NCT02897102

Brief Summary

The aim of this study was to investigate the effects of a structured program, which was based on abacus training associated with other activities, administered as weekly group classes over a 7 month period in older adults.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

7 months

First QC Date

August 18, 2016

Last Update Submit

September 6, 2016

Conditions

Outcome Measures

Primary Outcomes (7)

  • Reasoning score change

    Reasoning score change will be measured using the Z-score of Matrix Reasoning subtest of the BETA III

    After 7 month

  • Attention score change

    Attention score change will be measured using the average of the Z-scores of the Codes subtest of the BETA III and the Cogstate Identification Task

    After 7 month

  • Speed of processing score change

    Speed of processing score change will be measured using the Z-score of the Cogstate Detection Task

    After 7 month

  • Working memory score change

    Working memory score change will be measured using the average of the Z-scores of the Cogstate One Back and Two Back tasks

    After 7 month

  • Verbal learning and memory score change

    Verbal learning and memory score change will be measured using the average of the Z-scores of the Cogstate International Shopping List and International Shopping List - Delayed Recall tasks

    After 7 month

  • Visual learning and memory score change

    Visual learning and memory score change will be measured using the average of the Z-scores of the Cogstate Continuous Paired Associate Learning, One Card Learning and Groton Maze Learning Test - Delayed Recall tasks

    After 7 month

  • Executive function score change

    Executive function score change will be measured using the average of the Z-scores of the Cogstate Groton Maze Learning Test and Set Shifting Task

    After 7 month

Secondary Outcomes (2)

  • Motivation

    After 7 months

  • Quality of life

    After 7 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

The individuals in the control group chose to participate in different group activities: ballroom dancing (5 participants), belly dancing (4 participants), chorus (16 participants), Spanish classes (8 participants) and chorus and Spanish classes (6 participants). The activities were offered once per week in 2 hours classes for 35 weeks and were held between April and November of 2013.

Other: Different group activities

Training group

EXPERIMENTAL

was offered in one weekly class for 2 hours for 35 weeks between April and November of 2013. The first 50 minutes were spent performing exercises with the abacus, with increasing difficulty. One or two of the following activities followed the abacus training: playing games, neurobic and group dynamics.

Behavioral: Training

Interventions

TrainingBEHAVIORAL

Training program based on abacus and other activities

Training group

ballroom dancing (5 participants), belly dancing (4 participants), chorus (16 participants), Spanish classes (8 participants) and chorus and Spanish classes (6 participants).

Control group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 60 years
  • Score ≥ 26 on the Mini-Mental State Examination
  • Portuguese as a native language.

You may not qualify if:

  • A neurological or serious medical condition that would prevent participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 18, 2016

First Posted

September 13, 2016

Study Start

April 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

September 13, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share