Otago Exercise Program Plus Usual Care for Dementia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Augusta University, Augusta, GA
Dementia
Otago Exercise Program - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 52 Secondary · Reporting Duration: 3x/week for 6 months

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

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Usual Care Only
1 of 2
Otago Exercise Program Plus Usual Care
1 of 2
Active Control
Experimental Treatment

42 Total Participants · 2 Treatment Groups

Primary Treatment: Otago Exercise Program Plus Usual Care · No Placebo Group · N/A

Otago Exercise Program Plus Usual Care
Other
Experimental Group · 1 Intervention: Otago Exercise Program · Intervention Types: Other
Usual Care OnlyNoIntervention Group · 1 Intervention: Usual Care Only · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3x/week for 6 months

Trial Background

Prof. Deborah Jehu, Assistant Professor
Principal Investigator
Augusta University
Closest Location: Augusta University · Augusta, GA
Photo of Augusta University  1Photo of Augusta University  2Photo of Augusta University  3
2019First Recorded Clinical Trial
3 TrialsResearching Dementia
109 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have mild to moderate dementia.
You are able to walk 3 meters with or without the assistance of another person.
You have a life expectancy of ≥12 months.
You can read, write, and speak English with acceptable visual and auditory acuity.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.