Efficacy of Mixed Reality Motor-Cognitive Exercise Interventions

University of Michigan30 enrolled

Overview

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.

A two-arm randomized controlled trial was conducted with ≥30 older adults aged 60+ with cognitive frailty during the winter semester of 2026. This study aimed to enroll a minimum of 30 community-dwelling older adults with cognitive frailty to participate in this study, which took place in School of Kinesiology facilities from February 16 to May 8, 2026. Participants in the intervention group 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. 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. The study outcomes were assessed at baseline and post-intervention assessment. 1. Cognitive function: The participant's cognitive function including attention, memory, processing speed, and executive function was measured by taking the NIH-Toolbox Cognition Battery Fluid test. 2. Physical function: The participant's physical function including gait speed, lower-extremity strength, and balance was assessed by taking the Short Physical Performance Battery test. 3. Daily physical activity minutes: The participant's daily physical activity minutes were objectively measured by wearing the ActiGraph activity monitor for 7 days in a row at the baseline and the end of the intervention. A minimum wear time of 10 hours/day four days a week will be required for analysis. 4. Demographics: age, sex, race/ethnicity, education, marital status, and health conditions were collected from each participant. 5. Biomarkers of Exercise Outcomes in Blood (optional for participants). Blood samples were obtained by venipuncture at baseline and the post-intervention test. Each blood draw will be no more than 5 ml. The total volume of blood drawn over the entire study period will be no more than 10 ml. 6. Feasibility was measured by using recruitment rates, adherence rates, and retention rates measured during and at the end of the interventions. Additionally, each participant will complete the Assessing Acceptability, and Appropriateness, and Feasibility of the Intervention Questionnaire, consisting of 12 questions rated on a 5-point Likert scale. Descriptive statistics for demographic information and the study outcomes were conducted first. To examine the effects of the interventions on cognitive function, physical function, and daily physical activity minutes, repeated measures ANOVA was performed within subjects (time: baseline vs. post-intervention tests) and between groups (MR-MCT group vs. active comparison group). Additionally, recruitment, adherence, and retention rates were calculated by means of percentage, respectively. All data analysis was performed using the IBM SPSS statistics 30.0 version with a significant level set as α ≤0.5.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Intervention 1: Cognitive and Physical Training Intervention 2: Multimodal Exercise

Interventions

Cognitive and Physical TrainingBEHAVIORAL

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.

Multimodal exerciseBEHAVIORAL

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).

Eligibility

Sex: ALLMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. age 60 years or older; 2. self-determined to be able to exercise safely; 3. voluntarily completing all study activities; 4. voluntarily signing the informed consent; 5. willing to be randomized to either MR-MCT intervention group or the active comparison group; and 6. meeting one of the following criteria: 1. having subjective cognitive decline (self-report) or MCI: indicated by a Mini-Cog TM score of \<4 to increase sensitivity of MCI; 2. 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. 3. 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. Exclusion Criteria: 1. recent history of myocardial infarction, stroke, or physical limitations as identified on the Physical Activity Readiness Questionnaire (PARQ); 2. Severe obesity: Body mass index (BMI) of 40 or higher; or 3. concurrent participation in another intervention study.

Locations (1)

School of Kinesiology, University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Short Physical Performance Battery test

The participant's physical function including gait speed, lower-extremity strength, and balance will be assessed by taking the Short Physical Performance Battery test.

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

Assessing Acceptability, Appropriateness, and Feasibility of the Intervention Questionnnaire

Participant completed the Assessing Acceptability, Appropriateness, and Feasibility of the Intervention Questionnaire, consisting of 12 questions rated on a 5-point Likert scale, ranging from 1=not at all to 5=extremely

Time frame: Through completion of the study, up to 9 weeks.

Neurology Biomarkers of Exercise Outcomes in Blood

Blood samples will be obtained by venipuncture at baseline and the post-intervention test. Each blood draw will be no more than 5 ml. The total volume of blood drawn over the entire study period will be no more than 10 ml. The subject will be observed for any lightheadedness, bruising, or bleeding during and after the procedure. If the subject is lightheaded, he/she will be reclined and monitored until symptoms are resolved. If the subject is asymptomatic after the phlebotomy procedure, he/she will be released.

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

ActiGraph activity monitor

The participant's daily physical activity minutes will be objectively measured by wearing the ActiGraph activity monitor for 7 days in a row at the baseline and the end of the intervention. A minimum wear time of 10 hours/day four days a week will be required for analysis. For a participant who fails to meet the minimum wear time, we will document why we cannot include this participant's data into the final data set for analysis on a specific data set created for either baseline assessment or the post-intervention assessment. We will not include that participant's data for the final data set for analysis.

Data from ClinicalTrials.gov

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