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

Primary Purpose

Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Jigsaw puzzles
Cognitive health counseling
Sponsored by
University of Ulm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Impairment focused on measuring Cognition, Cognitive Aging, Dementia, Neurocognitive Disorders, Cognitive Therapy, Cognitive Reserve, Cognitive Enrichment, Jigsaw Puzzles

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical and Biological Psychology, University of Ulm

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Jigsaw Puzzle Group

Cognitive Health Counseling Group

Arm Description

Jigsaw puzzles & Cognitive health counseling

Cognitive health counseling only

Outcomes

Primary Outcome Measures

Change in global visuospatial cognition from baseline to post intervention and to the 1.5-year follow-up
Averaged score of eight z-standardized visuospatial cognitive ability scores (see secondary outcomes 2 - 9)

Secondary Outcome Measures

Change in visual perception from baseline to post intervention and to the 1.5-year follow-up
Judgment of Line Orientation Test
Change in visuoconstruction from baseline to post intervention and to the 1.5-year follow-up
Copying in Complex Figure Tests; parallel versions for baseline and post-test
Change in mental rotation from baseline to post intervention and to the 1.5-year follow-up
Mental Rotations Test-Letters (2D) and Form A (3D)
Change in visuospatial processing speed from baseline to post intervention and to the 1.5-year follow-up
Trail Making Test A
Change in visuospatial flexibility from baseline to post intervention and to the 1.5-year follow-up
Trail Making Test B
Change in visuospatial working memory from baseline to post intervention and to the 1.5-year follow-up
Block span (Wechsler Memory Scale, German version)
Change in visuospatial reasoning from baseline to post intervention and to the 1.5-year follow-up
Block design (Wechsler Adult Intelligence Scale-III, German version)
Change in visuospatial episodic memory from baseline to post intervention and to the 1.5-year follow-up
Recall in Complex Figure Tests (sum score of immediate and delayed recall); parallel versions for baseline and post-test
Change in psychological health from baseline to post intervention and to the 1.5-year follow-up
Averaged score of three z-standardized psychological health sub-scores (see secondary outcomes 11 - 13)
Change in psychological well-being from baseline to post intervention and to the 1.5-year follow-up
WHO-Five Well-being Index (WHO-5), German version
Change in self-efficacy from baseline to post intervention and to the 1.5-year follow-up
General Self-Efficacy Scale, German version
Change in perceived stress from baseline to post intervention and to the 1.5-year follow-up
Perceived Stress Scale-14, German translation
Change in objective everyday functioning from baseline to post intervention and to the 1.5-year follow-up
TIADL (1-3): Timed instrumental activities of daily living (Task 1-3; sum-score)
Change in self-reported everyday functioning from baseline to post intervention and to the 1.5-year follow-up
CFQ (visuospatial items): Cognitive Failures Questionnaire, sum score of visuo-spatial items; German version
Change in jigsaw puzzle performance from baseline to post intervention and to the 1.5-year follow-up
40-pieces mini puzzle (completed pieces per minute)
Hair cortisol concentration at the 1.5-year follow-up
Hair cortisol will be measured in 1cm segements
Hair dehydroepiandrosteron concentration at the 1.5-year follow-up
Hair dehydroepiandrosteron will be measured in 1cm segements
Hair brain-derived neurotrophic factor concentration at the 1.5-year follow-up
Hair brain-derived neurotrophic factor will be measured in 1cm segements
Neurocognitive disorder
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).

Full Information

First Posted
January 20, 2016
Last Updated
November 28, 2018
Sponsor
University of Ulm
Collaborators
Ravensburger Spieleverlag GmbH (RSV), Germany
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1. Study Identification

Unique Protocol Identification Number
NCT02667314
Brief Title
The Effect of Solving Jigsaw Puzzles on Visuospatial Cognition in Older Adults: Jigsaw Puzzles As Cognitive Enrichment
Acronym
PACE
Official Title
Jigsaw Puzzles As Cognitive Enrichment
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulm
Collaborators
Ravensburger Spieleverlag GmbH (RSV), Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
see References section below for the study protocol article

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment
Keywords
Cognition, Cognitive Aging, Dementia, Neurocognitive Disorders, Cognitive Therapy, Cognitive Reserve, Cognitive Enrichment, Jigsaw Puzzles

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Jigsaw Puzzle Group
Arm Type
Experimental
Arm Description
Jigsaw puzzles & Cognitive health counseling
Arm Title
Cognitive Health Counseling Group
Arm Type
Active Comparator
Arm Description
Cognitive health counseling only
Intervention Type
Behavioral
Intervention Name(s)
Jigsaw puzzles
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive health counseling
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change in global visuospatial cognition from baseline to post intervention and to the 1.5-year follow-up
Description
Averaged score of eight z-standardized visuospatial cognitive ability scores (see secondary outcomes 2 - 9)
Time Frame
Baseline and post intervention (after 5 weeks and 1.5 years)
Secondary Outcome Measure Information:
Title
Change in visual perception from baseline to post intervention and to the 1.5-year follow-up
Description
Judgment of Line Orientation Test
Time Frame
Baseline and post intervention (after 5 weeks and 1.5 years)
Title
Change in visuoconstruction from baseline to post intervention and to the 1.5-year follow-up
Description
Copying in Complex Figure Tests; parallel versions for baseline and post-test
Time Frame
Baseline and post intervention (after 5 weeks and 1.5 years)
Title
Change in mental rotation from baseline to post intervention and to the 1.5-year follow-up
Description
Mental Rotations Test-Letters (2D) and Form A (3D)
Time Frame
Baseline and post intervention (after 5 weeks and 1.5 years)
Title
Change in visuospatial processing speed from baseline to post intervention and to the 1.5-year follow-up
Description
Trail Making Test A
Time Frame
Baseline and post intervention (after 5 weeks and 1.5 years)
Title
Change in visuospatial flexibility from baseline to post intervention and to the 1.5-year follow-up
Description
Trail Making Test B
Time Frame
Baseline and post intervention (after 5 weeks and 1.5 years)
Title
Change in visuospatial working memory from baseline to post intervention and to the 1.5-year follow-up
Description
Block span (Wechsler Memory Scale, German version)
Time Frame
Baseline and post intervention (after 5 weeks and 1.5 years)
Title
Change in visuospatial reasoning from baseline to post intervention and to the 1.5-year follow-up
Description
Block design (Wechsler Adult Intelligence Scale-III, German version)
Time Frame
Baseline and post intervention (after 5 weeks and 1.5 years)
Title
Change in visuospatial episodic memory from baseline to post intervention and to the 1.5-year follow-up
Description
Recall in Complex Figure Tests (sum score of immediate and delayed recall); parallel versions for baseline and post-test
Time Frame
Baseline and post intervention (after 5 weeks and 1.5 years)
Title
Change in psychological health from baseline to post intervention and to the 1.5-year follow-up
Description
Averaged score of three z-standardized psychological health sub-scores (see secondary outcomes 11 - 13)
Time Frame
Baseline and post intervention (after 5 weeks and 1.5 years)
Title
Change in psychological well-being from baseline to post intervention and to the 1.5-year follow-up
Description
WHO-Five Well-being Index (WHO-5), German version
Time Frame
Baseline and post intervention (after 5 weeks and 1.5 years)
Title
Change in self-efficacy from baseline to post intervention and to the 1.5-year follow-up
Description
General Self-Efficacy Scale, German version
Time Frame
Baseline and post intervention (after 5 weeks and 1.5 years)
Title
Change in perceived stress from baseline to post intervention and to the 1.5-year follow-up
Description
Perceived Stress Scale-14, German translation
Time Frame
Baseline and post intervention (after 5 weeks and 1.5 years)
Title
Change in objective everyday functioning from baseline to post intervention and to the 1.5-year follow-up
Description
TIADL (1-3): Timed instrumental activities of daily living (Task 1-3; sum-score)
Time Frame
Baseline and post intervention (after 5 weeks and 1.5 years)
Title
Change in self-reported everyday functioning from baseline to post intervention and to the 1.5-year follow-up
Description
CFQ (visuospatial items): Cognitive Failures Questionnaire, sum score of visuo-spatial items; German version
Time Frame
Baseline and post intervention (after 5 weeks and 1.5 years)
Title
Change in jigsaw puzzle performance from baseline to post intervention and to the 1.5-year follow-up
Description
40-pieces mini puzzle (completed pieces per minute)
Time Frame
Baseline and post intervention (after 5 weeks and 1.5 years)
Title
Hair cortisol concentration at the 1.5-year follow-up
Description
Hair cortisol will be measured in 1cm segements
Time Frame
1.5-year follow-up
Title
Hair dehydroepiandrosteron concentration at the 1.5-year follow-up
Description
Hair dehydroepiandrosteron will be measured in 1cm segements
Time Frame
1.5-year follow-up
Title
Hair brain-derived neurotrophic factor concentration at the 1.5-year follow-up
Description
Hair brain-derived neurotrophic factor will be measured in 1cm segements
Time Frame
1.5-year follow-up
Title
Neurocognitive disorder
Description
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).
Time Frame
1.5-year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iris-Tatjana Kolassa, Prof.
Organizational Affiliation
University of Ulm, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical and Biological Psychology, University of Ulm
City
Ulm
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28877756
Citation
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.
Results Reference
background
PubMed Identifier
30327598
Citation
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.
Results Reference
result
Links:
URL
http://rdcu.be/vEhX
Description
PACE study protocol article (open access)
URL
https://doi.org/10.3389/fnagi.2018.00299
Description
PACE results for primary outcome at follow-up I (open access)

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

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