Accessing Mobility Using Wearable Sensors
Primary Purpose
COPD, Pulmonary Disease, Pulmonary Restrictive Disease
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional screening trial for COPD focused on measuring COPD, CHF, Cardiovascular Diseases
Eligibility Criteria
Inclusion Criteria:
- Any individual 18 years old or 65+ older is eligible to participate.
- Must be diagnosed with a chronic illness such as COPD or CHF.
- Should be refereed to one of the tele-rehabilitation program offered at VA-Houston.
The investigators will be enrolling veteran subjects
Exclusion Criteria:
- Non-ambulatory (unable to walk with or without assistance a distance of at least 10 meter).
- Unlikely to fully comply with the protocol (e.g., long-distance travel if multiple follow-up visits are required)
- Unwilling to provide informed consent.
- Severe visual and hearing problems who may not be able to interact with tele-rehabilitation.
- Unstable medical region (those who may change medication over next 12 weeks).
- Severe cognitive impairment and psychiatric problems who may not be able to follow tele-rehabilitation instructions based on judgement of clinical investigators.
- Participating in another active intervention that may affect cognitive-motor performance, and those who do not have capacity to consent.
The investigators will not exclude patients with internal devices such as a deep brain stimulator or electronic devices for pain management, but the investigators will not be placing Bioharness device in people with such conditions.
Sites / Locations
- Michael E. DeBakey Veterans Affairs Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tele-rehabilitation exercise Group
Arm Description
Participants who are suffering from a chronic illness such as COPD or CHF and are referred for tele-rehabilitation intervention at the VA-Houston will be qualified for the purpose of this study.
Outcomes
Primary Outcome Measures
Change from baseline gait speed at 12 weeks
Gait change from Baseline to 12 weeks
The investigators will quantify gait speed using a validated wearable device, called LEGSys
Change from baseline balance at 12 weeks
Balance will be quantified by measuring body sway during still upright standing for duration of 30 seconds. The investigators will use a validated wearable device, called BALANSens to measure body sway.
Change from baseline frailty index at 12 weeks
Physical frailty is quantified by frailty index. Frailty index will be measured using a validated wearable device, called Frailty meter. scale is 0 to 1, higher value indicates more severity in frailty.
Secondary Outcome Measures
Change from baseline Fear of Falling at 12 weeks
Fear of falling is assessed using Fall Efficacy Scale International (FES-I) questionnaire. Scores range from 16 (no concern about falling) to maximum 64 (severe concern about falling).
Change from baseline depression at 12 weeks
Depression will be assessed using Center of Epidemiologic Depression Scale (CES-D) questionnaire. Scores range from 0 to 60, with high scores indicating greater depressive symptoms. The CES-D also provides cutoff scores (e.g., 16 or greater) that aid in identifying individuals at risk for clinical depression.
Change from baseline cognitive performance 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.
Change from baseline functional performance at 12 weeks
Functional Performance using 6 minute walk distance (6MWD) test
Change from baseline Risk of falling at 12 weeks
Risk of falling will be assessed using timed Up and Go test
Change from baseline motor capacity at 12 weeks
Motor capacity will be assessed by 5 times sit to stand test
Full Information
NCT ID
NCT04306588
First Posted
March 9, 2020
Last Updated
March 23, 2023
Sponsor
Baylor College of Medicine
Collaborators
Michael E. DeBakey VA Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04306588
Brief Title
Accessing Mobility Using Wearable Sensors
Official Title
Accessing Mobility Quality Using Wearable Sensors
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 21, 2018 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
Michael E. DeBakey VA Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will examine whether wearable sensors can be used to track changes in cognitive-motor performance in response to a disease or an intervention.
The investigators specific aims are twofold, first aim to explore whether and how a clinical condition such as Chronic obstructive pulmonary disease (COPD) or Congestive Heart Failure (CHF) may impact motor-cognitive performance measurable using validated wearable devices (e.g., LEGSys, BalanSENS, and Frailty Meter). Second, the investigators will explore whether an exercise intervention provided via tele-medicine (tele-rehabilitation) can enhance motor-cognitive performance.
Detailed Description
The investigators specific research questions: (1) Which motor-cognitive parameters measurable by wearable sensors (e.g. gait, balance, frailty index, etc) are linked to specific diseases (e.g. COPD, CHF) (2) Which motor-cognitive parameters are most responsive to identify changes in patients ambulatory performance related to Tele-rehabilitation
The investigators will recruit a minimum of 15 per clinical condition with a maximum of 150 per clinical condition in subjects suffering from different disorders, which may impact motor-cognitive. Targeted disorders: COPD and CHF. Other chronic illness may also be recruited such as Diabetes, Peripheral Arterial Disease, Morbus Parkinson, Cancer, Neuropathy, Frailty, Mild Cognitive Impairment, Depression, and patients undergoing major surgical intervention. Fifteen or more people with the same disorder would form a group.
The investigators will measure motor-cognitive performance from each subject. For this purpose several sensors will be attached to the body using elastic straps. Each subject will be asked to dedicate approximately 1 hour of their time for each visit. A series of health related questionnaires will be used to evaluate the quality of life, clinical problems, cognition, and pain intensity levels, respectively. Medical history (from the subject's chart) and demographic information will be obtained.
