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Telemonitoring Physical Activity in Daily Life on Chronic Respiratory Patients

Impact of Pulmonary Rehabilitation on Physical Activity in Daily Life on Chronic Respiratory Patients - SmartReab Telemonitoring

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03930511
Acronym
SmartReab
Enrollment
100
Registered
2019-04-29
Start date
2017-01-18
Completion date
2019-10-30
Last updated
2020-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Respiratory Disease

Keywords

Telemonitoring, Physical activity, Pulmonary Rehabilitation

Brief summary

Physical inactivity is a consequence of chronic diseases and on Chronic Obstructive Pulmonary Disease patients is an independent predictor of the risk of hospitalizations and early mortality. As physical inactivity is a modifiable risk factor with healthy lifestyle interventions, health professionals should clinically assess physical activity as a vital sign of patients' general physical condition. SmartReab study aims to characterize physical activity in daily life of 100 chronic respiratory patients at baseline when starting Pulmonary Rehabilitation, at discharge time of the program, at 6 months and 1 year follow-up. The Pulmonary Rehabilitation program will be individually tailored according to patients needs and goals settled within the Rehabilitation team and it will take place at Hospital Pulido Valente, from Centro Hospitalar Universitário Lisboa Norte, in Lisbon, Portugal. To access physical activity in daily life patients will participate in a telemonitoring study for 4 days using a smartphone and an oximeter and also answer to the International Physical Activity Questionnaire. SmartReab technology will provide data of physical activity intensity, heart rate and oxygen levels during awakening periods of daytime. To associate physical activity with other aspects related with health and the impact of Pulmonary Rehabilitation, patients will also take a 6 minute walk test and answer questionnaires related with self-perceived health status, impact of respiratory symptoms on quality of life, dyspnea impact on general mobility and on daily life situations, and also anxiety and depression feelings. The research hypothesis is that Pulmonary Rehabilitation will have a positive impact on physical activity in the short, medium and long terms.

Detailed description

The Global Alliance Against Chronic Respiratory Diseases (GARD) stated physical inactivity as a modifiable risk factor for all chronic respiratory diseases and advocates stakeholders for action, including the health care community. With respect to chronic respiratory conditions, evidence on Chronic Obstructive Pulmonary Disease indicates physical inactivity as an independent predictor of the risk of hospitalizations due to acute exacerbations and untimely mortality. Exercise is Medicine® is an initiative of the American College of Sports Medicine which encourages all health care professionals to promptly assess physical activity habits as a vital sign of general physical condition, optimizing exercise counselling or referral and enhancing chronic disease management. Because of this, research directions on Pulmonary Rehabilitation target on methodology development for physical activity assessment, combining subjective patient reported experience and accurate objective measurement on patients' daily life. Hospital Pulido Valente in Lisbon, Portugal, started TELEMOLD, which developed an Android smartphone telemonitoring system with a mobile software application connected to an oximeter and accelerometer sensors. Presently the project evolved to SMARTREAB applying such technology to a combined assessment of pulse oximetry and physical activity as a routine procedure with respiratory patients. This study aims to characterize baseline physical activity in daily life of 100 chronic respiratory patients on Pulmonary Rehabilitation as a primary endpoint. Secondary endpoints include reassessments of physical activity in daily life at discharge from the program, 6 months and 1 year follow-up. The Pulmonary Rehabilitation program will be individually tailored according to patients needs and goals settled within the Rehabilitation team and it will take place at Hospital Pulido Valente, from Centro Hospitalar Universitário Lisboa Norte, in Lisbon, Portugal. Patients' assessments include a 4 days SmartReab telemonitoring study providing data of physical activity intensity, heart rate and oxygen levels during awakening periods of daytime. Patients will further participate in a 6 minute walk test and answer selected questionnaires: the International Physical Activity Questionnaire (IPAQ) , the visual analogue scale of the EuroQoL (EuroQoL-VAS), the modified Medical Research Council dyspnea scale (mMRC), the COPD assessment test (CAT), the London Chest Activity of Daily Living scale (LCADL) and the Hospital Anxiety and Depression Scale (HADS). The research hypothesis is that Pulmonary Rehabilitation will have a positive impact on physical activity in the short, medium and long terms in association with other secondary outcomes assessed. All patients gave informed consent and ethical approval was obtained by the Ethics Committee of Centro Hospitalar Universitário Lisboa Norte, EPE and Centro Académico de Medicina de Lisboa (number 02/17). Statistical analysis will be performed using the Statistical Package for the Social Sciences (SPSS) version 25.0 (SPSS Inc., Chicago, IL, USA).

Interventions

PROCEDUREPulmonary Rehabilitation

According to patients' needs and physician referral, individually tailored treatments of respiratory physiotherapy, functional training, exercise training and patient education

Sponsors

Centro Hospitalar Lisboa Norte
CollaboratorOTHER
CAST - Consultoria e Aplicações em Sistemas e Tecnologia, Lda.
CollaboratorUNKNOWN
Fundação para a Ciência e a Tecnologia
CollaboratorOTHER
University of Lisbon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* chronic lung disease * patient referenced to Pulmonary Rehabilitation

Exclusion criteria

* pleural effusion * infectious disease * unstable cardiac disease * neurologic or musculoskeletal conditions affecting exercise performance * cognitive deficit affecting questionnaire comprehensive answer * psychiatric disease

Design outcomes

Primary

MeasureTime frameDescription
Objective Physical Activity in Daily Life4 days excluding night sleepingPercentage of time spent (0-100%) on three categories of physical activity measured as metabolic equivalent of task (MET) by telemonitoring with an accelerometer incorporated in a smartphone: less than 2 MET, between 2 and 3 MET, above 3 MET.
Reported Physical Activity in Daily Life1 weekMETS per week as answered to the International Physical Activity Questionnaire considering the domains of work, transport, domestic and gardening, and leisure time; additional data for reported sedentary time with sitting time per week

Secondary

MeasureTime frameDescription
Perceived dyspnea1 daymodified Medical Research Council scale graduating perceived dyspnea from 0 to 4, with higher values associated to increased dyspnea on minimal activities
Symptoms impact on quality of life1 dayCOPD Assessment Test (CAT) score (0-40) with higher values associated to greater impact of respiratory disease symptoms on quality of life
Functional capacity6 minutesdistance (meters) on the 6 minute walk test
Anxiety and Depression1 weekHospital Anxiety and Depression Scale (HADS) assessing on a scale from 0-3, seven questions about anxiety and seven questions about depression; score is reported ranging from 0-21 separately to depression and anxiety; higher values are associated with increased anxiety/depression
Perceived dyspnea on daily activities1 dayLondon Chest Activity of Daily Living (LCADL) scale score (0-75) assessing on a scale from 0-5 (with higher values indicating increased limitation or dependency) subscores of self-care (0-20), domestic (0-30), social (0-15) and physical activities (0-10)
Perceived general health1 dayEuroQoL visual analogue scale (0-100) of perceived general health

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026