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Completed

NCT Number: NCT03799666

(Re)Vitalizing Pulmonary Rehabilitation for Patients With Chronic Respiratory Diseases

3R aims to increase the access of patients with chronic respiratory diseases (CRD) to pulmonary rehabilitation (PR) in Portugal. The main goals of 3R are: i) design and implement an innovative community-based PR programme; ii) assess the cost-benefit of the community-based PR programme; iii) disseminate and perform knowledge transfer about PR across the country.

PR is an evidence-based intervention for the management of CRD and offering PR has been defined as a priority by national/international organizations. However, in Portugal PR is practically inexistent (<1% of "candidate" patients have access). Currently, PR programmes are hospital-based and directed to patients with advanced disease. One of the recommendations to enhance the implementation of PR is the development on novel models of programme delivery. It is hypothesised that community-based programs, direct to patients at all grades of the disease, and involving all stakeholders (health professionals, patients, society, policy makers) may turn PR more accessible.

The plan is to implement community-based PR programs in 4 primary care centres of 2 ACES of the centre region of Portugal and assess the impact of such intervention in several domains using surrogate and patient-/family-centered outcomes. A cost-benefit analysis will be performed on acute exacerbations and healthcare utilization. Dissemination will include one conference, activities with the community, courses and an online PR toolkit. Four schools of 2 polytechnics, 2 city councils, the Health Regional Administration-Centre (ARS-Centro) and all respiratory professional and civic national associations are partners.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Aveiro

Aveiro, 3810-193, Portugal

About this study

More than 1 billion people suffer from chronic respiratory diseases worldwide and, in Europe, the total annual cost of respiratory diseases amounts to more than €380 billion. In Portugal, respiratory diseases are the 3rd leading cause of death and direct costs related to hospitalizations (in 2013 - €213 millions). Management of chronic respiratory diseases are high priorities for the National Health Service, and particularly, for the Center Health Regional Administration.

Pulmonary rehabilitation (PR) is an evidence-based intervention for the management of patients with chronic respiratory diseases (grade A). Offering PR has long been defined as a priority by several national and international organizations. Despite this firm recommendation and the knowhow on the provision of PR, in Portugal, PR is practically inexistent, with <1% of "candidate" patients having access to this standard care. Therefore, the need for a National Network on PR has been acknowledged as a priority.

It is hypothesised that community-based programmes, direct to patients at all grades of the disease, and involving all stakeholders (health professionals, patients/family, society, policy makers) may turn PR more accessible. Thus, the main goal of this project is to increase the access of patients with chronic respiratory diseases, namely COPD, to PR in the center region of Portugal and disseminate this intervention nationally.

3R aims to implement and disseminate community-based PR programs in Portugal. Specifically, it will:

  • Implement 4 community-based PR programmes (Task 1);
  • Create an online platform for clinical storage and analysis of the data collected (Task 2);
  • Perform a cost-benefit analysis of the implemented PR programmes (Task 3);
  • Create a Portuguese online PR toolkit (Task 4);
  • Promote knowledge transfer about PR (Task 5). The plan is to implement community-based PR programmes in 4 primary care centres of 2 ACES (Baixo Vouga - BV, and Baixo-Mondego - BM) of the centre region and assess the impact of such intervention in several domains. Surrogate and patient/family centered outcome measures will be used. A cost-benefit analysis will be performed on acute exacerbations and healthcare utilization and costs. Finally, dissemination and knowledge transfer of the project will be conducted through: an international conference, activities with the community, three PR courses; the development of the Portuguese online PR toolkit to support the widespread implementation of PR in Portugal and via publications.

To bring PR from bench to Portuguese common practice, 3R brings together a strong consortium composed of 4 schools of 2 Polytechnic Institutions, 2 City Councils, Health Regional Administration - Centre and all respiratory national associations (Sociedade, Portuguesa do Pulmão - SPP, RESPIRA and Fundação Portuguesa do Pulmão - FPP). This consortium involves an experienced team with complementary backgrounds and integrates students from the several institutions during all activities. It is strongly believed that jointly this multidisciplinary team has the experience and complementary skills, as well as the means, to guarantee the success and outreach of the project.

It is estimated that 73 patients will be required to detect significant differences in patients' health-related quality of life (HRQOL), based on a previous study. Stable patients with CRD and their family members will be recruited from Primary Care Centres (PCCs) of the ACES of Baixo Vouga and Baixo Mondego (ACES-BV & BM). Family doctors from PCCs will provide a list of eligible individuals. Individuals/families will be contacted and those interested will meet with researchers to receive further information about the study and sign the informed consents. Participants will be divided in two groups: experimental (EG) and control (CG). The EG will include participants/families wanting to participate in a 12-week community-based PR programme and the CG will include those willing to collaborate in data collection but not in the PR programmes (Task 1). The PR programme will include exercise training (endurance, strength and balance training) twice a week and psychoeducational sessions every two weeks performed by a multidisciplinary team.

Data will be collected at baseline, at 12 weeks (i.e., immediately post-PR), 3 and 6 months post-PR.

Data analysis will be undertaken using Statistical Package for the Social Sciences (SPSS) software and will include descriptive and inferential statistics. To analyse changes in outcome measures, data from baseline and after treatment assessments will be compared. Moreover, between groups comparisons will also be performed for baseline, after intervention and follow-ups assessments. Effect sizes for the interventions will also be calculated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • clinical diagnosis of a chronic respiratory disease
  • clinically stable in the previous month
  • ≥ 18 years old
  • able to provide their own informed consent

Exclusion criteria

  • cognitive impairments
  • inability to understand and co-operate
  • history of neoplasic /immunologic disease or acute cardiac condition or a significant cardiac, musculoskeletal, neuromuscular or psychiatric condition.

Treatment and study plan

Pulmonary Rehabilitation

Other

Patients will be treated with daily medication prescribed by the physician. Additionally patients will participate in a 12-w.eek community-based pulmonary rehabilitation programme, with two exercise training sessions per week and six psycho-education sessions, managed by a multidisciplinary team, once every two weeks. Patient's families will be invited to participate in the psychoeducational component

Daily medication

Other

Patients will be treated with daily medication prescribed by the physician and will continue to receive the standard care from the primary care centre team.

Primary outcomes

  1. Change in Health Related quality-of-life: St. George Respiratory Questionnaire

    Time frame: Up to 9 months

    St. George Respiratory Questionnaire (SGRQ) will be used to assess Health Related quality-of-life. The SGRQ is a comprehensive well-established 50-item questionnaire to measure health status in patients with chronic respiratory diseases. Scores can be provided for each domain and as a total score, ranging from 0 (no impairment) to 100 (worst possible health status).

Secondary outcomes

  1. Change in airflow obstruction

    Time frame: Up to 9 months

    Forced expiratory volume in one second and forced vital capacity will be measured with a portable spirometer to assess the degree of airflow obstruction. Results will be expressed in liters and percentage of predicted. We will calculate the ratio between the forced expiratory volume in one second and the forced vital capacity.

  2. Change in exercise capacity

    Time frame: Up to 9 months

    Exercise capacity will be tested in a 6-minute walk test, since it allows exercise prescription. The test results will be presented as the walked distance (meters).

  3. Change in functionality

    Time frame: Up to 9 months

    Functionality will be tested with the 1-minute sit-to-stand, with the results presented as number of sit-to-stand repetitions.

  4. Change in quadriceps muscle strength

    Time frame: Up to 9 months

    Quadriceps muscle strength will be measured using a handheld dynamometer (kilogram/force).

  5. Change in biceps muscle strength

    Time frame: Up to 3 months

    Biceps muscle strength will be measured using a handheld dynamometer (kilogram/force).

  6. Change in muscle cross sectional area

    Time frame: Up to 3 months

    Cross-sectional will be measured with ultrasound of the lower (quadriceps) and upper (biceps) limb muscles.

  7. Change in upper limb muscle strength

    Time frame: Up to 9 months

    Upper limb strength will be measured with Handgrip (kg)

  8. Change in respiratory muscle strength

    Time frame: Up to 3 months

    Respiratory muscle strength will be measured through a respiratory pressure meter to assess inspiratory and expiratory muscle strength (cm/H20)

  9. Change in frequency of exacerbations

    Time frame: Up to 9 months

    Number of exacerbations in the previous year, healthcare utilization, such as emergency department visits or hospital admissions, in the previous year, which are related to COPD decline

  10. Change in Healthcare utilization

    Time frame: Up to 9 months

    Healthcare utilization will be assessed through the number of participants that visit emergency department and the number of visits of each participant in the previous year. The number and duration of hospital admissions in the previous year will also be assessed.

  11. Change in family adaptability/cohesion

    Time frame: Up to 3 months

    Family function was assessed with the family adaptability and cohesion evaluation scale (FACES-IV). The FACES-IV is a 62 items subdivided in: cohesion and flexibility dimensions, and family communication and family satisfaction scales. The cohesion and flexibility dimensions provide six family scales, two balanced scales (Balanced cohesion and balanced flexibility, with percentile scores ranging from 16 to 85) and four unbalanced scales (Disengaged, Enmeshed, Rigid and Chaotic, with percentile scores ranging from 10 to 99). The six family types (Balanced, Rigidly Cohesive, Midrange, Flexibly unbalanced, chaotically unbalanced and unbalanced) can be plotted onto the Circumplex Model. The family communications and Satisfaction scales are composed of 10 items each, with percentile scores ranging from 10 to 99. In all FACES-IV subscales higher scores indicate better family cohesion, flexibility, communication or satisfaction.

  12. Change in balance

    Time frame: Up to 3 months

    Balance will be assessed with the Brief-Best tests.

  13. Change in Physical activity

    Time frame: Up to 3 months

    Accelerometry will be used to assess physical activity.

  14. Change in Physical activity

    Time frame: Up to 9 months

    The Brief Physical Activity questionnaire will be used to assess physical activity. It a 2 items questionnaire, with scores ranging from 0 to 8. If the sum of the two items score is above or equal 4 the subject will be considered physically active.

  15. Change in Diaphragm excursion

    Time frame: Up to 3 months

    Ultrasound will be used to assess the diaphragm excursion, only volunteer from patients who agree to come to ESSUA and will be seen previously by a physician

  16. Change in Dyspnoea

    Time frame: Up to 9 months

    Medical Research Council scale will be used to assess functional dyspnoea related to respiratory impairment. It is a 5-point scale, rated from 0 to 4, with higher scores denoting greater breathlessness severity.

  17. Change in symptom's impact in patients life

    Time frame: Up to 9 months

    COPD Assessment Test (CAT) will be used to assess burdensome symptoms in patients' life with 8 items (cough, sputum, dyspnoea, chest tightness, capacity of exercise and home daily activities, confidence leaving home, sleep and energy levels).he scores range from 0-40, organised in 4 categories, namely <10 low impact, 10-20 medium, 21-30 high and >30 very high impact, with 5 representing the upper limit of normal in healthy non-smokers

  18. Change in Emotional state

    Time frame: Up to 9 months

    Hospital Anxiety and Depression Scale will be used to assess symptoms of anxiety and depression. It is a 14 item questionnaire that can be subdivided in two subscales: anxiety and depression. Scores are provided for each subscale and range from 0 to 21, with higher scores meaning more symptoms of anxiety and depression.

  19. Change in Fatigue symptoms

    Time frame: Up to 3 months

    The fatigue subscale of the Checklist of Individual Strength (CIS-20) will be used to assess fatigue.The subscale of subjective fatigue is a 8-item questionnaire, with higher scores indicating higher levels of fatigue. The total scores range from 8 to 56.

  20. Change in Fatigue

    Time frame: Up to 3 months

    The Functional Assessment of Cancer Therapy - Fatigue subscale (FACIT-F) will be used to assess fatigue levels. It is multi-dimensional 13-item questionnaire assessing tiredness, weakness and difficulty in handling daily activities due to fatigue. Scores range from 0 to 52, with higher scores indicating less fatigue.

  21. Change in cough-related quality of life: Leicester Cough Questionnaire

    Time frame: Up to 3 months

    Cough-related quality of life will be assessed with the Leicester Cough Questionnaire, which is a 19 items scale organised in 3 domains (physical, psychological and social). Each domain has a score ranging from 1 to 7 and the LCQ total score varies from 3 to 21. Higher scores express a better quality of life and less impact of cough.

  22. Change in cough and sputum symptoms

    Time frame: Up to 3 months

    The Cough and Sputum Assessment Questionnaire (CASA-Q) will be used to assess cough and sputum symptoms, based on their reported frequency and severity, and their impact on daily activities. t is a 20-item questionnaire containing 4 domains: cough symptoms, cough impact, sputum symptoms and sputum impact. All items are rescored and summed, achieving a score ranging from 0 to 100 for each domain, with higher scores indicating fewer symptoms or less cough and sputum impact.

  23. Digital Technology access

    Time frame: At baseline

    A survey asking about the use of internet and access to computers, smartphones (combination of mobile phone, web browser and computer capabilities)/tablets and cell phones (simple devices mainly for voice calls and text messages) will be used to assess digital technology access. Confidence in using these technologies will be assessed using a numerical scale from 0 (not at all confident) to 10 (completely confident).

Other outcomes

  1. Change in Body Mass Index

    Time frame: Up to 9 months

    Patients' body mass index will be assessed in kg/m^2 based on patients' height and weight.

Sponsors and collaborators

Lead sponsor

Aveiro University

Other

Collaborators

  • Fundação para a Ciência e a Tecnologia

Registry information

Official study title

(Re)Vitalizing Pulmonary Rehabilitation

Acronym: 3R

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jan 10, 2019
Registry last updated
Jul 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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