Telemonitoring Physical Activity in Daily Life on Chronic Respiratory Patients

NCT03930511 | Completed

• 1 other identifier: 02/17
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Respiratory Disease

Keywords

Telemonitoring; Physical activity; Pulmonary Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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.

  4 days excluding night sleeping

• 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

  1 week

Secondary Outcomes (6)

• Functional capacity

  6 minutes

• Perceived general health

  1 day

• Perceived dyspnea

  1 day

• Symptoms impact on quality of life

  1 day

• Perceived dyspnea on daily activities

  1 day

Study Arms (4)

PADL at the beginning of PR

NO INTERVENTION

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).

PADL at discharge of PR

EXPERIMENTAL

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).

Procedure: Pulmonary Rehabilitation

PADL at 6 months follow-up

NO INTERVENTION

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).

PADL at 1 year follow-up

NO INTERVENTION

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).

Interventions

Pulmonary Rehabilitation PROCEDURE

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

PADL at discharge of PR

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic lung disease
• patient referenced to Pulmonary Rehabilitation

You may not qualify if:

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

Sponsors & Collaborators

• University of Lisbon: lead
• Centro Hospitalar Lisboa Norte: collaborator
• CAST - Consultoria e Aplicações em Sistemas e Tecnologia, Lda.: collaborator
• Fundação para a Ciência e a Tecnologia: collaborator

Study Sites (2)

Universidade de Lisboa, Faculdade de Medicina, Instituto de Saúde Ambiental (ISAMB)

Lisbon, 1649-028, Portugal

Location

CAST - Consultoria e Aplicações em Sistemas e Tecnologia, Lda.

Lisbon, 1800-075, Portugal

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Catarina D Santos, MSc

  University of Lisbon

  PRINCIPAL INVESTIGATOR

• Cristina Bárbara, PhD

  University of Lisbon

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student, Physiotherapist MSc

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 29, 2019
• Study Start: January 18, 2017
• Primary Completion: October 31, 2018
• Study Completion: October 30, 2019
• Last Updated: November 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

PT (2)