Pulmonary Rehabilitation in Functional Outcomes and Its Relationship With Morbidity and Mortality in Patients With COPD

NCT03692793 | Terminated

• 1 other identifier: NuReabPRP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The pulmonary rehabilitation effects on various outcomes of COPD are well known. However, they may be lost over time due to poor adherence to therapy with absence of regular exercise maintenance in long term, disease progression, comorbidities, falls incidence and higher exacerbations frequency. Currently, the main focus is to make the patient more active and ensure the benefits maintenance. However, few studies have been concerned with the aim of to investigate the long-term effect of this intervention and the relationship of the change promoted in important outcomes of the disease with its morbidity and mortality. Design: Non-controlled clinical trial, prospective and longitudinal. Setting: Outpatient pulmonary rehabilitation program in Florianopolis, Brazil Subjects: Patients with COPD (GOLD II-IV). Interventions: Pulmonary rehabilitation program (PRP) based on physical training, conducted over 24 sessions supervised, three times a week, including aerobic training in treadmill and resistance training for upper and lower limbs. Main measures: Before, post-PRP, 6 months post-PRP and 12 months post-PRP will be measured Spirometry or Total Body Plethysmography, Triaxial Accelerometry by Dynaport Activity Monitor, Glittre ADL-Test to evaluated functional capacity and functional performance, Six-Minute Walk Test distance on tracks of 20 and 30 meters, muscle oxygenation variables by NIRS PortaLite®, force platform NeuroCom® SMART Equitest®, Timed Up and Go Test, Berg Balance Scale, Activities-specific Balance Confidence, Falls Efficacy Scale - International - Brasil, London Chest Activity of Daily Living score, Modified Medical Research Council score, Saint George Respiratory Questionnaire score, COPD Assessment Test score and Hospital Anxiety and Depression Scale, Behavioural Regulation in Exercise Questionnaire-2, Basic Psychological Needs in Exercise Scale, General self-efficacy scale, COPD self-efficacy scale, Pulmonary Rehabilitation Adapted Index of Self-Efficacy. The death cases and numbers of exacerbations and hospitalizations will be measured by monthly phone calls after PRP.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Pulmonary Disease, Chronic Obstructive; Minimal Clinically Important Difference; Exercise Test; Rehabilitation; Disability Evaluation; Activities of Daily Living; Motivation; Self-efficacy

Outcome Measures

Primary Outcomes (3)

• Physical activity in daily life

  Change in physical activity in daily life monitoring by accelerometry

  baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP

• Morbidity

  Relationship of changes in outcomes with exacerbation, hospitalization and death

  Every month after the PRP up to 24 months

• Mortality

  Relationship of changes in outcomes with death

  Every month after the PRP up to 24 months

Secondary Outcomes (27)

• Dyspnea

  baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP

• Health status - COPD Assessment Test (CAT)

  baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP

• Health status - Saint George Respiratory questionnaire (SGRQ)

  baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP

• Anxiety and depression symptoms - Hospital Anxiety and Depression Scale (HADS)

  baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP

• Functional status - Glittre-ADL Test (TGlittre)

  baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP

Study Arms (1)

Pulmonary rehabilitation

EXPERIMENTAL

The PRP (24-session, three times for week) will be delivered according to ATS/ERS (Spruit et al, 2013),

Other: Pulmonary rehabilitation

Interventions

Pulmonary rehabilitation OTHER

Patients will perform continuous aerobic training (treadmill walking) during 30min (60% of the 6MWT mean speed) and progression according to dyspnea (4-6 of the modified Borg scale). Upper limbs resistance training will be performed using the modified diagonals from the proprioceptive neuromuscular facilitation method (2 sets of 2min). Lower limbs strength training will be performed for quadriceps and triceps sural (2 sets of 10 repetitions), with progression when the patients report that the exercise are ´easy´. All the muscle exercised and the breathing accessory muscles will be stretched for 30s. Eleven educational sessions will be delivered addressing topics related to COPD self-management.

Pulmonary rehabilitation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of COPD confirmed by spirometry (COPD GOLD stages II, III and IV);
• Clinical stability in the past four weeks.

You may not qualify if:

• Hospital admission in the past 12 weeks;
• Any other disease or health condition that could compromise the test´s execution or physical training;
• Participation in pulmonary rehabilitation program completed in the last six months;
• Current smoking or its cessation in less than six months;
• Interruption of pulmonary rehabilitation program for any reason;
• Any change in symptoms during the study protocol assessments.

Sponsors & Collaborators

• University of the State of Santa Catarina: lead

Study Sites (1)

Núcleo de Assistência, Ensino e Pesquisa em Reabilitação Pulmonar

Florianópolis, Santa Catarina, Brazil

Location

Related Publications (24)

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  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Anamaria F Mayer, PhD

  University of the State of Santa Catarina

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 16, 2018
• First Posted: October 2, 2018
• Study Start: April 1, 2013
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: immediately following publication and ending 5 years following article publication
• Access Criteria: With Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose to achieve aims in the approved proposal; proposals should be directed to anamaria.mayer@udesc.br to gain access.

Locations

BR (1)