Dual-task Training for Function in MCI

Mild Cognitive Impairment Clinical Trial

Official title:

The Impact of Dual-task Training on Attention and Motor Function in Older Adults With Mild Cognitive Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04059705
• Other study ID #: STUDY00003525
• Status: Completed
• Phase: N/A
• Start date: April 4, 2023
• Est. completion date: September 17, 2023

Study information

• Verified date: November 2023
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Mild cognitive impairment (MCI) is an intermediate stage between the expected cognitive decline of normal aging and severe dementia associated with Alzheimer's disease (AD). In the United States about 20% of older adults have MCI. Loss of cognitive function in aging can have far-reaching and devastating impacts on functional status, independence, and quality of life. Unfortunately, the therapeutic options to slow progression of cognitive decline in aging are limited. Dual-task training; that which involves simultaneous cognitive and motor challenges, is a high-impact potential therapy to slow progressive loss of both motor and cognitive function in aging. The purpose of this trial is to examine the feasibility and therapeutic impact of a novel dual-task physical activity intervention on executive and motor functions among adults, 65 years or older, who have MCI. the investigative team anticipates that findings from this trial will inform development of larger community-based studies focused on improving function and ability to maintain independence in older age.

Description:

Mild cognitive impairment (MCI) is an intermediate stage between the expected cognitive decline of normal aging and severe dementia associated with Alzheimer's disease (AD). In the United States about 20% of older adults have MCI, and approximately 15% per year of those with MCI will progress to AD. With our rapidly aging society, we are approaching a public health crisis for which we are not fully prepared. Impaired cognitive function in aging can have far-reaching and devastating impacts on functional status, ability to maintain independence, and overall quality of life. Unfortunately, the therapeutic options to slow progression of cognitive decline in aging are limited. Dual-task training that involves simultaneous cognitive and motor challenges improves certain domains of both cognitive and motor function in older adults with MCI. However, we do not yet know the optimal methods of delivering this high-impact potential therapy in community-based settings with unique limitations and strengths. Therefore, the aims are to; 1) test the feasibility of conducting a community-based dual-task (thinking while exercising) physical activity intervention among adults, 65 years or older, with MCI; and 2) examine the impact of dual-task training on attention and motor function among adults, 65 years or older, with MCI. To accomplish these aims the investigators will conduct an 12-week, dual-task training program using the SmartFit Multisensory Fitness System (Oxnard, CA) among older adults with MCI. Our group-based training program involves two 1-hour training sessions per week, designed to simultaneously engage the mind and body, while promoting self-efficacy. Attention and motor function will be assessed prospectively. The investigators anticipate that findings from this trial will inform development of methods to bring evidence-based, non-invasive therapies into communities in need, in order to preserve function, independence, and quality of life well into older age.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 17, 2023
• Est. primary completion date: September 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 65 years of age or older
• Male or female
• Mild (23 - 26 points) cognitive impairment as screened by the Montreal Cognitive Assessment
• Having no absolute contraindications to non-physician supervised exercise as guided by the American College of Sports Medicine and Centers for Disease Control and Prevention.

Exclusion Criteria:

• Having any condition that prevents safe participation in non-physician supervised exercise as screened using the Physical Activity Readiness Questionnaire for Older Adults
• Blood pressure >180 mmHg systolic or 100 mmHg diastolic at baseline
• Presence of severe illness or disability
• Lower body amputation
• Cognitive Impairment beyond mild level, preventing provision of informed consent.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• Dual-Task Training
The ThinkFIT intervention will involve two days per week participation in simultaneous cognitive and motor training activities, facilitated by the SMARTFit Multisensory FItness System.

Locations

Country	Name	City	State
United States	Buffalo-Niagara YMCA	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Motor Function from baseline to 12 weeks	Change in motor function will be assessed prospectively using the Short Physical Performance Battery.	baseline, week 6, week 12
Primary	Change in Attention from baseline to 12 weeks	Attention will be assessed prospectively using the Stroop Task and Trail-making Test.	baseline, week 6, week 12
Secondary	Change in Exercise Self Efficacy from baseline to 12 weeks	Self efficacy for exercise will be assessed using the Self Efficacy for Exercise Scale. Total score is derived by summing the individual scores for each question. Scoring range for this instrument is 0 - 90 points with higher scores representing better outcomes.	baseline, week 12
Secondary	Outcome Expectations for Exercise from baseline to 12 weeks	Outcome Expectations for exercise will be assessed using the Outcome Expectations for Exercise Scale. This instrument has 9 total items. Total score is derived by summing the responses to these items and dividing by the number of responses. Scoring is out of 9 points, with higher scores demonstrating higher outcomes expectations.	baseline, week 12