Accessing Mobility Using Wearable Sensors

Cardiovascular Diseases Clinical Trial

Official title:

Accessing Mobility Quality Using Wearable Sensors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04306588
• Other study ID #: 40765
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 21, 2018
• Est. completion date: December 30, 2025

Study information

• Verified date: April 2024
• Source: Baylor College of Medicine
• Contact: Maria Noun
• Phone: 713-798-7537
• Email: maria.noun[@]bcm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Congestive Heart Failure
• COPD
• Heart Failure
• Pulmonary Disease
• Pulmonary Restrictive Disease

Intervention

Other:
• Exercise
Participants are undergoing a 12 weeks tele-rehabilitation program.

Locations

Country	Name	City	State
United States	Michael E. DeBakey Veterans Affairs Medical Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	Michael E. DeBakey VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline and 3 months
Primary	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.	Baseline and 3 months
Primary	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.	Baseline and 3 months
Secondary	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).	Baseline and 3 months
Secondary	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.	Baseline and 3 months
Secondary	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.	Baseline to 3 months
Secondary	Change from baseline functional performance at 12 weeks	Functional Performance using 6 minute walk distance (6MWD) test	Baseline to 3 months
Secondary	Change from baseline Risk of falling at 12 weeks	Risk of falling will be assessed using timed Up and Go test	Baseline and 3 months
Secondary	Change from baseline motor capacity at 12 weeks	Motor capacity will be assessed by 5 times sit to stand test	Baseline and 3 months