Virtual Exercise For Older Adults With Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Official title:

Virtual Exercise Intervention for Older Adults With MCI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05318703
• Other study ID #: AG059546-02S1
• Status: Completed
• Phase: N/A
• Start date: January 20, 2021
• Est. completion date: October 30, 2022

Study information

• Verified date: March 2023
• Source: Oregon Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: October 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• tai ji quan
cognitively enhanced tai ji quan exercise
• Stretching
Stretching exercise

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
Primary	(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	assess the extent to which interventionists successfully implement the prespecified exercise training protocol.	16 weeks
Primary	number of dropouts from the intervention and study as assessed by a study recording sheet	assess intervention dropout rate and retention rate	16 weeks
Primary	Number of participants expressing intervention program satisfaction as assessed by a self-report survey	assess the program acceptability among tai ji quan participants	16 weeks
Primary	Change in global cognitive function assessed by Montreal Cognitive Assessment	assess change from baseline cognitive function at 16 weeks	baseline, 16 weeks
Primary	Change in attention and working memory as assessed by Digit Span - forward and backward	assess change from baseline in attention and working memory at 16 weeks	baseline, 16 weeks
Primary	Change in dual-task cost as assessed by Timed Up and Go with a cognitive task	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	baseline, 16 weeks
Primary	Change in executive function as assessed by Trail Making B	assess change from baseline executive function at 16 weeks	baseline, 16 weeks
Primary	Change in executive function as assessed by Category Fluency for Animals	assess change from baseline executive function at 16 weeks	baseline, 16 weeks
Primary	Change in cognitive functioning assessed by Everyday Cognition	assess change from baseline cognitive functioning at 16 weeks	baseline, 16 weeks
Primary	Change in physical performance as measured by Timed Up and Go test	assess change from baseline in the ability to stand up from a chair, walk, and sit down at 16 weeks	baseline, 16 weeks
Primary	change in leg strength as assessed by 30-second chair stand test	assess change from baseline in leg strength at 16 weeks	baseline, 16 weeks
Primary	Change in balance using a 4-stage balance test	assess change from baseline in balance at 16 weeks	baseline, 16 weeks
Secondary	Change in depression as assessed by Geriatric Depression scale	assess change from baseline in the level of depression at 16 weeks	baseline, 16 weeks
Secondary	Change in physical activity as assessed by International Physical Activity Questionnaire	assess change from baseline in physical activity at 16 weeks	baseline, 16 weeks
Secondary	Change in quality of life as assessed by EuroQol (EQ-5D-3L)	assess change from baseline in quality of life at 16 weeks	baseline, 16 weeks