Project Gnosis: the Neurophysical and Psychosocial Health Outcomes of Tai Chi for Older Adults with Cognitive Concerns or Mild Cognitive Impairment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorOhio University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants who are older adults, defined as ≥60 years old.

Participants must have the ability to independently stand without the use of an assistive device for 20 minutes.

People with Mild Cognitive Impairment (MCI) (initial cohort) and without MCI (age-gender matched healthy controls). A score of between >18 and ≤26 on the Montreal Cognitive Assessment (MoCA) will be used to classify MCI. A score above 26 is considered normal.

Disqualifiers

Participants with significant uncontrolled medication, and cardiovascular, respiratory, and metabolic symptoms will be excluded from participation in the study, as these symptoms could impact their engagement with the engagement of Tai Chi.

Investigators will administer a brief screening questionnaire to assess (a) hypotension symptoms related to intensive treatment of hypertension and (b) hypoglycemia related to intensive treatment of diabetes, as these conditions are associated with cognitive decline.

Investigators will capture data on potential sleep apnea and administer the Stop-Bang Questionnaire to identify potential sleep-disordered breathing. Participants with significant uncontrolled sleep apnea will be excluded as this could also impact their engagement in the intervention and influence the primary outcome measure of cognitive function.

Trial design

Design model

Single group

Treatments tested in this trial

  • Tai Chi

    Behavioral

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Tai ChiExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

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
2

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
3

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
4

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

Sponsors and contacts

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