Trial Outcomes & Findings for Physical Exercise for Augmenting Cognitive Health (PEACH) (NCT NCT04922710)

Physical Exercise for Augmenting Cognitive Health (PEACH)

Data regarding the average number of minutes spent engaging in moderate to vigorous exercise (via heart rate monitoring and comparison of heart rate to calculations based on heart rate reserve) will be collected to operationalize adherence. Adherence will be used as a metric of feasibility and acceptability.

Data regarding the number of exercise sessions completed will be collected to operationalize adherence. Adherence will be used as a metric of feasibility and acceptability.

Systolic blood pressure (SBP) will be measured at baseline and 12-weeks to determine whether there is a change in SBP.

Participants will complete one week of actigraphy at baseline and again at follow-up to determine whether physical activity levels change. This will be operationalized as change in average number of steps per day.

Heart rate will be measured throughout the intervention and changes in heart rate from baseline to the end of the intervention will be calculated.

Participants will be weighed on a calibrated stadiometer both before and after the intervention. The investigators will examine percent changes in body weight before and after the intervention.

This will be calculated via scores from the Positive and Negative Affect Scale. Scores can range from 1 to 100, with 1 meaning less positive affect and 100 meaning more positive affect.

Participants will complete the Center for Epidemiological Studies-Depression Scale, a measure of the frequency of 20 common depressive symptoms rated along a 0 ("rarely or none of the time") to 3 ("most or all of the time") Likert scale. Responses are summed to yield a total symptom score (maximum possible score of 60) with higher scores reflecting more severe depressive symptoms.

Participants will complete the Perceived Stress Scale (PSS) a measure of the frequency of 20 common depressive symptoms rated along a 0 ("rarely or non, a 14-item measure that assesses experiences of daily life stress. The PSS is an instrument on which respondents use a 0 ("never") to 4 ("very often") Likert scale to rate the degree to which daily life events are perceived to be uncontrollable, unpredictable, or unmanageable. Responses are summed to form a total score (maximum possible score of 56).

A Picture Sequence task will be administered at baseline, and then following the intervention (12-weeks). The main outcome from this task is the cumulative number of adjacent pictures in which a participant correctly remembered the sequence. A lower number of correct items indicates worse episodic memory.

A Picture Vocabulary task will be administered at baseline, and then following the intervention (12-weeks). Participants will be presented with visual stimuli along with an auditory cue and will have to judge which of the visual stimuli match the auditory cue. The main outcome from this task is total items answered correctly, with a lower number of items being indicative or worse language ability.

A Pattern Comparison task will be administered at baseline, and then following the intervention (12-weeks). Participants will be presented with visual patterns and asked to respond whether the patterns are the same or different. The main outcome from this task is total items answered correctly in the 90 seconds allotted for the task, with a lower number of items being indicative or worse processing speed.

Data regarding the average duration of sessions will be collected to operationalize adherence. Adherence will be used as a metric of feasibility and acceptability.

A Flanker task will be administered at baseline, and then following the intervention (12-weeks). The main outcome from this task is an interference effect (in ms) which indicates how much longer it takes for a participant to make a directional response to a center arrow when the flanking arrows are arranged in congruent vs. incongruent direction from the center stimulus. A higher interference effect indicates worse executive functioning.

A Dimensional Card Sort task will be administered at baseline, and then following the intervention (12-weeks). The main outcome from this task is an interference effect (in ms) which indicates how much longer it takes for a participant to match a stimulus to other choice stimuli based on a feature (shape or color), with the feature participants must match on switching without warning during the task. A higher interference effect indicates worse executive functioning.

A List Sorting task will be administered at baseline, and then following the intervention (12-weeks). Participants will be presented with a series of stimuli and then be asked to repeat the stimuli in order of size from smallest to largest. The main outcome from this task is total items answered correctly, with a lower scoring being indicative or worse working memory.