Physical InactivityNCT06085235
An Investigation Into the Effects of Acute Exercise on Activities of Daily Living and Cognition in Older Adults
A study testing exercise in people with Physical Inactivity, run by Ball State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 5 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over the age of 60.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Physical Inactivity
- Being tested
- exercise
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
cycling exercise for 15min, with 5min warm up
| Study group | Role | What they receive |
|---|---|---|
| exercise | Experimental | 15min of cycling at moderate intensity Receives: Behavioral: exercise |
| video control | No intervention | watching a video on healthy living |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start1 May 2018
- Primary completion5 Mar 2022
- Study completion5 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial: exercise or video control condition
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ball State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Charles Lebeau, Ball State University
- Investigators
- Jean-Charles Lebeau, PHD, Principal investigator, Ball State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085235
- Sponsor's protocol ID
- 1141661-20
- Status last verified
- Oct 2023
- First submitted
- 5 Oct 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: dataset
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into the Effects of Acute Exercise on Activities of Daily Living and Cognition in Older Adults
- ClinicalTrials.gov ID
- NCT06085235
- Acronym / sponsor ID
- 1141661-20
- Conditions
- Physical Inactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Ball State UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 5 Mar 2022 (actual)
- Study completion
- 5 Mar 2022 (actual)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Control Trial: exercise or video control condition
| Arm | Type | Receives |
|---|---|---|
| exercise | Experimental | Behavioral: exercise15min of cycling at moderate intensity |
| video control | No intervention | –watching a video on healthy living |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- over the age of 60.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercisecycling exercise for 15min, with 5min warm up | Behavioural | exercise |
Primary outcome
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.
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).
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.
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.
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).
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Individual participant dataSharing planned: Yes. dataset
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Charles Lebeau, PHD principal investigator
Ball State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Physical Inactivity, run by Ball State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Executive functions (time frame: 1 week). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.