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Telemonitoring Physical Activity in Daily Life on Chronic Respiratory Patients (SmartReab)

Primary Purpose

Chronic Respiratory Disease

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Pulmonary Rehabilitation
Sponsored by
University of Lisbon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Respiratory Disease focused on measuring Telemonitoring, Physical activity, Pulmonary Rehabilitation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidade de Lisboa, Faculdade de Medicina, Instituto de Saúde Ambiental (ISAMB)
  • CAST - Consultoria e Aplicações em Sistemas e Tecnologia, Lda.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

No Intervention

No Intervention

Arm Label

PADL at the beginning of PR

PADL at discharge of PR

PADL at 6 months follow-up

PADL at 1 year follow-up

Arm Description

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).

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).

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).

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).

Outcomes

Primary Outcome Measures

Objective Physical Activity in Daily Life
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.
Reported Physical Activity in Daily Life
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

Secondary Outcome Measures

Functional capacity
distance (meters) on the 6 minute walk test
Perceived general health
EuroQoL visual analogue scale (0-100) of perceived general health
Perceived dyspnea
modified 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 life
COPD Assessment Test (CAT) score (0-40) with higher values associated to greater impact of respiratory disease symptoms on quality of life
Perceived dyspnea on daily activities
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)
Anxiety and Depression
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

Full Information

First Posted
April 24, 2019
Last Updated
November 9, 2020
Sponsor
University of Lisbon
Collaborators
Centro Hospitalar Lisboa Norte, CAST - Consultoria e Aplicações em Sistemas e Tecnologia, Lda., Fundação para a Ciência e a Tecnologia
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1. Study Identification

Unique Protocol Identification Number
NCT03930511
Brief Title
Telemonitoring Physical Activity in Daily Life on Chronic Respiratory Patients
Acronym
SmartReab
Official Title
Impact of Pulmonary Rehabilitation on Physical Activity in Daily Life on Chronic Respiratory Patients - SmartReab Telemonitoring
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 18, 2017 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lisbon
Collaborators
Centro Hospitalar Lisboa Norte, CAST - Consultoria e Aplicações em Sistemas e Tecnologia, Lda., Fundação para a Ciência e a Tecnologia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Respiratory Disease
Keywords
Telemonitoring, Physical activity, Pulmonary Rehabilitation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PADL at the beginning of PR
Arm Type
No Intervention
Arm Description
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).
Arm Title
PADL at discharge of PR
Arm Type
Experimental
Arm Description
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).
Arm Title
PADL at 6 months follow-up
Arm Type
No Intervention
Arm Description
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).
Arm Title
PADL at 1 year follow-up
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Pulmonary Rehabilitation
Intervention Description
According to patients' needs and physician referral, individually tailored treatments of respiratory physiotherapy, functional training, exercise training and patient education
Primary Outcome Measure Information:
Title
Objective Physical Activity in Daily Life
Description
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.
Time Frame
4 days excluding night sleeping
Title
Reported Physical Activity in Daily Life
Description
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
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Functional capacity
Description
distance (meters) on the 6 minute walk test
Time Frame
6 minutes
Title
Perceived general health
Description
EuroQoL visual analogue scale (0-100) of perceived general health
Time Frame
1 day
Title
Perceived dyspnea
Description
modified Medical Research Council scale graduating perceived dyspnea from 0 to 4, with higher values associated to increased dyspnea on minimal activities
Time Frame
1 day
Title
Symptoms impact on quality of life
Description
COPD Assessment Test (CAT) score (0-40) with higher values associated to greater impact of respiratory disease symptoms on quality of life
Time Frame
1 day
Title
Perceived dyspnea on daily activities
Description
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)
Time Frame
1 day
Title
Anxiety and Depression
Description
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
Time Frame
1 week

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catarina D Santos, MSc
Organizational Affiliation
University of Lisbon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cristina Bárbara, PhD
Organizational Affiliation
University of Lisbon
Official's Role
Study Director
Facility Information:
Facility Name
Universidade de Lisboa, Faculdade de Medicina, Instituto de Saúde Ambiental (ISAMB)
City
Lisboa
ZIP/Postal Code
1649-028
Country
Portugal
Facility Name
CAST - Consultoria e Aplicações em Sistemas e Tecnologia, Lda.
City
Lisboa
ZIP/Postal Code
1800-075
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No

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Telemonitoring Physical Activity in Daily Life on Chronic Respiratory Patients

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