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

NCT05488951 | Unknown DMC

• 1 other identifier: 1838020
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

Dementia; Otago Exercise Program; Executive Function

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 6 months

Secondary Outcomes (52)

• 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

Other Outcomes (6)

• Montreal Cognitive Assessment

  Baseline

• Morse Fall Scale

  Baseline

• Cornell Depression Scale

  Baseline

Study Arms (2)

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).

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).

Interventions

Otago Exercise Program OTHER

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.

Otago Exercise Program Plus Usual Care

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Reside in the community
• Severe dementia (e.g., Montreal Cognitive Assessment ≤6/30) and are not able to follow instructions
• Severe psychiatric condition
• 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

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

RECRUITING

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Deborah A Jehu, PhD

  Augusta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah A Jehu, PhD

CONTACT

706-721-3980; djehu@augusta.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigators conducting the testing will be masked to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 5, 2022
• Study Start: July 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)