An interventional study of Tai Chi in Mild Cognitive Impairment (MCI) and Sarcopenia, sponsored by Ohio University. Recruiting at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-17.
Sponsored by Ohio University · Not applicable, Interventional, and Treatment
Mild Cognitive Impairment (MCI) in older adults is linked to muscle loss (sarcopenia) and can lead to dementia, with pain further impacting cognitive and physical performance. Tai Chi, a mind-body exercise, is recommended for managing MCI as it supports cognitive function, mood, and physical health.
The investigators' first goal is to characterize the correlation of heart rate variability and cortical activity on cognitive function and the psychosocial correlates of pain interference and social isolation on cognitive function at baseline and post-intervention (8 weeks of Tai Chi). The second goal is to explain the role of sarcopenia and obesity in the relationship between pain interference and cognitive function. The investigators also want to examine the index of the predictive capacity regarding sarcopenia and obesity on cognitive function outcomes.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's planned enrollment of 50 is below the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Ohio University is the lead sponsor of 65 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The Tai Chi program content is based on the Harvard Medical School (HMS) Guide to Tai Chi, developed by clinical scientist Dr. Peter M. Wayne. Each participant will receive a workbook that describes the philosophy, evidence, and practice of Tai Chi, along with a video series for home practice that features the exercises from the HMS Guide to Tai Chi program. The in-person classes will be led by the Principal Investigator (PI) and delivered weekly over 8 weeks, with 75-minute sessions. The in-person and video series will introduce practice principles and tips on establishing and maintaining a practice, followed by a series of warm-up exercises, Tai Chi movements, and cool-down exercises.
Behavioral: Tai Chi
The Tai Chi program content is based on the Harvard Medical School (HMS) Guide to Tai Chi, developed by clinical scientist Dr. Peter M. Wayne. Each participant will receive a workbook that describes the philosophy, evidence, and practice of Tai Chi, along with a video series for home practice that features the exercises from the HMS Guide to Tai Chi program. The in-person classes will be led by the PI and delivered weekly over 8 weeks, with 75-minute sessions. The in-person and video series will include an introduction to the principles of practice and tips on establishing and maintaining a practice, followed by a series of warm-up exercises, Tai Chi movements, and cool-down exercises. The Tin-person (and offer virtual live sessions for those who cannot attend in-person) over 8 weeks, accompanied by a workbook and video-recorded practices to promote self-management.
Executive Function - Stroop Color-Word Interference Test
Delis-Kaplan Executive Function System Stroop Color-Word Interference Test
Time frame: From enrollment to the end of treatment at 8 weeks
Executive Function - Semantic Fluency Test
Repeatable Battery for the Assessment of Neuropsychological Status - Semantic Fluency Test
Time frame: From enrollment to the end of treatment at 8 weeks
Cognitive Function - Processing Speed
Repeatable Battery for the Assessment of Neuropsychological Status Coding Test
Time frame: From enrollment to the end of treatment at 8 weeks
Pain Interference
Patient Reported Outcome Measurement Information System (PROMIS) - Pain Interference Item Bank
Time frame: From enrollment to the end of treatment at 8 weeks
Social Isolation
Patient Reported Outcome Measurement Information System (PROMIS) Social Isolation Item Bank
Time frame: From enrollment to the end of treatment at 8 weeks
Positive Affect
Patient Reported Outcome Measurement Information System (PROMIS) Positive Affect Item Bank
Time frame: From enrollment to the end of treatment at 8 weeks
Meaning and Purpose
Patient Reported Outcome Measurement Information System (PROMIS) Meaning and Purpose Item bank
Time frame: From enrollment to the end of treatment at 8 weeks
Heart Rate Variability
Heart Rate Variability recorded while sitting for 5 minutes using a photoplethysmogram.
Time frame: From enrollment to the end of treatment at 8 weeks
Cortical activity
Cortical activity will be recorded during a brief Tai Chi Practice before and after the 8-week Tai Chi intervention using a functional Near Infrared Spectroscopy system.
Time frame: From enrollment to the end of treatment at 8 weeks
Cognitive Assessment Screen
Montreal Cognitive Assessment used as a screening tool which measures short term memory, visuospatial abilities, executive functions, attention, concentration and working memory, and language orientation to time and place.
Time frame: From enrollment only
Body Mass Index
Body Mass Index (BMI) will be assessed to identify the moderating role of obesity on pain interference and executive function. Weight and height will be combined to report BMI in kg/m\^2).
Time frame: From enrollment only
Physical Performance Test Battery for Sarcopenia (1 of 6)
(1) Hand Grip Strength using a JAMAR® dynamometer, adjusted to fit participants' hands as described elsewhere. A minimum of three trials with 60 seconds of rest between trials, and additional trials if the highest two values differ by more than 3 kg. Unit: Force in kilograms The investigators will diagnose sarcopenia using the European Working Group's (EWGSOP2) revised consensus definition, which involves assessing two measures and current sarcopenia reference values: (i) hand grip strength via dynamometry and (ii) gait speed.
Time frame: From enrollment to the end of treatment at 8 weeks
Physical Performance Test Battery for Sarcopenia (2 of 6)
(2) Usual Gait Speed over 4 meters to assess for gait speed. Unit: Seconds The investigators will diagnose sarcopenia using the European Working Group's (EWGSOP2) revised consensus definition, which involves assessing two measures and current sarcopenia reference values: (i) hand grip strength via dynamometry and (ii) gait speed.
Time frame: From enrollment to the end of treatment at 8 weeks
Physical Performance Test Battery for Sarcopenia (3 of 6)
(3) Six Minute Walk Test to assess for submaximal aerobic walking capacity. Unit: Meters
Time frame: From enrollment to the end of treatment at 8 weeks
Physical Performance Test Battery for Sarcopenia (4 of 6)
(4) Four-Square Step Test to assess for dynamic balance that involves stepping over objects forward, sideways, and backward. Unit: Seconds
Time frame: From enrollment to the end of treatment at 8 weeks
Physical Performance Test Battery for Sarcopenia (5 of 6)
(5) 5x Repeated Sit-to-Stand Test to assess lower extremity strength. Unit: Seconds
Time frame: From enrollment to the end of treatment at 8 weeks
Physical Performance Test Battery for Sarcopenia (6 of 6)
(6) Stair Climb Power Test to assess lower extremity power. Unit: Seconds.
Time frame: From enrollment to the end of treatment at 8 weeks
Plan to share: Yes — There is a plan to make individual participant data (IPD) collected in this study, including data dictionaries, available to other researchers after the end of the study after de-identification.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Immediately following publication. No end date.
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