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| ID | Type | Description | Link |
|---|---|---|---|
| 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 |
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| Name | Class |
|---|---|
| Unidade Local de Saúde do Baixo Mondego | UNKNOWN |
| Unidade Local de Saúde de Lisboa Norte | UNKNOWN |
| Faculdade de Motricidade Humana de Lisboa | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group - Pulmonary rehabilitation + eHealth physical activity coaching intervention | Experimental | 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. |
|
| Control group - pulmonary rehabilitation | Other | Patients will attend pulmonary rehabilitation program for 10 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eHealth physical activity coaching intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Accelerometry (number of daily steps) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 6-Minute Walk Test (exercise capacity) | 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sofia Flora, PT, MSc | Contact | +351 917257840 | sofia.flora@ipleiria.pt | |
| Joana Cruz, PT, PhD | Contact | 969196218 | joana.cruz@ipleiria.pt |
| Name | Affiliation | Role |
|---|---|---|
| Sofia Flora, PT, MSc | Center for Innovative Care and Health Technology, Polytechnic of Leiria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Innovative Care and Health Technology (ciTechCare), Polytechnic of Leiria | Recruiting | Leiria | 2414-016 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Global Strategy for the Diagnosis Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD). Available from: https://goldcopd.org/2024-gold-report/. 2024. | ||
| 25705944 | Background | McCarthy B, Casey D, Devane D, Murphy K, Murphy E, Lacasse Y. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2015 Feb 23;2015(2):CD003793. doi: 10.1002/14651858.CD003793.pub3. | |
| 27475266 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 4, 2024 |
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| pulmonary rehabilitation | Behavioral | 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. |
|
| modified Medical Research Council (Dyspnoea) |
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) | 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) | 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) | 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) | 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 |
| Background |
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| Dec 9, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 4, 2024 | Dec 9, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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