- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03930511
Telemonitoring Physical Activity in Daily Life on Chronic Respiratory Patients (SmartReab)
November 9, 2020 updated by: Catarina Santos, University of Lisbon
Impact of Pulmonary Rehabilitation on Physical Activity in Daily Life on Chronic Respiratory Patients - SmartReab Telemonitoring
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lisboa, Portugal, 1649-028
- Universidade de Lisboa, Faculdade de Medicina, Instituto de Saúde Ambiental (ISAMB)
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Lisboa, Portugal, 1800-075
- CAST - Consultoria e Aplicações em Sistemas e Tecnologia, Lda.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: PADL at the beginning of PR
First assessment of patients starting Pulmonary Rehabilitation, including a 4 day time telemonitoring of physical activity on daily life, 6 minute walk test, International Physical Activity Questionnaire (IPAQ), EuroQoL, mMRC, COPD Assessment Test (CAT), London Chest Activity of Daily Living (LCADL) and Hospital Anxiety and Depression Scale (HADS).
|
|
Experimental: PADL at discharge of PR
Assessment of patients at discharge of Pulmonary Rehabilitation, including a 4 day time telemonitoring of physical activity on daily life, 6 minute walk test, International Physical Activity Questionnaire (IPAQ), EuroQoL, mMRC, COPD Assessment Test (CAT), London Chest Activity of Daily Living (LCADL) and Hospital Anxiety and Depression Scale (HADS).
|
According to patients' needs and physician referral, individually tailored treatments of respiratory physiotherapy, functional training, exercise training and patient education
|
No Intervention: PADL at 6 months follow-up
Half-a-year reassessment of patients on Pulmonary Rehabilitation, including a 4 day time telemonitoring of physical activity on daily life, 6 minute walk test, International Physical Activity Questionnaire (IPAQ), EuroQoL, mMRC, COPD Assessment Test (CAT), London Chest Activity of Daily Living (LCADL) and Hospital Anxiety and Depression Scale (HADS).
|
|
No Intervention: PADL at 1 year follow-up
Yearly reassessment of patients on Pulmonary Rehabilitation, including a 4 day time telemonitoring of physical activity on daily life, 6 minute walk test, International Physical Activity Questionnaire (IPAQ), EuroQoL, mMRC, COPD Assessment Test (CAT), London Chest Activity of Daily Living (LCADL) and Hospital Anxiety and Depression Scale (HADS).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Physical Activity in Daily Life
Time Frame: 4 days excluding night sleeping
|
Percentage 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.
|
4 days excluding night sleeping
|
Reported Physical Activity in Daily Life
Time Frame: 1 week
|
METS 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
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional capacity
Time Frame: 6 minutes
|
distance (meters) on the 6 minute walk test
|
6 minutes
|
Perceived general health
Time Frame: 1 day
|
EuroQoL visual analogue scale (0-100) of perceived general health
|
1 day
|
Perceived dyspnea
Time Frame: 1 day
|
modified Medical Research Council scale graduating perceived dyspnea from 0 to 4, with higher values associated to increased dyspnea on minimal activities
|
1 day
|
Symptoms impact on quality of life
Time Frame: 1 day
|
COPD Assessment Test (CAT) score (0-40) with higher values associated to greater impact of respiratory disease symptoms on quality of life
|
1 day
|
Perceived dyspnea on daily activities
Time Frame: 1 day
|
London 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)
|
1 day
|
Anxiety and Depression
Time Frame: 1 week
|
Hospital 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
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Catarina D Santos, MSc, University of Lisbon
- Study Director: Cristina Bárbara, PhD, University of Lisbon
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 18, 2017
Primary Completion (Actual)
October 31, 2018
Study Completion (Actual)
October 30, 2019
Study Registration Dates
First Submitted
April 24, 2019
First Submitted That Met QC Criteria
April 26, 2019
First Posted (Actual)
April 29, 2019
Study Record Updates
Last Update Posted (Actual)
November 10, 2020
Last Update Submitted That Met QC Criteria
November 9, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02/17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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