This study consists of Core and Ancillary Measurements. Core Measurements (Motor cognitive test) will be performed during all visits whereas Ancillary Measurements may not be required for anyone.
If the subject is undergoing tele-rehabilitation intervention, which may also benefit functional status (e.g. improvement in balance), the investigators will re-examine motor-cognitive performance using the test described above to evaluate the sensitivity of the proposed test in tracking outcomes in response to the intervention or predict outcomes based on baseline assessments. Specifically, depending on the type of intervention and frequency of standard of care visits for follow-up at the clinic, the investigators may re-assess functional performance at each follow-up standard of care visit, upon the availability of the subject. Please note that the number of follow up visits will not exceed 12 visits over the course of 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Pulmonary Disease, Pulmonary Restrictive Disease, Congestive Heart Failure, Cardiovascular Diseases
Keywords
COPD, CHF, Cardiovascular Diseases
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tele-rehabilitation exercise Group
Arm Type
Experimental
Arm Description
Participants who are suffering from a chronic illness such as COPD or CHF and are referred for tele-rehabilitation intervention at the VA-Houston will be qualified for the purpose of this study.
Intervention Type
Other
Intervention Name(s)
Exercise
Other Intervention Name(s)
Tele-rehabilitation
Intervention Description
Participants are undergoing a 12 weeks tele-rehabilitation program.
Primary Outcome Measure Information:
Title
Change from baseline gait speed at 12 weeks
Description
Gait change from Baseline to 12 weeks
The investigators will quantify gait speed using a validated wearable device, called LEGSys
Time Frame
Baseline and 3 months
Title
Change from baseline balance at 12 weeks
Description
Balance will be quantified by measuring body sway during still upright standing for duration of 30 seconds. The investigators will use a validated wearable device, called BALANSens to measure body sway.
Time Frame
Baseline and 3 months
Title
Change from baseline frailty index at 12 weeks
Description
Physical frailty is quantified by frailty index. Frailty index will be measured using a validated wearable device, called Frailty meter. scale is 0 to 1, higher value indicates more severity in frailty.
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Change from baseline Fear of Falling at 12 weeks
Description
Fear of falling is assessed using Fall Efficacy Scale International (FES-I) questionnaire. Scores range from 16 (no concern about falling) to maximum 64 (severe concern about falling).
Time Frame
Baseline and 3 months
Title
Change from baseline depression at 12 weeks
Description
Depression will be assessed using Center of Epidemiologic Depression Scale (CES-D) questionnaire. Scores range from 0 to 60, with high scores indicating greater depressive symptoms. The CES-D also provides cutoff scores (e.g., 16 or greater) that aid in identifying individuals at risk for clinical depression.
Time Frame
Baseline and 3 months
Title
Change from baseline cognitive performance at 12 weeks
Description
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.
Time Frame
Baseline to 3 months
Title
Change from baseline functional performance at 12 weeks
Description
Functional Performance using 6 minute walk distance (6MWD) test
Time Frame
Baseline to 3 months
Title
Change from baseline Risk of falling at 12 weeks
Description
Risk of falling will be assessed using timed Up and Go test
Time Frame
Baseline and 3 months
Title
Change from baseline motor capacity at 12 weeks
Description
Motor capacity will be assessed by 5 times sit to stand test
Time Frame
Baseline and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any individual 18 years old or 65+ older is eligible to participate.
Must be diagnosed with a chronic illness such as COPD or CHF.
Should be refereed to one of the tele-rehabilitation program offered at VA-Houston.
The investigators will be enrolling veteran subjects
Exclusion Criteria:
Non-ambulatory (unable to walk with or without assistance a distance of at least 10 meter).
Unlikely to fully comply with the protocol (e.g., long-distance travel if multiple follow-up visits are required)
Unwilling to provide informed consent.
Severe visual and hearing problems who may not be able to interact with tele-rehabilitation.
Unstable medical region (those who may change medication over next 12 weeks).
Severe cognitive impairment and psychiatric problems who may not be able to follow tele-rehabilitation instructions based on judgement of clinical investigators.
Participating in another active intervention that may affect cognitive-motor performance, and those who do not have capacity to consent.
The investigators will not exclude patients with internal devices such as a deep brain stimulator or electronic devices for pain management, but the investigators will not be placing Bioharness device in people with such conditions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Noun
Phone
713-798-7537
Email
maria.noun@bcm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ilse Torres
Phone
713-798-8714
Email
ilse.torresruiz@bcm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bijan Najafi, PhD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey Veterans Affairs Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bijan Najafi, PhD
Phone
713-798-7536
Email
bijan.najafi@bcm.edu
First Name & Middle Initial & Last Name & Degree
Maria Noun
Phone
713-798-7537
Email
maria.noun@bcm.edu
First Name & Middle Initial & Last Name & Degree
Amir Sharafkhaneh, MD PHD
First Name & Middle Initial & Last Name & Degree
Charlie Lan, MD
First Name & Middle Initial & Last Name & Degree
Monthaporn Bryant, PhD
First Name & Middle Initial & Last Name & Degree
Christina Nguyen, RRT
First Name & Middle Initial & Last Name & Degree
Venkata Bandi, MD
12. IPD Sharing Statement
Learn more about this trial
Accessing Mobility Using Wearable Sensors
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