Evaluation of a PMT Rehabilitation Nursing Plan for the Older Adults With MCI to Promote Cognitive Health

NCT ID: NCT07089654

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-10
• Study Completion Date: 2026-01-30

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.

Detailed Description

Introduction Research background In the wake of demographic shifts, China is experiencing the profound effects of an aging population. In 2022, China's population aged 65 and over was estimated to be 196 million, accounting for nearly 13.7% of the total population. With the change in population structure, China faces unprecedented challenges in health care, social welfare, and economic sustainability, which has a profound impact on the aging of the population, and cognitive impairment has become the most prominent problem in an aging society. Studies have shown that the overall prevalence of cognitive impairment in people aged 60 years and above in China is estimated to be 6% (95% CI: 5.8% ～ 6.3%), which increases the pressure on families, caregivers, and the healthcare system, and poses economic challenges to the country.

Similarly, population aging is a general trend around the world. According to the United Nations, by 2050, 1/6 of people in the world will be over 65 years old, compared to 1/11 in 2019. As the number of elderly people increases year by year, the prevalence of cognitive impairment in older adults is also increasing. It is reported that about 5-10% of people over 60 years old in the world suffer from dementia. Dementia is a disease characterized by cognitive decline with memory loss and impaired judgment. It not only affects the quality of life but also puts tremendous pressure on the world's healthcare systems and social support systems. Effective intervention measures are urgently needed to address this public health problem.

Mild Cognitive Impairment (MCI) refers to the prodromal stage of dementia that generally does not severely affect daily functioning, associated with an increased risk for Alzheimer's disease and other dementia. The clinical manifestations of MCI mainly include the decline of memory, language function, attention, executive function, visual-spatial structural function, and calculation ability, as well as sensory impairment and thinking disorder. While not all individuals with MCI will develop dementia. Studies have shown that MCI patients have a much higher risk of developing dementia than people with normal cognition. Early identification and intervention of MCI patients can slow or prevent the progression of dementia, thereby reducing the personal, social, and economic burden of dementia.

In recent years, there has been a large amount of literature in China that explores various aspects of dementia, including risk factors, biomarkers, diagnostic criteria, and intervention strategies. However, there are still some limitations for MCI. The diagnostic criteria and assessment tools for MCI in the Chinese population are still not unified, resulting in differences in prevalence estimates and diagnostic methods in different studies. In addition, there are insufficient longitudinal studies on the progression of MCI to dementia in older adults in China, which limits our exploration of the trajectory of the disease. Similarly, there is still no consensus on the heterogeneity of the MCI population, inconsistent diagnostic criteria, and the best treatment methods. Furthermore, the translation of research findings into clinical practice remains a significant bottleneck, with few evidence-based interventions available for preventing or delaying the onset of dementia among individuals with MCI.

Alzheimer's Disease International has advocated for and funded several studies, including some investigating the effectiveness of pharmacological and non-pharmacological interventions for early dementia. There is a great deal of ongoing research into pharmacological treatments, but traditionally, less research has been done into non-pharmacological treatments. Interventions can be broadly divided into those aimed at modifying the course of the disease, those targeting the cause of the disease, and those controlling the manifestations of the disease. PMT is often considered to fall into the last category because they may help slow cognitive decline, address symptoms related to psychosocially challenging behaviors, and improve quality of life.

Problem statement At present, there is a lot of discussion on MCI and dementia prevention. In addition to drug treatment, non-drug treatment is also a hot issue, such as music therapy, transcranial magnetic stimulation (TMS), light therapy (phototherapy), electrotherapy, acupuncture therapy, Taijiquan, Baduanjin, hyperbaric oxygen therapy (HBOT), memory therapy, etc. At present, most of the non-drug treatments target a relatively single cognitive domain, and it is difficult to solve the decline of multiple cognitive domains with one therapy. It still needs more research and discussion.

PMT is not a traditional biological model, but a kind of rehabilitation therapy under the biological-psychological-social model, which focuses on the concept of integrity. It is not focused on motor functions, but on motor skills in relationships, and is related to emotional, sensory, and cognitive functions. By mobilizing the initiative of dementia patients, stimulating their own weakened function, and assisting with personalized PMT treatment plans, a better effect of rehabilitation nursing treatment is achieved. Few published literature has applied PMT theory to the rehabilitation treatment of older adults with MCI, and the intervention plans are not uniform. At present, PMT therapy just started in China. Is it effective for older adults with MCI in China? Which group is it applicable to? Do older adults and their families accept them? There are few studies on it.

The purpose of this study is to develop a PMT rehabilitation nursing plan and evaluate the effectiveness of the rehabilitation nursing plan in older adults with MCI. The findings of this study may be useful for future studies and provide useful reference for nursing care homes, rehabilitation hospitals, communities, and families.

Research Question(s)

1. Is the PMT rehabilitation nursing plan effective in promoting cognitive health for older adults with MCI?

2. How does the PMT rehabilitation nursing plan affect the cognitive health in older adults?

Objective General: This study aimed to develop a psychomotor rehabilitation nursing plan and elucidate the effect of the PMT rehabilitation nursing plan among older adults with mild cognitive impairment in promoting cognitive function.

Specific:

1. To develop the psychomotor therapy (PMT) rehabilitation nursing plan through Delphi method for older adults with mild cognitive impairment (MCI) in promoting cognitive function.

2. To validate the psychomotor therapy (PMT) rehabilitation nursing plan for older adults with mild cognitive impairment (MCI) through content and face validation.

3. To evaluate the effectiveness of the psychomotor rehabilitation nursing plan in enhancing cognitive function among older adults with mild cognitive impairment.

Methodology Description of methodology

1. Research design: Quasi-Experimental Design (Non-randomized controlled trial) with experiment and control groups for comparison. Because of ethical considerations on older adults for logistical and economical wise, easy to travel, practical, less budget. Similar studies involving rehabilitation or behavioural interventions in real-world settings have widely used quasi-experimental designs. Studies by MA Handley and AD Harris demonstrated reliable outcomes using this approach.

2. Study area: Liaoning Province, China.

3. Study population i) Reference population: Older adults living in Liaoning. ii) Source population / sampling pool: Elderly care institutions and rehabilitation centers, Liaoning Province.

iii) Target population: Jinzhou Comprehensive Elderly Care Institution and Rehabilitation Center, Liaoning Province.

iv) Sampling frame: List of members from the two elderly care institution and rehabilitation center; Jinzhou Pension Comprehensive Service Center (JPCSC), and Jinzhou Rehabilitation Hospital (JRH), Liaoning Province.

The data collection form was created by the researcher to record general information about older adults, such as age, gender, education level, family history of dementia, marital status, personal annual income, chronic disease. It will take no more than 5 minutes. Then, It will conduct questionnaire surveys before the intervention (baseline) and after the intervention (12 weeks). The questionnaires involved include Montreal Cognitive Assessment (MoCA), which has 11 questions and takes about 10 minutes; Positive and Negative Syndrome Scale (PANSS), which has 30 questions and takes about 20 minutes; Hamilton Anxiety Rating Scale (HAMA-14), which has 14 questions and takes about 10 minutes; Hamilton Depression Rating Scale (HAMD-17), which has 17 questions and takes about 15 minutes. All questionnaires will take no more than 60 minutes. Due to ethical issues, the names of the elderly participating in this study are only used for data collection, and their identity information will not be disclosed.

Data entry and analysis will be performed using SPSS 28.0 software. Descriptive statistics will be used to summarize the general information of older adults. Numerical data will be presented as mean (SD) or median (IQR) based on their normality distribution. Categorical data will be presented as frequency (%). 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).

Conditions

Mild Cognitive Impairment (MCI)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

A PMT rehabilitation nursing plan

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.

Group Type: EXPERIMENTAL

A PMT rehabilitation nursing plan

Intervention Type: BEHAVIORAL

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.

General rehabilitation nursing

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

Group Type: OTHER

General rehabilitation nursing

Intervention Type: BEHAVIORAL

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

Interventions

A PMT rehabilitation nursing plan

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.

Intervention Type: BEHAVIORAL

General rehabilitation nursing

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Older adults are aged 50 years and above.

2. Subjective cognitive complaints from the individual or caregiver.

3. Screening for MCI using the Mini-Cog scores between 0-2 ( SN Abayomi, 2024).

4. Basic language communication, listening, speaking, and understanding skills.

5. Ability to provide informed consent.

Exclusion Criteria

1. Diagnosed with severe psychiatric conditions (e.g., schizophrenia, major depressive disorder).

2. It is at the end stage of important functional organ diseases, such as malignant tumors, cardiac failure, etc.

3. Limb dysfunction.

4. Diagnosed with dementia.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universiti Sains Malaysia

OTHER

Sponsor Role: collaborator

Jinzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Wang Ying

Lecture

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wang Ying Lecture Wang Ying, Master

Role: PRINCIPAL_INVESTIGATOR

Jinzhou Medical University / Universiti Sains Malaysia

Locations

Jinzhou Pension Comprehensive Service Center

Jinzhou, Liaoning, China

Jinzhou Rehabilitation Hospital

Jinzhou, Liaoning, China

Countries

China

Central Contacts

Wang Ying Lecture Wang Ying, Master

Role: CONTACT

wangy@student.usm.my

+86 18640669145

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

Role: CONTACT

masturamujar@usm.my

+60124946411

Facility Contacts

Liu Jiyuan Dean Liu Jiyuan

Role: primary

576827011@qq.com

+8613604967370

Shuai Yi Dean Shuai Yi

Role: primary

617414700@qq.com

+8618940697555

References

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.

Reference Type: BACKGROUND

PMID: 33960574 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28776280 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 32611388 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37249513 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32460123 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://www.alzint.org/resource/world-alzheimer-report-2021/

Alzheimer's Disease International. World Alzheimer Report 2021: Journey through the diagnosis of dementia.

https://www.alzint.org/resource/world-alzheimer-report-2011/

Alzheimer's Disease International. World Alzheimer Report 2011: The benefits of early diagnosis and intervention.

Other Identifiers

USM/JEPeM/PP/24090806

Identifier Type: OTHER

Identifier Source: secondary_id

JZMULL2025230

Identifier Type: -

Identifier Source: org_study_id