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Telerehabilitation physical activity behavioral (TPAB) intervention for Mild Cognitive Impairment

N/A
Recruiting
Research Sponsored by Creighton University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinically diagnosed with amnestic MCI (patient only)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and after the 12 week intervention
Awards & highlights

Study Summary

"This trial aims to help people with mild cognitive impairment improve their physical activity using a mobile health technology intervention. The goal is to prevent the progression to dementia, specifically Alzheimer's Disease. Participants will be recruited

Who is the study for?
This trial is for pairs of individuals where one person has mild cognitive impairment (MCI) aged between 50-85, and their caregiver who is over 19. The patient should have a diagnosis of amnestic MCI, score within a specific range on a cognitive assessment test, not be very physically active, and be stable on medications. Both must speak English and have internet access.Check my eligibility
What is being tested?
The study tests a Telerehabilitation physical activity behavioral intervention using mobile-health technology to improve daily physical activity in patients with MCI. Thirty pairs will either receive this 12-week intervention or usual care to see if it's feasible and effective at increasing steps measured by accelerometry.See study design
What are the potential side effects?
Since the intervention involves non-invasive methods like behavior change techniques delivered remotely, significant side effects are not anticipated. However, any potential risks related to increased physical activity would be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with memory loss that affects my daily life.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and after the 12 week intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and after the 12 week intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of the TPAB Intervention (Semi-Structured Interviews)
TPAB Intervention Acceptability
TPAB Intervention Attendance
+2 more
Secondary outcome measures
Daily step count change

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Telerehabilitation physical activity behavioral (TPAB) interventionExperimental Treatment1 Intervention
Individuals in the TPAB intervention will participate in a weekly session for 12 weeks with their primary caregiver and the research interventionist (RH). Established behavior-change techniques will be used in the TPAB intervention, based largely on the combination of the Social Cognitive Theory, Control Theory, and Operant Conditioning,43 including behavioral techniques, and patient-centered communication (e.g., motivational interviewing).44 The behavior-change techniques are designed to target and improve daily steps. Individuals in the CTL group will receive usual care and no intervention over the 12 weeks.
Group II: Control GroupActive Control1 Intervention
Individuals in the CTL group will receive usual care and no intervention over the 12 weeks.

Find a Location

Who is running the clinical trial?

Creighton UniversityLead Sponsor
125 Previous Clinical Trials
25,636 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,790 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients in this ongoing clinical trial?

"Indeed, the details on clinicaltrials.gov indicate that this research study is actively seeking suitable individuals. The trial was initially published on February 1st, 2023, and most recently revised on February 8th, 2024. It aims to recruit a total of 60 participants from one designated site."

Answered by AI

Which individuals are eligible to participate in this clinical trial?

"The study seeks to enroll 60 participants aged between 50 and 85 with mild cognitive impairment. Eligible patients must fulfill the subsequent requirements: be within the age range of 50-85 years (patient), have a caregiver aged at least 19 years, possess a clinical diagnosis of amnestic MCI, score between 18-24 on the Montreal Cognitive Assessment indicating potential MCI, not currently labeled as "Active" based on the Rapid Assessment of Physical Activity, maintain stable medication doses for at least the preceding month before baseline assessment, own a computer or wireless device with Internet connectivity, enlist a primary caregiver willing to engage in"

Answered by AI

Does this medical study include participants who are above the age of 70?

"For those wishing to participate in this research, the age range is limited to individuals between 50 and 85 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Improving Physical Activity With Cognitive Impairment
2023. "Improving Physical Activity With Cognitive Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05370118.
~4 spots leftby Jun 2024
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