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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
ENABLED Trial Summary
This trial will compare the effects of the Otago Exercise Program plus usual care to usual care alone on people living with mild to moderate dementia. The primary outcome measure is executive function, and the secondary outcome measures are inflammatory blood biomarkers, kynurenine metabolites, epigenetics, mobility, balance, cognition, mood, fall-related self-efficacy, health-related quality of life, sleep, physical activity, and 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.Check my eligibility
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.See study design
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.
ENABLED Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the Color Word Stroop Test
Secondary outcome measures
Change in Functional Comorbidity Index
Change in Health Utilities Index-3
Change in body composition (fat (%))
+49 moreOther outcome measures
Adverse Events
Cornell Depression Scale
Exercise adherence, measured by the average number of exercise sessions attended
+3 moreENABLED 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).
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Who is running the clinical trial?
Augusta UniversityLead Sponsor
211 Previous Clinical Trials
85,026 Total Patients Enrolled
2 Trials studying Dementia
699 Patients Enrolled for Dementia
Deborah A Jehu, PhDPrincipal InvestigatorAugusta University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Experiencing confusion or disorientation.You had a surgery that has made it hard for you to move around recently.You are unable to see.You are 55 years old or older.You have severe dementia and cannot follow instructions.You have a serious mental health condition.You have a neurological disease that is getting worse over time, except for mild and stable conditions like Parkinson's.Difficulty speaking or understanding language.You are currently receiving end-of-life care.You have been diagnosed with mild to moderate dementia by a doctor or through medical records.You can walk 3 meters by yourself or with someone's help.
Research Study Groups:
This trial has the following groups:- Group 1: Otago Exercise Program Plus Usual Care
- Group 2: Usual Care Only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being considered for participation in this trial?
"Indeed, the clinicaltrials.gov database confirms that this medical investigation is currently recruiting patients. It was first posted on August 1st 2022 and its last update was on August 3rd of the same year. 42 participants are needed from a single site for participation in the trial."
Answered by AI
Is enrollment for this clinical trial still open?
"Affirmative. Clinicaltrials.gov displays that this medical experiment is actively searching for participants, with the initial posting appearing on August 1st 2022 and an update happening as recently as August 3rd 2022. The study seeks 42 patients from one site."
Answered by AI
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