Inspiring Seniors Towards Exercise Promotion - 2
ConditionOld Age
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorEmory University
About this trial
Older adults' low adherence to the national physical activity guidelines may stem from a failure to increase positive affective responses to exercise (e.g., enjoyment). Exercising with personalized, tempo-synchronous music playlists has shown promising effects on physical activity promotion in midlife-to-older adults during a cardiac rehab program. The purpose of this study is to determine how personalized, tempo-synchronous music playlists called rhythmic auditory stimulation (RAS) influence exercise behavior change and affective responses to exercise over 8 months among community-dwelling, sedentary older adults.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults over 65 years old.
Ambulatory 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
Diagnosed progressive, neurodegenerative, or severe central nervous system disorders (e.g., Alzheimer's disease, Parkinson's disease, Multiple Sclerosis, or history of stroke with residual deficits) that significantly impair cognitive function, motor skills, or the ability to engage in independent exercise training over moderate intensity
Participants with a history of episodic or peripheral neurological conditions (such as neuralgia or migraines) or stable cardiovascular/metabolic conditions may be included if they receive formal written medical clearance from their primary care physician or treating specialist, confirming it is safe for them to engage in unsupervised exercise training at moderate intensity.
Known exercise contraindications (uncontrolled hypertension, joint problems, diabetes, metabolic conditions, etc.), determined by self-report on the PAR-Q+.
Current or upcoming cancer treatment, determined by self-report on the PAR-Q+.
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise intervention with RAS (EX+RAS)
BehavioralSupervised exercise sessions will be led by an exercise specialist at an open-floor gym. All participants will be asked to attend a supervised group exercise session for moderate aerobic training (MAT) for 15-40 minutes/day and muscle-strengthening training (ST) for 15-20 minutes/day for 2 days/week for the first 3 months, while being encouraged to independently perform MAT on up to 3 more days/week. Then, the same training session will be offered for 1 day/week for an additional 3 months while encouraging participants to independently perform ST on 1 more day of the week and MAT up to 4 more days of the week. Participants will be instructed on set and track exercise goals, supplemented with a series of behavioral supports during the 6-month intervention and until a 2-month post-intervention follow-up.
Exercise intervention without RAS (EX)
BehavioralSupervised exercise sessions will be led by an exercise specialist at an open-floor gym. All participants will be asked to attend a supervised group exercise session for moderate aerobic training (MAT) for 15-40 minutes/day and muscle-strengthening training (ST) for 15-20 minutes/day for 2 days/week for the first 3 months, while being encouraged to independently perform MAT on up to 3 more days/week. Then, the same training session will be offered for 1 day/week for an additional 3 months while encouraging participants to independently perform ST on 1 more day of the week and MAT up to 4 more days of the week. Participants will be instructed on set and track exercise goals, supplemented with a series of behavioral supports during the 6-month intervention and until a 2-month post-intervention follow-up.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Exercise intervention with RAS (EX+RAS)Experimental treatment 1 intervention
Group B: Exercise intervention without RAS (EX)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Weekly volume of light, moderate, and vigorous physical activity as assessed by ActiGraph
Duration, intensity, and frequency of physical activity will be 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 6 (during intervention) and month 8 (2 months post-intervention)2
Daily duration of aerobic and strenght training as recorded on an Exercise Log
Self-reported daily duration and types of physical activity will be self-reported on an exercise log.
Time frame
During month 1, 2, 3, 4, 5, 6, 7 (during the intervention) and month 8 (2 months post - intervention until 2-month post-intervention)3
Affective response to exercise measured by the single-item Feeling Scale (FS)
The single-item Feeling Scale (FS) will be used to measure affective responses to physical activity as assessed by Ecological Momentary Assessment (EMA). How are you feeling right now? with 11-point rating scale scores ranging from -5 to +5, with labels -5 = very bad, -3 = bad, -1 = somewhat bad, 0 = neutral, +1 = somewhat good, +3 = good, and +5 = very good.
Time frame
For 3 days at Baseline (before the intervention), weekly during month 1, 2, 3, 4, 5, and 6 (during intervention), and for 3 days in month 8 (2 months post-intervention)Secondary outcomes
1
Perceived exertion measured by the Borg's Rating of Perceived Exertion (RPE) scale
Borg's Rating of Perceived Exertion (RPE) scale will be used to assess perceived exertion during physical activity as assessed by Ecological Momentary Assessment (EMA). Scores range from 6 to 20, with verbal anchors of 7 = very, very light, 9 = very light, 11 = fairly light, 13 = somewhat hard, 15 = hard, 17 = very hard, and 19 = very, very hard.
Time frame
For 3 days at Baseline (before the intervention), weekly during month 1, 2, 3, 4, 5, and 6 (during intervention), and for 3 days in month 8 (2 months post-intervention)2
Subjective cognitive decline measured by the Cognitive Change Index (CCI-12)
The Cognitive Change Index (CCI-12) is a 12-item questionnaire assessing self or informant-perceived decline in episodic memory over the past 5 years. It uses a 5-point Likert scale (1=no change, 5=much worse), with higher total scores (range 12-60) indicating greater perceived decline. It acts as a marker for dementia risk, subjective cognitive decline (SCD), and early Alzheimer's. The CCI-12 ranges from 12 to 60. Higher scores signify greater perceived decline.
Time frame
At pre-test (before the intervention) and 6 weeks post-intervention3
Exercise motivation measured by the Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3)
The Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3) is a 19 to 24-item tool (commonly 23-24 items) used to assess motivation for physical activity based on Self-Determination Theory. It measures six types of motivation, ranging from not at all motivated to intrinsically motivated,. Likert Scale Range: 0 to 4 (0 = "Not true for me", 4 = "Very true for me"). Higher average scores (closer to 4) indicate that a particular regulation style is a strong reason for exercising.
Time frame
Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention)4
Affective attitude toward physical activity measured by the Physical Activity Enjoyment Scale (PACES)
Physical Activity Enjoyment Scale (PACES) to assess affective attitude toward PA. Self-reported affective states relative to physical activity. The Physical Activity Enjoyment Scale has 18 items on a 7-point Likert scale, and the total score ranges from 18 to 126. A total score of 63 can be used to distinguish between enjoyment (\>63) and lack of enjoyment (\<63).
Time frame
Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov