Clinical trial NCT03930511: Telemonitoring Physical Activity in Daily Life on Chronic Respiratory Patients
Official title: Impact of Pulmonary Rehabilitation on Physical Activity in Daily Life on Chronic Respiratory Patients - SmartReab Telemonitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Respiratory Disease
Keywords: Telemonitoring
Physical activity
Pulmonary Rehabilitation
Lead sponsor: University of Lisbon
Sponsor class: OTHER
Collaborators: name: Centro Hospitalar Lisboa Norte
name: CAST - Consultoria e Aplicações em Sistemas e Tecnologia, Lda.
name: Fundação para a Ciência e a Tecnologia
First posted: 2019-04-29
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Objective Physical Activity in Daily Life
timeFrame: 4 days excluding night sleeping
measure: Reported Physical Activity in Daily Life
timeFrame: 1 week
Secondary outcomes:
measure: Functional capacity
timeFrame: 6 minutes
measure: Perceived general health
timeFrame: 1 day
measure: Perceived dyspnea
timeFrame: 1 day
measure: Symptoms impact on quality of life
timeFrame: 1 day
measure: Perceived dyspnea on daily activities
timeFrame: 1 day
measure: Anxiety and Depression
timeFrame: 1 week
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Universidade de Lisboa, Faculdade de Medicina, Instituto de Saúde Ambiental (ISAMB)
city: Lisboa
country: Portugal
facility: CAST - Consultoria e Aplicações em Sistemas e Tecnologia, Lda.
Study officials:
affiliation: University of Lisbon
name: Catarina D Santos, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Lisbon
name: Cristina Bárbara, PhD
role: STUDY_DIRECTOR
References: