- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06085235
An Investigation Into the Effects of Acute Exercise on Activities of Daily Living and Cognition in Older Adults
October 13, 2023 updated by: Jean-Charles Lebeau, Ball State University
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Muncie, Indiana, United States, 47306
- Ball State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- over the age of 60.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: exercise
15min of cycling at moderate intensity
|
cycling exercise for 15min, with 5min warm up
|
|
No Intervention: video control
watching a video on healthy living
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Executive functions
Time Frame: 1 week
|
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
Time Frame: 1 week
|
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
Time Frame: 1 week
|
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
Time Frame: 1 week
|
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 Frame: 1 week
|
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
Time Frame: 1 week
|
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
Time Frame: 1 week
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jean-Charles Lebeau, PHD, Ball State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2018
Primary Completion (Actual)
March 5, 2022
Study Completion (Actual)
March 5, 2022
Study Registration Dates
First Submitted
October 5, 2023
First Submitted That Met QC Criteria
October 13, 2023
First Posted (Actual)
October 16, 2023
Study Record Updates
Last Update Posted (Actual)
October 16, 2023
Last Update Submitted That Met QC Criteria
October 13, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 1141661-20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
dataset
IPD Sharing Time Frame
available immediately, no time frame
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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