NCT07016893

Brief Summary

Purpose: The aim of the project is to contribute to the physical, social, and psychological well-being of elderly individuals with cognitive impairment within a multidisciplinary approach framework, and to increase the level of knowledge and awareness about diseases and aging by organizing exercise, art, and education workshops under the guidance of expert health and art professionals. Scope and Target Group: Cognitive impairment affects daily life activities by impacting cognitive abilities such as memory, attention, and concentration. Mild Cognitive Impairment (MCI), Dementia, and Alzheimer's Disease (AD) are common cognitive impairments in the elderly. Early prevention strategies and intervention measures during this period are crucial. It is known that non-pharmacological interventions, especially in the early stages of MCI, are a window of opportunity that is promising and cost-effective. The primary target audience of this project is elderly individuals diagnosed with MCI, Dementia, and AD. To maximize the impact, some of the planned training sessions included family members of patients. Method and Expected Results: The project carried out in collaboration with Balıkesir University and Balıkesir Altıeylül Municipality. Various exercise and art workshops organized. Workshop activities conducted for eight weeks and included an Exercise Workshop (music-based exercises, exercise with active video games, clinical Pilates training, cognitive exercise therapy approach, Nordic walking, dance therapy), Skill-Oriented Art Workshop (systemic calligraphy therapy, soap-candle making workshop, culinary arts workshop), and Disease Awareness Studies (disease awareness information and education, the process from diagnosis to acceptance, experiences of patients and relatives, use of daily life technologies, home adjustments against falls, introduction of municipal services for the elderly).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

1 month

First QC Date

June 3, 2025

Last Update Submit

June 11, 2025

Conditions

Keywords

Mild Cognitive Impairmentdementiaalzheimer's diseaseawarenessworkshopartexerciseelderly health

Outcome Measures

Primary Outcomes (2)

  • Mini Mental State Test

    It is emphasized in the literature that the Mini Mental State Examination (MMST) is the most frequently used test worldwide for cognitive disorders (Ciesielska et al., 2016). MMST tests orientation, memory, attention, calculation, recall, language, motor function and perception, and visuospatial abilities, and its greatest advantage is that it can be applied easily and quickly (Salis et al., 2023). MMST was used to evaluate cognitive functions in our study. A score between 27-30 on the MMST is considered normal, 24-27 as MCI, 20-23 as mild stage, 10-19 as moderate stage, and 0-9 as advanced stage dementia (Güngen et al., 2002). Individuals with a score of 27 or less on the MMST were included in our study.

    From enrollment to the end of intervention at 8 weeks

  • Montreal Cognitive Assessment Scale (MoCA)

    MoCA is one of the most frequently used tools in clinics to assess cognitive functions and has been translated into 35 languages (Sokolowska et al., 2018). It tests many cognitive domains including short-term memory, visual-spatial skills, executive functions, attention, concentration and working memory, language and orientation. It has been reported that its sensitivity varies between 67-100% and its specificity between 50-95% when evaluated using different cutoffs (Zhuang et al., 2021). The advantage of the test is that it provides a more comprehensive assessment compared to the assessment methods used in the field and is used quite frequently in the elderly population (Breton et al., 2019). MoCA was used in the project to assess the change in cognitive functions of individuals with cognitive impairment.

    From enrollment to the end of intervention at 8 weeks

Secondary Outcomes (7)

  • Muscle Strength Assessment

    From enrollment to the end of intervention at 8 weeks

  • Flexibility Assessment

    From enrollment to the end of intervention at 8 weeks

  • Physical Activity Level

    From enrollment to the end of intervention at 8 weeks

  • Depression Assessment

    From enrollment to the end of intervention at 8 weeks

  • Quality of Life Assessment

    From enrollment to the end of intervention at 8 weeks"

  • +2 more secondary outcomes

Study Arms (1)

Exercise, art, awareness group

EXPERIMENTAL

Mild cognitive impairment (MCI) is an important risk factor for Alzheimer's disease (AD) (Hwang and Lee, 2017). The literature emphasizes that the prevalence of MCI and AD will continue to increase and draws attention to this area (Realdon et al., 2016). The MCI stage, which is the most active part of AD, provides a "window of opportunity" for the prevention and treatment of AD (Wu, 2020). Early prevention strategies are considered important, especially during this period. Improving the individual's cognitive functions and reducing symptoms in the MCI stage will reduce the incidence of AD, thereby reducing healthcare costs and improving the individual's condition and quality of life (Jak, 2012). Since AD is irreversible and faces significant treatment challenges, the key to preventing and treating the disease is to take early prevention and intervention measures (Zhang et al., 2021). When considering these interventions, focus is placed on potentially modifiable risk factors that ma

