Behaviour-change intervention in a multicentre, randomised, placebo-controlled COPD study: methodological considerations and implementation

Bourbeau, Jean; Lavoie, Kim; Sedeno, Maria; Sousa, Dorothy De; Eržen, Damijan; Hamilton, Alan; Maltais, François; Troosters, Thierry; Leidy, Nancy Kline

doi:10.1136/bmjopen-2015-010109

Cited by 25 publications

(22 citation statements)

References 35 publications

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“… 22 Indeed, modifying behavior is a much more complex process than the provision of drug treatment for patients. 34 Importantly, the initial increase in physical activity was not lost in patients receiving AB/FF when the BI was added, which is encouraging.…”

Section: Discussionmentioning

confidence: 78%

ACTIVATE: the effect of aclidinium/formoterol on hyperinflation, exercise capacity, and physical activity in patients with COPD

Watz¹,

Troosters²,

Beeh³

et al. 2017

COPD

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The Phase IV, 8-week, randomized, double-blind, placebo-controlled ACTIVATE study (NCT02424344) evaluated the effect of aclidinium/formoterol (AB/FF) 400/12 μg twice daily on lung hyperinflation, exercise capacity, and physical activity in patients with moderate-to-severe COPD. Patients received AB/FF (n=134) or placebo (n=133) (1:1) via the Genuair™/Pressair® dry powder inhaler for 8 weeks. From Weeks 5 to 8, all patients participated in behavioral intervention (BI; daily messages providing step goals). The primary end point was trough functional residual capacity (FRC) at Week 4. Exercise endurance time and physical activity were assessed at Week 4 (pharmacotherapy only) and at Week 8 (8 weeks of pharmacotherapy plus 4 weeks of BI). Other end points included post-dose FRC, residual volume, and inspiratory capacity (IC) at rest and during exercise. After 4 weeks, trough FRC improved with AB/FF versus placebo but did not reach significance (125 mL; P=0.0690). However, post-dose FRC, residual volume, and IC at rest improved significantly with AB/FF at Week 4 versus placebo (all P<0.0001). AB/FF significantly improved exercise endurance time and IC at isotime versus placebo at Week 4 (P<0.01 and P<0.0001, respectively) and Week 8 (P<0.05 and P<0.0001, respectively). AB/FF achieved higher step counts (P<0.01) with fewer inactive patients (P<0.0001) at Week 4 versus placebo. Following BI, AB/FF maintained improvements in physical activity at Week 8 and nonsignificant improvements were observed with placebo. AB/FF 400/12 μg demonstrated improvements in lung hyperinflation, exercise capacity, and physical activity versus placebo that were maintained following the addition of BI. A 4-week period of BI might be too short to augment the improvements of physical activity observed with AB/FF.

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Section: Discussionmentioning

confidence: 78%

ACTIVATE: the effect of aclidinium/formoterol on hyperinflation, exercise capacity, and physical activity in patients with COPD

Watz¹,

Troosters²,

Beeh³

et al. 2017

COPD

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“…Recently published protocols describe large RCTs designed to test the effects of home-based PR using motivational interviewing,61 patient-centered home and community-based PA coaching program,62 an integrated pharmacological, ET and self-management program (the PHYSACTO trial)63 and behavioral change self-management program64 on activity levels using high-quality methodology. The outcomes of these refined interventions may provide more certainty regarding the most effective interventions to improve PA in COPD.…”

Section: Discussionmentioning

confidence: 99%

Exercise training alone or with the addition of activity counseling improves physical activity levels in COPD: a systematic review and meta-analysis of randomized controlled trials

Lahham¹,

McDonald²,

Holland³

2016

COPD

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BackgroundPhysical inactivity is associated with poor outcomes in COPD, and as a result, interventions to improve physical activity (PA) are a current research focus. However, many trials have been small and inconclusive.ObjectiveThe aim of this systematic review and meta-analysis was to study the effects of randomized controlled trials (RCTs) targeting PA in COPD.MethodsDatabases (Physiotherapy Evidence Database [PEDro], Embase, MEDLINE, CINAHL and the Cochrane Central Register for Controlled Trials) were searched using the following keywords: “COPD”, “intervention” and “physical activity” from inception to May 20, 2016; published RCTs that aimed to increase PA in individuals with COPD were included. The PEDro scale was used to rate study quality. Standardized mean differences (effect sizes, ESs) with 95% confidence intervals (CIs) were determined. Effects of included interventions were also measured according to the minimal important difference (MID) in daily steps for COPD (599 daily steps).ResultsA total of 37 RCTs with 4,314 participants (mean forced expiratory volume in one second (FEV1) % predicted 50.5 [SD=10.4]) were identified. Interventions including exercise training (ET; n=3 studies, 103 participants) significantly increased PA levels in COPD compared to standard care (ES [95% CI]; 0.84 [0.44–1.25]). The addition of activity counseling to pulmonary rehabilitation (PR; n=4 studies, 140 participants) showed important effects on PA levels compared to PR alone (0.47 [0.02–0.92]), achieving significant increases that exceeded the MID for daily steps in COPD (mean difference [95% CI], 1,452 daily steps [549–2,356]). Reporting of methodological quality was poor in most included RCTs.ConclusionInterventions that included ET and PA counseling during PR were effective strategies to improve PA in COPD.

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“…All patients participate in a 12-week behaviour-change self-management programme adapted from the ‘Living Well with COPD’ programme, 43 which consists of a self-management educational programme, support from a Site Case Manager (SCM) and evaluation using standardised questionnaires to monitor patients' motivation, confidence and movement through stages of change. This is described in detail in Bourbeau et al 35 Patients also receive a step-counter (OMRON HJ-321) to track their physical activity in real time towards achievement of their step-counter goals.…”

Section: Methodsmentioning

confidence: 99%

“… 34 The importance of behaviour change is reflected in the PHYSACTO trial by the inclusion of a standardised behaviour-change programme that is implemented in all treatment arms. This is described in the parallel publication by Bourbeau et al 35 …”

Section: Introductionmentioning

confidence: 94%

Enhancing exercise tolerance and physical activity in COPD with combined pharmacological and non-pharmacological interventions: PHYSACTO randomised, placebo-controlled study design

et al. 2016

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IntroductionChronic obstructive pulmonary disease (COPD) is associated with exercise limitation and physical inactivity, which are believed to have significant long-term negative health consequences for patients. While a number of COPD treatments and exercise training programmes increase exercise capacity, there is limited evidence for their effects on physical activity levels, with no clear association between exercise capacity and physical activity in clinical trials. Physical activity depends on a number of behaviour, environmental and physiological factors. We describe the design of the PHYSACTO trial, which is investigating the effects of bronchodilators, either alone or with exercise training, in combination with a standardised behaviour-change self-management programme, on exercise capacity and physical activity in patients with COPD. It is hypothesised that bronchodilators in conjunction with a behaviour-change self-management programme will improve physical activity and that this effect will be amplified by the addition of exercise training.Methods and analysisPatients are being recruited from 34 sites in Australia, New Zealand, the USA, Canada and Europe. Patients receiving a multicomponent intervention designed to support behaviour change related to physical activity are randomised to four treatment arms: placebo, tiotropium, tiotropium+olodaterol, and tiotropium+olodaterol+exercise training. The primary outcome is improvement in exercise capacity after 8 weeks, measured by endurance time during a shuttle walk test. The secondary outcome is improvement in physical activity, including objective accelerometer assessment and patient-reported functioning using the Functional Performance Inventory—Short Form and the novel hybrid PROactive instrument. Additionally, the influence of moderating variables (ie, factors influencing a patient's choice to be physically active) on increases in physical activity is also explored.Ethics and disseminationThe study has been approved by the relevant Institutional Review Boards, Independent Ethics Committee and Competent Authority according to national and international regulations. The findings of the trial will be disseminated through relevant peer-reviewed journals and international conference presentations.Trial registration numberNCT02085161.

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Behaviour-change intervention in a multicentre, randomised, placebo-controlled COPD study: methodological considerations and implementation

Cited by 25 publications

References 35 publications

ACTIVATE: the effect of aclidinium/formoterol on hyperinflation, exercise capacity, and physical activity in patients with COPD

ACTIVATE: the effect of aclidinium/formoterol on hyperinflation, exercise capacity, and physical activity in patients with COPD

Exercise training alone or with the addition of activity counseling improves physical activity levels in COPD: a systematic review and meta-analysis of randomized controlled trials

Enhancing exercise tolerance and physical activity in COPD with combined pharmacological and non-pharmacological interventions: PHYSACTO randomised, placebo-controlled study design

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