PRO-active

Physical Activity as a Crucial Patient Reported Outcome in COPD
Physical Activity as a Crucial Patient Reported Outcome in COPD

FACTS & FIGURES

Start Date
End Date
Call
IMI1 - Call 1
Grant agreement number
115011

Contributions
IMI Funding
6 767 597
EFPIA in kind
7 221 617
Other
1 761 866
Total Cost15 751 080

Summary

Although lack of physical activity is one of the most common predictors of mortality in patients with chronic obstructive respiratory disease, there are no validated tools to measure the impact of the disease on how patients experience physical activity. The PROactive project developed new, innovative patient reported outcome tools to capture both the experienced amount of physical activity and the difficulties during activity, opening the way for the development of more effective treatments. The project also developed innovative ways to enhance physical activity, both as it is objectively measured and as it is experienced by patients. Furthermore, the project succeeded in placing physical activity higher on the agenda of clinicians, patient organisations and researchers, and patients are already reaping the benefits.

Chronic Obstructive Pulmonary Disease (COPD) is one of the most prevalent chronic diseases, affecting 10% of people over the age of 50. The most common symptoms of COPD are breathlessness (shortness of breath), excessive sputum production, and a chronic cough. According to the World Health Organisation, 64 million people are affected worldwide and about 3 million died from the disease. Furthermore, WHO predicts it will become the third leading cause of death worldwide by 2030.

Patients with COPD often reduce their physical activity and their normal way of life because of unpleasant symptoms associated with the disease. Even though a lack of physical activity is one of the most common predictors of mortality, before PROactive there were no valid tests to measure the impact of the disease on physical activity levels and related dimensions (e.g. the symptoms experienced during physical activity). The commonly used lung function tests for COPD provide only limited information on the progression of the disease and the patients’ quality of life. Exercise tests, on the other hand are more an assessment of the capacity of the patient, rather than of the problems patients experience in their daily lives.

An innovative tool which simplifies the lives of patients

By following guidelines outlined by the regulatory authorities, the PROactive project developed innovative patient reported outcome (PRO) tools to measure patients’ experience of physical activity in terms of ‘amount’ of activity and ‘difficulty’. They did this in an innovative way by merging questions about patients’ experience of physical activity with information obtained through wearable physical activity monitors. This is not only an innovation but also a simplification in the PRO field which makes the life of patients easier: they have to answer only a few relevant questions and the rest is recorded via activity monitors sensitive enough to capture the activity of COPD patients. Moreover, the questionnaires were developed by patients and are therefore written in the language of patients, making them easy to use and understand.

In order to ensure the robustness of the new PRO tools, the consortium tested them in a heterogeneous group of more than 1000 patients in five EU languages. All the data gathered has been submitted to the European Medicines Agency for the qualification procedure of novel drug development methodologies. If accepted by the regulators, these new PRO tools would enable pharmaceutical companies and others to use them in clinical trials to assess the effectiveness of new treatments on physical activity. Such therapies could be drugs, but also non-pharmacological interventions such as rehabilitation.

In the meantime, the tool is already being used for research purposes by partners in the project, and at least one company outside of the consortium. Furthermore, more than 50 culturally sensitive translations are already available for use in global research.

Putting physical activity higher on the agenda

While the development of the PRO tools is the most significant project achievement, the project also contributed to the field in other ways.

  • It helped clarify the role that physical inactivity plays in COPD and put it higher on the agenda of patient organisations, researchers and clinicians. Patients are already experiencing benefits, as clinicians are increasingly recognising that tackling physical inactivity should be one of the key targets in the management of this disease.
  • While some activity monitors are valid tools to get insight in the amount of physical activity patients engage in, this project has shown that they are not enough to capture the physical activity experience of patients suffering from COPD. They need to be combined with questions providing further insight into how patients experience physical activity.
  • The project developed a methodology for evaluating activity monitors to identify those sensitive enough to measure physical activity in patients with a chronic disease such as COPD. Three such monitors were identified and two of these extensively used. Furthermore, the project developed the know-how on processing, standardising and analysing data from activity monitors, so this data can be successfully used in clinical trials.
  • It developed several new, innovative interventions for COPD patients, such as a tele-coaching method to boost patients’ activity levels. A short term multi-centre study showed that this tele-coaching intervention significantly increases the level of physical activity in COPD patients, opening up pathways for further research.

For the benefit of industry, academia and patients

PROactive’s new tools will provide drug companies with new ways of assessing the clinical benefits of novel treatments on the physical activity in COPD patients. The tools will also benefit patients by helping them evaluate the improvements or deterioration in their physical activity experience, including the effect of new treatments on this important aspect of their lives. Finally, participation in PROactive enabled academic researchers to master scientific rigour needed to develop such PRO tools, raising their profile in the field and helping them build a valuable network for future research.

What happens next?

Even though the project has officially ended, the project participants signed a memorandum of understanding to stay together and continue to develop their tools. The idea is to oversee future uses of the tools, such as translations to other languages and the development of the tools in other chronic disease areas. 

Read the interview with the project coordinators

Achievements & News

PROactive draws to a close, delivers on its promises – an interview with project coordinators
PROactive was launched in 2009 with the aim of developing an innovative tool to measure physical activity in chronic obstructive pulmonary disease (COPD) patients. The project has now drawn to a close, meeting its main goal. ###In interview with the IMI Programme Office, PROactive’s scientific coordinator, Thierry Troosters of the University of Leuven, and project coordinator, Mario Scuri of CHIESI Pharmaceuticals, explain how the new tool works and how it will benefit patients.  ‘A decade ago, physical activity monitors became available and people began using them, but little was known on how to interpret the outcomes’, said Troosters. ‘Now we have a tool which allows us to not only look at the amount of physical activity in COPD patients, but also to capture patients’ experience of this physical activity. I am quite pleased to see this project come to an end with the deliverable we had anticipated.’ Read the full interview. (November 2016)

ProACTIVe concludes telecoaching study for COPD patients
The ProACTIVE project has successfully concluded testing in its telecoaching study on physical activity in patients with chronic obstructive pulmonary disease (COPD). The goals of the study, ###which involved over 350 patients, were twofold: to validate the tools developed by the project to capture COPD patients’ experience of physical activity; and to test the effectiveness of telecoaching as a means of increasing physical activity in patients. Telecoaching was carried out via a smartphone app that provided patients with information on their physical activity levels and motivated them to become more active. Patients’ experience of physical activity (amount, difficulty) was captured via special hybrid patient reporting tools developed by the project that combine classic questionnaire items and outcomes from activity monitors. The project is now analysing the data and hopes to be able to report on its findings in the near future.

PROactive researcher wins COPD award
Professor Milo Puhan, a researcher from IMI’s PROactive project on chronic obstructive pulmonary disease (COPD) has been awarded the European Respiratory Society (ERS) COPD Research Award 2014. The €50 000 award goes to a young researcher who is active in, and has made an outstanding contribution to COPD research. ###Professor Puhan is based at the Epidemiology, Biostatistics & Prevention Institute, University of Zurich, and his research focuses on measurements that characterise COPD patients, on the effects of COPD treatments, and on statistical models for predicting and monitoring chronic disease. COPD (chronic obstructive pulmonary disease) refers to a group of lung diseases that cause obstruction of the airways and breathing difficulties. Patients may experience breathlessness, wheezing and a persistent cough. The PROactive project is developing tools to integrate the patient’s experience with physical activity to evaluate the effectiveness of new interventions taking a patient-centred perspective.
(September 2014)

PROactive trials for lung disease patients underway
IMI’s PROactive project on chronic obstructive pulmonary disease (COPD) has launched a number of trials and studies using its innovative tools for accurately capturing the impact of COPD on patients’ physical activity levels. COPD patients typically report ###difficulties carrying out daily activities, but measuring the level of difficulty accurately has proven extremely difficult. IMI’s PROactive project has developed hybrid tools to address this, which combine physical activity monitors (which are worn by the patient) with diaries that patients fill in on a daily or weekly basis. The project is now validating its tools in a range of studies across Europe, while also investigating ways of encouraging patients to become more active. For example, the project is trialling a telecoaching intervention programme designed to boost patient activity. Patients wear a step counter which sends information on a patient’s activity levels to a coach by mobile phone. The patients then receive personal physical activity goals to help them on the path to a more active lifestyle. Studies like this are important because promoting physical activity among COPD patients is not easy. Other studies trialling the PROactive tools include PHYSACTO, which is investigating the impacts of a combination of medication and exercise training on the disease, and a study in Spain which is studying the effect of providing patients with safe walking circuits in public spaces and around towns. Two other studies (info here and here) are using the PROactive tools in patients with COPD. Looking to the future, the project plans to launch further studies that will generate sufficient data for medicines regulators to formally assess the usefulness of the PROactive tools as measures of effectiveness in clinical trials.
(July 2014)

Physical activity in patients with chronic obstructive pulmonary disease
Chronic obstructive pulmonary disease (COPD) causes severe breathing difficulties and is one of the most common lung diseases. Research has shown that patients who suffer from lung diseases reduce their physical activity levels; this has an impact on ###their participation in social life. So far the interaction between physical activity and COPD related factors as well as the consequences of physical inactivity for patients with COPD had never been systematically reviewed.
This is why the IMI PROactive project conducted a review to identify and summarise existing studies. The studies taken into consideration focus on associations between physical activity, its determining factors, and its impact on patients with COPD. This review was recently published in the British Medical Journal (BMJ)’s Thorax, a leading international peer-reviewed journal for health professionals in respiratory medicine (IF 8.3).
The outcome of this systematic review will help clinicians to interpret previous research on the topic, and to identify research priorities. Its main findings are that many studies focus on clinical, functional, socio-demographic and lifestyle factors as the ones determining physical activity levels in patients with COPD. Few studies have taken an integrated approach and, unfortunately, the quality of evidence in these studies remains very low rendering results inconsistent.
This review’s key conclusion is that physical activity should be included in planned cohort studies and randomised trials to provide a stronger evidence base for determinants and outcomes of physical activity and for developing recommendations for or against treatments in clinical guidelines.
   -   Read the review published by PROactive in Thorax (open access).
   -   Follow PROactive on Twitter @PROactiveCOPD.
(March 2014)

PROactive and COPDMAP projects join forces
IMI project PROactive has signed a Memorandum of Understanding (MoU) with the UK's COPDMAP initiative. Like PROactive, COPDMAP is a public-private partnership (PPP) working on ###chronic obstructive pulmonary disease (COPD); it is supported by the UK’s Medical Research Council (MRC) and the Association of the British Pharmaceutical Industry (ABPI).
Under the MoU, COPDMAP will become the first external party to use PROactive’s newly-developed Patient Reported Outcome (PRO) tools. COPDMAP is running a study where pharmacotherapy and pulmonary rehabilitation are used to increase exercise tolerance and physical activity, and it will use PROactive’s tools to gather information on how these interventions change the experience of physical activity for patients with COPD. The COPDMAP study will help the PROactive team to calibrate its PRO tools against other relevant exercise tolerance outcomes, including laboratory tests (endurance and incremental cycle tests) and field based tests (6 Minute Walking Test, Incremental and Endurance Shuttle Walking Test, Short Physical Performance Battery). This information will be important to for PROactive’s efforts to get its PRO tools approved by regulatory authorities.
PROactive Managing Entity, Thierry Troosters of KU Leuven, comments: ‘This win-win collaboration is an excellent example of the mutual benefits of collaborations across large consortia.’
(July 2013)


PROactive puts activity monitors through their paces
IMI project PROactive has selected two activity monitors for further use in its studies on people with chronic obstructive pulmonary disease (COPD).### Activity monitors (small devices worn by the patient that measure activity levels) play a key role in PROactive, which is working to accurately determine the impacts of COPD on patients’ daily lives. The monitors picked by PROactive are the DynaPort MoveMonitor and the ActiGraph GT3X+. In total, PROactive tested 6 monitors on over 100 patients; monitors were scored for both accuracy and usability. According to Thierry Troosters of KU Leuven, the monitors that will be used ‘were considered valid according to our stringent criteria; they were judged as patient friendly by our main stakeholder, the patient; and they were judged as user friendly by investigators. Importantly both vendors of the monitors have pledged to help PROactive integrate data from the monitors into the project’s own, larger databases’. The monitors and a questionnaire will now be used to gain a comprehensive overview of physical activity in 250 COPD patients.
(September 2011)

IMI lung disease projects to present findings to press and patients
On 28 September IMI projects U-BIOPRED and PROactive and the European Lung Foundation will hold a special event for patients and the public.###IMI Executive Director Michel Goldman will open the event with a presentation on how Europe is responding to the needs of respiratory patients. Other talks will explain how patients and scientists are working together in the U-BIOPRED and PROactive projects and Marc Decramer, President of the European Respiratory Society, will discuss the roadmap for respiratory research in the years ahead. There will also be time for attendees to ask questions of some of Europe’s leading respiratory researchers. The event is part of the 2011 European Respiratory Society (ERS) Annual Congress in Amsterdam.
(September 2011)

PROactive – picking up on patients’ perceptions of COPD
The IMI project PROactive is developing new ways of gauging the impacts of chronic obstructive pulmonary disease (COPD) on patients’ daily lives. ###While current activity tests tell doctors what patients can manage in theory, they do not reveal what patients are actually doing on a day-to-day basis or how patients feel about their activity levels. Through interviews with patients, PROactive has found that patients consider three aspects of physical activity to be important to overall quality of life: the amount of physical activity (e.g. how far someone can walk), the symptoms triggered by the activity (e.g. shortness of breath or fatigue) and the way the patient copes with these symptoms (e.g. stopping to rest every few minutes). Based on the findings, the PROactive team has developed some questions that capture the impacts of COPD on patients’ quality of life. The team now plans to create a tool that combines these questions with input from activity monitors (small external devices that measure activity levels and are worn by the patient) to accurately assess physical activity levels from the patients’ point of view. The tool could be used by physicians and researchers alike to test the efficacy of treatments, for example. The tool could also be adapted for other chronic conditions that affect physical activity.
(September 2011)

Participants Show participants on map

EFPIA companies
  • AstraZeneca AB, Södertälje, Sweden
  • Boehringer Ingelheim International GmbH, Ingelheim, Germany
  • Chiesi Farmaceutici S.p.A, Parma, Italy
  • Glaxosmithkline Research And Development LTD, Brentford, Middlesex, United Kingdom
  • Laboratorios Almirall S.A., Barcelona, Spain
  • Novartis Pharma AG, Basel, Switzerland
  • UCB Biopharma SPRL, Brussels, Belgium
Universities, research organisations, public bodies, non-profit groups
  • Academisch Ziekenhuis Groningen, Groningen, Netherlands
  • Centre De Recerca En Epidemiologia Ambiental, Barcelona, Spain
  • European Respiratory Society, Lausanne, Switzerland
  • Katholieke Universiteit Leuven, Leuven, Belgium
  • Royal Brompton & Harefield NHS Foundation Trust, South Kensington, United Kingdom
  • Thorax Research Foundation, Kolonaki, Athens Greece, Greece
  • Universitaet Zuerich, Zürich, Switzerland
  • University of Edinburgh, Edinburgh, United Kingdom
Small and medium-sized enterprises (SMEs)
  • Choice Healthcare solutions Ltd, Hitchin, Hertfordshire, United Kingdom
Patient organisations
  • British Lung Foundation, London, United Kingdom
  • Netherlands Asthma Foundation, Leusden, Netherlands

CONTACT

Project coordinator
Mario Scuri
Chiesi Farmaceutici S.p.A
M.Scuri[at]chiesi.com
Managing entity
Thierry Troosters
Katholieke Universiteit Leuven
+
thierry.troosters[at]med.kuleuven.be