COPDPACENCT06732869
Effectiveness of a Physical ACtivity Coaching Intervention Using E-Health for COPD Patients in Pulmonary Rehabilitation
A study testing eHealth physical activity coaching intervention and pulmonary rehabilitation in people with COPD and Physical Activity, run by Instituto Politécnico de Leiria at 1 site in Portugal.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Physical Activity
- What is being tested?
- eHealth physical activity coaching intervention and pulmonary rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 sitePortugal
- Study dates
- 2 Dec 2024to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Center for Innovative Care and Health Technology (ciTechCare), Polytechnic of Leiria
Leiria, 2414-016
Maria Guarino, +351 244845050, citechcare@ipleiria.pt
About this study
Official title: 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.
Read the 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.
- Conditions
- COPD, Physical Activity
- Being tested
- eHealth physical activity coaching intervention, pulmonary rehabilitation
- Keywords
- physical activity, COPD, eHealth, pulmonary rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eHealth physical activity coaching interventionBehavioural
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.
pulmonary rehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: eHealth physical activity coaching intervention; Behavioral: pulmonary rehabilitation |
| Control group - pulmonary rehabilitation | Other | Patients will attend pulmonary rehabilitation program for 10 weeks. Receives: Behavioral: pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion
Secondary outcomes (6)
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.
Measured: weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion
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'.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start2 Dec 2024
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Politécnico de Leiria
- Sponsor type
- University, hospital or other
- Collaborators
- Unidade Local de Saúde do Baixo Mondego, Unidade Local de Saúde de Lisboa Norte, Faculdade de Motricidade Humana de Lisboa
- Responsible party
- Principal investigator, Sofia Flora, Instituto Politécnico de Leiria
- Investigators
- Sofia Flora, PT, MSc, Principal investigator, Center for Innovative Care and Health Technology, Polytechnic of Leiria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732869
- Sponsor's protocol ID
- ciTechCare_PhD_SF
- Other IDs
- doi.org/10.54499/2020.06954.BD, UIDB/05704/2020
- Acronym
- PACE
- Status last verified
- Dec 2024
- First submitted
- 27 Nov 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 25705944Ding D, Lawson KD, Kolbe-Alexander TL, Finkelstein EA, Katzmarzyk PT, van Mechelen W, Pratt M; Lancet Physical Activity Series 2 Executive Committee. The economic burden of physical inactivity: a global analysis of major non-communicable diseases. Lancet. 2016 Sep 24;388(10051):1311-24. doi: 10.1016/S0140-6736(16)30383-X. Epub 2016 Jul 28.
PubMed 27475266Puhan MA, Gimeno-Santos E, Cates CJ, Troosters T. Pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2016 Dec 8;12(12):CD005305. doi: 10.1002/14651858.CD005305.pub4.
PubMed 27930803Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST.
PubMed 24127811Spruit MA, Pitta F, McAuley E, ZuWallack RL, Nici L. Pulmonary Rehabilitation and Physical Activity in Patients with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2015 Oct 15;192(8):924-33. doi: 10.1164/rccm.201505-0929CI.
PubMed 26161676Burge AT, Cox NS, Abramson MJ, Holland AE. Interventions for promoting physical activity in people with chronic obstructive pulmonary disease (COPD). Cochrane Database Syst Rev. 2020 Apr 16;4(4):CD012626. doi: 10.1002/14651858.CD012626.pub2.
PubMed 32297320Wilson JJ, O'Neill B, Collins EG, Bradley J. Interventions to Increase Physical Activity in Patients with COPD: A Comprehensive Review. COPD. 2015 Jun;12(3):332-43. doi: 10.3109/15412555.2014.948992. Epub 2014 Sep 15.
PubMed 25221907Jiang X, Ming WK, You JH. The Cost-Effectiveness of Digital Health Interventions on the Management of Cardiovascular Diseases: Systematic Review. J Med Internet Res. 2019 Jun 17;21(6):e13166. doi: 10.2196/13166.
PubMed 31210136Kowatsch, T., et al., Design and Evaluation of a Mobile Chat App for the Open Source Behavioral Health Intervention Platform MobileCoach. 2017. 485-489
Blazun H, Saranto K, Kokol P, Vosner J. Information and communication technology as a tool for improving physical and social activity of the elderly. NI 2012 (2012). 2012 Jun 23;2012:26. eCollection 2012.
PubMed 24199042Solanas, A., et al., Smart health: A context-aware health paradigm within smart cities. IEEE Communications Magazine, 2014. 52(8): p. 74-81.
Laranjo L, Ding D, Heleno B, Kocaballi B, Quiroz JC, Tong HL, Chahwan B, Neves AL, Gabarron E, Dao KP, Rodrigues D, Neves GC, Antunes ML, Coiera E, Bates DW. Do smartphone applications and activity trackers increase physical activity in adults? Systematic review, meta-analysis and metaregression. Br J Sports Med. 2021 Apr;55(8):422-432. doi: 10.1136/bjsports-2020-102892. Epub 2020 Dec 21.
