Effectiveness of a Physical ACtivity Coaching Intervention Using E-Health for COPD Patients in Pulmonary Rehabilitation (PACE)

December 9, 2024 updated by: Sofia Flora, Instituto Politécnico de Leiria

PACE - Physical Activity in COPD Using E-Health: Effectiveness of a Personalised eHealth Platform Integrated Into Pulmonary Rehabilitation to Increase Physical Activity in Patients With COPD - a Randomized Controlled Trial

The goal of this randomized controlled trial is to evaluate the efficacy of a physical activity coaching intervention - delivered through an eHealth platform both during and after pulmonary rehabilitation - to enhance physical activity levels and health-related outcomes in patients with Chronic Obstructive Pulmonary Disease (COPD). All participants will attend the pulmonary rehabilitation program for 2 months; the experimental group will receive a physical activity coaching intervention at the end of the 1st month of the rehabilitation program, which will continue for 6 months following the completion of the program. Assessments will be conducted at the beginning, midway, and at the end of the coaching program, as well as 3 months and 6 months after its conclusion.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled trial aims to evaluate the efficacy of a physical activity coaching intervention - delivered through an eHealth platform, both during and after pulmonary rehabilitation - to enhance physical activity levels and health-related outcomes in patients with Chronic Obstructive Pulmonary Disease (COPD).

All participants will attend the pulmonary rehabilitation program for 10 weeks. At week 5 of the rehabilitation program, the experimental group will receive a physical activity coaching intervention, which will continue for 6 months following its completion. This intervention will include an eHealth platform divided into two applications (a mobile app for patients and a web app for researchers/healthcare professionals).

Goal setting and progression according to patients' performance and willingness to increase will occur every week, through phone calls. Barriers to physical activity and strategies to overcome them will be identified between the patient and researcher, during the goal-setting moments. Notifications about PA goals achievement and incentives will be sent to patients during the intervention.

The assessment moments will be conducted at the beginning, midway, and end of the pulmonary rehabilitation program, as well as 3- and 6 months after its conclusion.

Study Type

Interventional

Enrollment (Estimated)

57

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 Contact

Study Contact Backup

Study Locations

  • Portugal
      • Leiria, Portugal, 2414-016
        • Recruiting
        • Center for Innovative Care and Health Technology (ciTechCare), Polytechnic of Leiria
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • age > 40 years old
  • diagnosis of COPD according to GOLD criteria, clinically stable (i.e., with no exacerbations in the previous month)
  • being enrolled in a pulmonary rehabilitation program
  • having a smartphone with access to the internet
  • being able to understand and provide informed consent.

Exclusion criteria:

  • simultaneous participation in another behavioural modification program
  • having any clinical condition that precludes participation in a PA intervention (e.g., severe musculoskeletal or neurological disorders and unstable cardiovascular disease)
  • another primary respiratory disease
  • history of recent neoplasia (including last treatment) in the previous year.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group - Pulmonary rehabilitation + eHealth physical activity coaching intervention
Patients will attend a PR program for 10 weeks and receive an eHealth PA coaching intervention (smartband connected to a mobile application) in the week 5 of PR until months after end of PR.
Behavioral: eHealth physical activity coaching intervention
Patients will attend a PR program and in week 5 of PR will receive an eHealth PA coaching intervention until 6 months after end of PR. The PA goals will be prescribed through a phone call and the personalisation of goal prescription will be based on an algorithm considering patient's performance in the previous week, perceived easiness of achieving the previous goal and confidence to change it. If patient does not achieve the goal, reasons, barriers to PA and strategies to overcome them will be identified. Patients will receive a daily notification about their goal achievements, at 6PM every day, giving them the possibility to increase their PA to achieve the goal, if they have not reached it yet. Patients will also receive personalized notifications sent manually by the researcher whenever appropriate. PA goals will be prescribed on a weekly basis.
Behavioral: pulmonary rehabilitation
Patients will attend pulmonary rehabilitation program for 10 weeks. Pulmonary rehabilitation is evidence-based multidisciplinary intervention based on thorough patient assessment followed by patient-tailored therapies that include, but are not limited to exercise training, education, self-management intervention aiming at behaviour change, known to improve health status and psychological well-being, reducing dyspnoea and healthcare utilization and hospitalization. In this study, pulmonary rehabilitation programs will have 20 sessions, twice a week, including exercise training (aerobic and strength training), educational sessions about topics as medication, smoking cessation, energy conservation techniques, physical activity, stress and anxiety management, breathing control, inhaled therapy and nutrition; nutritional and psychosocial counselling. Education session about PA importance and recommendations will be also provided in both arms.
Other: Control group - pulmonary rehabilitation
Patients will attend pulmonary rehabilitation program for 10 weeks.
Behavioral: pulmonary rehabilitation
Patients will attend pulmonary rehabilitation program for 10 weeks. Pulmonary rehabilitation is evidence-based multidisciplinary intervention based on thorough patient assessment followed by patient-tailored therapies that include, but are not limited to exercise training, education, self-management intervention aiming at behaviour change, known to improve health status and psychological well-being, reducing dyspnoea and healthcare utilization and hospitalization. In this study, pulmonary rehabilitation programs will have 20 sessions, twice a week, including exercise training (aerobic and strength training), educational sessions about topics as medication, smoking cessation, energy conservation techniques, physical activity, stress and anxiety management, breathing control, inhaled therapy and nutrition; nutritional and psychosocial counselling. Education session about PA importance and recommendations will be also provided in both arms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accelerometry (number of daily steps)
Time Frame: weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion
PA will be objectively measured using the triaxial accelerometer Actigraph GT3X+, already validated in COPD. Patients will be instructed to wear the accelerometer for 7 days on the dominant side of their waist, held by an elastic strap, during waking hours, except for bathing or swimming. A valid day will be defined as a minimum of 8 hours of wearing time, and patients will need to have at least 4 valid days in each moment of data collection. Accelerometer-based data will be then downloaded and analysed using the algorithms of Freedson (1998) with 60-s epoch: daily time (in min) spent in light-intensity PA, moderate, vigorous and a combination of both. The number of steps per day and per week will also be collected, being the main outcome of the study.
weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-Minute Walk Test (exercise capacity)
Time Frame: weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion
Functional exercise capacity was measured using 6MWT, and predicted values were computed using the equation developed for Portuguese adults. The test will be conducted according to guidelines from ERS/ATS.
weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion
modified Medical Research Council (Dyspnoea)
Time Frame: weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion
Dyspnoea was assessed through the modified Medical Research Council (mMRC), on a scale from 0 to 4, in which 0 means 'dyspnoea only with strenuous exercise' and 4 means 'too dyspnoeic to leave house or breathless when dressing'.
weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion
Checklist of Individual Strength (Fatigue)
Time Frame: weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion
Fatigue will be assessed with the Checklist of Individual Strength (CIS20). This questionnaire consists of four dimensions (Subjective Fatigue, Concentration, Motivation and Physical Activity) that assess the fatigue severity.
weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion
COPD Assessment Test (Impact of symptoms on health status)
Time Frame: weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion
The COPD Assessment Test is designed to measure the impact of COPD on a person's life, and how this changes over time.The total score is a sum of the 8 questions. Higher scores indicates worse impact of the disease.
weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion
MOS Short-Form Health Survey 36 Item v2 (SF-36) (Quality of Life)
Time Frame: weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion
Quality of Life will be assessed with MOS Short-Form Health Survey 36 Item v2 (SF-36). The SF-36 is widely used to measure perceived health-related quality of life. The instrument includes scales for physical functioning, social functioning, limitations in function due to physical or emotional problems, mental health, energy, pain and general perception of health. The score ranges from 0 - 100 (higher scores indicate better levels of quality of life.
weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion
Physical Exercise Self-Efficacy Scale (self-efficacy for PA)
Time Frame: weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion
self-efficacy for PA will be assessed with Physical Exercise Self-Efficacy Scale which consists of 5 items that analyse an individual's confidence in performing physical exercise according to different emotional states (worried, depressed, nervous, tired and busy). The total score is the sum of the scores for each item, ranging from 5 to 20. The higher the score, the greater the belief or sense of self-efficacy for exercise.
weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Politécnico de Leiria

Collaborators

Unidade Local de Saúde do Baixo Mondego
Unidade Local de Saúde de Lisboa Norte
Faculdade de Motricidade Humana de Lisboa

Investigators

  • Principal Investigator: Sofia Flora, PT, MSc, Center for Innovative Care and Health Technology, Polytechnic of Leiria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 2, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

November 27, 2024

First Submitted That Met QC Criteria

December 9, 2024

First Posted (Estimated)

December 13, 2024

Study Record Updates

Last Update Posted (Estimated)

December 13, 2024

Last Update Submitted That Met QC Criteria

December 9, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ciTechCare_PhD_SF
  • doi.org/10.54499/2020.06954.BD (Other Grant/Funding Number: Foundation for Science and Technology (FCT))
  • UIDB/05704/2020 (Other Grant/Funding Number: ciTechCare, Polytechnic of Leiria)

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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