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Completed

NCT Number: NCT04059705

Dual-task Training for Function in MCI

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Buffalo-Niagara YMCA

Buffalo, New York, 14223, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dual-Task Training

Behavioral

The ThinkFIT intervention will involve two days per week participation in simultaneous cognitive and motor training activities, facilitated by the SMARTFit Multisensory FItness System.

Other names: ThinkFIT Intervention, SMARTFit Multisensory Fitness System

Primary outcomes

  1. Change in Motor Function from baseline to 12 weeks

    Time frame: baseline, week 6, week 12

    Change in motor function will be assessed prospectively using the Short Physical Performance Battery.

  2. Change in Attention from baseline to 12 weeks

    Time frame: baseline, week 6, week 12

    Attention will be assessed prospectively using the Stroop Task and Trail-making Test.

Secondary outcomes

  1. Change in Exercise Self Efficacy from baseline to 12 weeks

    Time frame: baseline, week 12

    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.

  2. Outcome Expectations for Exercise from baseline to 12 weeks

    Time frame: baseline, week 12

    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.

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 16, 2019
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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