PubMed 33355160Sim I. Mobile Devices and Health. N Engl J Med. 2019 Sep 5;381(10):956-968. doi: 10.1056/NEJMra1806949. No abstract available.
PubMed 31483966Demeyer H, Louvaris Z, Frei A, Rabinovich RA, de Jong C, Gimeno-Santos E, Loeckx M, Buttery SC, Rubio N, Van der Molen T, Hopkinson NS, Vogiatzis I, Puhan MA, Garcia-Aymerich J, Polkey MI, Troosters T; Mr Papp PROactive study group and the PROactive consortium. Physical activity is increased by a 12-week semiautomated telecoaching programme in patients with COPD: a multicentre randomised controlled trial. Thorax. 2017 May;72(5):415-423. doi: 10.1136/thoraxjnl-2016-209026. Epub 2017 Jan 30.
PubMed 28137918
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06732869
- Acronym / sponsor ID
- PACE / ciTechCare_PhD_SF
- Conditions
- COPD, Physical Activity
- Keywords
- physical activity, COPD, eHealth, pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Instituto Politécnico de LeiriaUniversity, hospital or other
- Collaborators
- Unidade Local de Saúde do Baixo Mondego, Unidade Local de Saúde de Lisboa Norte, Faculdade de Motricidade Humana de Lisboa
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group - Pulmonary rehabilitation + eHealth physical activity coaching intervention | Experimental | Behavioral: eHealth physical activity coaching intervention, Behavioral: pulmonary rehabilitationPatients 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 | Behavioral: pulmonary rehabilitationPatients will attend pulmonary rehabilitation program for 10 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eHealth physical activity coaching interventionPatients 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. | Behavioural | Experimental Group - Pulmonary rehabilitation + eHealth physical activity coaching intervention |
| pulmonary rehabilitationPatients 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. | Behavioural | Control group - pulmonary rehabilitation, Experimental Group - Pulmonary rehabilitation + eHealth physical activity coaching intervention |
Primary outcome
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.
6 secondary outcomes
6-Minute Walk Test (exercise capacity)
Time frame: 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
Checklist of Individual Strength (Fatigue)
Time frame: 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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- BackgroundGlobal 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.
- Background: PubMed 25705944McCarthy 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.
- Background: PubMed 27475266Ding D, Lawson KD, Kolbe-Alexander TL, Finkelstein EA, Katzmarzyk PT, van Mechelen W, Pratt M; Lancet Physical Activity Series 2 Executive Committee. The economic burden of physical inactivity: a global analysis of major non-communicable diseases. Lancet. 2016 Sep 24;388(10051):1311-24. doi: 10.1016/S0140-6736(16)30383-X. Epub 2016 Jul 28.
- Background: PubMed 27930803Puhan MA, Gimeno-Santos E, Cates CJ, Troosters T. Pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2016 Dec 8;12(12):CD005305. doi: 10.1002/14651858.CD005305.pub4.
- Background: PubMed 24127811Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST.
- Background: PubMed 26161676Spruit MA, Pitta F, McAuley E, ZuWallack RL, Nici L. Pulmonary Rehabilitation and Physical Activity in Patients with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2015 Oct 15;192(8):924-33. doi: 10.1164/rccm.201505-0929CI.
- Background: PubMed 32297320Burge AT, Cox NS, Abramson MJ, Holland AE. Interventions for promoting physical activity in people with chronic obstructive pulmonary disease (COPD). Cochrane Database Syst Rev. 2020 Apr 16;4(4):CD012626. doi: 10.1002/14651858.CD012626.pub2.
- Background: PubMed 25221907Wilson JJ, O'Neill B, Collins EG, Bradley J. Interventions to Increase Physical Activity in Patients with COPD: A Comprehensive Review. COPD. 2015 Jun;12(3):332-43. doi: 10.3109/15412555.2014.948992. Epub 2014 Sep 15.
- Background: PubMed 31210136Jiang X, Ming WK, You JH. The Cost-Effectiveness of Digital Health Interventions on the Management of Cardiovascular Diseases: Systematic Review. J Med Internet Res. 2019 Jun 17;21(6):e13166. doi: 10.2196/13166.
- BackgroundKowatsch, T., et al., Design and Evaluation of a Mobile Chat App for the Open Source Behavioral Health Intervention Platform MobileCoach. 2017. 485-489
- Background: PubMed 24199042Blazun H, Saranto K, Kokol P, Vosner J. Information and communication technology as a tool for improving physical and social activity of the elderly. NI 2012 (2012). 2012 Jun 23;2012:26. eCollection 2012.
- BackgroundSolanas, A., et al., Smart health: A context-aware health paradigm within smart cities. IEEE Communications Magazine, 2014. 52(8): p. 74-81.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sofia Flora, PT, MSc principal investigator
Center for Innovative Care and Health Technology, Polytechnic of Leiria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eHealth physical activity coaching intervention and pulmonary rehabilitation in people with COPD and Physical Activity, run by Instituto Politécnico de Leiria at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sofia Flora, PT, MSc (+351 917257840, sofia.flora@ipleiria.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accelerometry (number of daily steps) (time frame: weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06732869, which also lists 41 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.