AgingNCT02897102
Effects of a Training Program Based on Abacus and Other Activities in Healthy Older Adults
A study testing Training and Different group activities in people with Aging, run by Universidade Federal do Rio de Janeiro.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Training and Different group activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years
- Score ≥ 26 on the Mini-Mental State Examination
- Portuguese as a native language.
Who cannot join
- A neurological or serious medical condition that would prevent participation in the study.
About this study
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.
Read the detailed description
Cognitive stimulating activities are often recommended for older adults; however, little is known regarding the effects of these activities on cognition, motivation and quality of life in this population. 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. Eighty-eight older adults were enrolled in an open-label controlled clinical trial to evaluate the effects of this training program on cognition, motivation and quality of life. Training had a significant effect over time; the training group maintained their level of performance on verbal learning and memory tasks, whereas the control group exhibited a significant decrease in performance from baseline to post-intervention. The subjects in the training group were more motivated to learn at study entry; however, the training had no significant effect on motivation or quality of life. Abacus training associated with other activities may benefit verbal learning and memory in older adults. Additional studies with longer follow-ups are necessary to determine whether the results of this training will have a positive effect on the lives of older adults.
- Conditions
- Aging
- Being tested
- Training, Different group activities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingBehavioural
Training program based on abacus and other activities
Different group activitiesOther
ballroom dancing (5 participants), belly dancing (4 participants), chorus (16 participants), Spanish classes (8 participants) and chorus and Spanish classes (6 participants).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reasoning score change
Reasoning score change will be measured using the Z-score of Matrix Reasoning subtest of the BETA III
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: After 7 month
Secondary outcomes (2)
Motivation
Evaluated using the self-concept scales of cognitive competence and self-learning
Measured: After 7 months
Quality of life
Evaluated using the control, autonomy, self-realization, and pleasure scale (CASP-19)
Measured: After 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startApr 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rogerio Panizzutti, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897102
- Sponsor's protocol ID
- 257651
- Status last verified
- Sep 2016
- First submitted
- 18 Aug 2016
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Training Program Based on Abacus and Other Activities in Healthy Older Adults
- ClinicalTrials.gov ID
- NCT02897102
- Acronym / sponsor ID
- 257651
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cognitive stimulating activities are often recommended for older adults; however, little is known regarding the effects of these activities on cognition, motivation and quality of life in this population. 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. Eighty-eight older adults were enrolled in an open-label controlled clinical trial to evaluate the effects of this training program on cognition, motivation and quality of life. Training had a significant effect over time; the training group maintained their level of performance on verbal learning and memory tasks, whereas the control group exhibited a significant decrease in performance from baseline to post-intervention. The subjects in the training group were more motivated to learn at study entry; however, the training had no significant effect on motivation or quality of life. Abacus training associated with other activities may benefit verbal learning and memory in older adults. Additional studies with longer follow-ups are necessary to determine whether the results of this training will have a positive effect on the lives of older adults.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Different group activitiesThe 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. |
| Training group | Experimental | Behavioral: Trainingwas 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 60 years
- Score ≥ 26 on the Mini-Mental State Examination
- Portuguese as a native language.
Key exclusion criteria (1 listed)
- A neurological or serious medical condition that would prevent participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrainingTraining program based on abacus and other activities | Behavioural | Training group |
| Different group activitiesballroom dancing (5 participants), belly dancing (4 participants), chorus (16 participants), Spanish classes (8 participants) and chorus and Spanish classes (6 participants). | Other | Control group |
Primary outcome
Reasoning score change
Time frame: After 7 month
Reasoning score change will be measured using the Z-score of Matrix Reasoning subtest of the BETA III
Attention score change
Time frame: After 7 month
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
Speed of processing score change
Time frame: After 7 month
Speed of processing score change will be measured using the Z-score of the Cogstate Detection Task
Working memory score change
Time frame: After 7 month
Working memory score change will be measured using the average of the Z-scores of the Cogstate One Back and Two Back tasks
Verbal learning and memory score change
Time frame: After 7 month
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
Visual learning and memory score change
Time frame: After 7 month
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
Executive function score change
Time frame: After 7 month
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
2 secondary outcomes
Motivation
Time frame: After 7 months
Quality of life
Time frame: After 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Training and Different group activities in people with Aging, run by Universidade Federal do Rio de Janeiro.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reasoning score change (time frame: After 7 month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2016.