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Wearable Sensors for Monitoring Exercise Response in COPD

MN
IT
Overseen ByIlse Torres
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Baylor College of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether wearable sensors can track how well individuals with chronic conditions like COPD (a lung disease) or CHF (heart failure) perform physical and mental tasks. It also examines if exercise programs delivered through telemedicine can enhance these abilities. The goal is to determine if these sensors and exercises can monitor and improve health in those with such conditions. Ideal candidates for this trial are veterans with COPD or CHF who participate in a tele-rehabilitation program at VA-Houston and can walk at least 10 meters. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking health advancements.

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 prior data suggests that these wearable sensors are safe for monitoring exercise response in COPD?

Research has shown that tele-rehabilitation exercise is generally safe for people with long-term conditions like COPD. One study found that this method not only improved exercise ability and quality of life but was also safe for patients, as participants reported no unexpected issues or serious side effects while exercising at home.

Another study supported these findings, showing that people using tele-rehabilitation experienced similar improvements in exercise ability and quality of life compared to those receiving regular care. This suggests that tele-rehabilitation exercise is well-tolerated and does not introduce new risks to participants.

Overall, existing studies support the safety of tele-rehabilitation exercise for those with chronic breathing conditions.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores tele-rehabilitation as a way to monitor and enhance exercise response in patients with COPD using wearable sensors. Unlike traditional rehabilitation programs that require in-person visits, this method allows patients to engage in their exercise routines from home, making it more accessible and convenient. The use of wearable sensors provides real-time data on a patient's physiological response to exercise, allowing for personalized adjustments to their rehabilitation plan. This approach has the potential to improve adherence to exercise regimens and optimize outcomes for individuals managing COPD.

What evidence suggests that wearable sensors are effective for monitoring exercise response in COPD?

This trial will evaluate the effectiveness of tele-rehabilitation exercise for people with COPD. Studies have shown that tele-rehabilitation exercises can benefit people with COPD. This approach safely boosts exercise ability and improves overall quality of life. Research suggests that exercise programs can also enhance lung function and physical abilities in people with COPD. While more studies are needed to fully understand the long-term effects, current evidence is promising for using tele-rehabilitation to enhance physical health in those with COPD.12356

Who Is on the Research Team?

BN

Bijan Najafi, PhD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

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.
You must have a long-term illness like COPD or CHF.

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).
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Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

  • Exercise
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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Tele-rehabilitation exercise GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials
1,044
Recruited
6,031,000+

Michael E. DeBakey VA Medical Center

Collaborator

Trials
68
Recruited
17,200+

Published Research Related to This Trial

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

Citations

Effects of Home-Based Training with Internet Telehealth ...Telerehabilitation in COPD patients is a safe therapy approach that increases and maintains functional exercise capacity and quality of life.
Physical activity and chronic obstructive pulmonary diseaseThis study aimed to assess the 12-month efficacy and effectiveness of the Urban Training intervention on physical activity in people with COPD.
NCT03569384 | Feasibility & Effect of a Tele-rehabilitation ...There is still a need for more studies on the efficacy and cost-effectiveness of tele-rehabilitation (TR) and its long-term effects needs also to be determined.
Protocol for a Pilot Randomized Feasibility TrialCompared to medical management alone, strong evidence supports PR to improve lung function, exercise capacity, physical function, self-efficacy, ...
Efficacy of exercise treatments for chronic obstructive ...This systematic review highlights the benefit of exercise treatments as a potential adjunct treatment for COPD patients.
Telerehabilitation in Chronic Respiratory DiseaseTelerehabilitation compared with usual care significantly improved exercise capacity and health-related quality of life and demonstrated similar improvements
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