Virtual Exercise For Older Adults With Mild Cognitive Impairment

Sponsor
Oregon Research Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05318703
Collaborator
(none)
69
1
2
26.3
2.6

Study Details

Study Description

Brief Summary

This project is designed to develop and evaluate an Internet-based exercise intervention (tai ji quan Moving to Improve Brain Health) using real-time videoconferencing for older adults with mild cognitive impairment (MCI).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: tai ji quan
  • Behavioral: Stretching
N/A

Detailed Description

The project has three major goals: (a) transforming an in-person tai ji quan brain health intervention protocol into an online (virtual) class protocol and evaluating its feasibility of implementation in older adults with MCI, (b) developing and evaluating online assessment and data ascertainment procedures that encompass cognitive and physical performance measures, and (c) conducting a randomized controlled trial comparing the effectiveness of this new online intervention protocol with a conventional stretching exercise group in older adults with MCI.

Study Design

Study Type:
Interventional
Actual Enrollment :
69 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Virtual Exercise Intervention for Older Adults With MCI
Actual Study Start Date :
Aug 19, 2020
Anticipated Primary Completion Date :
Aug 30, 2022
Anticipated Study Completion Date :
Oct 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: cognitively enhanced tai ji quan

Participants receive a cognitively enhanced tai ji quan exercise intervention for 16 weeks.

Behavioral: tai ji quan
cognitively enhanced tai ji quan exercise

Active Comparator: stretching exercise

Participants receive a stretching exercise intervention for 16 weeks.

Behavioral: Stretching
Stretching exercise

Outcome Measures

Primary Outcome Measures

  1. (a) Total number of intervention sessions taught by instructors over the course of study (recorded by a class check sheet) and (b) total number of classes attended by participants over the course of intervention as recorded by class attendance sheet [16 weeks]

    assess the extent to which interventionists successfully implement the prespecified exercise training protocol.

  2. number of dropouts from the intervention and study as assessed by a study recording sheet [16 weeks]

    assess intervention dropout rate and retention rate

  3. Number of participants expressing intervention program satisfaction as assessed by a self-report survey [16 weeks]

    assess the program acceptability among tai ji quan participants

  4. Change in global cognitive function assessed by Montreal Cognitive Assessment [baseline, 16 weeks]

    assess change from baseline cognitive function at 16 weeks

  5. Change in attention and working memory as assessed by Digit Span - forward and backward [baseline, 16 weeks]

    assess change from baseline in attention and working memory at 16 weeks

  6. Change in dual-task cost as assessed by Timed Up and Go with a cognitive task [baseline, 16 weeks]

    assess change from baseline in the ability to stand up from a chair, walk, and sit down while performing an arithmetic task at 16 weeks

  7. Change in executive function as assessed by Trail Making B [baseline, 16 weeks]

    assess change from baseline executive function at 16 weeks

  8. Change in executive function as assessed by Category Fluency for Animals [baseline, 16 weeks]

    assess change from baseline executive function at 16 weeks

  9. Change in cognitive functioning assessed by Everyday Cognition [baseline, 16 weeks]

    assess change from baseline cognitive functioning at 16 weeks

  10. Change in physical performance as measured by Timed Up and Go test [baseline, 16 weeks]

    assess change from baseline in the ability to stand up from a chair, walk, and sit down at 16 weeks

  11. change in leg strength as assessed by 30-second chair stand test [baseline, 16 weeks]

    assess change from baseline in leg strength at 16 weeks

  12. Change in balance using a 4-stage balance test [baseline, 16 weeks]

    assess change from baseline in balance at 16 weeks

Secondary Outcome Measures

  1. Change in depression as assessed by Geriatric Depression scale [baseline, 16 weeks]

    assess change from baseline in the level of depression at 16 weeks

  2. Change in physical activity as assessed by International Physical Activity Questionnaire [baseline, 16 weeks]

    assess change from baseline in physical activity at 16 weeks

  3. Change in quality of life as assessed by EuroQol (EQ-5D-3L) [baseline, 16 weeks]

    assess change from baseline in quality of life at 16 weeks

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 95 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion criteria:
  • Self-report a change or decline in memory (corroborated by an informant)

  • Record a score of ≤0.5 on the Clinical Dementia Rating (CDR) scale (with information derived from both the participant and an informant)

  • Show no major impairment in cognitive function as indexed by a score of ≥24 on the Mini Mental State Evaluation (MMSE).

Exclusion criteria:
  • Have participated in a rigorous and structured physical activity or exercise program (including Tai Ji Quan) in the past 6 months,

  • Show major signs of depression as indicated by a score of ≥5 on the Geriatric Depression Scale

  • Have major medical or physical conditions that preclude exercise, as determined by their healthcare practitioner

  • Being unable to follow the consent process or sign the study consent form.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oregon Research Institute Eugene Oregon United States 97403

Sponsors and Collaborators

  • Oregon Research Institute

Investigators

  • Principal Investigator: Fuzhong Li, Ph.D., Oregon Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Oregon Research Institute
ClinicalTrials.gov Identifier:
NCT05318703
Other Study ID Numbers:
  • AG059546-02S1
First Posted:
Apr 8, 2022
Last Update Posted:
Jul 18, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Oregon Research Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 18, 2022