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Completed

NCT Number: NCT07588867

The Combined Multicomponent Intervention Specifically in Rural Community Older Adults at High Risk for Mild Cognition Impairment

This project aims to test whether a combined multicomponent (CM) program - including health education, cognitive training, and traditional Chinese exercises - is feasible and effective for rural older adults who are at high risk of mild cognitive impairment (MCI). The program is designed to help maintain or improve cognitive function and overall well-being.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yuxi, Gucuo, Su'an, Qianhong village

Quanzhou, Fujian, China

About this study

Health education sessions: One 30-minute lecture every 4 weeks, covering topics such as diet, sleep, chronic disease management, and brain health.

Cognitive training: Weekly 45-minute sessions using fun mini-games to train memory, attention, arithmetic, and logical thinking.

Physical exercise: Weekly 45-minute sessions of traditional Chinese exercises (Baduanjin and Shiqiaoshou) to improve balance, flexibility, and fitness.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 60;
  • Suffering from chronic diseases, such as hypertension, diabetes mellitus, hyperlipidemia, cardiovascular and cerebrovascular diseases, or osteoarthritis;
  • Mild cognitive impairment (defined as Mini-Mental State Examination (MMSE) score of 21-26 combined with either an AD8 self-rated cognitive impairment score ≥ 2 or a digit span (backward) test (DST) score < 4);
  • Mild physical impairment (defined as an Activities of Daily Living (ADL) score < 26 and a Short Physical Performance Battery (SPPB) score of 7-10).

Exclusion criteria

  • Age <60;
  • Unable to move physically;
  • Already suffering from Alzheimer's disease.

Treatment and study plan

the Combined Multicomponent(CM) Intervention

Behavioral

The CM intervention was a 24-week comprehensive program integrating health education, cognitive training, and physical exercise. The health education sessions were delivered once every four weeks, with each session lasting 30 minutes. In contrast, cognitive training and physical exercise sessions were conducted weekly, each with a duration of 45 minutes.

Primary outcomes

  1. Cognitive Function

    Time frame: From enrollment to the end of intervention at 48 weeks

    Cognitive function was assessed using the Minimum Mental State Examination (MMSE) scale (Folstein, Folstein, & McHugh, 1975).The MMSE evaluates five domains: orientation, registration, attention and calculation, recall, and language abilities. Total scores range from 0 to 30, with higher scores indicating better cognitive performance.

Secondary outcomes

  1. Body Mass Index

    Time frame: From enrollment to the end of intervention at 48 weeks

    Height (cm) was measured using a wall-mounted height board, with the participant standing upright without shoes. Weight (kg) was measured using a electronic load cell scale, with light indoor clothing and after voiding. Body Mass Index (BMI) was calculated by dividing a person's weight in kilograms by the square of their height in meters (kg/m²).

  2. Waist circumference

    Time frame: From enrollment to the end of intervention at 48 weeks

    Waist circumference (cm) was measured using a flexible, non-elastic tape measure at the midpoint between the lowest rib and the iliac crest, with the participant standing and breathing normally. The measurement is taken to the nearest 0.1 cm at the end of normal expiration.

  3. Blood pressure

    Time frame: From enrollment to the end of intervention at 48 weeks

    Blood pressure was assessed by measuring systolic and diastolic pressures (mmHg).

  4. Activities of daily living

    Time frame: From enrollment to the end of intervention at 48 weeks

    Activities of daily living were assessed via the Activities of daily living (ADL) scale (Ferrucci et al., 1996). It employs a scoring range of 14 to 56, with higher scores indicating poorer functional ability.

  5. Physical performance

    Time frame: From enrollment to the end of intervention at 48 weeks

    Physical performance was assessed via the Short Physical Performance Battery (SPPB) scale (Cruz-Jentoft et al., 2010). It has a scoring range of 0 to 12, with higher scores reflecting better physical performance.

  6. Participant adherence

    Time frame: From enrollment to the end of intervention at 48 weeks

    Participant adherence was summarized as the proportion of total participants who attended at least 50% of the intervention sessions, and separately for those who attended at least 75% of the sessions.

  7. Participant satisfaction

    Time frame: From intervention at 36 weeks to the end of intervention at 48 weeks

    Participant satisfaction was assessed using a self-developed scale, with a total score of 30 points; higher scores indicated greater satisfaction with the program.

Sponsors and collaborators

Lead sponsor

Xiaoying Wang

Other

Collaborators

  • The First Affiliated Hospital of Xiamen University
  • Xiamen University

Registry information

Official study title

Elderly Disability (Dementia) Prevention and Intervention Project in Jinjiang Community, China

Acronym: CMintervention

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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