Other: Healthy aging interventions

Interventions

In our study workshop activities conducted for eight weeks and included an Exercise Workshop (Music-Based Exercise Workshop, Exercise Training with Active Video Games (Exergaming), Clinical Pilates Training Workshop, Cognitive Exercise Therapy Approach Workshop, Nordic walking, dance therapy), Skill-Oriented Art Workshop (Systemic Calligraphy Therapy Workshop, soap-candle making workshop, culinary arts workshop), and Disease Awareness Studies (disease awareness information and education, the process from diagnosis to acceptance, experiences of patients and relatives, use of daily life technologies, home adjustments against falls, introduction of municipal services for the elderly).

Exercise, art, awareness group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Being over 65 years of age
  • Having one of the diagnoses of MCI, dementia, or Alzheimer's by a neurologist or geriatrician
  • Having less than 27 points on the Mini Mental State Examination (Zhuang et al., 2021).
  • Being between stages 2-5 on the Global Impairment Scale.

You may not qualify if:

  • Having a pulmonary, neurological, musculoskeletal, or rheumatological disease that may prevent exercise
  • Having balance problems or lower extremity asymmetry at a level that may prevent exercise
  • Individuals with unstable medical conditions (uncontrolled diabetes or hypertension, deep vein thrombosis, etc.)
  • Having vision or hearing problems at a level that will prevent participation in workshops

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balikesir University Cagis Campus 10145 Balikesir

Balıkesir, Balikesir University Cagis Campus, 10145, Turkey (Türkiye)

Location

Related Publications (18)

  • Stoner CR, Orrell M, Spector A. The psychometric properties of the control, autonomy, self-realisation and pleasure scale (CASP-19) for older adults with dementia. Aging Ment Health. 2019 May;23(5):643-649. doi: 10.1080/13607863.2018.1428940. Epub 2018 Jan 22.

    PMID: 29356567BACKGROUND
  • Shin C, Park MH, Lee SH, Ko YH, Kim YK, Han KM, Jeong HG, Han C. Usefulness of the 15-item geriatric depression scale (GDS-15) for classifying minor and major depressive disorders among community-dwelling elders. J Affect Disord. 2019 Dec 1;259:370-375. doi: 10.1016/j.jad.2019.08.053. Epub 2019 Aug 20.

    PMID: 31470180BACKGROUND
  • Sheline YI, Barch DM, Garcia K, Gersing K, Pieper C, Welsh-Bohmer K, Steffens DC, Doraiswamy PM. Cognitive function in late life depression: relationships to depression severity, cerebrovascular risk factors and processing speed. Biol Psychiatry. 2006 Jul 1;60(1):58-65. doi: 10.1016/j.biopsych.2005.09.019. Epub 2006 Jan 18.

    PMID: 16414031BACKGROUND
  • Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

    PMID: 12900694BACKGROUND
  • Mayorga-Vega D, Merino-Marban R, Viciana J. Criterion-Related Validity of Sit-and-Reach Tests for Estimating Hamstring and Lumbar Extensibility: a Meta-Analysis. J Sports Sci Med. 2014 Jan 20;13(1):1-14. eCollection 2014 Jan.

    PMID: 24570599BACKGROUND
  • Taspinar G, Angin E, Oksuz S. The effects of Pilates on pain, functionality, quality of life, flexibility and endurance in lumbar disc herniation. J Comp Eff Res. 2023 Jan;12(1):e220144. doi: 10.2217/cer-2022-0144. Epub 2022 Dec 1.

    PMID: 36453667BACKGROUND
  • Vermeulen J, Neyens JC, Spreeuwenberg MD, van Rossum E, Hewson DJ, de Witte LP. Measuring grip strength in older adults: comparing the grip-ball with the Jamar dynamometer. J Geriatr Phys Ther. 2015 Jul-Sep;38(3):148-53. doi: 10.1519/JPT.0000000000000034.

