PICk-UP: PersonalIsed CommUnity-based Physical Activities for Patients With Chronic Obstructive Pulmonary Disease

NCT04223362 | Completed

• 1 other identifier: SFRH/BD/148738/2019
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is a major individual, social and economic burden worldwide. Pulmonary rehabilitation is a fundamental evidence-based intervention to manage COPD. However, pulmonary rehabilitation benefits tend to decline over time and sustaining a long-term physical activity lifestyle is challenging, leading to worse health-related quality of life. Personalised post-pulmonary rehabilitation programmes, combining different physical activities modalities with social interaction, are warranted to enable a shift from a disease-based to a patient-centred model and encourage a sustainable behavioural change. Although such programmes have the potential to sustain pulmonary rehabilitation benefits and promote patients' long-term adherence to physical activity, their availability within the community is scarce. Hence, the investigators will implement a personalised community-based physical activity programme (PICk UP), using the available resources, adapted to patient's needs/preferences. PICk UP will be a sustainable response to support healthy lifestyles and enhance pulmonary rehabilitation benefits of respiratory patients, by integrating them within the community and embracing urban facilities. The aim of this study is to assess the effectiveness of PICk UP, a personalised community-based physical activity programme, tailored to patients' needs and preferences, on their physical activity levels. It is expected that PICk UP will empower patients to remain physically active and foster the maintenance of pulmonary rehabilitation benefits.

Conditions

COPD

Keywords

Physical activity; Community; Behavioural change; COPD

Outcome Measures

Primary Outcomes (1)

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

  Accelerometer-based activity monitors. Time spent in moderate and vigorous physical activities during the day, will be collected with the activity monitors GT3X+ (ActiGraph) during one week.

  Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.

Secondary Outcomes (20)

• Change in time spent in sedentary physical activities

  Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.

• Change in steps per day

  Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.

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

  Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.

• Change in exercise tolerance - 6MWT

  Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.

• Change in quadriceps muscle strength

  Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.

Other Outcomes (1)

• Change in Body Mass Index

  Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.

Study Arms (2)

Pulmonary rehabilitation + Community-based physical activity programme

EXPERIMENTAL

After pulmonary rehabilitation, the experimental group will integrate a community-based physical activity programme.

Other: Community-based physical activity programme; Other: Pulmonary Rehabilitation

Pulmonary Rehabilitation

ACTIVE COMPARATOR

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

Other: Pulmonary Rehabilitation

Interventions

Community-based physical activity programme OTHER

After completing a pulmonary rehabilitation programme, participants will enrol a 6-months personalised community-based physical activity programme, which will include 2 sessions/week, with the aerobic training being the cornerstone. Patients will receive the PICk UP manual and a diary to register their physical activities. During the 1st month the physiotherapist will guide patients through 4 types of outdoors and indoors physical activities. Patients will then be asked to choose and commit to 1 or 2 activities, according to their preferences, which they shall integrate for another 5 months. During this period, the support provided by physiotherapist will decrease over time.

Pulmonary rehabilitation + Community-based physical activity programme

Pulmonary Rehabilitation OTHER

Patients will receive the same pulmonary rehabilitation programme as the experimental group, i.e., exercise training twice a week and education and psychosocial support once every other week, which integrates physical activity recommendations.

Pulmonary Rehabilitation; Pulmonary rehabilitation + Community-based physical activity programme

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 obstructive pulmonary disease
• clinically stable in the previous month (no changes in medication or occurrence of acute exacerbations)
• ≥ 18 years old
• able to provide their own informed consent
• patients classified as a GOLD C or D (according to the global initiative for chronic obstructive pulmonary disease criteria), or classified as GOLD B and present a FEV1%predicted\<30%, or present peripheral oxygen saturation ≤90% at rest or \<85 during the 6MWT must be previously assessed by pneumologist or physiatrist.

You may not qualify if:

• Signs of cognitive impairment;
• Neoplasic /immunologic disease or an unstable/significant cardiac, musculoskeletal, neuromuscular or psychiatric condition limiting the ability to exercise or co-operate.

Sponsors & Collaborators

• Aveiro University: lead
• Fundação para a Ciência e a Tecnologia: collaborator
• Câmara Municipal de Aveiro: collaborator
• Câmara Municipal de Estarreja: collaborator
• Centro Hospitalar do Baixo Vouga: collaborator
• Administração Regional de Saúde do Centro: collaborator
• Escola Superior de Saúde da Universidade de Aveiro: collaborator
• Instituto de Biomedicina da Universidade de Aveiro: collaborator

Study Sites (1)

University of Aveiro

Aveiro, 3810-193, Portugal

Location

Related Publications (20)

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Related Links

• Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease 2020 report. The Global Initiative for Chronic Obstructive Lung Disease, Inc. 2020.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Alda S. Marques

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

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: January 10, 2020
• Study Start: February 5, 2020
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

PT (1)