Intervention 1: Cognitive and Physical Training, Intervention 2: Multimodal Exercise
Conditions
Keywords
Cognitive function, Physical function, Physical activity, Mixed reality, Multimodal exercise
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.
Detailed description
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.
Interventions
BEHAVIORALCognitive and Physical Training
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.
BEHAVIORALMultimodal exercise
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).
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Evaluators were blinded to arm/group allocation. In other words, evaluators did not know in which group/arm participants were.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The NIH Toolbox Cognition Battery-Fluid Test | Baseline and immediately after the intervention test, up to 14 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Physical Performance Battery test | Baseline and immediately after the intervention test, up to 14 weeks | The participant's physical function including gait speed, lower-extremity strength, and balance will be assessed by taking the Short Physical Performance Battery test. |
| Assessing Acceptability, Appropriateness, and Feasibility of the Intervention Questionnnaire | Through completion of the study, up to 9 weeks. | 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 |
| Neurology Biomarkers of Exercise Outcomes in Blood | Baseline and immediately after the intervention test, up to 14 weeks | 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. |
| ActiGraph activity monitor | Baseline and immediately after the intervention test, up to 14 weeks | 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. |
Countries
United States
Outcome results
None listed