- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05235113
Remote Game-based Exercise Program for Cognitive and Motor Function Improvement
Tele-exergame: Remotely-supervised Exercise Platform for Improving Cognition and Motor Function Using Telemedicine
Study Overview
Status
Intervention / Treatment
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.
110 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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maria Noun, BS
- Phone Number: 713-798-7538
- Email: maria.noun@bcm.edu
Study Contact Backup
- Name: Bijan Najafi, PhD
- Phone Number: 713-798-7536
- Email: bijan.najafi@bcm.edu
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77498
- Recruiting
- Baylor College of Medicine
-
Contact:
- Maria Noun, BS
- Phone Number: 713-798-7538
-
Contact:
- Bijan Najafi, PhD
- Phone Number: 713-798-7536
- Email: bijan.najafi@bcm.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Remote Exercise with tele-exergame
Subjects will perform exercises remotely twice a week with tele-exergaming 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.
|
Subjects will perform exercises in the home exercise twice a week without tele-exergaming platform.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 12 weeks
|
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.
|
Baseline and 12 weeks
|
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.
|
Baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 12 weeks
|
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.
|
Baseline and 12 weeks
|
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. |
Baseline and 12 weeks
|
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. |
Baseline and 12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Supportive care acceptability
Time Frame: Baseline and 12 weeks
|
To evaluate the acceptability of each in-home exercise program (both the tele-exergame and the non-tele-exergame exercises), we will employ a survey based on the Technology Acceptance Model. This survey will be administered to all participants, assessing their perceptions of ease of use, usefulness, technology anxiety, and intention to use. Each response will be rated on a 5-point Likert scale, ranging from "strongly disagree" to "strongly agree". This will be subsequently translated to a 0 to 4 scale for final evaluation, with higher scores indicating greater acceptability. The assessment will take place twice: initially at baseline, after the participants have tested the tele-exergame in the clinic for training purposes, and subsequently at the 12-week mark upon completion of the in-home exercise program. |
Baseline and 12 weeks
|
Adherence
Time Frame: week 4, week 8, week 12
|
We will assess adherence to the prescribed in-home exercise program through the use of an exercise diary and phone interview on monthly basis.
In the intervention group (IG), we will also objectively quantify adherence.
Adherence will be defined by the frequency and duration of in-home exercises performed over a 12-week period.
We will record and review adherence data on a monthly basis for three months.
|
week 4, week 8, week 12
|
intervention related dropout
Time Frame: week 4, week 8, week 12
|
We will categorize participants as intervention-related dropouts if they miss exercises for four consecutive weeks, decide to discontinue the exercise program, or experience any exercise-related adverse events. However, if a participant drops out due to non-exercise related reasons (e.g., developing a condition that limits their ability to participate in the program, passing away, traveling, relocating), we will not consider this an intervention-related dropout. Intervention-related dropout will be calculated as a percentage of the total number of participants in each group. We will collect this data on a monthly basis. |
week 4, week 8, week 12
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-44913
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cognitive Impairment
-
University of California, San FranciscoNational Institute on Aging (NIA)RecruitingMild Cognitive Impairment | Cognitive Decline | Cognitive Deterioration | Cognitive Impairment, Mild | Cognitive Deficits, MildUnited States
-
Stanford UniversityRecruitingMild Cognitive Impairment | Subjective Cognitive ImpairmentUnited States
-
Fondazione Don Carlo Gnocchi OnlusUniversity of Florence; Consorzio di Bioingeneria e Informatica Medica; Gutenberg...CompletedCognitive Dysfunction | Mild Cognitive Impairment | Vascular Cognitive ImpairmentItaly
-
University of California, Los AngelesCompletedMild Cognitive Impairment (MCI) | Age-associated Cognitive ImpairmentUnited States
-
Universidad de ZaragozaNot yet recruitingMild Cognitive Impairment | Randomized Controlled Trial | Subjective Cognitive Impairment
-
BaycrestCentre for Aging and Brain Health InnovationUnknownNeurocognitive Disorders | Cognitive Dysfunction | Mental Disorder | Cognitive Impairment, Mild | Cognitive Disorder | Nonamnestic Mild Cognitive ImpairmentCanada
-
Region SkaneLund University; Berry LabCompletedMemory Impairment | Cognitive Impairment, MildSweden
-
University of GeorgiaApplied Universal Dynamics, Corp.; Van Robotics, Inc.Active, not recruitingRobot-assisted Cognitive Training for Lonely Older Adults With Mild Cognitive Impairment (MCI) (MCI)Cognitive Change | Aging | Cognitive Impairment, MildUnited States
-
University Health Network, TorontoRecruiting
-
Wake Forest University Health SciencesActive, not recruiting
Clinical Trials on Tele-Exergame Platform
-
Professor Adrian CovicMedical Sciences Academy - Romania; Victor Babes Clinical Hospital of Infectious...UnknownCoronary Artery Disease | Hypertension | Covid-19 | Angina Pectoris | Acute Coronary Syndrome | Heart Failure, Systolic | Depression, Anxiety | Coronary Syndrome | Stent Restenosis | Angioplasty | Isolation, SocialRomania
-
Catholic University of the Sacred HeartFondazione Policlinico Universitario Agostino Gemelli IRCCS; Fondazione I.R...Enrolling by invitationDevelopmental DyslexiaItaly
-
University of LeicesterUniversity of Nottingham; University of Plymouth; University of Exeter; European...Recruiting
-
University of MinnesotaCompletedPreclinical Alzheimer's DiseaseUnited States
-
University of ZurichCompletedVestibular DiseasesSwitzerland
-
Washington Institute for CoagulationGenentech, Inc.CompletedHemophilia A | Joint BleedUnited States
-
MaineHealthRobert Wood Johnson FoundationCompleted
-
Eling DeBruinRecruitingMultiple SclerosisSwitzerland
-
Swiss Federal Institute of TechnologyCompletedEffects of Exergaming on Cognitive Functions in Young AthletenSwitzerland
-
Eling DeBruinCompletedMild Neurocognitive DisorderSwitzerland