COPDPhase 1/2NCT04306588
Accessing Mobility Using Wearable Sensors
A Phase 1/2 study testing Exercise in people with COPD and Pulmonary Disease, run by Baylor College of Medicine at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Pulmonary Disease, Pulmonary Restrictive Disease
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2018to 30 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, 77030
About this study
Official title: Accessing Mobility Quality Using Wearable Sensors
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.
Read the 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.
- Conditions
- COPD, Pulmonary Disease, Pulmonary Restrictive Disease, Congestive Heart Failure, Cardiovascular Diseases
- Being tested
- Exercise
- Keywords
- COPD, CHF, Cardiovascular Diseases
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Heart Failure, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Tele-rehabilitation
Participants are undergoing a 12 weeks tele-rehabilitation program.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: Baseline and 3 months
Secondary outcomes (6)
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).
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months
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.
Measured: Baseline to 3 months
Change from baseline functional performance at 12 weeks
Functional Performance using 6 minute walk distance (6MWD) test
Measured: Baseline to 3 months
Change from baseline Risk of falling at 12 weeks
Risk of falling will be assessed using timed Up and Go test
Measured: Baseline and 3 months
Change from baseline motor capacity at 12 weeks
Motor capacity will be assessed by 5 times sit to stand test
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start21 May 2018
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Why it stopped: The PI moved to another institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Michael E. DeBakey VA Medical Center
- Responsible party
- Principal investigator, Bijan Najafi, PhD, Baylor College of Medicine
- Investigators
- Bijan Najafi, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306588
- Sponsor's protocol ID
- 40765
- Status last verified
- Aug 2025
- First submitted
- 9 Mar 2020
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accessing Mobility Quality Using Wearable Sensors
- ClinicalTrials.gov ID
- NCT04306588
- Acronym / sponsor ID
- 40765
- Conditions
- COPD, Pulmonary Disease, Pulmonary Restrictive Disease, Congestive Heart Failure, Cardiovascular Diseases
- Keywords
- COPD, CHF, Cardiovascular Diseases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The PI moved to another institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Michael E. DeBakey VA Medical Center
- Study start
- 21 May 2018 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tele-rehabilitation exercise Group | Experimental | Other: ExerciseParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Tele-rehabilitationParticipants are undergoing a 12 weeks tele-rehabilitation program. | Other | Tele-rehabilitation exercise Group |
Primary outcome
Change from baseline gait speed at 12 weeks
Time frame: Baseline and 3 months
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
Time frame: Baseline and 3 months
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
Time frame: Baseline and 3 months
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.
6 secondary outcomes
Change from baseline Fear of Falling at 12 weeks
Time frame: Baseline and 3 months
Change from baseline depression at 12 weeks
Time frame: Baseline and 3 months
Change from baseline cognitive performance at 12 weeks
Time frame: Baseline to 3 months
Change from baseline functional performance at 12 weeks
Time frame: Baseline to 3 months
Change from baseline Risk of falling at 12 weeks
Time frame: Baseline and 3 months
Change from baseline motor capacity at 12 weeks
Time frame: Baseline and 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bijan Najafi, PhD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Exercise in people with COPD and Pulmonary Disease, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline gait speed at 12 weeks (time frame: Baseline and 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.