NCT05226039

Brief Summary

The current clinical study will have two groups of participants (young adults ages 20 - 30, and older adults ages 60 - 70) take part in three visits to the lab. On the first visit participants will fill out questionnaires assessing demographics and physical activity level. On the 2nd and 3rd visits participants will be engage in both a moderate intensity bout of aerobic exercise for 20 minutes, and 20 minutes of resting on a stationary bike watching an educational video. These two visits will be counterbalanced across age groups. Following both the exercise bout and the resting control condition participants will complete cognitive tasks assessing episodic memory and executive functioning. The first hypothesis is that older adults who are more physically active (assessed via questionnaire) will have significantly greater cognitive abilities compared to those who are less active or sedentary. The second hypothesis is that following a single bout of moderate intensity aerobic exercise, older adults will have a greater magnitude of change in their short-term memory, and long-term memory performance compared to younger adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

October 5, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 7, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2022

Completed
Last Updated

June 24, 2022

Status Verified

June 1, 2022

Enrollment Period

8 months

First QC Date

October 4, 2021

Last Update Submit

June 23, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • Episodic memory - Rey Auditory Verbal Learning Task Visit 1

    The Rey Auditory Verbal Learning task (RAVLT) will assess single-item episodic memory. The number of words correctly recalled on 8 trials will be measured.

    Approximately 20 minutes into visit 1.

  • Episodic memory - Rey Auditory Verbal Learning Task Visit 2

    The Rey Auditory Verbal Learning task (RAVLT) will assess single-item episodic memory. The number of words correctly recalled on 8 trials will be measured.

    immediately following exercise or control (witnin 5 minutes)

  • Episodic memory - Rey Auditory Verbal Learning Task Visit 3

    The Rey Auditory Verbal Learning task (RAVLT) will assess single-item episodic memory. The number of words correctly recalled on 8 trials will be measured.

    immediately following exercise or control (within 5 minutes)

  • Episodic memory - Associative memory task Visit 1

    Participants will hear pairs of words read to them over an audio recording. Following this they will be asked to name the second word in each pair during recall. The number of words correctly recalled on 3 trials will be measured.

    Approximately 45 minutes into visiti 1.

Secondary Outcomes (12)

  • Executive functioning - Stroop reaction time Visit 1

    Executive functioning will be measured 7 minutes after completion of the exercise or control conditions.

  • Executive functioning - Stroop reaction time Visit 2

    Executive functioning will be measured 7 minutes after completion of the exercise or control conditions.

  • Executive functioning - Stroop reaction time Visit 3

    Executive functioning will be measured 7 minutes after completion of the exercise or control conditions.

  • Executive functioning - Stroop accuracy Visit 1

    Executive functioning will be measured 7 minutes after completion of the exercise or control conditions.

  • Executive functioning - Stroop accuracy Visit 2

    Executive functioning will be measured 7 minutes after completion of the exercise or control conditions.

  • +7 more secondary outcomes

Study Arms (2)

Young adult group

OTHER

One group will consist of 20 to 30 year olds. Participants will complete all three visits that include both the treatment (exercise visit) and the control (rest) visits. The treatment visit will consist of 20 minutes of moderate intensity aerobic exercise on a stationary bike.

Behavioral: Moderate intensity acute exercise bout

Older adult group

OTHER

The other group will consist of 60 to 70 year olds. Participants will complete all three visits that include both the treatment (exercise visit) and the control (rest) visits. The treatment visit will consist of 20 minutes of moderate intensity aerobic exercise on a stationary bike.

Behavioral: Moderate intensity acute exercise bout

Interventions

The treatment/intervention will consist of 20 minutes of moderate intensity aerobic exercise on a stationary bike. Intensity will be prescribed based off of heart rate reserve.

Older adult groupYoung adult group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 30 years old for young adult group
  • to 70 years old for older adult group
  • Cognitive normal (assessed via Montreal Cognitive Assessment on visit 1)

You may not qualify if:

  • Do not have any contraindications to exercise (assessed via American College of Sport Medicine Health screening form)
  • No current musculoskeletal injuries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Greensboro

Greensboro, North Carolina, 27402, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Following the first visit, participants will be randomly counterbalanced to one of the two conditions first (exercise, or control condition). Following completion of the first condition, the third visit will be completion of the other condition.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 4, 2021

First Posted

February 7, 2022

Study Start

October 5, 2021

Primary Completion

May 20, 2022

Study Completion

May 20, 2022

Last Updated

June 24, 2022

Record last verified: 2022-06

Locations