Clinical trial NCT06828926: Project Gnosis: the Neurophysical and Psychosocial Health Outcomes of Tai Chi for Older Adults with Cognitive Concerns or Mild Cognitive Impairment
Official title: Project Gnosis: the Neural, Physical, and Psychosocial Processes and Health Outcomes of an 8-week Tai Chi Intervention in Older Adults with and Without Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment (MCI)
Sarcopenia
Keywords: Tai Chi
Cognitive Function
Lead sponsor: Ohio University
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

1. Participants who are older adults, defined as ≥60 years old.
2. Participants must have the ability to independently stand without the use of an assistive device for 20 minutes.
3. 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.

Exclusion Criteria:

1. 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.
2. 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.
3. 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.

2. Currently or recently practicing Tai Chi. Participants will be excluded if they are currently practicing Tai Chi. If participants have previously engaged in Tai Chi, there will be a washout period of at least 6 months before considering enrollment in the study.

Primary outcomes:
measure: Executive Function - Stroop Color-Word Interference Test
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Executive Function - Semantic Fluency Test
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: Cognitive Function - Processing Speed
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Pain Interference
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Social Isolation
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Positive Affect
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Meaning and Purpose
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Heart Rate Variability
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Cortical activity
timeFrame: From enrollment to the end of treatment at 8 weeks
Other outcomes:
measure: Cognitive Assessment Screen
timeFrame: From enrollment only
measure: Body Mass Index
timeFrame: From enrollment only
measure: Physical Performance Test Battery for Sarcopenia (1 of 6)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Physical Performance Test Battery for Sarcopenia (2 of 6)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Physical Performance Test Battery for Sarcopenia (3 of 6)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Physical Performance Test Battery for Sarcopenia (4 of 6)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Physical Performance Test Battery for Sarcopenia (5 of 6)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Physical Performance Test Battery for Sarcopenia (6 of 6)
timeFrame: From enrollment to the end of treatment at 8 weeks
Locations:
city: Athens
country: United States
facility: Ohio University
state: Ohio
Study officials:
References: