DementiaENABLEDNCT05488951
The Influence of the Otago Exercise Program on Executive Function Among People Living With Mild to Moderate Dementia
A study testing Otago Exercise Program in people with Dementia, run by Augusta University at 1 site in United States.
Trial summary
The primary aim of this study is to conduct a pilot 6-month assessor-blinded randomized controlled trial to determine if the Otago Exercise Program plus usual care improves executive function in people living with mild to moderate dementia compared to usual care among those living in a nursing home or assisted living… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Otago Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 31 Dec 2023
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 55 years and older
- Reside in a nursing home or assisted living facility
- Have any type of mild to moderate dementia confirmed by medical records and/or a physician
- Can read, write, and speak English with acceptable visual and auditory acuity
- Able to walk 3 meters with or without the assistance of another person
- Have a legally authorized representative who can provide informed consent
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- Able to provide assent
- Able to understand and follow instructions
- Have a life expectancy of ≥12 months as estimated by a healthcare provider
Who cannot join
- Reside in the community
- Severe dementia (e.g., Montreal Cognitive Assessment ≤6/30) and are not able to follow instructions
- Severe psychiatric condition
- Progressive neurological disease other than dementia (i.e., neurological disease, such as Parkinson's, that is mild and stable is not an exclusion)
- Delirium
- Acute medical condition
Show all 13Show fewer
- Medical condition precluding exercise (e.g., unstable cardiac disease)
- Recent surgery affecting mobility
- Enrolled in another research study
- Blindness
- Aphasia
- Enrolled in another research study
- Receiving hospice care
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Augusta University
Augusta, Georgia, 30912
Deborah A Jehu, PhD, 706-721-3980 ext. 3980, djehu@augusta.edu
About this study
Official title: The Effects of strEngth aNd BaLance Exercise on Executive Function in People Living With Dementia (ENABLED): A Randomized Controlled Trial
The primary aim of this study is to conduct a pilot 6-month assessor-blinded randomized controlled trial to determine if the Otago Exercise Program plus usual care improves executive function in people living with mild to moderate dementia compared to usual care among those living in a nursing home or assisted living facility. The exploratory aims are to determine if the Otago Exercise Program plus usual care improves inflammatory blood biomarkers, kynurenine metabolites, epigenetics, mobility, balance, cognition, mood, fall-related self-efficacy, health-related quality of life, sleep, physical activity, and falls by sex and race compared to usual care alone among people living with mild to moderate dementia.
Read the detailed description
Dementia is a growing public health problem. Approximately 46.8 million individuals worldwide were living with dementia in 2015, which is estimated to reach 131.5 million by 2050. The global healthcare expenditure of dementia was $604 billion in 2010, which is projected to dramatically increase. Therefore, there is an urgent need to alleviate this growing public health concern.
Executive function is important for maintaining independence in activities of daily living; yet, people living with dementia often have poor executive function. Executive function includes the abilities to: make decisions, reason, problem-solve, initiate and maintain tasks, as well as adapt to changing cognitive conditions. Poor executive function is linked with other important health markers, such as poor physical function, falls, and mortality. It is possible that these poor health outcomes in people living with dementia may, in part, be explained by shared mechanisms including inflammation, autophagy, and apoptosis. Interestingly, these poor health outcomes among people living with dementia seem to depend on sex and race, with females and African Americans exhibiting greater comorbidities; nevertheless, the underlying mechanisms are poorly understood.
Poor executive function is linked with other important health markers, such as poor physical function and falls via reduced judgement and self-regulation. Cognitive and physical frailty are frequently observed together, likely due to common pathophysiological mechanisms. People living with dementia are often frail and prone to multiple tipping point incidents, potentially leading to adverse health outcomes. Cognitive and physical frailty also seems to depend on sex and race, with females and African Americans exhibiting a higher incidence of dementia; nevertheless, the underlying mechanisms are poorly understood. Overall, people living with dementia often have multiple comorbidities and complex medical needs; thus, research targeted at addressing these health disparities should be a frontline priority.
Exercise may be a viable strategy to improve executive function in people living with dementia. Mounting evidence suggests that strength and balance interventions (≥3x/week) are safe and effective at improving cognition and mobility, as well as reducing falls in cognitively intact community-dwelling older adults. Yet, historically, people living with dementia have been systematically excluded from intervention studies due to researchers' ineligibility criteria. Few studies have examined the influence of exercise on executive functioning among people living with dementia, but have shown no effect; it is possible that the small sample sizes may have contributed to these null findings. Therefore, further research is warranted to improve executive function and other health outcomes among people living with mild to moderate dementia.
- Conditions
- Dementia
- Being tested
- Otago Exercise Program
- Keywords
- Dementia, Otago Exercise Program, Executive Function
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otago Exercise ProgramOther
The Otago Exercise Program will be led by a physical therapist in a group setting (5-7 participants/exercise class). The exercise will be 20 min of walking and 30 min of strength and balance exercises (i.e., 50 min exercise class) 3x/week for 6 months. The physical therapist will select suitable exercises for each participant, such that the exercise is individualized and progressive.
| Study group | Role | What they receive |
|---|---|---|
| Otago Exercise Program Plus Usual Care | Experimental | The Otago Exercise Program will be led by a physical therapist in a group setting (5-7 participants/exercise class). The exercise will be 20 min of walking and 30 min of strength and balance exercises 3x/week for 6 months. The physical therapist will select suitable exercises for each participant, such that the exercise is individualized and progressive. Participants will also receive usual care from health care providers (e.g., specialist and local doctor visits, community nurse visits, paid care provider visits, hospitalizations as required, and any ongoing treatment for any illness and/or their comorbidities). Receives: Other: Otago Exercise Program |
| Usual Care Only | No intervention | Usual care will consist of routine care from their health care providers (e.g., specialist and local doctor visits, community nurse visits, paid care provider visits, hospitalizations as required, and any ongoing treatment for any illness and/or their comorbidities). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Color Word Stroop Test
Response inhibition involves deliberately suppressing dominant, automatic, or prepotent responses, and will be assessed using the Stroop Colour-Word Test. For the Stroop Test, there will be three conditions. First, participants will be asked to read aloud words printed in black ink (e.g., BLUE). Second, they were instructed to read aloud the color of colored rectangles. Finally, they will shown a page of color-words printed in incongruent colored ink (e.g., the word "BLUE" printed in red ink). Participants will be asked to name the ink color in which the words are printed (while ignoring the word itself). There will 50 trials for each condition and the time taken to read each condition will recorded.
Measured: Baseline, 6 months
Secondary outcomes (52)
Change in the Digit Symbol Substitution Test
The Digit Symbol Substitution Test is a measure of processing speed and consists of nine digit-symbol pairs. Participants will be asked to fill in as many corresponding symbols for the given digits within 90 s, with a greater number of items correctly coded indicating better processing speed. Performance will be measured by the number of correct symbols; a greater number of symbols indicates better performance.
Measured: Baseline, 6 months
Change in the oral Trail Making Test
Set-shifting will be assessed using the oral Trail-Making Test Part B minus A. It will involve going back and forth between multiple tasks or mental sets. Part A will assess psychomotor speed; participants will count numbers aloud in sequential order, starting at 1 and ending at 25. We will record the amount of time (in seconds) for the participants to complete the task. Part B will consist of orally switching back and forth from numbers to letters (the numbers extend from 1 to 13 and the letters from A to L). Participants will be instructed to orally count as quickly and as accurately as possible from 1 to A, A to 2, 2 to B, B to 3, and so on, until they complete the task. We will record the amount of time (in seconds) for participants to complete the task. To index set shifting, the completion time difference between Part B and Part A will be calculated. Smaller difference scores indicate better set shifting.
Measured: Baseline, 6 months
Change in the Digit Span Forwards and Backwards
Working memory will be assessed using the verbal digit span forward and backward task. This task involves presenting a series of random digits (from 1 to 9), after which participants will be asked to verbally repeat the list in the same order and in the reverse order, respectively, in separate trials. If successful, they will be provided a longer number sequence. The total number of correct trials and the longest correct trial will be recorded.
Measured: Baseline, 6 months
Change in the Rey Auditory Verbal Learning Test
The Rey Auditory Verbal Learning Test is a measure of learning and short-term memory. We will read a list of 15 words and participants will be asked to recall as many words as they can remember. We will record the total recall, intrusions, and repetitions for: immediate recall, delayed recall, and word recognition.
