Intervention 1: Cognitive and Physical TrainingMR-MCTNCT07652996

Efficacy of Mixed Reality Motor-Cognitive Exercise Interventions

A study testing Cognitive and Physical Training and Multimodal exercise in people with Intervention 1: Cognitive and Physical Training and Intervention 2: Multimodal Exercise, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: Intervention 1: Cognitive and Physical Training, Intervention 2: Multimodal Exercise
What is being tested?: Cognitive and Physical Training and Multimodal exercise
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 3 Feb 2026to 8 May 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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:

Show all 9Show fewer

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

School of Kinesiology, University of Michigan
Ann Arbor, Michigan, 48109-1048

Other trials in United States

About this study

Official title: Efficacy of Mixed Reality Motor-Cognitive Exercise Interventions on Cognitive and Physical Functions Among Older Adults

Read the 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.

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.
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.
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.
Demographics: age, sex, race/ethnicity, education, marital status, and health conditions were collected from each participant.
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.
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.

Conditions: Intervention 1: Cognitive and Physical Training, Intervention 2: Multimodal Exercise
Being tested: Cognitive and Physical Training, Multimodal exercise
Keywords: Cognitive function, Physical function, Physical activity, Mixed reality, Multimodal exercise
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive and Physical TrainingBehavioural
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 exerciseBehavioural
Also called ME
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).

Study groups in NCT07652996
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Multimodal exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Feb 20268 May 2026

First posted17 Jun 2026
Study start3 Feb 2026
Primary completion8 May 2026
Study completion8 May 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Intervention 1: Cognitive and Physical TrainingStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07652996
Sponsor's protocol ID: HUM00284237)
Other IDs: G033702
Acronym: MR-MCT
Status last verified: Jun 2026
First submitted: 4 Jun 2026
Last updated: 17 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: We will share the data upon request.

Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Mixed Reality Motor-Cognitive Exercise Interventions on Cognitive and Physical Functions Among Older Adults
ClinicalTrials.gov ID: NCT07652996
Acronym / sponsor ID: MR-MCT / HUM00284237)
Conditions: Intervention 1: Cognitive and Physical Training, Intervention 2: Multimodal Exercise
Keywords: Cognitive function, Physical function, Physical activity, Mixed reality, Multimodal exercise
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Study start: 3 Feb 2026 (actual)
Primary completion: 8 May 2026 (actual)
Study completion: 8 May 2026 (actual)
First posted: 17 Jun 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

The study outcomes were assessed at baseline and post-intervention assessment.

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.
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.
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.
Demographics: age, sex, race/ethnicity, education, marital status, and health conditions were collected from each participant.
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.
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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
Cognitive and Physical Training	Experimental	Behavioral: Cognitive and Physical TrainingParticipants 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.
Multimodal exercise	Active comparator	Behavioral: Multimodal exerciseParticipants 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.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cognitive and Physical TrainingParticipants 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.	Behavioural	Cognitive and Physical Training
Multimodal exerciseAlso: MEParticipants 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).	Behavioural	Multimodal exercise

Primary outcome

The NIH Toolbox Cognition Battery-Fluid Test
Time frame: 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.

4 secondary outcomes

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
Time frame: Through completion of the study, up to 9 weeks.
Neurology Biomarkers of Exercise Outcomes in Blood
Time frame: Baseline and immediately after the intervention test, up to 14 weeks
ActiGraph activity monitor
Time frame: Baseline and immediately after the intervention test, up to 14 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
Individual participant dataSharing planned: No. We will share the data upon request.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The NIH Toolbox Cognition Battery-Fluid Test (time frame: Baseline and immediately after the intervention test, up to 14 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07652996.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.