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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02667314
Other study ID # Klipsy_044_PACE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2016
Est. completion date February 2018

Study information

Verified date November 2018
Source University of Ulm
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

see References section below for the study protocol article


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date February 2018
Est. primary completion date February 2018
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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)

Locations

Country Name City State
Germany Clinical and Biological Psychology, University of Ulm Ulm

Sponsors (2)

Lead Sponsor Collaborator
University of Ulm Ravensburger Spieleverlag GmbH (RSV), Germany

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Fissler P, Küster 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. eCo — View Citation

Fissler P, Küster 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Baseline and post intervention (after 5 weeks and 1.5 years)
Secondary Change in visual perception from baseline to post intervention and to the 1.5-year follow-up Judgment of Line Orientation Test Baseline and post intervention (after 5 weeks and 1.5 years)
Secondary 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 Baseline and post intervention (after 5 weeks and 1.5 years)
Secondary 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) Baseline and post intervention (after 5 weeks and 1.5 years)
Secondary Change in visuospatial processing speed from baseline to post intervention and to the 1.5-year follow-up Trail Making Test A Baseline and post intervention (after 5 weeks and 1.5 years)
Secondary Change in visuospatial flexibility from baseline to post intervention and to the 1.5-year follow-up Trail Making Test B Baseline and post intervention (after 5 weeks and 1.5 years)
Secondary 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) Baseline and post intervention (after 5 weeks and 1.5 years)
Secondary 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) Baseline and post intervention (after 5 weeks and 1.5 years)
Secondary 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 Baseline and post intervention (after 5 weeks and 1.5 years)
Secondary 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) Baseline and post intervention (after 5 weeks and 1.5 years)
Secondary 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 Baseline and post intervention (after 5 weeks and 1.5 years)
Secondary Change in self-efficacy from baseline to post intervention and to the 1.5-year follow-up General Self-Efficacy Scale, German version Baseline and post intervention (after 5 weeks and 1.5 years)
Secondary Change in perceived stress from baseline to post intervention and to the 1.5-year follow-up Perceived Stress Scale-14, German translation Baseline and post intervention (after 5 weeks and 1.5 years)
Secondary 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) Baseline and post intervention (after 5 weeks and 1.5 years)
Secondary 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 Baseline and post intervention (after 5 weeks and 1.5 years)
Secondary 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) Baseline and post intervention (after 5 weeks and 1.5 years)
Secondary Hair cortisol concentration at the 1.5-year follow-up Hair cortisol will be measured in 1cm segements 1.5-year follow-up
Secondary Hair dehydroepiandrosteron concentration at the 1.5-year follow-up Hair dehydroepiandrosteron will be measured in 1cm segements 1.5-year follow-up
Secondary Hair brain-derived neurotrophic factor concentration at the 1.5-year follow-up Hair brain-derived neurotrophic factor will be measured in 1cm segements 1.5-year follow-up
Secondary 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). 1.5-year follow-up
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