Measured: Baseline, 6 months
Change in the Benton Judgement of Line Orientation
Perception will be assessed using the Benton Judgement of Line Orientation. Participants will be presented with 15 pairs of lines. Participants will judge the angle of both lines with respect to the reference line angle. The total score ranges from 0 to 15.
Measured: Baseline, 6 months
Change in the Boston Naming Test
Language skills will be assessed with the Boston Naming Test, which involves visually looking at 15 printed pictures on a piece of paper and verbalizing the name of the objects. The total score ranges from 0 to 15.
Measured: Baseline, 6 months
Change in Health Utilities Index-3
The Health Utilities Index-3 is a questionnaire related to quality of life. We will use the total score as the outcome measure.
Measured: Baseline, 6 months
Change in the Visual Analogue Scale
The Visual Analogue Scale (VAS) is a measure of overall perceived rating of health. The endpoint of 100 is labelled "The best health you can imagine" while a score of 0 was labelled "The worse health you can imagine". Participants will be asked to report their perceived health on the day of the assessment.
Measured: Baseline, 6 months
Change in the Geriatric Depression Scale
The Geriatric Depression Scale is a 15-item questionnaire that assesses depressed mood. A score of greater than 5 points is suggestive of depression, while a score of greater than or equal to a score of 10 is almost always indicative of depression.
Measured: Baseline, 6 months
Change in the short-Falls Efficacy Scale International
The Short-Falls Efficacy Scale International measures fear when performing 7 daily activities. Scores between 7-8 are indicative of low concern for falling, 9-13 are indicative of moderate concern for falling, and 14-28 are indicative of high concern for falling.
Measured: Baseline, 6 months
Change in Functional Comorbidity Index
The Functional Comorbidity Index includes 18 evenly weighted comorbidities that stratify on physical functional status. This scale's score was the total number of comorbidities.
Measured: Baseline, 6 months
Change in body composition (weight (kg))
Change in body composition will be measured using the Omron Body Composition Monitor. We will record weight (kg).
Measured: Baseline, 6 months
Change in body composition (fat (%))
Change in body composition will be measured using the Omron Body Composition Monitor. We will record body fat composition (%).
Measured: Baseline, 6 months
Change in body composition (muscle (%))
Change in body composition will be measured using the Omron Body Composition Monitor. We will record skeletal muscle composition (%).
Measured: Baseline, 6 months
Change in the Short Physical Performance Battery
The Short Physical Performance Battery is a valid and reliable measure of physical performance and is comprised of three components, including: balance, gait, and chair stands. Balance will be assessed over 10 s of stance with feet together, semi-tandem, and tandem stance. Gait speed will be measured over 4 m with a stopwatch. The five times sit to stand will be measured with a stopwatch. The total score ranges from 0 worst) to 12 (best).
Measured: Baseline, 6 months
Change in dual-task posture (sway area (degrees/s squared))
Dual-task posture will be measured with APDM inertial sensors. Dual-task posture will involve standing with feet apart with no cognitive task, as well as while counting backwards by 1's. We will examine sway area (degrees/s squared).
Measured: Baseline, 6 months
Change in dual-task posture (root mean square sway (degrees))
Dual-task posture will be measured with APDM inertial sensors. Dual-task posture will involve standing with feet apart with no cognitive task, as well as while counting backwards by 1's. We will examine root mean square sway (degrees).
Measured: Baseline, 6 months
Change in dual-task posture (frequency of sway (Hz))
Dual-task posture will be measured with APDM inertial sensors. Dual-task posture will involve standing with feet apart with no cognitive task, as well as while counting backwards by 1's. We will examine frequency of sway (Hz).
Measured: Baseline, 6 months
Change in dual-task posture (jerk (m²/s^5))
Dual-task posture will be measured with APDM inertial sensors. Dual-task posture will involve standing with feet apart with no cognitive task, as well as while counting backwards by 1's. We will examine jerk (m²/s^5).
Measured: Baseline, 6 months
Change in dual-task posture (mean velocity (m/s))
Dual-task posture will be measured with APDM inertial sensors. Dual-task posture will involve standing with feet apart with no cognitive task, as well as while counting backwards by 1's. We will examine mean velocity (m/s)
Measured: Baseline, 6 months
Change in dual-task posture (path length(m/s²))
Dual-task posture will be measured with APDM inertial sensors. Dual-task posture will involve standing with feet apart with no cognitive task, as well as while counting backwards by 1's. We will examine path length(m/s²).
Measured: Baseline, 6 months
Change in dual-task gait (gait speed (m/s))
Dual-task gait will be measured with APDM inertial sensors. Dual-task gait will involve walking 4 m with no cognitive task as well as while naming all the words starting with a specific letter. We will examine gait speed (m/s).
Measured: Baseline, 6 months
Change in dual-task gait (double support (%))
Dual-task gait will be measured with APDM inertial sensors. Dual-task gait will involve walking 4 m with no cognitive task as well as while naming all the words starting with a specific letter. We will examine double support (%).
Measured: Baseline, 6 months
Change in dual-task gait (stride length (m))
Dual-task gait will be measured with APDM inertial sensors. Dual-task gait will involve walking 4 m with no cognitive task as well as while naming all the words starting with a specific letter. We will examine stride length (m).
Measured: Baseline, 6 months
Change in dual-task gait (upper body range of motion (degrees))
Dual-task gait will be measured with APDM inertial sensors. Dual-task gait will involve walking 4 m with no cognitive task as well as while naming all the words starting with a specific letter. We will examine upper body range of motion (degrees).
Measured: Baseline, 6 months
Change in dual-task mobility (task duration (s))
Dual-task mobility will be assessed with the timed-up-and-go (TUG). The TUG involves getting up from a chair, walking 3 m, turning around, walking back, and sitting down. Participants will complete the TUG with no cognitive task, as well as while completing a category task. We will examine task duration (s).
Measured: Baseline, 6 months
Change in dual-task mobility (turn duration (s))
Dual-task mobility will be assessed with the timed-up-and-go (TUG). The TUG involves getting up from a chair, walking 3 m, turning around, walking back, and sitting down. Participants will complete the TUG with no cognitive task, as well as while completing a category task. We will examine turn duration (s).
Measured: Baseline, 6 months
Change in dual-task mobility (turn velocity (degrees/s))
Dual-task mobility will be assessed with the timed-up-and-go (TUG). The TUG involves getting up from a chair, walking 3 m, turning around, walking back, and sitting down. Participants will complete the TUG with no cognitive task, as well as while completing a category task. We will examine turn velocity (degrees/s).
Measured: Baseline, 6 months
Change in dual-task mobility (lean angle (degrees))
Dual-task mobility will be assessed with the timed-up-and-go (TUG). The TUG involves getting up from a chair, walking 3 m, turning around, walking back, and sitting down. Participants will complete the TUG with no cognitive task, as well as while completing a category task. We will examine lean angle (degrees).
Measured: Baseline, 6 months
Change in turning (task duration (s))
Turning will be assessed with a 360 degree turn with APDM inertial sensors. We will examine task duration (s).
Measured: Baseline, 6 months
Change in turning (turn angle (degrees))
Turning will be assessed with a 360 degree turn with APDM inertial sensors. We will examine turn angle (degrees).
Measured: Baseline, 6 months
Change in turning (turn velocity (degrees/s))
Turning will be assessed with a 360 degree turn with APDM inertial sensors. We will examine turn velocity (degrees/s).
Measured: Baseline, 6 months
Change in functional lower extremity strength (task duration (s))
Functional lower extremity strength will be assessed with the five times sit to stand using APDM inertial sensors. We will examine task duration (s).
Measured: Baseline, 6 months
Change in functional lower extremity strength (lean angle (degrees))
Functional lower extremity strength will be assessed with the five times sit to stand using APDM inertial sensors. We will examine lean angle (degrees).
Measured: Baseline, 6 months
Change in hand grip strength
To measure hand grip strength, participants will be asked to hold the dynamometer in their hand, with the arm parallel to the side of the body. Participants will then squeeze the dynamometer with maximum isometric effort for about 3-5 seconds. The average of two trials will be recorded for the right and left hands.
Measured: Baseline, 6 months
Change in quadriceps grip strength
We will use the JTECH Commander handheld dynamometer to measure quadriceps strength. From the seated position, the investigator will secure a strap around the participants' lower shank and a secured object, such that the lower shank is at 60 degrees from flexion. Participants will extend their knee with maximum isometric effort for about 3-5 seconds. The average of two trials will be recorded for the right and left legs.
