Tai Ji Quan and Cognitive Function in Older Adults With Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Official title:

Efficacy of Adapted Tai Ji Quan to Slow Cognitive Decline in Older Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04070703
• Other study ID #: AG059546
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: May 28, 2024

Study information

• Verified date: April 2024
• Source: Oregon Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the efficacy of a cognitively enhanced exercise intervention - Tai Ji Quan: Moving to Maintain Brain Health in improving global cognitive function and dual-task ability in older adults with mild cognitive impairment.

Description:

The primary aim of the study is to determine the efficacy of a cognitively enhanced exercise intervention - Tai Ji Quan: Moving to Maintain Brain Health, relative to a standard Tai Ji Quan intervention and an exercise stretching control, in improving global cognitive function and dual-task ability among community-dwelling older adults with amnestic mild cognitive impairment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 332
• Est. completion date: May 28, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 95 Years

Eligibility

Inclusion Criteria:

• complaint of memory loss
• clinical dementia rating (CDR) scale score =0.5
• having normal general cognitive function screened, with MMSE =24
• capable of exercising safely, as determined by a healthcare provider
• willingness to be randomly assigned to an intervention condition and complete the 24-week intervention and 6-month follow-up

Exclusion Criteria:

• having medical conditions likely to compromise survival, such as metastatic cancer, or render a participant unable to engage in physical activity, such as severe cardiac failure
• participating in any type of Tai Ji Quan or daily and/or structured vigorous physical activity (i.e., brisk walking for exercise 30 minutes or longer at a time, or engaging in muscle-strengthening activities, e.g., weight lifting on 3 or more days per week 3 months prior to the study)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• The Go for Exercise & Healthy Aging Project
Exercise and Cognition

Locations

Country	Name	City	State
United States	Oregon Research Institute	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sleep quality - Pittsburgh Sleep Quality Index (PSQI)	Change in sleep quality from baseline to 24 weeks. The PSQI total score ranges from 0 to 21 points, with high scores indicating poorer sleep quality.	baseline, 6 months
Other	Depression - Geriatric Depression Scale (GDS)	Change in depression from baseline to 24 weeks. The GDS score ranges from 0 to 15 with scores higher than 5 indicative of depression.	baseline, 6 months
Other	Activity and movement confidence scales	Change in activity and movement confidence from baseline to 24 weeks. The total score ranges from 0 to 10 with high scores indicating high confidence.	baseline, 6 months
Other	Quality of life - EuroQol.	Change in quality of life from baseline to 24 weeks. The EQ-5D-3L version will be used that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The scores of EQ-5D-3L will be combined to generate a single utility value ranging from 1.00 for the "best health" state to -0.594 for the "worst health" state, where a score of 0 is indicative of death, and scores less than 0 are considered as "worse than death." Participants who die during the trial period will be registered as 0 in utility terms for the assessment period from when the death occurred.	baseline, 6 months
Other	Physical activity - International Physical Activity Questionnaire (IPAQ)	Level of physical activity. IPAQ measures physical activity by self-report over the previous 7 days with levels of activities classified into low, moderate, or high. The results in this study will be presented in MET minutes a week with high values indicating high amount of energy expended carrying out physical activity.	baseline.
Primary	Montreal Cognitive Assessment	Change in global cognitive function from baseline to 24 weeks	baseline, 6 months
Primary	gait under a dual-task condition - walking with no cognitive task, walking with a concurrent cognitive task	Change in dual-task ability from baseline to 24 weeks	baseline, 6 months
Secondary	Clinical Dementia Rating	Change in cognitive decline from baseline to 24 weeks	baseline, 6 months
Secondary	Paper-and-pencil domain-specific cognitive battery tests	Change in domain-specific cognitive function from baseline to 24 weeks	baseline, 6 months
Secondary	Computerized cognitive battery tests	Change in domain-specific cognitive function from baseline to 24 weeks	baseline, 6 months
Secondary	Physical performance - Functional Reach; Short Physical Performance Battery	Change in physical performance from baseline to 24 weeks	baseline, 6 months