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NCT05370118 · ClinicalTrials.gov registry record · NA
Improving Physical Activity With Cognitive Impairment
A NA study of Mild Cognitive Impairment and Caregiver Burnout, sponsored by Creighton University.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05370118: Recruiting NA study of Mild Cognitive Impairment and Caregiver Burnout, sponsored by Creighton University.
NCT05370118 is a NA study of Mild Cognitive Impairment and Caregiver Burnout that is actively recruiting participants, run by Creighton University. The registered enrollment target is 60 participants, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05370118, a NA study of Mild Cognitive Impairment and Caregiver Burnout, is actively recruiting participants, sponsored by Creighton University.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Individuals with mild cognitive impairment are often physically inactive and at risk for progressing to dementia. Physical inactivity is considered a modifiable risk factor for dementia. Therefore, interventions must be developed to foster sustainable improvement in daily physical activity. To address this problem, our pilot study aims are directed at assessing the feasibility and preliminary improvement of physical activity following the use of a mobile-health technology physical activity behavior change intervention. Similar interventions have shown to be very effective in older adults without cognitive impairment. We specifically focus on the subtype of amnestic mild cognitive impairment since this subtype often progresses to Alzheimer's Disease, a leading cause of death in the US. Improving physical activity is one approach to reduce the progression to Alzheimer's Disease and subsequently lower mortality. To increase the impact of the intervention, participants with amnestic mild cognitive impairment will be recruited along with a primary caregiver (dyads). Thirty dyads will be recruited and randomized to either an intervention group (15 dyads) or usual care group (15 dyads). The intervention group will receive a 12-week mobile-health technology physical activity behavior change intervention structured to improve physical activity. The intervention is unique in the combination of established behavior change theories and techniques and remote delivery for individuals with amnestic mild cognitive impairment. This pilot study is designed to assess the feasibility of the intervention by examining participant and primary caregiver retention, intervention session attendance, intervention acceptability and safety, and qualitative perspectives. Secondly, this pilot study will assess preliminary improvement in physical activity (i.e., daily steps). Improvement will be determined based on significant changes in participants' daily steps observed via accelerometry post-int
Primary Outcome
The number of participants that complete the 12 week intervention will be calculated to determine participant retention.
Conditions Studied
Interventions
- BEHAVIORAL Telerehabilitation physical activity behavioral (TPAB) intervention
Study Locations (1)
Nebraska
- Creighton University - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-02-01 |
| Est. Completion | 2025-06 |
| Phase | NA |
What NCT05370118 shows while recruiting
NCT05370118 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Mild Cognitive Impairment appearing as the primary indexed condition, and to 1 intervention - of which Telerehabilitation physical activity behavioral (TPAB) intervention is the first listed.
NCT05370118 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT05370118 about?
NCT05370118 is a clinical study titled "Improving Physical Activity With Cognitive Impairment". Individuals with mild cognitive impairment are often physically inactive and at risk for progressing to dementia. Physical inactivity is considered a modifiable risk factor for dementia. Therefore, interventions must be developed to foster sustainable improvement in daily physical activity. To addre...
What is the current status of trial NCT05370118?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2023-02-01. Estimated completion is 2025-06.
What conditions does trial NCT05370118 study?
This clinical trial studies the following conditions: Mild Cognitive Impairment, Caregiver Burnout.
What interventions are being tested in trial NCT05370118?
The interventions under investigation include: Telerehabilitation physical activity behavioral (TPAB) intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT05370118?
This trial is sponsored by Creighton University, which has 98 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05370118 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05370118's enrollment target sits among peer trials
60 124th of 205 higher than 73 of 205 other Mild Cognitive Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mild Cognitive Impairment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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