Exacerbations in patients with chronic obstructive pulmonary disease receiving physical therapy: a cohort-nested randomised controlled trialReport as inadecuate




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BMC Pulmonary Medicine

, 14:71

COPD and occupational lung disease

Abstract

BackgroundPhysical exercise training aims at reducing disease-specific impairments and improving quality of life in patients with chronic obstructive pulmonary disease COPD. COPD exacerbations in particular negatively impact COPD progression. Physical therapy intervention seems indicated to influence exacerbations and their consequences. However, information on the effect of physical therapy on exacerbation occurrence is scarce. This study aims to investigate the potential of a protocol-directed physical therapy programme as a means to prevent or postpone exacerbations, to shorten the duration or to decrease the severity of exacerbations in patients with COPD who have recently experienced an exacerbation. Besides, this study focuses on the effect of protocol-directed physical therapy on health status and quality of life and on cost-effectiveness and cost-utility in patients with COPD who have recently experienced an exacerbation.

Methods-DesignA prospective cohort of 300 COPD patients in all GOLD stages will be constructed. Patients will receive usual multidisciplinary COPD care including guideline-directed physical therapy. Patients in this cohort who have GOLD stage 2 to 4 post-bronchodilator FEV1-FVC < 0.7 and FEV1 < 80% of predicted, who receive reimbursement by health insurance companies for physical therapy post-bronchodilator Tiffeneau-index < 0.6 and who experience a COPD exacerbation will be asked within 56 days to participate in a cohort-nested prospective randomised controlled trial RCT. In this RCT, the intervention group will receive a strict physical therapy programme for patients with COPD. This protocol-directed physical therapy pdPT will be compared to a control group that will receive sham-treatment, meaning no or very low-intensity exercise training ST. An economic evaluation will be embedded in the RCT. Anthropometric measurements, comorbidities, smoking, functional exercise capacity, peripheral muscle strength, physical activity level, health related quality of life, patients’ perceived benefit, physical therapy compliance, motivation level, level of effective mucus clearance, exacerbation symptoms and health care contacts due to COPD will be recorded. Follow-up measurements are scheduled at 3 and 6 weeks, 3, 6, 12 and 24 months after inclusion.

DiscussionWays to minimise potential problems regarding the execution of this study will be discussed.

Trial registrationThe Netherlands National Trial Register NTR1972.

KeywordsChronic obstructive pulmonary disease MESH Disease exacerbation MESH Physical therapy modalities MESH Physiotherapy Exercise therapy MESH Pulmonary rehabilitation Costs and cost analysis MESH Quality of life MESH Comorbidity MESH Cohort studies MESH Randomized controlled trial MESH AbbreviationsCOPDChronic obstructive pulmonary disease

DO-IT‘Designing optimal interventions in physical therapy’, the research programme in which this study is embedded

WHOWorld Health Organisation

GOLDThe Global Initiative for Chronic Obstructive Lung Disease

FEV1Forced expiratory volume in one second

FVCForced vital capacity

VCVital capacity

KNGFThe royal Dutch Society for Physical Therapy

NHGThe Dutch college of general practitioners

RCTRandomised controlled trial

gdPTGuideline-directed physical therapy

pdPTProtocol-directed physical therapy

STSham-treatment, including no or very low-intensity exercise training

GPGeneral practitioner

NPiThe Dutch Paramedical Institute

CPETMaximal cardiopulmonary exercise test

NNGBThe Dutch Standard for Healthy Exercise

ICFThe International Classification of Functioning, Disability and Health

HRQLHealth related quality of life

CCQClinical COPD Questionnaire

CRQ-SRChronic Respiratory Questionnaire, self-reported

EQ-5DEuro-Qol, 5 domains

DS14Questionnaire to measure type D personality: negative affectivity and social inhibition

MRCMedical Research Council dyspnoea score

GPEGlobal perceived effect

BMIBody mass index

FFMFat free mass

MVICMaximal voluntary isometric contraction

6MWTSix-minute walk test

6MWDSix-minute walk distance

mGUGModified Get Up and Go test

RM ANOVARepeated measures analysis of variance

QALYsQuality adjusted life years

WMOThe medical research involving human subjects act.

Electronic supplementary materialThe online version of this article doi:10.1186-1471-2466-14-71 contains supplementary material, which is available to authorized users.

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Author: Emmylou Beekman - Ilse Mesters - Erik JM Hendriks - Jean WM Muris - Geertjan Wesseling - Silvia MAA Evers - Guus M Asij

Source: https://link.springer.com/



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