Clinical trial NCT06496425: Inspiring Seniors Towards Exercise Promotion to Protect Cognition
Official title: Inspiring Seniors Towards Exercise Promotion to Protect Cognition
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Physical Activity
Keywords: music
aerobic exercise
strength training
cognition
physical activity
muscular strength
memory complaint
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Alzheimer's Association
name: University of North Carolina, Greensboro
First posted: 2024-07-11
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).


Eligibility criteria: Inclusion Criteria:

* Adults at least 65 years old.
* Ambulatory/capable of walking for 6 minutes without pain or aid such as a walker/cane.
* 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 (6 months).
* Having a reliable means of transportation.
* Having a safe place (at least 6 feet by 6 feet of open space) at home for unsupervised exercise training.
* Having self-perceived memory complaints.
* Having no symptoms of suicidal ideation and not meeting criteria for depressive disorder.
* Physically low-active by doing \< 60 min/week of moderate-intensity aerobic exercise and no strength training for the last 3 months.

Exclusion Criteria:

* Diagnosis of neurological disorder or spinal cord disorder.
* Known exercise contraindications.
* 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 3x/week in Months 1-2 and 1x/week in Months 3-4.
* Currently participating in any other physical activity or fitness-related research study.
* Use of medication for Alzheimer's disease. Change in dosage of medications prescribed for anxiety or depression within the previous 6 months.
* 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.

Primary outcomes:
measure: Changes of physical activity behaviors as assessed by ActiGraph wGT3X-BT
timeFrame: 7 consecutive days at Baseline (before the intervention) and during month 1, 2, 3, 4, 5, and 6
measure: Affective responses to physical activity as assessed by Physical Activity Enjoyment Scale
timeFrame: At baseline (before the intervention), month 3 and month 5 during the intervention, and post-test (within 4 weeks after the intervention)
measure: Adherence to the physical activity program
timeFrame: A daily exercise log for the entire 6-month period
Secondary outcomes:
measure: General cognition as assessed using the Montreal Cognitive Assessment
timeFrame: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention).
measure: Executive function as assessed using the Tower of London - Freiburg version
timeFrame: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention).
measure: Executive function as assessed using the NIH Toolbox Flanker Inhibitory Control and Attention test
timeFrame: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention).
measure: Executive function as assessed using the NIH Toolbox Dimensional Change Card Sort test
timeFrame: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention).
measure: Executive function as assessed using the NIH Toolbox List Sorting Working Memory test
timeFrame: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention).
measure: Episodic memory as assessed using the NIH Toolbox Picture Sequence Memory test
timeFrame: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention).
measure: Episodic memory as assessed using the Mnemonic Similarity Task
timeFrame: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention).
measure: Health-related quality of life as assessed using the RAND 36-Item Short-Form Health Survey
timeFrame: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention).
measure: Physical activity behaviors as assessed by physical activity and sedentary behaviour questionnaire.
timeFrame: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention).
measure: The progress of aerobic capacity and endurance as assessed by 6-minute walk test
timeFrame: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention).
measure: The progress of balance, sit-to-stand, and walking as assessed by Timed Up and Go test
timeFrame: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention).
measure: The progress of lower-body strength as assessed by 30-Second Sit-to-Stand test
timeFrame: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention).
measure: The progress of upper-body strength as assessed by Grip Strength test
timeFrame: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention).
measure: The progress of balance as assessed by 4-Stage Balance Test
timeFrame: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention).
measure: Individual differences in music-related reward experiences as assessed by the Barcelona Music Reward Questionnaire (BMRQ)
timeFrame: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention).
measure: Treatment satisfaction as assessed by the Client Satisfaction Questionnaire (CSQ-8)
timeFrame: At post-test (within 4 weeks after the intervention).
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Greensboro
country: United States
facility: UNC Greensboro
state: North Carolina
Study officials:
affiliation: Emory University
name: Kyoung Shin Park, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.