Clinical trial NCT05488951: The Influence of the Otago Exercise Program on Executive Function Among People Living With Mild to Moderate Dementia
Official title: The Effects of strEngth aNd BaLance Exercise on Executive Function in People Living With Dementia (ENABLED): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dementia
Keywords: Dementia
Otago Exercise Program
Executive Function
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 42
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion criteria

* 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
* Able to provide assent
* Able to understand and follow instructions
* Have a life expectancy of ≥12 months as estimated by a healthcare provider

Exclusion criteria

* 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
* 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

Primary outcomes:
measure: Change in the Color Word Stroop Test
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change in the Digit Symbol Substitution Test
timeFrame: Baseline, 6 months
measure: Change in the oral Trail Making Test
timeFrame: Baseline, 6 months
measure: Change in the Digit Span Forwards and Backwards
timeFrame: Baseline, 6 months
measure: Change in the Rey Auditory Verbal Learning Test
timeFrame: Baseline, 6 months
measure: Change in the Benton Judgement of Line Orientation
timeFrame: Baseline, 6 months
measure: Change in the Boston Naming Test
timeFrame: Baseline, 6 months
measure: Change in Health Utilities Index-3
timeFrame: Baseline, 6 months
measure: Change in the Visual Analogue Scale
timeFrame: Baseline, 6 months
measure: Change in the Geriatric Depression Scale
timeFrame: Baseline, 6 months
measure: Change in the short-Falls Efficacy Scale International
timeFrame: Baseline, 6 months
measure: Change in Functional Comorbidity Index
timeFrame: Baseline, 6 months
measure: Change in body composition (weight (kg))
timeFrame: Baseline, 6 months
measure: Change in body composition (fat (%))
timeFrame: Baseline, 6 months
measure: Change in body composition (muscle (%))
timeFrame: Baseline, 6 months
measure: Change in the Short Physical Performance Battery
timeFrame: Baseline, 6 months
measure: Change in dual-task posture (sway area (degrees/s squared))
timeFrame: Baseline, 6 months
measure: Change in dual-task posture (root mean square sway (degrees))
timeFrame: Baseline, 6 months
measure: Change in dual-task posture (frequency of sway (Hz))
timeFrame: Baseline, 6 months
measure: Change in dual-task posture (jerk (m²/s^5))
timeFrame: Baseline, 6 months
measure: Change in dual-task posture (mean velocity (m/s))
timeFrame: Baseline, 6 months
measure: Change in dual-task posture (path length(m/s²))
timeFrame: Baseline, 6 months
measure: Change in dual-task gait (gait speed (m/s))
timeFrame: Baseline, 6 months
measure: Change in dual-task gait (double support (%))
timeFrame: Baseline, 6 months
measure: Change in dual-task gait (stride length (m))
timeFrame: Baseline, 6 months
measure: Change in dual-task gait (upper body range of motion (degrees))
timeFrame: Baseline, 6 months
measure: Change in dual-task mobility (task duration (s))
timeFrame: Baseline, 6 months
measure: Change in dual-task mobility (turn duration (s))
timeFrame: Baseline, 6 months
measure: Change in dual-task mobility (turn velocity (degrees/s))
timeFrame: Baseline, 6 months
measure: Change in dual-task mobility (lean angle (degrees))
timeFrame: Baseline, 6 months
measure: Change in turning (task duration (s))
timeFrame: Baseline, 6 months
measure: Change in turning (turn angle (degrees))
timeFrame: Baseline, 6 months
measure: Change in turning (turn velocity (degrees/s))
timeFrame: Baseline, 6 months
measure: Change in functional lower extremity strength (task duration (s))
timeFrame: Baseline, 6 months
measure: Change in functional lower extremity strength (lean angle (degrees))
timeFrame: Baseline, 6 months
measure: Change in hand grip strength
timeFrame: Baseline, 6 months
measure: Change in quadriceps grip strength
timeFrame: Baseline, 6 months
measure: Change in physical activity (% of time in different levels of physical activity)
timeFrame: Baseline, 6 months
measure: Change in physical activity (step count)
timeFrame: Baseline, 6 months
measure: Change in physical activity (number of sedentary bouts)
timeFrame: Baseline, 6 months
measure: Change in physical activity (time in sedentary bouts (min))
timeFrame: Baseline, 6 months
measure: Change in sleep efficiency (total sleep time/total time in bed)
timeFrame: Baseline, 6 months
measure: Change in sleep (number of awakenings)
timeFrame: Baseline, 6 months
measure: Change in sleep (average awake length (min))
timeFrame: Baseline, 6 months
measure: Change in sleep (Sleep Fragmentation Index)
timeFrame: Baseline, 6 months
measure: Falls
timeFrame: Retrospective and Prospective for 6 months
measure: Change in inflammatory blood biomarkers (Interleukin-6)
timeFrame: Baseline, 6 months
measure: Change in inflammatory blood biomarkers (Interleukin-1)
timeFrame: Baseline, 6 months
measure: Change in inflammatory blood biomarkers (Tumor Necrosis Factor-α)
timeFrame: Baseline, 6 months
measure: Change in kynurenine pathway metabolites (kynurenine)
timeFrame: Baseline, 6 months
measure: Change in kynurenine pathway metabolites (tryptophan)
timeFrame: Baseline, 6 months
measure: Change in kynurenine pathway metabolites (kynurenic acid)
timeFrame: Baseline, 6 months
measure: Change in epigenetics
timeFrame: Baseline, 6 months
Other outcomes:
measure: Montreal Cognitive Assessment
timeFrame: Baseline
measure: Morse Fall Scale
timeFrame: Baseline
measure: Cornell Depression Scale
timeFrame: Baseline
measure: Adverse Events
timeFrame: Monthly for 6 months
measure: Exercise adherence, measured by the average number of exercise sessions attended
timeFrame: 3x/week for 6 months
measure: Intervention Satisfaction, measured on a Likert scale
timeFrame: 6 months
Locations:
city: Augusta
country: United States
facility: Augusta University
state: Georgia
Study officials:
affiliation: Augusta University
name: Deborah A Jehu, PhD
role: PRINCIPAL_INVESTIGATOR
References: