NCT07089654

Brief Summary

With the aging of the population, the number of older adults with mild cognitive impairment (MCI) has increased year by year, which has caused serious social and family burdens. At present, the existing drug treatment effect is limited. Studies show the application value of non-drug treatment in the older adults with mild cognitive impairment. Psychomotor Therapy (PMT) is now widely used in European countries and has formed an independent scientific system. Therefore, this topic pays attention to older adults with mild cognitive impairment, intending to promote cognitive stimulation, using PMT methods to build a rehabilitation nursing plan. Relying on older adults care institutions, older adults with mild cognitive impairment in a certain period were divided into a control group (CG) and an experimental group (EG). Older adults will be engaged in a 12-week PMT rehabilitation nursing plan involving relaxation and breathing exercises, face exercises, hand exercises, and mind exercises to promote cognitive health. SPSS 28.0 software was used to analyze data. The comparison of scores of various scales are based on paired t-test statistical methods. The P value \<0.05 will be considered to indicate statistically significant with 95% confidence interval (CI). The rehabilitation effect of the two groups was evaluated according to cognitive assessments (Montreal Cognitive Assessment, MoCA), psychological assessment (Positive and Negative Syndrome Scale, PANSS), and emotional assessment (Hamilton Depression Rating Scale, HAMD-17; Hamilton Anxiety Rating Scale, HAMA-14) . The expected findings of this study may be useful for cognitive rehabilitation plans for the elderly in care institutions, rehabilitation hospitals, communities, and families.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

July 10, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 10, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

July 10, 2025

Last Update Submit

August 26, 2025

Conditions

Mild Cognitive Impairment (MCI)

Keywords

PMT rehabilitation nursing plan

Outcome Measures

Primary Outcomes (1)

  • Cognitive assessment

    The cognitive status of older adults will be assessed by the Montreal Cognitive Assessment (MoCA) scale. Developed by Nasreddine et al. in Canada with reference to the MMSE, the MoCA evaluates multiple cognitive domains, including attention, executive function, memory, language, visuospatial skills, abstract thinking, calculation, and orientation, making it suitable for a comprehensive assessment of various types of cognitive impairment. The Montreal Cognitive Assessment (MoCA) scale has a minimum score of 0 and a maximum score of 30, with higher scores indicating better cognitive function (e.g., scores near 30 reflect normal cognition), while lower scores suggest greater cognitive impairment. In Western countries, a cutoff score of 26 is commonly used to identify MCI.The results below 26 typically warrant clinical concern, though individuals with ≤12 years of education often receive a +1 point adjustment to their total score.

    From baseline (pre-intervention) to the end of the intervention (after-intervention) at 12 weeks.

Secondary Outcomes (3)

  • Psychological assessment

    From baseline (pre-intervention) to the end of the intervention (after-intervention) at 12 weeks.

  • Emotional assessment

    From baseline (pre-intervention) to the end of the intervention (after-intervention) at 12 weeks.

  • Emotional assessment

    From baseline (pre-intervention) to the end of the intervention (after-intervention) at 12 weeks.

Study Arms (2)

A PMT rehabilitation nursing plan

EXPERIMENTAL

Older adults will be engaged in a 12-week PMT rehabilitation nursing plan involving 2 phases of relaxation and breathing exercises, face exercises, hand exercises and mind exercises to promote cognitive health.

Behavioral: A PMT rehabilitation nursing plan

General rehabilitation nursing

OTHER

The control group will be given a standard health education on cognitive health.

Behavioral: General rehabilitation nursing

Interventions

A PMT rehabilitation nursing planBEHAVIORAL

Older adults will be engaged in a 12-week PMT rehabilitation nursing plan involving 2 phases of relaxation and breathing exercises, face exercises, hand exercises and mind exercises to promote cognitive health. Phase 1 (Weeks 1-6): Includes relaxation and breathing exercises (10 minutes), facial exercises (10 minutes), bead maze activities (10 minutes), geometric shape puzzles (10 minutes), and finger exercises (20 minutes). Phase 2 (Weeks 7-12): Includes relaxation and breathing exercises (10 minutes), Tai Chi ball exercises (10 minutes), screw and nut assembly activities (10 minutes), tangram puzzles (10 minutes), and upper limb music exercises (20 minutes). The experimental group will be given interventions, twice a week every Tuesday and Thursday 9-10 am along with the study intervention.

A PMT rehabilitation nursing plan
General rehabilitation nursingBEHAVIORAL

The control group will be given a standard health education on cognitive health.

General rehabilitation nursing

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older adults are aged 50 years and above.
  • Subjective cognitive complaints from the individual or caregiver.
  • Screening for MCI using the Mini-Cog scores between 0-2 ( SN Abayomi, 2024).
  • Basic language communication, listening, speaking, and understanding skills.
  • Ability to provide informed consent.

You may not qualify if:

  • Diagnosed with severe psychiatric conditions (e.g., schizophrenia, major depressive disorder).
  • It is at the end stage of important functional organ diseases, such as malignant tumors, cardiac failure, etc.
  • Limb dysfunction.
  • Diagnosed with dementia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jinzhou Pension Comprehensive Service Center

Jinzhou, Liaoning, 121000, China

Location

Jinzhou Rehabilitation Hospital

Jinzhou, Liaoning, 121000, China

Location

Related Publications (6)

  • Kwag E, Stuckenschneider T, Schneider S, Abeln V. The effect of a psychomotor intervention on electroencephalography and neuropsychological performances in older adults with and without mild cognitive impairment. Psychogeriatrics. 2021 Jul;21(4):528-539. doi: 10.1111/psyg.12702. Epub 2021 May 7.

    PMID: 33960574BACKGROUND

  • Pereira C, Rosado H, Cruz-Ferreira A, Marmeleira J. Effects of a 10-week multimodal exercise program on physical and cognitive function of nursing home residents: a psychomotor intervention pilot study. Aging Clin Exp Res. 2018 May;30(5):471-479. doi: 10.1007/s40520-017-0803-y. Epub 2017 Aug 3.

    PMID: 28776280BACKGROUND

  • Aziz NA, Subramaniam P, Ghazali SE, Mustafa WA. The impact of cognitive intervention on the cognition of adults over 50 with mild cognitive impairment (MCI) in Asia: A systematic review. IIUM Medical Journal Malaysia. 2022 Apr 1;21(2). doi: 10.31436/imjm.v21i2.1837

    BACKGROUND

  • Bruderer-Hofstetter M, Sikkes SAM, Munzer T, Niedermann K. Development of a model on factors affecting instrumental activities of daily living in people with mild cognitive impairment - a Delphi study. BMC Neurol. 2020 Jul 1;20(1):264. doi: 10.1186/s12883-020-01843-9.

    PMID: 32611388BACKGROUND

  • Feng Z, Wu B. Embracing Challenges for Population Aging in China: Building Scientific Evidence to Inform Long-Term Care Policymaking and Practice. J Aging Soc Policy. 2023 Sep 3;35(5):543-553. doi: 10.1080/08959420.2023.2217979. Epub 2023 May 30.

    PMID: 37249513BACKGROUND

  • Biazus-Sehn LF, Schuch FB, Firth J, Stigger FS. Effects of physical exercise on cognitive function of older adults with mild cognitive impairment: A systematic review and meta-analysis. Arch Gerontol Geriatr. 2020 Jul-Aug;89:104048. doi: 10.1016/j.archger.2020.104048. Epub 2020 May 12.

    PMID: 32460123BACKGROUND

Related Links

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Wang Ying Lecture Wang Ying, Master

    Jinzhou Medical University / Universiti Sains Malaysia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Ying Lecture Wang Ying, Master

CONTACT

+86 18640669145wangy@student.usm.my

Noor Mastura Mohd Mujar Dr. Noor Mastura Mohd Mujar, PhD

CONTACT

+60124946411masturamujar@usm.my

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This experimental method will be used in Quasi-Experimental Design (Non-randomized controlled trial) with experiment and control groups for comparison. Ethics consideration on older adults which would psychologically and emotionally impact in case not selected for experimental group. This research will be carried out in Liaoning Province of China. The rehabilitation nursing intervention will be carried out for older adults with MCI admitted in two China elderly care institutions which the name is Jinzhou Pension Comprehensive Service Center (JPCSC) and Jinzhou Rehabilitation Hospital (JRH). Because of ethical consideration on older adults for logistical and economical wise, easy to travel, practical, less budget. So the experimenatl group is JRH, and the control group is JPCSC. Purposive sampling, whereby older adults with MCI will be selected and invited to participate the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecture

Study Record Dates

First Submitted

July 10, 2025

First Posted

July 28, 2025

Study Start

September 10, 2025

Primary Completion

December 30, 2025

Study Completion

January 30, 2026

Last Updated

August 27, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

De-identified IPD that underlie the primary and secondary outcomes reported in publications will be shared. Data will be available upon reasonable request from 6 months after publication. Data sharing will occur through direct collaboration with the principal investigator. Interested researchers must contact wangy@jzmu.edu.cn with a scientifically justified proposal. Data sharing complies with China's Personal Information Protection Law (PIPL). International requests require approval from the local data oversight committee and sign a data use agreement.

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

CN(2)