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Remote Game-based Exercise Program for Cognitive and Motor Function Improvement

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05235113
Recruitment Status : Active, not recruiting
First Posted : February 11, 2022
Last Update Posted : March 24, 2023
Sponsor:
Collaborator:
BioSensics LLC
Information provided by (Responsible Party):
Bijan Najafi, PhD, Baylor College of Medicine

Study Description
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Brief Summary:
As our population ages, more older adults face motor-cognitive declines, increasing their risk of falls and fear of falling. Exercise is an effective way to maintain cognitive function, as supported by recent studies. However, those with poor motor and cognitive abilities often struggle to visit rehabilitation centers, leading to high dropout rates and low adherence to unsupervised programs. A remote exercise program tailored for individuals with cognitive impairments is urgently needed to preserve cognitive function, promote independent living, and reduce related costs. Researchers aim to develop an in-home system for adults with mild cognitive issues or dementia, designed to improve balance and cognition while being remotely supervised through telemedicine.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Dementia Cognitive Impairment Memory Loss Device: Tele-Exergame Platform Device: No Tele-Exergame Platform Not Applicable

Detailed Description:

This study aims to develop and validate a remote exercise intervention for individuals at risk of or experiencing dementia using a wearable sensor-enabled platform, called Tele-Exergame. This approach could preserve cognitive function, promote independent living, reduce costs related to cognitive-motor decline, and advance remote technology use for screening cognitive and motor performance in older adults. The findings are crucial for healthcare providers, clinicians, seniors, and caregivers.

100 participants will be randomly assigned to either the intervention or control group, both undergoing a 12-week home exercise program for 30 minutes twice weekly. The intervention group will complete sessions remotely using Tele-exergame, while the control group will participate in home-based exercise without technology.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to intervention (IG) or control group (CG) with ratio of 1:1. The entire cohort will perform leg and foot exercises twice a week. The IG will use the Tele-exergaming platform, and the CG will do the exercises without the platform.
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Tele-exergame: Remotely-supervised Exercise Platform for Improving Cognition and Motor Function Using Telemedicine
Actual Study Start Date : December 22, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : March 21, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Remote Exercise with tele-exergame
Subjects will perform exercises remotely twice a week with tele-exergaming platform.
 Device: Tele-Exergame Platform
Subjects will perform exercises remotely twice a week with tele-exergaming platform.
Sham Comparator: home-based exercise without technology
Subjects will perform exercises at home without tele-exergaming platform twice a week.
 Device: No Tele-Exergame Platform
Subjects will perform exercises in the clinic twice a week without tele-exergaming platform.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Balance [ Time Frame: Baseline and 12 weeks ]
    Change in balance from baseline to 12 weeks will be measured. Balance will be assessed by measuring center of mass sway. The investigator will use a validated wearable platform (BalanSen) to measure body sway.

  2. Change in Gait speed [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in Gait speed at 12 weeks. Gait speed will be measured using a validated wearable platform (LEGSys) during habitual walking speed.

  3. Change in Cognitive Function [ Time Frame: Baseline and 12 weeks ]
    Changes from baseline in cognitive function at 12 weeks. Cognitive performance will be assessed using Montreal Cognitive Assessment (MoCA). Scores on the MoCA range from zero to 30, with a score of 26 and higher generally considered normal.

  4. Change in Fear of Falling [ Time Frame: Baseline and 12 weeks ]
    Changes in Fear of falling will be assessed by Short Falls Efficacy Scale International (FES I) questionnaire at 12 weeks and will be compared to baseline measurements. Scores range from 16 to 64, the higher the score the more concerned the subject is with falling.


Secondary Outcome Measures :
  1. Change in Physical Activity [ Time Frame: Baseline and 12 weeks ]
    Changes in physical activity from baseline to 12 weeks will be assessed. Physical activity will be quantified by measuring number of taken steps per day and will be measured using a validated wearable sensor named PAMSys. Monitoring of physical activity will be done during 48h baseline and 48 hour at 12 weeks.

  2. Change in Quality of Life [ Time Frame: Baseline and 12 weeks ]

    Quality of life will be assessed using a validated questionnaire, called PROMIS Global-10.

    The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.


  3. change in depression [ Time Frame: Baseline and 12 weeks ]

    Changes in depression from baseline to 12 weeks will be assessed. Depression will be quantified by the Center for Epidemiologic Studies Depression Scale (CES-D) at baseline and 12 weeks. The CES-D consists of 20 items, and each item is scored on a scale of 0 to 3, with 0 representing "Rarely or none of the time" and 3 representing "Most or all of the time." The total score for the CES-D ranges from 0 to 60, with higher scores indicating a greater severity of depressive symptoms.

    A score of 16 or higher is often considered as a cutoff point for identifying individuals who may be at risk for clinical depression. However, it is important to note that the CES-D is a screening tool, not a diagnostic tool, and a higher score should prompt further evaluation by a mental health professional.



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults with diagnosed with dementia or cognitive impairment
  • Living independently in a residential home with a caregiver/informant
  • Able to walk at least 30 feet with or without assistance

Exclusion Criteria:

  • Immobility or major mobility disorder or inability to engage safely in the proposed weight-bearing exercise program
  • Diagnosed with severe cognitive impairment (MoCA score < 16)
  • Subjects with major hearing/visual impairment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05235113


Locations
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United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77498
Sponsors and Collaborators
Baylor College of Medicine
BioSensics LLC
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

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Responsible Party: Bijan Najafi, PhD, Professor of Surgery, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT05235113    
Other Study ID Numbers: H-44913
First Posted: February 11, 2022    Key Record Dates
Last Update Posted: March 24, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Bijan Najafi, PhD, Baylor College of Medicine:
tele-exercise
exergame
tele-rehabilitation
 Telehealth
telemedicine
virtual reality
Additional relevant MeSH terms:
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Memory Disorders
Cognitive Dysfunction
Nervous System Diseases
Neurocognitive Disorders
 Mental Disorders
Cognition Disorders
Neurobehavioral Manifestations
Neurologic Manifestations