NCT07652996

Brief Summary

This study aimed to compare the effects of an 8-week mixed reality motor-cognitive training (MR-MCT) intervention to an active comparison group on cognitive and physical functioning and age-related biomarkers in older adults aged 60 years or older with cognitive frailty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

February 3, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2026

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

June 4, 2026

Last Update Submit

June 11, 2026

Conditions

Keywords

Cognitive functionPhysical functionPhysical activityMixed realityMultimodal exercise

Outcome Measures

Primary Outcomes (1)

  • The NIH Toolbox Cognition Battery-Fluid Test

    The participant's cognitive function including attention, memory, processing speed, and executive function will be measured by taking the NIH-Toolbox Cognition Battery Fluid test.

    Baseline and immediately after the intervention test, up to 14 weeks

Secondary Outcomes (4)

  • Short Physical Performance Battery test

    Baseline and immediately after the intervention test, up to 14 weeks

  • Assessing Acceptability, Appropriateness, and Feasibility of the Intervention Questionnnaire

    Through completion of the study, up to 9 weeks.

  • Neurology Biomarkers of Exercise Outcomes in Blood

    Baseline and immediately after the intervention test, up to 14 weeks

  • ActiGraph activity monitor

    Baseline and immediately after the intervention test, up to 14 weeks

Study Arms (2)

Cognitive and Physical Training

EXPERIMENTAL

Participants in the intervention group received 16 MR-CPT group sessions over eight weeks (March 13- May 2). Each week, participants attended two 45-minute sessions delivered by trained instructors.

Behavioral: Cognitive and Physical Training

Multimodal exercise

ACTIVE COMPARATOR

Participants in the active comparison group engaged in an 8-week Tai Chi and multicomponent exercise group sessions, one 45-minute Tai Chi group session, and one 45-minute multicomponent exercise group session each week, starting from March 10 through April 30.

Behavioral: Multimodal exercise

Interventions

Participants in the intervention group received 16 CPT group sessions over eight weeks (March 13- May 2). Each week, participants attended two 45-minute sessions delivered by trained instructors.

Cognitive and Physical Training

Participants in this active comparison group received 8 group sessions of functional fitness (aerobic, strength, and balance exercises) and 8 group sessions of Tai Chi (10-form Yang style) for 8 weeks during the same period of the intervention group (March 10-April 30).

Also known as: ME
Multimodal exercise

Eligibility Criteria

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

You may qualify if:

  • age 60 years or older;
  • self-determined to be able to exercise safely;
  • voluntarily completing all study activities;
  • voluntarily signing the informed consent;
  • willing to be randomized to either MR-MCT intervention group or the active comparison group; and
  • meeting one of the following criteria:
  • having subjective cognitive decline (self-report) or MCI: indicated by a Mini-Cog TM score of \<4 to increase sensitivity of MCI;
  • exhibiting pre-physical frailty or physical frailty, as indicated by a score of 1-2 (pre-frailty) or 3-5 (frailty) on the 5-item FRAIL scale.
  • low physical activity, defined as less than 600 Metabolic Equivalent of Task (MET)-min/week and fewer than two 10-min sessions of strengthening exercises per week in the past three months on the International Physical Activity Questionnaire -Short Form (IPAQ-SF) with Muscle Strength.

You may not qualify if:

  • recent history of myocardial infarction, stroke, or physical limitations as identified on the Physical Activity Readiness Questionnaire (PARQ);
  • Severe obesity: Body mass index (BMI) of 40 or higher; or
  • concurrent participation in another intervention study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Kinesiology, University of Michigan

Ann Arbor, Michigan, 48109-1048, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Evaluators were blinded to arm/group allocation. In other words, evaluators did not know in which group/arm participants were.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants were randomized into one of two arms: Intervention vs. comparison. Intervention condition Participants in the intervention condition engaged in an 8-week MR-MCT intervention, consisting of two 45-minute MR-MCT sessions per week, starting from March 13 through May 2. A structured format was used to deliver each session. (1) Warm-Up (5-minutes): the instructor led the participant to perform 3-5 gentle stretching exercises and engage the participant in 3-4 minutes of MR-MCT preparation tasks. (2) Skill Building (30-35 minutes): The instructor engaged each participant in performing 3 sets of MR-MCT tasks, each set consisting of 6-8 progressive MR-MCT tasks lasting 8-10 minutes. Following each set, two-minute interval: the instructor led the participant to perform stretching exercises. and (3) Cool Down (5-minutes): the instructor led the participant to perform mindful stretching exercises with the session debrief.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 4, 2026

First Posted

June 17, 2026

Study Start

February 3, 2026

Primary Completion

May 8, 2026

Study Completion

May 8, 2026

Last Updated

June 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

We will share the data upon request.

Locations