Accessing Mobility Using Wearable Sensors

NCT04306588 | Withdrawn Phase 1

• 1 other identifier: 40765
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

COPD; CHF; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (6)

• Change from baseline Fear of Falling at 12 weeks

  Baseline and 3 months

• Change from baseline depression at 12 weeks

  Baseline and 3 months

• Change from baseline cognitive performance at 12 weeks

  Baseline to 3 months

• Change from baseline functional performance at 12 weeks

  Baseline to 3 months

• Change from baseline Risk of falling at 12 weeks

  Baseline and 3 months

Study Arms (1)

Tele-rehabilitation exercise Group

EXPERIMENTAL

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.

Other: Exercise

Interventions

Exercise OTHER

Participants are undergoing a 12 weeks tele-rehabilitation program.

Also known as: Tele-rehabilitation

Tele-rehabilitation exercise Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Michael E. DeBakey VA Medical Center: collaborator

Study Sites (1)

Michael E. DeBakey Veterans Affairs Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases; Heart Failure; Cardiovascular Diseases

Interventions

Exercise; Telerehabilitation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Bijan Najafi, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 13, 2020
• Study Start: May 21, 2018
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

US (1)