What side effects are associated with this type of intervention?

Exercise-based interventions for dementia, such as the Otago Exercise Program, generally have minimal side effects. Commonly reported issues include muscle soreness, fatigue, and a temporary increase in pain, particularly in individuals with pre-existing musculoskeletal conditions. There is also a risk of falls or injuries if exercises are not performed correctly or if the environment is not safe. However, these risks can be mitigated with proper supervision and individualized exercise plans. Overall, the benefits of improved physical and potentially cognitive function often outweigh these minor side effects.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments for dementia, including cholinesterase inhibitors (donepezil, rivastigmine, and galantamine) and an NMDA receptor antagonist (memantine). However, non-pharmacological interventions like the Otago Exercise Program, which focuses on structured physical activity to improve physical and cognitive function, are gaining attention. While the FDA does not specifically approve exercise programs, clinical trials and studies have shown that regular physical activity can have beneficial effects on cognitive function and overall quality of life in dementia patients. These findings support the integration of exercise-based interventions as a complementary approach to traditional pharmacological treatments.

What other types of research exist?

Promising alternatives to the Otago Exercise Program for dementia patients include: 1) Tai Chi, which has been shown to improve balance, reduce fall risk, and enhance cognitive function. 2) Dance therapy, which can improve functional mobility, motor symptoms, and quality of life. 3) Multicomponent agility interventions, which have demonstrated improvements in clinical and motor symptoms. 4) Mindfulness Yoga, which has been effective in reducing anxiety and depression while improving physical function. These alternatives offer structured physical activities with potential cognitive and physical benefits for dementia patients.

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Otago Exercise Program for Dementia (ENABLED Trial)

N/A

Recruiting

Led By Deborah A Jehu, PhD

Research Sponsored by Augusta University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3x/week for 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if the Otago Exercise Program combined with usual care can improve thinking skills in people with mild to moderate dementia living in nursing homes. The exercises aim to boost strength and balance, which may help with daily activities and reduce falls.

Who is the study for?

This trial is for people aged 55 or older living with mild to moderate dementia in a nursing home or assisted living facility. Participants must be able to walk, read, write, and speak English, have good enough vision and hearing, expect to live at least another year, and can follow instructions. They need consent from a legal representative.

What is being tested?

The study tests if the Otago Exercise Program plus usual care improves brain function related to planning and decision-making (executive function) over six months better than just usual care. It also looks into other health benefits like mood and balance.

What are the potential side effects?

Since this trial involves an exercise program designed for elderly individuals with dementia, potential side effects may include muscle soreness, fatigue, increased risk of falls during exercises or joint pain due to physical activity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3x/week for 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3x/week for 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3x/week for 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the Color Word Stroop Test

Secondary study objectives

Change in Functional Comorbidity Index

Change in Health Utilities Index-3

Change in body composition (fat (%))

+49 more

Other study objectives

Adverse Events

Cornell Depression Scale

Exercise adherence, measured by the average number of exercise sessions attended

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Otago Exercise Program Plus Usual CareExperimental Treatment1 Intervention

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).

Group II: Usual Care OnlyActive Control1 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).

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Exercise interventions, such as the Otago Exercise Program, aim to improve physical and cognitive function in dementia patients through structured physical activity. These programs enhance cardiovascular health, increase cerebral blood flow, reduce inflammation, and promote neuroplasticity, which are essential for maintaining brain health. By improving these physiological parameters, exercise can help slow cognitive decline, improve mood, and enhance the overall quality of life for dementia patients, making it a valuable component of dementia care.