NCT06085235

Brief Summary

Research has demonstrated the positive effects of chronic exercise on cognitive functioning and performance of Activities of Daily Living (ADLs). However, minimal research exists regarding the effects of acute exercise. To address this gap in the literature, the present study investigated the effect of an acute bout of exercise on executive functions, balance, and ADLs among healthy older adults. Based on the current literature, we expected participants in the exercise group to perform better on executive function tasks and ADLs compared to participants in the control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 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

Study Start

First participant enrolled

May 1, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
Last Updated

October 16, 2023

Status Verified

October 1, 2023

Enrollment Period

3.8 years

First QC Date

October 5, 2023

Last Update Submit

October 13, 2023

Conditions

Outcome Measures

Primary Outcomes (7)

  • Executive functions

    Stroop test. The Stroop test is a measure of executive functions, specifically the ability to inhibit a habitual response, selective attention, and shifting (Pachana et al., 2014). This test requires participants to identify the color name printed in the same ink color (e.g., BLUE printed in blue ink; congruent condition) or different ink color (e.g., BLUE printed in red ink; incongruent condition). Each stimulus word (i.e., red, green, and blue) was presented in equal proportions to minimize specific word facilitation. After nine practice trials, 72 stimuli (i.e., 2 blocks of 36) were presented to the participants using the Eprime software (Version 3.0). Participants were asked to press the key with the dot sticker corresponding to the three stimuli colors (i.e., red, blue, or green). Reaction time (RT) and accuracy were used as indices of performance.

    1 week

  • Balance

    Berg Balance Scale (BBS). The BBS was developed to measure balance and fall risk among older adults. This scale is comprised of 14 tasks to assess balance, such as standing with eyes closed and retrieving an object from the floor. Performance is rated on a 0 to 4 scale for each task, with "0" indicating the lowest level of function and "4" the highest level of function. Total scores of 41 to 56 indicate a low fall risk, 21 to 40 a medium fall risk, and 0 to 20 a high fall risk (Berg et al., 1992).

    1 week

  • Activity of daily living

    Medication task. A medication task was developed to test the participants' ability to properly complete their pill organizers. Participants read a fictional story about prescribed medications and were asked to determine the required frequency and dosage of the medications based on the prescription and the label on fake medication bottles filled with candy pills. Participants had to place the medications in a weekly pill organizer for each required day and time slot (AM and PM). Two scenarios were designed to both require a similar number of pills to be placed in the weekly container for pre and post-test. Time to complete the task and number of mistakes for each day and time slot were recorded as indices of performance. Mistakes were recorded when participants added too many or too little pills, when pills were placed in the incorrect AM/PM time slot, or when participants added the wrong type of medication on a given day.

    1 week

  • Functional ability

    15 feet task. The 15-feet task measures functional ability in older adults. Participants are instructed to walk for 15 feet at their own pace while their performance is timed.

    1 week

  • Fall risk

    Time up and go (TUG). The TUG is used to measure fall risk in the elderly population and consists of instructing the participant to stand up from a chair, walk three meters, turn around, walk back, and sit down in the chair. The participants were instructed to walk at their regular pace and performance was measured as the time required to complete the activity. A timed score of greater than 14 seconds indicated a high risk of falls (Bohannon, 2006).

    1 week

  • Grip strength

    Grip strength. Verbecq et al. (2017) reported that low muscle strength, as measured by hand grip strength, was associated with a history of falls in older adults To measure hand grip strength, participants were asked to squeeze the handle of a handgrip dynamometer as hard as possible with their dominant hand and the mean score of three trials was recorded.

    1 week

  • Commitment check

    A commitment check was developed to test participants' commitment to the tasks. Participated were asked how committed they were while performing (a) the Stroop task, (b) the medication task, (c) the BBS tasks, (d) the TUG task, and (e) the grip strength task. Each item was rated on a scale ranging from 1 (none / not at all) to 10 (very much / very well).

    1 week

Study Arms (2)

exercise

EXPERIMENTAL

15min of cycling at moderate intensity

Behavioral: exercise

video control

NO INTERVENTION

watching a video on healthy living

Interventions

exerciseBEHAVIORAL

cycling exercise for 15min, with 5min warm up

exercise

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over the age of 60.

You may not qualify if:

  • health complications preventing the ability to cycle on a recumbent bike and walking at moderate intensity as indicated by the health history questionnaire, taking anti-depressant medication, or having color blindness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ball State University

Muncie, Indiana, 47306, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jean-Charles Lebeau, PHD

    Ball State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Randomized Control Trial: exercise or video control condition
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Sport and Exercise Psychology

Study Record Dates

First Submitted

October 5, 2023

First Posted

October 16, 2023

Study Start

May 1, 2018

Primary Completion

March 5, 2022

Study Completion

March 5, 2022

Last Updated

October 16, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

dataset

Time Frame
available immediately, no time frame
More information

Available IPD Datasets

Individual Participant Data Set Access

Locations