Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dual-task Training for Function in MCI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04059705
Recruitment Status : Not yet recruiting
First Posted : August 16, 2019
Last Update Posted : October 9, 2020
Sponsor:
Information provided by (Responsible Party):
Nikhil Satchidanand, State University of New York at Buffalo

Tracking Information
First Submitted Date  ICMJE August 12, 2019
First Posted Date  ICMJE August 16, 2019
Last Update Posted Date October 9, 2020
Estimated Study Start Date  ICMJE January 4, 2021
Estimated Primary Completion Date January 4, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dual-task Training for Function in MCI
Official Title  ICMJE The Impact of Dual-task Training on Attention and Motor Function in Older Adults With Mild Cognitive Impairment
Brief 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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
This study utilizes a one-group design with repeated measures.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Mild Cognitive Impairment
Intervention  ICMJE 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.
Other Name: ThinkFIT Intervention, SMARTFit Multisensory Fitness System
Study Arms  ICMJE Experimental: Dual-Task Intervention
This study arm will receive the dual-task training program.
Intervention: Behavioral: Dual-Task Training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 15, 2019)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 15, 2021
Estimated Primary Completion Date January 4, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nikhil Satchidanand, PhD 716-881-7901 ns1@buffalo.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04059705
Other Study ID Numbers  ICMJE STUDY00003525
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Investigators will allow data and supportive documents to be available to users only under a defined data-sharing agreement that enforces (a) their commitment to using the data only for research purposes and does not identify any individual research participant; (b) the commitment to secure all research data using appropriate technology; (c) prohibition of redistribution of the data to third parties, as well as proper acknowledgement of the data resource, and (d) a commitment to destroying and/or returning the data after analyses have been completed. De-identified data will be maintained on a University at Buffalo server and will be shared via encrypted devices. Co-Investigators may access the data collected as part of their aims. Investigators working on the project will have access to the data only through the principal investigator. The data will be monitored routinely to maintain security, safety, and productivity.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: 1-year after first publication
Access Criteria: Final data sets will be made available upon specific request and under an authorized Data Use Agreement. This, in addition to the publications being made available via PubMed Central, will enable validation of results by recipients.
Responsible Party Nikhil Satchidanand, State University of New York at Buffalo
Study Sponsor  ICMJE State University of New York at Buffalo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nikhil Satchidanand, PhD University at Buffalo, State University of New York
PRS Account State University of New York at Buffalo
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP