The Second Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang, 310009, China
NCT Number: NCT07554027
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 opening soon.
Get Notified60 year and older
All sexes
Interventional
Not applicable
Hangzhou, Zhejiang, 310009, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants will be eligible for inclusion if they are 60 years of age or older and meet all of the following four criteria:
Exclusion criteria
Participants will be excluded if they meet any of the following conditions:
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.
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.
Time frame: At baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and four weeks after the end of the intervention (week 16, T4)
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.
Time frame: 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 level was assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF), which includes seven items evaluating the frequency and duration of vigorous activity, moderate activity, and walking for at least 10 minutes during the past week. Weekly activity levels (MET-minutes/week) were calculated by multiplying the MET value of each activity category by the reported frequency and duration.
Time frame: 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 was determined based on WHO guidelines. Participants were classified as meeting physical activity recommendations if they achieved at least 150-300 minutes of moderate-intensity aerobic activity per week or 75-150 minutes of vigorous-intensity activity per week, as calculated from the IPAQ-SF. The compliance rate was defined as the proportion of participants who met these criteria.
Time frame: 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 was assessed using a computerized intertemporal choice task adapted from Figner et al. Participants completed 60 trials in which they chose between a smaller-sooner (SS) reward and a larger-later (LL) reward across varying delays and reward differences. The discounting parameter k was estimated using a hyperbolic discounting model (V = A / (1 + αk)), with higher k values indicating steeper delay discounting.
Time frame: 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 was measured using the short version of the Consideration of Future Consequences Scale (CFC-S), which includes two subscales: CFC-Future (5 items) and CFC-Immediate (7 items). All items are rated on a 7-point Likert scale, and subscale scores are calculated as the mean of their respective items, with higher scores indicating a stronger tendency to consider future outcomes.
Time frame: At baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and four weeks after the end of the intervention (week 16, T4).
Outcome expectations for exercise were assessed using the Multidimensional Outcome Expectations for Exercise Scale (MOEES), which includes three subscales: physical (6 items), social (4 items), and self-evaluative (5 items). Participants rated each item on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree) and additionally indicated how soon they expected each outcome to occur using a 7-point temporal expectancy scale (1 = distant future to 7 = immediate). Higher scores reflect more positive and more immediate outcome expectations for exercise.
Time frame: At baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and four weeks after the end of the intervention (week 16, T4).
Subjective cognitive decline was assessed using the 9-item Subjective Cognitive Decline Questionnaire (SCD-9), which evaluates perceived changes in memory and other cognitive domains, including overall memory problems and comparisons with past cognitive functioning. Each item is scored and summed to generate a total score, with higher scores indicating greater subjective cognitive decline. A cutoff score of >5 has been suggested to indicate abnormal subjective cognitive decline in Chinese populations.
Time frame: At baseline (T0), week 12 (T3), and four weeks after the end of the intervention (week 16, T4).
Lower-extremity physical function was assessed using the Short Physical Performance Battery (SPPB), which includes three subtests: gait speed, balance tests, and the chair stand test. The SPPB provides a composite score reflecting balance, lower-limb strength, and functional mobility in older adults.
Time frame: At baseline (T0), week 12 (T3), and four weeks after the end of the intervention (week 16, T4).
Handgrip strength was measured using a handheld dynamometer. Participants performed two trials with each hand, and the highest value (in kilograms) was recorded as the final grip strength. Higher values indicate better upper-extremity muscle strength.
Time frame: At baseline (T0), week 12 (T3), and four weeks after the end of the intervention (week 16, T4).
Calf circumference was measured using a flexible, non-elastic tape at the point of the greatest calf girth while the participant was standing with feet shoulder-width apart. Measurements were recorded in centimeters, with larger values indicating greater lower-limb muscle mass.
Contact information is provided by the study sponsor or research team.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
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