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Trial · NCT04515758

Registered outcomes30

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryRecruitment RatePre-program (baseline)Total number of people enrolled divided by the total number of people invited to participate (multiplied by 100 to calculate a percentage)
PrimaryCompletion RateThrough study completion, 12 weeksPercentage of people who completed the full program and all assessments
PrimaryAttendanceThroughout entire intervention (12 weeks, 2 sessions/week per group)Percentage of people who attended program sessions (exercise and cognitive training components)
PrimaryChange in Participant and Instructor Rating of experience, satisfaction, and feasibility of programMid-point (6 weeks) and post-program (12 weeks)
Participant and instructors rating of program components and overall program (via hand-written questionnaire). Participants and instructors must rate their level of agreement (1 = strongly disagree, 2 = disagree, 3 = no opinion, 4 = agree, 5 = strongly agree) with various statements. The higher the rating, the greater the satisfaction. They also must rate if the difficulty of the program was optimal, somewhat easy or hard, or too easy or hard. They must also specify how much money they would be willing to spend on the program. They are also given an opportunity to record optional additional comments/recommendation.
PrimaryCost of programPost-program (12 weeks)Financial cost of running program (equipment purchased for study - cognitive training tablet and stands - and YMCA staff pay) as reported by researcher and YMCA staff
PrimarySexPre-program (baseline)Self-reported biological sex (at birth) using basic demographics questionnaire
PrimaryParticipant and Instructor perceived program experience and satisfactionPost-program (at 12 weeks)One-on-one interview with researcher, answering broad questions about their experience in the program and study
PrimaryParticipant and Instructor observer-perceived program experience and satisfactionThroughout entire intervention (12 weeks, 2 sessions/week per group)
Experience of participants and instructors will also be observed by the researcher (observational notes will be taken by the researcher during each class). No names of participants and instructors will be recorded.
PrimaryEducationPre-program (baseline)Self-reported years of formal education and training (training years for instructors only) using basic demographics questionnaire
PrimaryOccupationPre-program (baseline)Self-reported previous and current occupations using basic demographics questionnaire
PrimaryMedical ConditionPre-program (baseline)Self-reported previous and current medical conditions using basic demographics questionnaire
PrimaryMedicationsPre-program (baseline)Self-reported previous and current medications using basic demographics questionnaire
PrimaryMontreal Cognitive Assessment (global cognitive function)Pre-program (baseline)
Using the Montreal Cognitive Assessments (brief clinical tool) to assess visual/spatial abilities, working memory, executive functioning, language, abstraction, and orientation). Will be used to describe participants' baseline cognitive status (a score out of 30 is measured).
PrimaryPhysical Activity LevelPre-program (baseline)
Using the International Physical Activities Questionnaire (IPAQ) to assess physical activity level based on self-reported frequency and duration of job-related, house work-related, transportation-related, and leisure-related physical activities done in the past week. METS-minutes/week will be calculated and reported (i.e. take the number of minutes doing an activity in the past week and multiply by the appropriate metabolic equivalent, which will vary based on the intensity of the physical activity).
PrimaryParticipant cognitive activityPre-program (baseline)
Using a cognitive activity scale (score of 0-4 per activity) that requires participants to self-report how often they typically engage in a variety of mentally stimulating activities (i.e. playing card games, reading, cooking, etc.) The more frequently they engage in the activity, the higher the score.
PrimaryParticipant social activityPre-program (baseline)
Using a scale (score of 0-3 per group) that requires participants to self-report how often they typically interact (face-to-face or virtually) with different groups of people (i.e. their spouse, family, friends, co-workers, etc.). The more frequently they interact with the group, the higher the score.
PrimaryParticipant and Instructor AgePre-program (baseline)Self-reported years of age using basic demographics questionnaire
SecondaryChange in Stroop Task PerformancePre-program (baseline) and post-program (12 weeks)
STROOP task which assesses the length of time (seconds) it takes for a participant to correctly name a coloured square (test 1), read the name of a colour (test 2), and say the name of the colour that a word is printed in (test 3). Number of corrected and uncorrected errors are also recorded.
SecondaryChange in Trail Making Task PerformancePre-program (baseline) and post-program (12 weeks)
Trails Making Test Part A and B. Part A assesses visual search (participants must connect numbered circles in ascending numerical order (1-2-3-etc). Part B assesses working memory and task-switching (participants must connect circles in ascending numerical and alphabetical order (1-A-2-B- etc.). Time to complete the tests (second) and errors (number) made during the tests are recorded.
SecondaryChange in Resting Heart RatePre-program (baseline) and post-program (12 weeks)Resting (seated) heart rate (beats per minute) using an automatic blood pressure cuff

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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