- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02667314
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
Completed
Conditions
Intervention / Treatment
Detailed Description
see References section below for the study protocol article
Study Type
Interventional
Enrollment (Actual)
100
Phase
- 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
-
-
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Ulm, Germany
- Clinical and Biological Psychology, University of Ulm
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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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Jigsaw Puzzle Group
Jigsaw puzzles & Cognitive health counseling
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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.
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
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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
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)
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Baseline and post intervention (after 5 weeks and 1.5 years)
|
Secondary Outcome Measures
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
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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)
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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)
|
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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)
|
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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
|
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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
|
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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
Collaborators
Investigators
- 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
- Fissler P, Kuster OC, Loy LS, Laptinskaya D, Rosenfelder MJ, von Arnim CAF, Kolassa IT. Jigsaw Puzzles As Cognitive Enrichment (PACE) - the effect of solving jigsaw puzzles on global visuospatial cognition in adults 50 years of age and older: study protocol for a randomized controlled trial. Trials. 2017 Sep 6;18(1):415. doi: 10.1186/s13063-017-2151-9.
- Fissler P, Kuster OC, Laptinskaya D, Loy LS, von Arnim CAF, Kolassa IT. Jigsaw Puzzling Taps Multiple Cognitive Abilities and Is a Potential Protective Factor for Cognitive Aging. Front Aging Neurosci. 2018 Oct 1;10:299. doi: 10.3389/fnagi.2018.00299. eCollection 2018.
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
February 1, 2016
Primary Completion (Actual)
February 1, 2018
Study Completion (Actual)
February 1, 2018
Study Registration Dates
First Submitted
January 20, 2016
First Submitted That Met QC Criteria
January 25, 2016
First Posted (Estimate)
January 28, 2016
Study Record Updates
Last Update Posted (Actual)
November 30, 2018
Last Update Submitted That Met QC Criteria
November 28, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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