The Effect of Solving Jigsaw Puzzles on Visuospatial Cognition in Older Adults: Jigsaw Puzzles As Cognitive Enrichment (PACE)

November 28, 2018 updated by: Iris Kolassa, University of Ulm

Jigsaw Puzzles As Cognitive Enrichment

Meta-analyses indicate beneficial effects of cognitive training and cognitively challenging video games on cognition. However, cognitive effects of solving jigsaw puzzles - a popular, visuospatial cognitive leisure activity - have not been investigated, yet. Thus, the primary aim of this study is to evaluate the effect of solving jigsaw puzzles on visuospatial cognition. As secondary aims, effects on psychological outcomes (self-efficacy, perceived stress, well-being) and visuospatial everyday functioning (instrumental activities of daily living and self-reported cognitive failures in everyday life) are examined.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

see References section below for the study protocol article

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Ulm, Germany
        • Clinical and Biological Psychology, University of Ulm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • No cognitive impairment (Mini-Mental State Examination ≥ 24)
  • Commitment to minimum jigsaw puzzle time (1 hour/day, 6 days/week, 5 weeks)
  • Interest in jigsaw puzzles
  • Low jigsaw puzzle experience (less than 5 completed puzzles within the last 5 years)

Exclusion Criteria:

  • Cognitive impairment (Mini-Mental State Examination < 24)
  • Participation in another interventional study
  • Self-reported psychiatric, neurologic or other disease, which could affect cognitive change over time
  • Self-reported, severe visual impairment or motoric impairment of the upper extremity which significantly affects ability to solve jigsaw puzzles

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Jigsaw Puzzle Group
Jigsaw puzzles & Cognitive health counseling
Behavioral: Jigsaw puzzles

Intervention period 1: Participants are asked to solve jigsaw puzzles at home 6 times per week for at least 1 hour over a period of 5 weeks.

Intervention period 2 (voluntary): Participants receive the possibility to solve jigsaw puzzles free-of-charge at home for a period of at least 3 month before the 1.5-year follow-up.

Behavioral: Cognitive health counseling
Cognitive health counseling regarding modifiable risk and protective factors of cognitive decline and dementia at baseline, and four telephone calls for expert monitoring (three calls during the 5-week period between pre- and posttest, and one call 12 month later)
Active Comparator: Cognitive Health Counseling Group
Cognitive health counseling only
Behavioral: Cognitive health counseling
Cognitive health counseling regarding modifiable risk and protective factors of cognitive decline and dementia at baseline, and four telephone calls for expert monitoring (three calls during the 5-week period between pre- and posttest, and one call 12 month later)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in global visuospatial cognition from baseline to post intervention and to the 1.5-year follow-up
Time Frame: Baseline and post intervention (after 5 weeks and 1.5 years)
Averaged score of eight z-standardized visuospatial cognitive ability scores (see secondary outcomes 2 - 9)
Baseline and post intervention (after 5 weeks and 1.5 years)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in visual perception from baseline to post intervention and to the 1.5-year follow-up
Time Frame: Baseline and post intervention (after 5 weeks and 1.5 years)
Judgment of Line Orientation Test
Baseline and post intervention (after 5 weeks and 1.5 years)
Change in visuoconstruction from baseline to post intervention and to the 1.5-year follow-up
Time Frame: Baseline and post intervention (after 5 weeks and 1.5 years)
Copying in Complex Figure Tests; parallel versions for baseline and post-test
Baseline and post intervention (after 5 weeks and 1.5 years)
Change in mental rotation from baseline to post intervention and to the 1.5-year follow-up
Time Frame: Baseline and post intervention (after 5 weeks and 1.5 years)
Mental Rotations Test-Letters (2D) and Form A (3D)
Baseline and post intervention (after 5 weeks and 1.5 years)
Change in visuospatial processing speed from baseline to post intervention and to the 1.5-year follow-up
Time Frame: Baseline and post intervention (after 5 weeks and 1.5 years)
Trail Making Test A
Baseline and post intervention (after 5 weeks and 1.5 years)
Change in visuospatial flexibility from baseline to post intervention and to the 1.5-year follow-up
Time Frame: Baseline and post intervention (after 5 weeks and 1.5 years)
Trail Making Test B
Baseline and post intervention (after 5 weeks and 1.5 years)
Change in visuospatial working memory from baseline to post intervention and to the 1.5-year follow-up
Time Frame: Baseline and post intervention (after 5 weeks and 1.5 years)
Block span (Wechsler Memory Scale, German version)
Baseline and post intervention (after 5 weeks and 1.5 years)
Change in visuospatial reasoning from baseline to post intervention and to the 1.5-year follow-up
Time Frame: Baseline and post intervention (after 5 weeks and 1.5 years)
Block design (Wechsler Adult Intelligence Scale-III, German version)
Baseline and post intervention (after 5 weeks and 1.5 years)
Change in visuospatial episodic memory from baseline to post intervention and to the 1.5-year follow-up
Time Frame: Baseline and post intervention (after 5 weeks and 1.5 years)
Recall in Complex Figure Tests (sum score of immediate and delayed recall); parallel versions for baseline and post-test
Baseline and post intervention (after 5 weeks and 1.5 years)
Change in psychological health from baseline to post intervention and to the 1.5-year follow-up
Time Frame: Baseline and post intervention (after 5 weeks and 1.5 years)
Averaged score of three z-standardized psychological health sub-scores (see secondary outcomes 11 - 13)
Baseline and post intervention (after 5 weeks and 1.5 years)
Change in psychological well-being from baseline to post intervention and to the 1.5-year follow-up
Time Frame: Baseline and post intervention (after 5 weeks and 1.5 years)
WHO-Five Well-being Index (WHO-5), German version
Baseline and post intervention (after 5 weeks and 1.5 years)
Change in self-efficacy from baseline to post intervention and to the 1.5-year follow-up
Time Frame: Baseline and post intervention (after 5 weeks and 1.5 years)
General Self-Efficacy Scale, German version
Baseline and post intervention (after 5 weeks and 1.5 years)
Change in perceived stress from baseline to post intervention and to the 1.5-year follow-up
Time Frame: Baseline and post intervention (after 5 weeks and 1.5 years)
Perceived Stress Scale-14, German translation
Baseline and post intervention (after 5 weeks and 1.5 years)
Change in objective everyday functioning from baseline to post intervention and to the 1.5-year follow-up
Time Frame: Baseline and post intervention (after 5 weeks and 1.5 years)
TIADL (1-3): Timed instrumental activities of daily living (Task 1-3; sum-score)
Baseline and post intervention (after 5 weeks and 1.5 years)
Change in self-reported everyday functioning from baseline to post intervention and to the 1.5-year follow-up
Time Frame: Baseline and post intervention (after 5 weeks and 1.5 years)
CFQ (visuospatial items): Cognitive Failures Questionnaire, sum score of visuo-spatial items; German version
Baseline and post intervention (after 5 weeks and 1.5 years)
Change in jigsaw puzzle performance from baseline to post intervention and to the 1.5-year follow-up
Time Frame: Baseline and post intervention (after 5 weeks and 1.5 years)
40-pieces mini puzzle (completed pieces per minute)
Baseline and post intervention (after 5 weeks and 1.5 years)
Hair cortisol concentration at the 1.5-year follow-up
Time Frame: 1.5-year follow-up
Hair cortisol will be measured in 1cm segements
1.5-year follow-up
Hair dehydroepiandrosteron concentration at the 1.5-year follow-up
Time Frame: 1.5-year follow-up
Hair dehydroepiandrosteron will be measured in 1cm segements
1.5-year follow-up
Hair brain-derived neurotrophic factor concentration at the 1.5-year follow-up
Time Frame: 1.5-year follow-up
Hair brain-derived neurotrophic factor will be measured in 1cm segements
1.5-year follow-up
Neurocognitive disorder
Time Frame: 1.5-year follow-up
Neurocognitive disorder is a categorical outcome and includes mild and major neurocognitive disorders. Mild neurocognitive disorder (mild cognitive impairment) is defined by subjective cognitive decline (self-report), and an objective cognitive impairments in at least one cognitive abilitiy score (below -1 SD of the norm group), without an essential impairment of daily functioning compared to the premorbid level (self-report). In major neurocognitive decline (dementia), in addition to cognitive decline and impairment, daily functioning is essentially impaired compared to the permorbid level (self-report).
1.5-year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Ulm

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ravensburger Spieleverlag GmbH (RSV), Germany

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Iris-Tatjana Kolassa, Prof., University of Ulm, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 30, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Klipsy_044_PACE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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