulation (BMS)Experimental treatment 3 interventions
Group B: Exercise intervention without BMSActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Changes of physical activity behaviors as assessed by ActiGraph wGT3X-BT
Duration, intensity, and frequency of physical activity assessed using a waist-worn accelerometer.
Time frame
7 consecutive days at Baseline (before the intervention) and during month 1, 2, 3, 4, 5, and 62
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.
Time frame
At baseline (before the intervention), month 3 and month 5 during the intervention, and post-test (within 4 weeks after the intervention)3
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.
Time frame
4 days at baseline and months 1, 2, 3, 4, 5, and 64
Adherence to the physical activity program
Daily duration of aerobic exercise and strength training is self-reported on an exercise log.
Time frame
A daily exercise log for the entire 6-month periodSecondary outcomes
1
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.
Time frame
At pre-test (before the intervention) and post-test (within 4 weeks after the intervention)2
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.
Time frame
At pre-test (before the intervention) and post-test (within 4 weeks after the intervention)3
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.
Time frame
At pre-test (before the intervention) and post-test (within 4 weeks after the intervention)4
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.
Time frame
At pre-test (before the intervention) and post-test (within 4 weeks after the intervention)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
Alzheimer's Association
Collaborator
University of North Carolina, Greensboro
Collaborator
Source ClinicalTrials.gov