NCT07554027

Brief Summary

Motor Cognitive Risk (MCR), a pre-dementia state characterized by the coexistence of subjective cognitive decline (SCD) and slow gait speed, has a high prevalence among community-dwelling older adults in China and is associated with significantly increased risks of progression to dementia and other adverse health outcomes. Physical activity is the most cost-effective non-pharmacological intervention for slowing cognitive decline and the modifiable factor with the greatest contribution to dementia prevention. However, older adults with cognitive impairment commonly face behavioral challenges such as insufficient physical activity and difficulty maintaining adherence. Episodic Future Thinking (EFT), a novel intervention strategy grounded in health psychology and behavioral economics, has been shown to promote healthy behaviors by reducing delay discounting rates and enhancing future orientation. The goal of this randomized controlled study is to test the effect of EFT intervention in promoting physical activity among older adults with MCR.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
May 2026Mar 2027

First Submitted

Initial submission to the registry

April 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 28, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

April 21, 2026

Last Update Submit

April 21, 2026

Conditions

Keywords

Physical ActivitiesEpisodic Futhre ThinkingMotoric Cognitive Risk Syndrome

Outcome Measures

Primary Outcomes (1)

  • Intention to engage in physical activity

    Behavioral intention toward physical activity was assessed using the Behavioral Intention subscale of the Theory of Planned Behavior Exercise Questionnaire developed by Hu et al. Participants rated three items (e.g., their acceptance, intention, and plan to engage in ≥3 sessions of ≥20 minutes of exercise per week over the next four weeks) on a 6-point Likert scale, with higher scores indicating stronger behavioral intention.

    At baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and four weeks after the end of the intervention (week 16, T4)

Secondary Outcomes (9)

  • Physical activity level

    At baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and four weeks after the end of the intervention (week 16, T4).

  • Physical Activity Compliance Rate

    At baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and four weeks after the end of the intervention (week 16, T4).

  • Delay Discounting Rate

    At baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and four weeks after the end of the intervention (week 16, T4)

  • Consideration of future consequences

    At baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and four weeks after the end of the intervention (week 16, T4)

  • Multidimensional Outcome Expectations for Exercise Scale

    At baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and four weeks after the end of the intervention (week 16, T4).

  • +4 more secondary outcomes

Study Arms (2)

EFT group

EXPERIMENTAL

For participants in this group, on the basis of health education regarding physical exercise for individuals with MCR, episodic future thinking intervention will be additionally provided.

Behavioral: Episodic Future ThinkingOther: Brochure-Based Health Education

Control group

OTHER

Participants in this group will be provided with health education regarding physical exercise for individuals with MCR.

Other: Brochure-Based Health Education

Interventions

Participants will receive a 12-week structured Episodic Future Thinking (EFT) intervention. At baseline, participants select multiple Daily Events (activities they can currently perform independently) and Aspirational Events (activities they wish to regain or improve) from a pre-developed event library. Each event has a corresponding structured video. Video sessions include relaxation, vivid future scenarios, sensory cues, and explicit links between physical activity and future functional independence. The intervention progresses across three phases (Weeks 1-4, 5-8, 9-12), shifting from Daily Events to Aspirational Events with gradually reduced frequency(from 4 days/week, 2 sessions/day to 4 days/week, 1 session/day). Participants receive individualized audio files with reminder messages and attend biweekly in-person group sessions where standardized FET videos are viewed under staff supervision. Adherence is monitored through WeChat feedback and weekly check-ins.

EFT group

Participants will receive a one-time standardized health education session immediately after baseline assessment. The session is delivered face-to-face by trained research staff and provides foundational knowledge about MCR syndrome, including its definition, clinical significance, associated health risks, and the role of physical activity in maintaining cognitive and physical function. Participants are provided with a printed educational brochure titled Exercise Guidance for Older Adults with Motoric Cognitive Risk Syndrome. The brochure includes evidence-based recommendations on exercise types (aerobic, balance, flexibility, strength), recommended frequency and duration based on expert consensus, and safety precautions for older adults with MCR engaging in physical activity.

Control groupEFT group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Subjective Cognitive Decline (SCD) Assessed using the Chinese version of the Subjective Cognitive Decline Questionnaire-9 (SCD-9). A total score greater than 5 is considered indicative of SCD.
  • \. Slow Gait Participants will walk 4 meters at their usual pace. Gait speed will be calculated using the recorded time, and gait speed \<1.0 m/s will be classified as slow gait.
  • \. No Difficulty in Basic Activities of Daily Living (ADL) Participants must report no difficulty in the following six basic ADL domains: bathing, dressing, toileting, transferring, continence, and eating.
  • \. No Dementia No self-reported history of dementia and a Mini-Mental State Examination (MMSE) score of ≥24, indicating the absence of dementia.

You may not qualify if:

  • Participants will be excluded if they meet any of the following conditions:
  • \. Severe visual or hearing impairment that interferes with communication or assessment.
  • \. Primary psychiatric disorders, such as schizophrenia or bipolar disorder.
  • \. Significant language or communication difficulties that prevent completion of assessments or participation in the intervention.
  • \. Severe diseases of major organs or systems, such as advanced heart failure, end-stage renal disease, or active malignancy, that may affect safety or participation.
  • \. Any other condition that, in the judgment of the research team, makes the participant unsuitable for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Medical College of Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jingfen Jin

    The Second Affiliated Hospital of Medical College of Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2026

First Posted

April 28, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations