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

NCT03799666 | Completed

• 1 other identifier: SAICT-POL/23926/2016
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Respiratory Disease

Keywords

Pulmonary rehabilitation; Community-based; Chronic Respiratory Diseases; Cost-benefit analysis

Outcome Measures

Primary Outcomes (1)

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

  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).

  Up to 9 months

Secondary Outcomes (23)

• Change in airflow obstruction

  Up to 9 months

• Change in exercise capacity

  Up to 9 months

• Change in functionality

  Up to 9 months

• Change in quadriceps muscle strength

  Up to 9 months

• Change in biceps muscle strength

  Up to 3 months

Other Outcomes (1)

• Change in Body Mass Index

  Up to 9 months

Study Arms (2)

Pulmonary Rehabilitation Group

EXPERIMENTAL

Patients will participate in a 12-week community-based pulmonary rehabilitation programme.

Other: Pulmonary Rehabilitation

Standard Care Group

ACTIVE COMPARATOR

Patients will continue to receive the standard care, which means the daily medication prescribed by the pshysician from the primary care centre team.

Other: Daily medication

Interventions

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

Pulmonary Rehabilitation Group

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.

Standard Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aveiro University: lead
• Fundação para a Ciência e a Tecnologia: collaborator

Study Sites (1)

University of Aveiro

Aveiro, 3810-193, Portugal

Location

Related Publications (3)

• Paixao C, Rebelo P, Oliveira A, Jacome C, Cruz J, Martins V, Simao P, Marques A. Responsiveness and Minimal Clinically Important Difference of the Brief-BESTest in People With COPD After Pulmonary Rehabilitation. Phys Ther. 2021 Nov 1;101(11):pzab209. doi: 10.1093/ptj/pzab209.

  PMID: 34499161 DERIVED

• Rebelo P, Oliveira A, Andrade L, Valente C, Marques A. Minimal Clinically Important Differences for Patient-Reported Outcome Measures of Fatigue in Patients With COPD Following Pulmonary Rehabilitation. Chest. 2020 Aug;158(2):550-561. doi: 10.1016/j.chest.2020.02.045. Epub 2020 Mar 14.

  PMID: 32184112 DERIVED

• Marques A, Jacome C, Rebelo P, Paixao C, Oliveira A, Cruz J, Freitas C, Rua M, Loureiro H, Peguinho C, Marques F, Simoes A, Santos M, Martins P, Andre A, De Francesco S, Martins V, Brooks D, Simao P. Improving access to community-based pulmonary rehabilitation: 3R protocol for real-world settings with cost-benefit analysis. BMC Public Health. 2019 May 31;19(1):676. doi: 10.1186/s12889-019-7045-1.

  PMID: 31151409 DERIVED

Study Officials

• Alda S. Marques, PhD

  School of Health Sciences of the University of Aveiro (ESSUA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: January 10, 2019
• Study Start: January 7, 2019
• Primary Completion: December 30, 2019
• Study Completion: June 30, 2020
• Last Updated: July 8, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)