Wearable Sensors for Monitoring Exercise Response in COPD

Overseen by Bijan Najafi, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Baylor College of Medicine

Disqualifiers: Non-ambulatory, Severe cognitive impairment, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who are likely to change medications in the next 12 weeks. This suggests that you may need to stay on your current medications during the trial.

What data supports the effectiveness of this treatment for COPD?

Research shows that using wearable sensors like accelerometers can help track physical activity in COPD patients, which is important because staying active is linked to better health outcomes. These devices can provide accurate measurements of daily activity, helping patients and doctors understand and improve exercise habits. ^{1 2 3 4 5}

Is it safe to use wearable sensors for monitoring exercise in humans?

The studies reviewed did not report any safety concerns related to the use of wearable sensors for monitoring physical activity in humans, including those with chronic obstructive pulmonary disease (COPD). However, some studies noted technical issues with the devices, such as memory storage problems and inaccuracy of counts. ^{1 6 7 8 9}

How does the treatment using wearable sensors for monitoring exercise response in COPD differ from other treatments?

This treatment is unique because it uses wearable sensors, like accelerometers, to monitor physical activity and exercise response in real-time, providing objective data on activity levels and potentially increasing patient motivation. Unlike traditional treatments that focus on medication or supervised rehabilitation, this approach offers continuous, non-invasive monitoring to help manage COPD. ^{1 6 7 8 10}

Research Team

Bijan Najafi, PhD

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

This trial is for veterans aged 18 or older with chronic illnesses like COPD or CHF, who can walk at least 10 meters and are enrolled in VA-Houston's tele-rehabilitation programs. It excludes those unable to walk, unlikely to follow the protocol, unwilling to consent, on unstable medications, with severe cognitive issues or psychiatric problems affecting participation.

Inclusion Criteria

Should be referred to one of the tele-rehabilitation programs offered at VA-Houston.

The investigators will be enrolling veteran subjects.

People who are 18 years old or older than 65 can join the study.

Exclusion Criteria

Unwilling to provide informed consent.

You are unable to walk at least 10 meters with or without help.

Unlikely to fully comply with the protocol (e.g., long-distance travel if multiple follow-up visits are required).

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Core Measurements

Core motor-cognitive tests are performed using wearable sensors to measure parameters such as gait, balance, and frailty index.

12 weeks

Multiple visits (in-person)

Tele-rehabilitation Intervention

Participants undergo tele-rehabilitation exercises to enhance motor-cognitive performance, with re-assessment of functional performance at follow-up visits.

12 weeks

Up to 12 visits (virtual and in-person)

Follow-up

Participants are monitored for changes in motor-cognitive performance and other health parameters after the intervention.

12 months

Up to 12 visits (in-person)

Treatment Details

Interventions

• Exercise (Behavioural Intervention)

Trial Overview The study tests if wearable sensors can monitor motor-cognitive performance changes due to chronic diseases like COPD/CHF. It will also assess if exercise via tele-rehabilitation improves these functions. Participants' movements and balance will be tracked using devices such as LEGSys and BalanSENS.

Participant Groups

Group I: Tele-rehabilitation exercise Group Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Paul Klotman

Baylor College of Medicine

Chief Executive Officer since 2010

MD, PhD

James Versalovic

Baylor College of Medicine

Chief Medical Officer since 2020

MD from Baylor College of Medicine

Michael E. DeBakey VA Medical Center

Collaborator

Trials

68

Recruited

17,200+

Lindsey Crain

Michael E. DeBakey VA Medical Center

Interim Medical Center Director

Master's in Healthcare Administration from Texas State University

Dr. Hamid Afshar

Michael E. DeBakey VA Medical Center

Chief Medical Officer since 2019

MD

Findings from Research

Patients with COPD successfully adhered to a 16-week physical activity monitoring protocol using an accelerometer, with an impressive adherence rate of 97.6%, indicating that such devices can be used effectively in chronic disease management.

The study captured fluctuations in physical activity patterns surrounding COPD exacerbations, suggesting that monitoring these patterns could provide valuable insights for managing the condition, although further research with larger samples is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of accelerometers to characterize physical activity patterns with COPD exacerbations. Nguyen, HQ., Steele, B., Benditt, JO.[2021]

A task-oriented physical activity checklist was developed and tested in two COPD cohorts (Cohort 1: 109 participants, Cohort 2: 175 participants) to assess daily physical activity, showing significant correlations with daily step counts measured by pedometers.

The checklist identified specific tasks, such as putting on shoes and walking for exercise, that were associated with increased daily step counts, suggesting that self-reported assessments can effectively complement direct monitoring and aid in exercise counseling for COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-reported task-oriented physical activity: A comparison with objective daily step count in COPD. Wan, ES., Kantorowski, A., Homsy, D., et al.[2019]

The hip-worn activity tracker significantly underestimates daily step counts in patients with Chronic Obstructive Pulmonary Disease (COPD), while the wrist-worn tracker tends to overestimate steps in healthy individuals, indicating that their accuracy as clinical endpoints is limited.

Despite their inaccuracies in measuring total steps, both types of activity trackers effectively capture day-to-day variability in physical activity, making them useful as coaching tools for encouraging physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of consumer-based activity trackers as measuring tool and coaching device in patients with COPD and healthy controls. Blondeel, A., Demeyer, H., Janssens, W., et al.[2020]

In a study of 173 patients with moderate to very severe COPD, using accelerometers to objectively measure daily physical activity (VMUs) was found to significantly reduce the risk of mortality and hospitalization due to exacerbations.

Higher levels of daily physical activity (measured in VMUs) were associated with a lower risk of hospitalization and a longer time until the first COPD exacerbation, highlighting the importance of physical activity in managing COPD outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic value of the objective measurement of daily physical activity in patients with COPD. Garcia-Rio, F., Rojo, B., Casitas, R., et al.[2022]

In a study involving 134 COPD patients across three Northern European sites, high compliance with physical activity monitoring was observed, with 94-97% of patients meeting the valid measurement criteria, indicating that using activity monitors is feasible in multi-center research.

Significant associations were found between physical activity levels and various disease characteristics, such as lung function (FEV1), exercise capacity (6-min walk distance), and health status, suggesting that monitoring physical activity can provide valuable insights into the health of COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity monitoring in COPD: compliance and associations with clinical characteristics in a multicenter study. Waschki, B., Spruit, MA., Watz, H., et al.[2021]

The ActiHealth accelerometer demonstrated high accuracy in measuring step counts, achieving a median percent step capture of 96% in nondisabled males, but only 86% in patients with chronic obstructive pulmonary disease (COPD).

Walking speed was identified as a significant predictor of the device's accuracy in COPD patients, indicating that clinicians should evaluate walking speed before using the accelerometer for monitoring activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of uniaxial accelerometer in chronic obstructive pulmonary disease. Moy, ML., Garshick, E., Matthess, KR., et al.[2021]

The triaxial accelerometer demonstrated high test-retest reliability (rICC = 0.84) and strong concurrent validity in measuring walking distance in COPD patients, indicating it is a dependable tool for assessing physical activity.

The accelerometer correlated well with various indicators of functional capacity, such as exercise capacity (r = 0.74) and level of obstructive disease (r = 0.62), suggesting it can provide more accurate measurements of daily activity compared to self-reported methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitating physical activity in COPD using a triaxial accelerometer. Steele, BG., Holt, L., Belza, B., et al.[2022]

In a study involving 13 patients undergoing a 3-week pulmonary rehabilitation program, accelerometers effectively monitored physical activity, showing no significant difference in activity levels between training days and non-supervised days.

The use of physical activity sensors, like the SenseWear armband, can motivate patients with chronic obstructive pulmonary disease (COPD) to engage in more activity by providing measurable feedback on their performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring Physical Activity with a Wearable Sensor in Patients with COPD during In-Hospital Pulmonary Rehabilitation Program: A Pilot Study. Rutkowski, S., Buekers, J., Rutkowska, A., et al.[2021]

The multi-sensor activity monitor (SWM) accurately detects slow walking speeds in patients with chronic obstructive pulmonary disease (COPD), making it a reliable tool for measuring physical activity in this population.

In a study involving 57 COPD patients, the SWM demonstrated good reproducibility in measuring total energy expenditure and step count during the incremental shuttle walk test, indicating its effectiveness for monitoring physical activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity monitoring: addressing the difficulties of accurately detecting slow walking speeds. Harrison, SL., Horton, EJ., Smith, R., et al.[2018]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Use of accelerometers to characterize physical activity patterns with COPD exacerbations. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Self-reported task-oriented physical activity: A comparison with objective daily step count in COPD. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Accuracy of consumer-based activity trackers as measuring tool and coaching device in patients with COPD and healthy controls. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Prognostic value of the objective measurement of daily physical activity in patients with COPD. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Physical activity monitoring in COPD: compliance and associations with clinical characteristics in a multicenter study. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Accuracy of uniaxial accelerometer in chronic obstructive pulmonary disease. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Quantitating physical activity in COPD using a triaxial accelerometer. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Monitoring Physical Activity with a Wearable Sensor in Patients with COPD during In-Hospital Pulmonary Rehabilitation Program: A Pilot Study. [2021]

9. New Zealand pubmed.ncbi.nlm.nih.gov

The use of wearable technology to monitor physical activity in patients with COPD: a literature review. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Physical activity monitoring: addressing the difficulties of accurately detecting slow walking speeds. [2018]