    PMID: 25594521BACKGROUND
  • Breton A, Casey D, Arnaoutoglou NA. Cognitive tests for the detection of mild cognitive impairment (MCI), the prodromal stage of dementia: Meta-analysis of diagnostic accuracy studies. Int J Geriatr Psychiatry. 2019 Feb;34(2):233-242. doi: 10.1002/gps.5016. Epub 2018 Nov 27.

    PMID: 30370616BACKGROUND
  • Zhuang L, Yang Y, Gao J. Cognitive assessment tools for mild cognitive impairment screening. J Neurol. 2021 May;268(5):1615-1622. doi: 10.1007/s00415-019-09506-7. Epub 2019 Aug 14.

    PMID: 31414193BACKGROUND
  • Sokolowska N, Sokolowski R, Polak-Szabela A, Mazur E, Podhorecka M, Kedziora-Kornatowska K. Comparison of the effectiveness of the Montreal Cognitive Assessment 7.2 and the Mini-Mental State Examination in the detection of mild neurocognitive disorder in people over 60 years of age. Preliminary study. Psychiatr Pol. 2018 Oct 27;52(5):843-857. doi: 10.12740/PP/68611. Epub 2018 Oct 27. English, Polish.

    PMID: 30584818BACKGROUND
  • Gungen C, Ertan T, Eker E, Yasar R, Engin F. [Reliability and validity of the standardized Mini Mental State Examination in the diagnosis of mild dementia in Turkish population]. Turk Psikiyatri Derg. 2002 Winter;13(4):273-81. Turkish.

    PMID: 12794644BACKGROUND
  • Salis F, Costaggiu D, Mandas A. Mini-Mental State Examination: Optimal Cut-Off Levels for Mild and Severe Cognitive Impairment. Geriatrics (Basel). 2023 Jan 12;8(1):12. doi: 10.3390/geriatrics8010012.

    PMID: 36648917BACKGROUND
  • Ciesielska N, Sokolowski R, Mazur E, Podhorecka M, Polak-Szabela A, Kedziora-Kornatowska K. Is the Montreal Cognitive Assessment (MoCA) test better suited than the Mini-Mental State Examination (MMSE) in mild cognitive impairment (MCI) detection among people aged over 60? Meta-analysis. Psychiatr Pol. 2016 Oct 31;50(5):1039-1052. doi: 10.12740/PP/45368. English, Polish.

    PMID: 27992895BACKGROUND
  • Zhang XX, Tian Y, Wang ZT, Ma YH, Tan L, Yu JT. The Epidemiology of Alzheimer's Disease Modifiable Risk Factors and Prevention. J Prev Alzheimers Dis. 2021;8(3):313-321. doi: 10.14283/jpad.2021.15.

    PMID: 34101789BACKGROUND
  • Jak AJ. The impact of physical and mental activity on cognitive aging. Curr Top Behav Neurosci. 2012;10:273-91. doi: 10.1007/7854_2011_141.

    PMID: 21818703BACKGROUND
  • Wu C, Yang L, Li Y, Dong Y, Yang B, Tucker LD, Zong X, Zhang Q. Effects of Exercise Training on Anxious-Depressive-like Behavior in Alzheimer Rat. Med Sci Sports Exerc. 2020 Jul;52(7):1456-1469. doi: 10.1249/MSS.0000000000002294.

    PMID: 32028456BACKGROUND
  • Realdon O, Rossetto F, Nalin M, Baroni I, Cabinio M, Fioravanti R, Saibene FL, Alberoni M, Mantovani F, Romano M, Nemni R, Baglio F. Technology-enhanced multi-domain at home continuum of care program with respect to usual care for people with cognitive impairment: the Ability-TelerehABILITation study protocol for a randomized controlled trial. BMC Psychiatry. 2016 Nov 25;16(1):425. doi: 10.1186/s12888-016-1132-y.

    PMID: 27887597BACKGROUND
  • Hwang J, Lee S. The effect of virtual reality program on the cognitive function and balance of the people with mild cognitive impairment. J Phys Ther Sci. 2017 Aug;29(8):1283-1286. doi: 10.1589/jpts.29.1283. Epub 2017 Aug 10.

    PMID: 28878448BACKGROUND

Related Links

MeSH Terms

Conditions

Cognitive DysfunctionDementiaAlzheimer DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Balıkesir University

Study Record Dates

First Submitted

June 3, 2025

First Posted

June 12, 2025

Study Start

September 28, 2024

Primary Completion

October 28, 2024

Study Completion

November 30, 2024

Last Updated

June 12, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations