CENTR(AR): Lungs Moving

NCT04711057 | Completed

• 1 other identifier: POISE-03-4639-FSE-000597
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Respiratory Diseases (CRDs) are associated with substantial morbidity and mortality, ranking as the third leading cause of death worldwide. Pulmonary rehabilitation (PR) is a fundamental evidence-based intervention for the management of a variety of CRDs, such as Chronic Obstructive Pulmonary Disease (COPD) and Interstitial Lung Diseases (ILDs). However, the benefits of PR tend to decline over time and there is currently no strong evidence that patients translate those benefits into a more active lifestyle. There is an urgent need for evidence-based interventions to promote physical activity (PA) participation, whilst maintaining PR positive effects in the long-term. Community-based PA interventions adjusted to the local context, as well as patients' needs and preferences, might be a key strategy to meet this target. CENTR(AR) will be a sustainable response to support healthy lifestyles and enhance long-term PR benefits, by providing access to PR within Primary Healthcare Centres (PHC), followed by the inclusion in a community-based PA program, which embraces urban facilities and available resources.

Conditions

Chronic Respiratory Disease; Lung Diseases; Pulmonary Disease; Chronic Obstructive Pulmonary Disease; Interstitial Lung Disease

Keywords

Chronic Respiratory Disease; Pulmonary Rehabilitation; Physical Activity; Behavioral Change

Outcome Measures

Primary Outcomes (1)

• Change in PA levels (time spent in moderate to vigorous physical activity (MVPA))

  Time spent in MVPA will be collected with the ActiGraph accelerometry-based activity monitors (wGT3X-BT) during for week. Raw data will be downloaded, summed and filtered by the ActiLife software (Version 6.13.4) to determine the average MVPA (min/wk).

  before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.

Secondary Outcomes (24)

• Change in PA levels (time spent in sedentary behaviour)

  before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.

• Change in step count (steps/day-1)

  before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.

• Change in health-related quality of life (HRQoL) - St. George Respiratory Questionnaire

  before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.

• Change in exercise capacity/tolerance - 6-minute walk test (6MWT)

  before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.

• Change in overall functional status/physical function - Physical Performance Test

  before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.

Study Arms (2)

Pulmonary Rehabilitation + Community-based PA program

EXPERIMENTAL

After PR, the experimental group will integrate a community-based PA program.

Other: Community-based PA program; Other: Pulmonary Rehabilitation

Pulmonary Rehabilitation

ACTIVE COMPARATOR

The control group will only receive pulmonary rehabilitation, which integrates PA recommendations.

Other: Pulmonary Rehabilitation

Interventions

Community-based PA program OTHER

After completing the PR program, the experimental group (EG) will enroll in a 6-month personalized community-based PA program, which should be attended twice-weekly, minimum. During the first month the physiotherapist will guide patients through all available physical activities; afterwards, patients will be asked to choose one or two activities, according to their preference, which they'll attend for five more months. Physiotherapists' support will gradually decrease over time.

Pulmonary Rehabilitation + Community-based PA program

Pulmonary Rehabilitation OTHER

Exercise training, twice a week, and education and psychosocial support once every other week during 12 weeks.

Pulmonary Rehabilitation; Pulmonary Rehabilitation + Community-based PA program

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;
• Stable clinical condition (defined as no acute exacerbation or hospitalization in the previous month).

You may not qualify if:

• Signs of cognitive impairment;
• Neoplasic/Immunologic disease or an unstable/significant cardiac (e.g., exertional angina, valvular heart disease, congestive heart failure, etc.), musculoskeletal/orthopaedic, neuromuscular or psychiatric condition limiting ability to exercise or co-operate.

Sponsors & Collaborators

• Aveiro University: lead
• Programa Operacional Inclusão Social e Emprego (POISE): collaborator
• Programa Operacional Competitividade e Internacionalização (POCI) - Compete2020: collaborator
• Portuguese National Funding Agency for Science, Research and Technology (FCT): collaborator
• Aveiro Institute of Biomedicine (iBiMED): collaborator
• School of Health Sciences, University of Aveiro (ESSUA): collaborator
• City Council/Municipality: a) Aveiro; b) Estarreja; c) Oliveira do Bairro; d) Montemor-o-Velho: collaborator
• Administração Regional de Saúde do Centro, IP (ARS Centro): collaborator
• Centro Hospitalar do Baixo Vouga (CHBV), E.P.E.: collaborator

Study Sites (1)

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

Aveiro, 3810-193, Portugal

Location

Related Publications (23)

• GBD Chronic Respiratory Disease Collaborators. Prevalence and attributable health burden of chronic respiratory diseases, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Respir Med. 2020 Jun;8(6):585-596. doi: 10.1016/S2213-2600(20)30105-3.

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  PMID: 27103381 BACKGROUND

• Robinson H, Williams V, Curtis F, Bridle C, Jones AW. Facilitators and barriers to physical activity following pulmonary rehabilitation in COPD: a systematic review of qualitative studies. NPJ Prim Care Respir Med. 2018 Jun 4;28(1):19. doi: 10.1038/s41533-018-0085-7.

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  BACKGROUND

MeSH Terms

Conditions

Lung Diseases; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial; Motor Activity

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Alda S. Marques, PhD

  School of Health Sciences, University of Aveiro (ESSUA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 15, 2021
• Study Start: April 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: December 31, 2023
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)