Measured: Baseline, 6 months
Change in physical activity (% of time in different levels of physical activity)
An Axivity Monitor will be worn on the wrist over 7 days and will measure physical activity. The Axivity Monitor will provide information: percentage of time in light, moderate, vigorous, and very vigorous activity (%).
Measured: Baseline, 6 months
Change in physical activity (step count)
An Axivity Monitor will be worn on the wrist over 7 days and will measure physical activity. The Axivity Monitor will provide information: average daily step count (steps).
Measured: Baseline, 6 months
Change in physical activity (number of sedentary bouts)
An Axivity Monitor will be worn on the wrist over 7 days and will measure physical activity. The Axivity Monitor will provide information: number of sedentary bouts (count).
Measured: Baseline, 6 months
Change in physical activity (time in sedentary bouts (min))
An Axivity Monitor will be worn on the wrist over 7 days and will measure physical activity. The Axivity Monitor will provide information: average time in sedentary bouts (min).
Measured: Baseline, 6 months
Change in sleep efficiency (total sleep time/total time in bed)
An Axivity Monitor will be worn on the wrist over 7 days and will measure sleep. The Axivity Monitor will provide information: sleep efficiency (total sleep time/total time in bed).
Measured: Baseline, 6 months
Change in sleep (number of awakenings)
An Axivity Monitor will be worn on the wrist over 7 days and will measure sleep. The Axivity Monitor will provide information: number of awakenings (number).
Measured: Baseline, 6 months
Change in sleep (average awake length (min))
An Axivity Monitor will be worn on the wrist over 7 days and will measure sleep. The Axivity Monitor will provide information: average awake length (min).
Measured: Baseline, 6 months
Change in sleep (Sleep Fragmentation Index)
An Axivity Monitor will be worn on the wrist over 7 days and will measure sleep. The Axivity Monitor will provide information: sleep fragmentation index. The Sleep Fragmentation Index = the sum of the Movement Index and Fragmentation Index. The Movement Index = the total of scored awake minutes divided by Total time in bed in hours x 100. The Fragmentation Index = the percentage of one-minute periods of sleep vs. all periods of sleep in the sleep period.
Measured: Baseline, 6 months
Falls
Falls will be recorded by the nursing home or assisted living facility staff on incident reports.
Measured: Retrospective and Prospective for 6 months
Change in inflammatory blood biomarkers (Interleukin-6)
We will draw blood at baseline and 6 months. We will examine inflammatory blood biomarkers, including Interleukin-6 (ng/ml), measured using multiplex assay.
Measured: Baseline, 6 months
Change in inflammatory blood biomarkers (Interleukin-1)
We will draw blood at baseline and 6 months. We will examine inflammatory blood biomarkers, including Interleukin-1α (ng/µg), measured using multiplex assay.
Measured: Baseline, 6 months
Change in inflammatory blood biomarkers (Tumor Necrosis Factor-α)
We will draw blood at baseline and 6 months. We will examine inflammatory blood biomarkers, including Tumor Necrosis Factor-α (ng/ml), measured using multiplex assay.
Measured: Baseline, 6 months
Change in kynurenine pathway metabolites (kynurenine)
We will draw blood at baseline and 6 months. We will examine kynurenine pathway metabolites, including kynurenine (ng/ml), measured using mass spectroscopy.
Measured: Baseline, 6 months
Change in kynurenine pathway metabolites (tryptophan)
We will draw blood at baseline and 6 months. We will examine kynurenine pathway metabolites, including tryptophan (µmol/L), measured using mass spectroscopy.
Measured: Baseline, 6 months
Change in kynurenine pathway metabolites (kynurenic acid)
We will draw blood at baseline and 6 months. We will examine kynurenine pathway metabolites, including kynurenic acid (ng/ml), measured using mass spectroscopy.
Measured: Baseline, 6 months
Change in epigenetics
We will draw blood at baseline and 6 months. We will examine epigenetics (genome-wide test, global methylation, and aging clock). DNA samples will be extracted with Applied Biosystem MagMAX DNA Multi-Sample Ultra 2.0 kit using KingFisher Duo Prime automated system, quantified by NanoDrop 2000 Spectrophotometer system. Genome-wide DNA methylation analysis will be conducted using the Illumina Infinium MethylationEPIC BeadChip (Illumina Inc., Denver, CO) in DNA samples. DNA methylation beta values will be used to estimate the DNA methylation age (DNAm age) prior to normalization using the online epigenetic age calculator (http://dnamage.genetics.ucla.edu).
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start1 Jul 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For this pilot study, participants will be randomly assigned (1:1) to the exercise (n=21) or control group (n=21). The statisticians (Dr Jennifer Waller and Dr. Brittany Ange) will generate the randomization sequence and provide it to the study coordinator after the baseline assessment; they will also conceal the treatment allocation from the assessors. Randomization will be stratified by biological sex (female/male) and study site. Blocked randomization will be performed using random block sizes of 2 and 4. Permutations of exercise or control will be performed in each block.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Jehu, Augusta University
- Investigators
- Deborah A Jehu, PhD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488951
- Sponsor's protocol ID
- 1838020
- Acronym
- ENABLED
- Status last verified
- Jan 2023
- First submitted
- 28 Jul 2022
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jehu DA, Hanson M, Huang Y, Soares A, Patel C, Hergott C, Waller JL, Young L, Hall W, Robinson-Johnson D, Allen C, Sams R, Carrick RM, Fulzele S, Hamrick M, Zhu H, Dong Y. Preliminary effects of a modified Otago Exercise Program on metabolic, cellular, and epigenetic biomarkers in people living with dementia: A pilot randomized controlled trial. Mol Cell Neurosci. 2026 Jun;137:104077. doi: 10.1016/j.mcn.2026.104077. Epub 2026 Mar 18.
PubMed 41856444Jehu DA, Patel C, Soares A, Waller JL, Carrick RM, Hergott C, Young L, Hall W, Robinson-Johnson D, Allen C, Sams R, Hamrick M, Huang Y, Zhu H, Dong Y. The feasibility, acceptability, and effects of the adapted 6-month Otago exercise program on cognitive, physical, and psychological function in people living with dementia in residential care facilities: The ENABLED randomized controlled trial. J Alzheimers Dis. 2025 Nov;108(2):629-642. doi: 10.1177/13872877251378670. Epub 2025 Sep 17.
PubMed 40961133
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of strEngth aNd BaLance Exercise on Executive Function in People Living With Dementia (ENABLED): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05488951
- Acronym / sponsor ID
- ENABLED / 1838020
- Conditions
- Dementia
- Keywords
- Dementia, Otago Exercise Program, Executive Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Aug 2022 (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.
The primary aim of this study is to conduct a pilot 6-month assessor-blinded randomized controlled trial to determine if the Otago Exercise Program plus usual care improves executive function in people living with mild to moderate dementia compared to usual care among those living in a nursing home or assisted living facility. The exploratory aims are to determine if the Otago Exercise Program plus usual care improves inflammatory blood biomarkers, kynurenine metabolites, epigenetics, mobility, balance, cognition, mood, fall-related self-efficacy, health-related quality of life, sleep, physical activity, and falls by sex and race compared to usual care alone among people living with mild to moderate dementia.
Detailed description
Dementia is a growing public health problem. Approximately 46.8 million individuals worldwide were living with dementia in 2015, which is estimated to reach 131.5 million by 2050. The global healthcare expenditure of dementia was $604 billion in 2010, which is projected to dramatically increase. Therefore, there is an urgent need to alleviate this growing public health concern.
Executive function is important for maintaining independence in activities of daily living; yet, people living with dementia often have poor executive function. Executive function includes the abilities to: make decisions, reason, problem-solve, initiate and maintain tasks, as well as adapt to changing cognitive conditions. Poor executive function is linked with other important health markers, such as poor physical function, falls, and mortality. It is possible that these poor health outcomes in people living with dementia may, in part, be explained by shared mechanisms including inflammation, autophagy, and apoptosis. Interestingly, these poor health outcomes among people living with dementia seem to depend on sex and race, with females and African Americans exhibiting greater comorbidities; nevertheless, the underlying mechanisms are poorly understood.
Poor executive function is linked with other important health markers, such as poor physical function and falls via reduced judgement and self-regulation. Cognitive and physical frailty are frequently observed together, likely due to common pathophysiological mechanisms. People living with dementia are often frail and prone to multiple tipping point incidents, potentially leading to adverse health outcomes. Cognitive and physical frailty also seems to depend on sex and race, with females and African Americans exhibiting a higher incidence of dementia; nevertheless, the underlying mechanisms are poorly understood. Overall, people living with dementia often have multiple comorbidities and complex medical needs; thus, research targeted at addressing these health disparities should be a frontline priority.
