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NCT01129115 · ClinicalTrials.gov registry record · Early Phase 1
Dose Response Study of Aerobic Exercise in Older Adults
A Early Phase 1 study of Alzheimers Disease, sponsored by Jeff Burns, MD.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 101
- Enrollment target
- 1
- Study location
NCT01129115: Completed Early Phase 1 study of Alzheimers Disease, sponsored by Jeff Burns, MD.
NCT01129115 is a Early Phase 1 study of Alzheimers Disease that has completed, run by Jeff Burns, MD. The registered enrollment target is 101 participants, below the 3,926-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01129115, a Early Phase 1 study of Alzheimers Disease, has completed, sponsored by Jeff Burns, MD.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 101 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized, 26-week study of supervised exercise assessing three doses of exercise in sedentary individuals 65 years of age and over with age-related cognitive changes. A total of 100 subjects (n=25 in each of four groups) will be randomized to a non-aerobic control group, 75 minutes, 150 minutes, or 225 minutes a week of moderate intensity aerobic exercise spread over 3 to 5 days a week for 26 weeks. These exercise doses represent 50%, 100%, or 150% of the recommended exercise dose. Participants will be directly supervised during all exercise sessions for the first two months after which direct supervision will occur during at least one session a week. This is intended to provide increased flexibility while also maintaining direct contact with the participant to enhance adherence. Aerobic fitness, physical function, and cognition will be assessed at baseline and 26 weeks to examine the dose-response relationships.
Primary Outcome
Visuospatial Processing is a latent derived variable derived estimated mean.The reported latent means for this trial are created from the well-known neuropsychological tests: Block Design, Stroop Color Reading, Digit Symbol Substitution and Trailmaking Test A. Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value repr
Conditions Studied
Interventions
- BEHAVIORAL Nonexercise control group
- BEHAVIORAL Aerobic Exercise Group 1
- BEHAVIORAL Aerobic Exercise Group 2
- BEHAVIORAL Aerobic Exercise Group 3
Study Locations (1)
Kansas
- University of Kansas Medical Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2010-05 |
| Est. Completion | 2014-04 |
| Phase | Early Phase 1 |
What the finished NCT01129115 record still lists
NCT01129115 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 3,926-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Alzheimers Disease appearing as the primary indexed condition, and to 4 interventions - of which Nonexercise control group is the first listed.
NCT01129115 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT01129115 about?
NCT01129115 is a clinical study titled "Dose Response Study of Aerobic Exercise in Older Adults". This is a randomized, 26-week study of supervised exercise assessing three doses of exercise in sedentary individuals 65 years of age and over with age-related cognitive changes. A total of 100 subjects (n=25 in each of four groups) will be randomized to a non-aerobic control group, 75 minutes, 150 ...
What is the current status of trial NCT01129115?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 101 participants. The study started on 2010-05. Estimated completion is 2014-04.
What conditions does trial NCT01129115 study?
This clinical trial studies the following conditions: Alzheimers Disease.
What interventions are being tested in trial NCT01129115?
The interventions under investigation include: Nonexercise control group (BEHAVIORAL), Aerobic Exercise Group 1 (BEHAVIORAL), Aerobic Exercise Group 2 (BEHAVIORAL), Aerobic Exercise Group 3 (BEHAVIORAL).
Who is sponsoring clinical trial NCT01129115?
This trial is sponsored by Jeff Burns, MD, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01129115 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01129115's enrollment target sits among peer trials
101 75th of 147 higher than 73 of 147 other Alzheimers Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimers Disease 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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