Inspiring Seniors Towards Exercise Promotion to Protect Cognition (NCT06496425) | Clinical Trial Compass
RecruitingNot Applicable
Inspiring Seniors Towards Exercise Promotion to Protect Cognition
United States80 participantsStarted 2024-05-15
Plain-language 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).
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* Living in the community for the duration of the study.
* Having a reliable means of transportation.
* Having a safe place at home or a residential area (at least 6 feet by 6 feet of open space) for unsupervised exercise training.
* Being low-active (\< 60 min/week of moderate-intensity aerobic exercise and no strength training for the last 3 months).
* Having SCC, defined by the Cognitive Change Index (CCI) ≥ 15.
Exclusion Criteria:
* 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.
* Hip/knee/spinal fracture or surgery in the past 6 months.
* Unable or unwilling to attend intervention classes.
* Currently participating in any other physical activity or fitness-related research study.
* Use of medication for cognitive impairment.
* 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 visua…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
Affective responses to physical activity as assessed by Physical Activity Enjoyment Scale (PACES)
Timeframe: 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
Timeframe: 4 days at baseline and months 1, 2, 3, 4, 5, and 6
4
Adherence to the physical activity program
Timeframe: A daily exercise log for the entire 6-month period