Clinical trial NCT04306588: Accessing Mobility Using Wearable Sensors
Official title: Accessing Mobility Quality Using Wearable Sensors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: COPD
Pulmonary Disease
Pulmonary Restrictive Disease
Congestive Heart Failure
Cardiovascular Diseases
Keywords: COPD
CHF
Cardiovascular Diseases
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Michael E. DeBakey VA Medical Center
First posted: 2020-03-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: Change from baseline gait speed at 12 weeks
timeFrame: Baseline and 3 months
measure: Change from baseline balance at 12 weeks
timeFrame: Baseline and 3 months
measure: Change from baseline frailty index at 12 weeks
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Change from baseline Fear of Falling at 12 weeks
timeFrame: Baseline and 3 months
measure: Change from baseline depression at 12 weeks
timeFrame: Baseline and 3 months
measure: Change from baseline cognitive performance at 12 weeks
timeFrame: Baseline to 3 months
measure: Change from baseline functional performance at 12 weeks
timeFrame: Baseline to 3 months
measure: Change from baseline Risk of falling at 12 weeks
timeFrame: Baseline and 3 months
measure: Change from baseline motor capacity at 12 weeks
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey Veterans Affairs Medical Center
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Bijan Najafi, PhD
role: PRINCIPAL_INVESTIGATOR
References: