The Influence of the Otago Exercise Program on Executive Function Among People Living With Mild to Moderate Dementia

The Effects of strEngth aNd BaLance Exercise on Executive Function in People Living With Dementia (ENABLED): A Randomized Controlled Trial

Sponsors

Lead Sponsor: Augusta University

Source Augusta University
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.

Overall Status Recruiting
Start Date 2022-08-01
Completion Date 2023-12-31
Primary Completion Date 2023-12-31
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in the Color Word Stroop Test Baseline, 6 months
Secondary Outcome
Measure Time Frame
Change in the Digit Symbol Substitution Test Baseline, 6 months
Change in the oral Trail Making Test Baseline, 6 months
Change in the Digit Span Forwards and Backwards Baseline, 6 months
Change in the Rey Auditory Verbal Learning Test Baseline, 6 months
Change in the Benton Judgement of Line Orientation Baseline, 6 months
Change in the Boston Naming Test Baseline, 6 months
Change in Health Utilities Index-3 Baseline, 6 months
Change in the Visual Analogue Scale Baseline, 6 months
Change in the Geriatric Depression Scale Baseline, 6 months
Change in the short-Falls Efficacy Scale International Baseline, 6 months
Change in Functional Comorbidity Index Baseline, 6 months
Change in body composition (weight (kg)) Baseline, 6 months
Change in body composition (fat (%)) Baseline, 6 months
Change in body composition (muscle (%)) Baseline, 6 months
Change in the Short Physical Performance Battery Baseline, 6 months
Change in dual-task posture (sway area (degrees/s squared)) Baseline, 6 months
Change in dual-task posture (root mean square sway (degrees)) Baseline, 6 months
Change in dual-task posture (frequency of sway (Hz)) Baseline, 6 months
Change in dual-task posture (jerk (m²/s^5)) Baseline, 6 months
Change in dual-task posture (mean velocity (m/s)) Baseline, 6 months
Change in dual-task posture (path length(m/s²)) Baseline, 6 months
Change in dual-task gait (gait speed (m/s)) Baseline, 6 months
Change in dual-task gait (double support (%)) Baseline, 6 months
Change in dual-task gait (stride length (m)) Baseline, 6 months
Change in dual-task gait (upper body range of motion (degrees)) Baseline, 6 months
Change in dual-task mobility (task duration (s)) Baseline, 6 months
Change in dual-task mobility (turn duration (s)) Baseline, 6 months
Change in dual-task mobility (turn velocity (degrees/s)) Baseline, 6 months
Change in dual-task mobility (lean angle (degrees)) Baseline, 6 months
Change in turning (task duration (s)) Baseline, 6 months
Change in turning (turn angle (degrees)) Baseline, 6 months
Change in turning (turn velocity (degrees/s)) Baseline, 6 months
Change in functional lower extremity strength (task duration (s)) Baseline, 6 months
Change in functional lower extremity strength (lean angle (degrees)) Baseline, 6 months
Change in hand grip strength Baseline, 6 months
Change in quadriceps grip strength Baseline, 6 months
Change in physical activity (% of time in different levels of physical activity) Baseline, 6 months
Change in physical activity (step count) Baseline, 6 months
Change in physical activity (number of sedentary bouts) Baseline, 6 months
Change in physical activity (time in sedentary bouts (min)) Baseline, 6 months
Change in sleep efficiency (total sleep time/total time in bed) Baseline, 6 months
Change in sleep (number of awakenings) Baseline, 6 months
Change in sleep (average awake length (min)) Baseline, 6 months
Change in sleep (Sleep Fragmentation Index) Baseline, 6 months
Falls Retrospective and Prospective for 6 months
Change in inflammatory blood biomarkers (Interleukin-6) Baseline, 6 months
Change in inflammatory blood biomarkers (Interleukin-1) Baseline, 6 months
Change in inflammatory blood biomarkers (Tumor Necrosis Factor-α) Baseline, 6 months
Change in kynurenine pathway metabolites (kynurenine) Baseline, 6 months
Change in kynurenine pathway metabolites (tryptophan) Baseline, 6 months
Change in kynurenine pathway metabolites (kynurenic acid) Baseline, 6 months
Change in epigenetics Baseline, 6 months
Enrollment 42
Condition
Intervention

Intervention Type: Other

Intervention Name: Otago Exercise Program

Description: 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.

Arm Group Label: Otago Exercise Program Plus Usual Care

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

Gender:

All

Minimum Age:

55 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Deborah A Jehu, PhD Principal Investigator Augusta University
Overall Contact

Last Name: Deborah A Jehu, PhD

Phone: 706-721-3980

Phone Ext.: 3980

Email: [email protected]

Location
Facility: Status: Contact: Augusta University Deborah A Jehu, PhD 706-721-3980 3980 [email protected]
Location Countries

United States

Verification Date

2022-08-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Augusta University

Investigator Full Name: Deborah Jehu

Investigator Title: Assistant Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Otago Exercise Program Plus Usual Care

Type: Experimental

Description: 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).

Label: Usual Care Only

Type: No Intervention

Description: 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).

Acronym ENABLED
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

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

Masking: Single (Outcomes Assessor)

Masking Description: The investigators conducting the testing will be masked to group assignment.

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