ACTIVE: Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE)
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ClinicalTrials.gov Identifier: NCT00298558 |
Recruitment Status :
Completed
First Posted : March 2, 2006
Results First Posted : February 24, 2014
Last Update Posted : April 16, 2014
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Sponsor:
HealthCore-NERI
Collaborators:
National Institute on Aging (NIA)
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
HealthCore-NERI
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Prevention |
Conditions |
Aging Healthy |
Intervention |
Behavioral: Cognitive Training |
Enrollment | 2832 |
Participant Flow
Recruitment Details | Recruitment occurred from March 1998 through October 1999 at six metropolitan field centers: University of Alabama at Birmingham, Boston Hebrew Rehabilitation Center for Aged (now Hebrew Senior Life), Indiana University School of Medicine, Johns Hopkins University, Pennsylvania State University, and Wayne State University. |
Pre-assignment Details | Eligibility and demographics were gathered at telephone screening.Health history, physical status, functional status, mental status, cognitive and function measures were gathered via in-person exams in individual and small-group formats at baseline.Eligible subjects were randomly assigned to one of three interventions or no-contact control group. |
Arm/Group Title | Memory Training | Reasoning Training | Speed of Processing Training | Control |
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Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information. | Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem. | Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer. | This group did not complete any cognitive training interventions |
Period Title: Baseline | ||||
Started | 711 | 705 | 712 | 704 |
Completed | 711 | 705 | 712 | 704 |
Not Completed | 0 | 0 | 0 | 0 |
Period Title: Intervention | ||||
Started | 711 | 705 | 712 | 704 |
Completed | 620 | 627 | 637 | 285 |
Not Completed | 91 | 78 | 75 | 419 |
Period Title: Immediate Post Test | ||||
Started | 711 | 705 | 712 | 704 |
Completed | 640 | 629 | 653 | 639 |
Not Completed | 71 | 76 | 59 | 65 |
Period Title: Booster | ||||
Started | 372 | 371 | 370 | 0 |
Completed | 283 | 301 | 295 | 0 |
Not Completed | 89 | 70 | 75 | 0 |
Period Title: 1st Annual (A1) | ||||
Started | 640 | 629 | 653 | 639 |
Completed | 585 | 566 | 601 | 584 |
Not Completed | 55 | 63 | 52 | 55 |
Period Title: 2nd Annual (A2) | ||||
Started | 585 | 566 | 601 | 584 |
Completed | 563 | 555 | 574 | 552 |
Not Completed | 22 | 11 | 27 | 32 |
Period Title: 3rd Annual Booster | ||||
Started | 372 | 371 | 370 | 0 |
Completed | 250 | 243 | 230 | 0 |
Not Completed | 122 | 128 | 140 | 0 |
Period Title: 3rd Annual (A3) and 5th Annual (A5) | ||||
Started | 563 | 555 | 574 | 552 |
Completed | 472 | 469 | 490 | 448 |
Not Completed | 91 | 86 | 84 | 104 |
Period Title: 10th Annual (A10) | ||||
Started | 472 | 469 | 490 | 448 |
Completed | 300 | 316 | 319 | 285 |
Not Completed | 172 | 153 | 171 | 163 |
Baseline Characteristics
Arm/Group Title | Memory Training | Reasoning Training | Speed of Processing Training | Control | Total | |
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Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information. | Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem. | Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer. | This group did not complete any cognitive training interventions | Total of all reporting groups | |
Overall Number of Baseline Participants | 703 | 699 | 702 | 698 | 2802 | |
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Of 2832 randomized subjects, 30 subjects were randomized inappropriately in violation of the protocol and excluded from the analysis. Therefore, 2802 subjects were used for the baseline analysis.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 703 participants | 699 participants | 702 participants | 698 participants | 2802 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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>=65 years |
703 100.0%
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699 100.0%
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702 100.0%
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698 100.0%
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2802 100.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 703 participants | 699 participants | 702 participants | 698 participants | 2802 participants | |
73.5 (6.02) | 73.5 (5.76) | 73.4 (5.78) | 74.0 (6.05) | 73.6 (5.91) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 703 participants | 699 participants | 702 participants | 698 participants | 2802 participants | |
Female |
537 76.4%
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537 76.8%
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538 76.6%
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514 73.6%
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2126 75.9%
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Male |
166 23.6%
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162 23.2%
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164 23.4%
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184 26.4%
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676 24.1%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 703 participants | 699 participants | 702 participants | 698 participants | 2802 participants |
703 | 699 | 702 | 698 | 2802 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title: | Sharon L. Tennstedt, PhD |
Organization: | New England Research Institutes |
Phone: | 617-972-3362 |
EMail: | stennstedt@neriscience.com |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | HealthCore-NERI |
ClinicalTrials.gov Identifier: | NCT00298558 |
Other Study ID Numbers: |
IA0091 U01NR004507 ( U.S. NIH Grant/Contract ) U01NR004508 ( U.S. NIH Grant/Contract ) U01AG014260 ( U.S. NIH Grant/Contract ) U01AG014282 ( U.S. NIH Grant/Contract ) U01AG014263 ( U.S. NIH Grant/Contract ) U01AG014289 ( U.S. NIH Grant/Contract ) U01AG014276 ( U.S. NIH Grant/Contract ) |
First Submitted: | February 28, 2006 |
First Posted: | March 2, 2006 |
Results First Submitted: | April 24, 2013 |
Results First Posted: | February 24, 2014 |
Last Update Posted: | April 16, 2014 |