Recruiting

Otago Exercise Program

Sponsor:

Augusta University

Code:

NCT05488951

Conditions

Dementia

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Otago Exercise Program

Study Details

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

Study ID

NCT05488951

Start date

Jul 1, 2022

Status verified date

Jan, 2023

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Otago Exercise Program Plus Usual Care

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).

no intervention: Usual Care Only

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

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.

Primary outcome measure

  • Change in the Color Word Stroop Test [ Time Frame: Baseline, 6 months ]

Central Contacts and Locations

Central contacts

Deborah A Jehu, PhD

706-721-3980djehu@augusta.edu

Locations

Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Deborah A Jehu, PhD

706-721-3980djehu@augusta.edu

More Information

Sponsor

Augusta University

Last update posted

Jan 31, 2023

Last verified

Jan, 2023

Keywords

  • Dementia
  • Otago Exercise Program
  • Executive Function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Augusta University on 2023-01-31.