Exercise may be a viable strategy to improve executive function in people living with dementia. Mounting evidence suggests that strength and balance interventions (≥3x/week) are safe and effective at improving cognition and mobility, as well as reducing falls in cognitively intact community-dwelling older adults. Yet, historically, people living with dementia have been systematically excluded from intervention studies due to researchers' ineligibility criteria. Few studies have examined the influence of exercise on executive functioning among people living with dementia, but have shown no effect; it is possible that the small sample sizes may have contributed to these null findings. Therefore, further research is warranted to improve executive function and other health outcomes among people living with mild to moderate dementia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- For this pilot study, participants will be randomly assigned (1:1) to the exercise (n=21) or control group (n=21). The statisticians (Dr Jennifer Waller and Dr. Brittany Ange) will generate the randomization sequence and provide it to the study coordinator after the baseline assessment; they will also conceal the treatment allocation from the assessors. Randomization will be stratified by biological sex (female/male) and study site. Blocked randomization will be performed using random block sizes of 2 and 4. Permutations of exercise or control will be performed in each block.
| Arm | Type | Receives |
|---|---|---|
| Otago Exercise Program Plus Usual Care | Experimental | Other: Otago Exercise ProgramThe Otago Exercise Program will be led by a physical therapist in a group setting (5-7 participants/exercise class). The exercise will be 20 min of walking and 30 min of strength and balance exercises 3x/week for 6 months. The physical therapist will select suitable exercises for each participant, such that the exercise is individualized and progressive. Participants will also receive usual care from health care providers (e.g., specialist and local doctor visits, community nurse visits, paid care provider visits, hospitalizations as required, and any ongoing treatment for any illness and/or their comorbidities). |
| Usual Care Only | No intervention | –Usual care will consist of routine care from their health care providers (e.g., specialist and local doctor visits, community nurse visits, paid care provider visits, hospitalizations as required, and any ongoing treatment for any illness and/or their comorbidities). |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 55 years and older
- Reside in a nursing home or assisted living facility
- Have any type of mild to moderate dementia confirmed by medical records and/or a physician
- Can read, write, and speak English with acceptable visual and auditory acuity
- Able to walk 3 meters with or without the assistance of another person
Key exclusion criteria (13 listed)
- Reside in the community
- Severe dementia (e.g., Montreal Cognitive Assessment ≤6/30) and are not able to follow instructions
- Severe psychiatric condition
- Progressive neurological disease other than dementia (i.e., neurological disease, such as Parkinson's, that is mild and stable is not an exclusion)
- Delirium
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 |
|---|---|---|
| Otago Exercise ProgramThe Otago Exercise Program will be led by a physical therapist in a group setting (5-7 participants/exercise class). The exercise will be 20 min of walking and 30 min of strength and balance exercises (i.e., 50 min exercise class) 3x/week for 6 months. The physical therapist will select suitable exercises for each participant, such that the exercise is individualized and progressive. | Other | Otago Exercise Program Plus Usual Care |
Primary outcome
Change in the Color Word Stroop Test
Time frame: Baseline, 6 months
Response inhibition involves deliberately suppressing dominant, automatic, or prepotent responses, and will be assessed using the Stroop Colour-Word Test. For the Stroop Test, there will be three conditions. First, participants will be asked to read aloud words printed in black ink (e.g., BLUE). Second, they were instructed to read aloud the color of colored rectangles. Finally, they will shown a page of color-words printed in incongruent colored ink (e.g., the word "BLUE" printed in red ink). Participants will be asked to name the ink color in which the words are printed (while ignoring the word itself). There will 50 trials for each condition and the time taken to read each condition will recorded.
52 secondary outcomes
Change in the Digit Symbol Substitution Test
Time frame: Baseline, 6 months
Change in the oral Trail Making Test
Time frame: Baseline, 6 months
Change in the Digit Span Forwards and Backwards
Time frame: Baseline, 6 months
Change in the Rey Auditory Verbal Learning Test
Time frame: Baseline, 6 months
Change in the Benton Judgement of Line Orientation
Time frame: Baseline, 6 months
Change in the Boston Naming Test
Time frame: Baseline, 6 months
Change in Health Utilities Index-3
Time frame: Baseline, 6 months
Change in the Visual Analogue Scale
Time frame: Baseline, 6 months
Change in the Geriatric Depression Scale
Time frame: Baseline, 6 months
Change in the short-Falls Efficacy Scale International
Time frame: Baseline, 6 months
Change in Functional Comorbidity Index
Time frame: Baseline, 6 months
Change in body composition (weight (kg))
Time frame: Baseline, 6 months
Change in body composition (fat (%))
Time frame: Baseline, 6 months
Change in body composition (muscle (%))
Time frame: Baseline, 6 months
Change in the Short Physical Performance Battery
Time frame: Baseline, 6 months
Change in dual-task posture (sway area (degrees/s squared))
Time frame: Baseline, 6 months
Change in dual-task posture (root mean square sway (degrees))
Time frame: Baseline, 6 months
Change in dual-task posture (frequency of sway (Hz))
Time frame: Baseline, 6 months
Change in dual-task posture (jerk (m²/s^5))
Time frame: Baseline, 6 months
Change in dual-task posture (mean velocity (m/s))
Time frame: Baseline, 6 months
Change in dual-task posture (path length(m/s²))
Time frame: Baseline, 6 months
Change in dual-task gait (gait speed (m/s))
Time frame: Baseline, 6 months
Change in dual-task gait (double support (%))
Time frame: Baseline, 6 months
Change in dual-task gait (stride length (m))
Time frame: Baseline, 6 months
Change in dual-task gait (upper body range of motion (degrees))
Time frame: Baseline, 6 months
Change in dual-task mobility (task duration (s))
Time frame: Baseline, 6 months
Change in dual-task mobility (turn duration (s))
Time frame: Baseline, 6 months
Change in dual-task mobility (turn velocity (degrees/s))
Time frame: Baseline, 6 months
Change in dual-task mobility (lean angle (degrees))
Time frame: Baseline, 6 months
Change in turning (task duration (s))
Time frame: Baseline, 6 months
Change in turning (turn angle (degrees))
Time frame: Baseline, 6 months
Change in turning (turn velocity (degrees/s))
Time frame: Baseline, 6 months
Change in functional lower extremity strength (task duration (s))
Time frame: Baseline, 6 months
Change in functional lower extremity strength (lean angle (degrees))
Time frame: Baseline, 6 months
Change in hand grip strength
Time frame: Baseline, 6 months
Change in quadriceps grip strength
Time frame: Baseline, 6 months
Change in physical activity (% of time in different levels of physical activity)
Time frame: Baseline, 6 months
Change in physical activity (step count)
Time frame: Baseline, 6 months
Change in physical activity (number of sedentary bouts)
Time frame: Baseline, 6 months
Change in physical activity (time in sedentary bouts (min))
Time frame: Baseline, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Derived from this study: PubMed 41856444Jehu DA, Hanson M, Huang Y, Soares A, Patel C, Hergott C, Waller JL, Young L, Hall W, Robinson-Johnson D, Allen C, Sams R, Carrick RM, Fulzele S, Hamrick M, Zhu H, Dong Y. Preliminary effects of a modified Otago Exercise Program on metabolic, cellular, and epigenetic biomarkers in people living with dementia: A pilot randomized controlled trial. Mol Cell Neurosci. 2026 Jun;137:104077. doi: 10.1016/j.mcn.2026.104077. Epub 2026 Mar 18.
- Derived from this study: PubMed 40961133Jehu DA, Patel C, Soares A, Waller JL, Carrick RM, Hergott C, Young L, Hall W, Robinson-Johnson D, Allen C, Sams R, Hamrick M, Huang Y, Zhu H, Dong Y. The feasibility, acceptability, and effects of the adapted 6-month Otago exercise program on cognitive, physical, and psychological function in people living with dementia in residential care facilities: The ENABLED randomized controlled trial. J Alzheimers Dis. 2025 Nov;108(2):629-642. doi: 10.1177/13872877251378670. Epub 2025 Sep 17.
- Individual participant dataSharing planned: No
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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.
Deborah A Jehu, PhD principal investigator
Augusta 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 Otago Exercise Program in people with Dementia, run by Augusta 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 9 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 31 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deborah A Jehu, PhD (706-721-3980 ext. 3980, djehu@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Color Word Stroop Test (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05488951, which also lists 2 linked publications.
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 31 Jan 2023.