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Trial record 1 of 1 for:    ag059546
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Tai Ji Quan and Cognitive Function in Older Adults With Mild Cognitive Impairment

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ClinicalTrials.gov Identifier: NCT04070703
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Oregon Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Behavioral: The Go for Exercise & Healthy Aging Project Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Adapted Tai Ji Quan to Slow Cognitive Decline in Older Adults
Actual Study Start Date : October 15, 2019
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cognitively enhanced Tai Ji Quan
Participants in this arm will exercise a series of Tai Ji Quan-based movements with configurations that are specifically designed for older adults to improve cognitive function, dual-task ability, strength/balance, and mobility.
Behavioral: The Go for Exercise & Healthy Aging Project
Exercise and Cognition

Active Comparator: Standard Tai Ji Quan
Serving as an active comparison arm, participants in this intervention will exercise a series of Tai Ji Quan-based movements that are specifically designed for older adults to improve strength/balance, cognitive function, and mobility.
Behavioral: The Go for Exercise & Healthy Aging Project
Exercise and Cognition

Sham Comparator: Stretching
Serving as a control arm, participants in this intervention will engage in a series of light exercise activities consisting of breathing, stretching, and body relaxation.
Behavioral: The Go for Exercise & Healthy Aging Project
Exercise and Cognition




Primary Outcome Measures :
  1. Montreal Cognitive Assessment [ Time Frame: baseline, 6 months ]
    Change in global cognitive function from baseline to 24 weeks

  2. gait under a dual-task condition - walking with no cognitive task, walking with a concurrent cognitive task [ Time Frame: baseline, 6 months ]
    Change in dual-task ability from baseline to 24 weeks


Secondary Outcome Measures :
  1. Clinical Dementia Rating [ Time Frame: baseline, 6 months ]
    Change in cognitive decline from baseline to 24 weeks

  2. Paper-and-pencil domain-specific cognitive battery tests [ Time Frame: baseline, 6 months ]
    Change in domain-specific cognitive function from baseline to 24 weeks

  3. Computerized cognitive battery tests [ Time Frame: baseline, 6 months ]
    Change in domain-specific cognitive function from baseline to 24 weeks

  4. Physical performance - Functional Reach; Short Physical Performance Battery [ Time Frame: baseline, 6 months ]
    Change in physical performance from baseline to 24 weeks


Other Outcome Measures:
  1. Sleep quality - Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: baseline, 6 months ]
    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.

  2. Depression - Geriatric Depression Scale (GDS) [ Time Frame: baseline, 6 months ]
    Change in depression from baseline to 24 weeks. The GDS score ranges from 0 to 15 with scores higher than 5 indicative of depression.

  3. Activity and movement confidence scales [ Time Frame: baseline, 6 months ]
    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.

  4. Quality of life - EuroQol. [ Time Frame: baseline, 6 months ]
    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.

  5. Physical activity - International Physical Activity Questionnaire (IPAQ) [ Time Frame: baseline. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04070703


Contacts
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Contact: Fuzhong Li, Ph.D. 541-484-2123 fuzhongl@ori.org

Locations
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United States, Oregon
Oregon Research Institute Recruiting
Eugene, Oregon, United States, 97403
Contact: Fuzhong Li, Ph.D.    541-484-2123 ext 2137    fuzhongl@ori.org   
Principal Investigator: Fuzhong Li, Ph.D.         
Sponsors and Collaborators
Oregon Research Institute
Investigators
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Principal Investigator: Fuzhong Li, Ph.D. Oregon Research Institute
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Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT04070703    
Other Study ID Numbers: AG059546
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The individual level data in this study will not be shared with others for reasons of confidentiality. However, a dataset with identifiable private information removed may be made available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oregon Research Institute:
Cognitive function
mild cognitive impairment
Tai Ji Quan
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders