Validity and responsiveness of the Daily- and Clinical visit-PROactive Physical Activity in COPD (D-PPAC and C-PPAC) instruments

Background: The Daily-PROactive and Clinical visit-PROactive Physical Activity (D-PPAC and C-PPAC) instruments in chronic obstructive pulmonary disease (COPD) combines questionnaire with activity monitor data to measure patients' experience of physical activity. Their amount, difficulty and total scores range from 0 (worst) to 100 (best) but require further psychometric evaluation. Objective: To test reliability, validity and responsiveness, and to define minimal important difference (MID), of the D-PPAC and C-PPAC instruments, in a large population of patients with stable COPD from diverse severities, settings and countries. Methods: We used data from seven randomised controlled trials to evaluate D-PPAC and C-PPAC internal consistency and construct validity by sex, age groups, COPD severity, country and language as well as responsiveness to interventions, ability to detect change and MID. Results: We included 1324 patients (mean (SD) age 66 (8) years, forced expiratory volume in 1 s 55 (17)% predicted). Scores covered almost the full range from 0 to 100, showed strong internal consistency after stratification and correlated as a priori hypothesised with dyspnoea, health-related quality of life and exercise capacity. Difficulty scores improved after pharmacological treatment and pulmonary rehabilitation, while amount scores improved after behavioural physical activity interventions. All scores were responsive to changes in self-reported physical activity experience (both worsening and improvement) and to the occurrence of COPD exacerbations during follow-up. The MID was estimated to 6 for amount and difficulty scores and 4 for total score. Conclusions: The D-PPAC and C-PPAC instruments are reliable and valid across diverse COPD populations and responsive to pharmacological and non-pharmacological interventions and changes in clinically relevant variables

Physical activity as a crucial patient-reported outcome in Chronic Obstructive Pulmonary Disease

Physical inactivity is a hallmark of Chronic Obstructive Pulmonary Disease (COPD), which relates to outcomes relevant for patients and healthcare providers. Despite its importance, no patient reported outcome (PRO) instrument exists that captures physical activity that maximally reflects the experience of patients with COPD. The aim of the PROactive project is to develop, validate and use two PRO instruments (one for daily assessment, while the second as a clinical measure) to measure physical activity in COPD, researching and incorporating all dimensions of physical activity reported by patients. These tools are developed in accordance with the guidelines from the Food and Drug Administration (FDA) and European Medicines Agency (EMA). At the end of the first phase of the project, it has an initial version of the two PROs instruments validated. In the second phase, the PROs instruments are used and validated in several clinical trials that will determine, among other things, the utility, viability and sensitivity to change in different samples from patients with COPDLa inactivitat física és un aspecte clau en la MPOC que es relaciona amb esdeveniments de salut rellevants tant per als pacients com per als proveïdors de salut. Malgrat la importància de l’activitat física, no existeix cap instrument de resultats percebuts pels pacients (patient-reported outcomes – PRO) que capturi l'activitat física reflectint al màxim l'experiència dels pacients amb MPOC. L'objectiu del projecte PROactive és desenvolupar, validar i utilitzar dos instruments PRO (un per a l'avaluació diària, i un com a mesura clínica) per mesurar l'activitat física en la MPOC, investigant i incorporant totes les dimensions de l'activitat física reportades pels pacients. Aquestes eines es desenvolupen d'acord amb les directrius de l'Administració d'Aliments i Medicaments (FDA) i l'Agència Europea de Medicaments (EMA). Al final de la primera fase del projecte, que compta amb una versió inicial dels instruments PRO validats. A la segona fase, els qüestionaris PROs són utilitzats i validats en diversos assajos clínics que determinaran, entre altres coses, la utilitat, la viabilitat i sensibilitat al canvi en diferents mostres de pacients amb MPOC

The PROactive instruments to measure physical activity in patients with chronic obstructive pulmonary disease

No current patient-centred instrument captures all dimensions of physical activity in chronic obstructive pulmonary disease (COPD). Our objective was item reduction and initial validation of two instruments to measure physical activity in COPD.Physical activity was assessed in a 6-week, randomised, two-way cross-over, multicentre study using PROactive draft questionnaires (daily and clinical visit versions) and two activity monitors. Item reduction followed an iterative process including classical and Rasch model analyses, and input from patients and clinical experts.236 COPD patients from five European centres were included. Results indicated the concept of physical activity in COPD had two domains, labelled "amount" and "difficulty". After item reduction, the daily PROactive instrument comprised nine items and the clinical visit contained 14. Both demonstrated good model fit (person separation index >0.7). Confirmatory factor analysis supported the bidimensional structure. Both instruments had good internal consistency (Cronbach's α>0.8), test-retest reliability (intraclass correlation coefficient ≥0.9) and exhibited moderate-to-high correlations (r>0.6) with related constructs and very low correlations (r<0.3) with unrelated constructs, providing evidence for construct validity.Daily and clinical visit "PROactive physical activity in COPD" instruments are hybrid tools combining a short patient-reported outcome questionnaire and two activity monitor variables which provide simple, valid and reliable measures of physical activity in COPD patients.This study was supported by the European Commission Innovative Medicines Initiative Joint Undertaking (IMI JU #115011). This project was supported by the National Institute for Health Research Respiratory Biomedical Research Unit at the Royal Brompton and Harefield NHS Foundation Trust and Imperial College (London, UK) who part-fund Michael I. Polkey’s salary

Investigating the prognostic value of digital mobility outcomes in patients with chronic obstructive pulmonary disease: a systematic literature review and meta-analysis

Background: Reduced mobility is a central feature of COPD. Assessment of mobility outcomes that can be measured digitally (digital mobility outcomes (DMOs)) in daily life such as gait speed and steps per day is increasingly possible using devices such as pedometers and accelerometers, but the predictive value of these measures remains unclear in relation to key outcomes such as hospital admission and survival. Methods: We conducted a systematic review, nested within a larger scoping review by the MOBILISE-D consortium, addressing DMOs in a range of chronic conditions. Qualitative and quantitative analysis considering steps per day and gait speed and their association with clinical outcomes in COPD patients was performed. Results: 21 studies (6076 participants) were included. Nine studies evaluated steps per day and 11 evaluated a measure reflecting gait speed in daily life. Negative associations were demonstrated between mortality risk and steps per day (per 1000 steps) (hazard ratio (HR) 0.81, 95% CI 0.75-0.88, p<0.001), gait speed (<0.80 m·s-1) (HR 3.55, 95% CI 1.72-7.36, p<0.001) and gait speed (per 1.0 m·s-1) (HR 7.55, 95% CI 1.11-51.3, p=0.04). Fewer steps per day (per 1000) and slow gait speed (<0.80 m·s-1) were also associated with increased healthcare utilisation (HR 0.80, 95% CI 0.72-0.88, p<0.001; OR 3.36, 95% CI 1.42-7.94, p=0.01, respectively). Available evidence was of low-moderate quality with few studies eligible for meta-analysis. Conclusion: Daily step count and gait speed are negatively associated with mortality risk and other important outcomes in people with COPD and therefore may have value as prognostic indicators in clinical trials, but the quantity and quality of evidence is limited. Larger studies with consistent methodologies are called for.This work was supported by the Mobilise-D project; the Mobilise-D project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement no. 820820. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA). This publication reflects the authors’ views and neither IMI nor the European Union, EFPIA or any Associated Partners are responsible for any use that may be made of the information contained herein. H. Demeyer is a postdoctoral research fellow of the FWO-Flanders. ISGlobal acknowledges support from the grant CEX2018–000806-S funded by MCIN/AEI/ 10.13039/501100011033, and the Generalitat de Catalunya through the CERCA Program and L. Delgado-Ortiz is funded by the following grant: Contratos Predoctorales de Formación en Investigación en Salud (PFIS) 2021 of the AES with Exp. FI21/00113 from ISCIII, and the European Social Fund Plus (ESF+). This research was supported by the NIHR Imperial Biomedical Research Centre (BRC). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, the Department of Health and Social Care, the IMI, the European Union, the EFPIA or any Associated Partners. Funding information for this article has been deposited with the Crossref Funder Registry

Validity of instruments to measure physical activity may be questionable due to a lack of conceptual frameworks: a systematic review

Background: Guidance documents for the development and validation of patient-reported outcomes (PROs) advise the use of conceptual frameworks, which outline the structure of the concept that a PRO aims to measure. It is unknown whether currently available PROs are based on conceptual frameworks. This study, which was limited to a specific case, had the following aims: (i) to identify conceptual frameworks of physical activity in chronic respiratory patients or similar populations (chronic heart disease patients or the elderly) and (ii) to assess whether the development and validation of PROs to measure physical activity in these populations were based on a conceptual framework of physical activity. Methods: Two systematic reviews were conducted through searches of the Medline, Embase, PsycINFO, and Cinahl databases prior to January 2010. Results: In the first review, only 2 out of 581 references pertaining to physical activity in the defined populations provided a conceptual framework of physical activity in COPD patients. In the second review, out of 103 studies developing PROs to measure physical activity or related constructs, none were based on a conceptual framework of physical activity. Conclusions: These findings raise concerns about how the large body of evidence from studies that use physical activity PRO instruments should be evaluated by health care providers, guideline developers, and regulatory agencies.This work was conducted within the PROactive project which is funded by the Innovative Medicines Initiative Joint Undertaking [IMI JU # 115011]. JGA has a researcher contract from the Instituto de Salud Carlos III (CP05/00118), Ministry of Health, Spain. CIBERESP is funded by the Instituto de Salud Carlos III, Ministry of Health, Spai

Nordic walking enhances oxygen uptake without increasing the rate of perceived exertion in patients with chronic obstructive pulmonary disease

Background: In healthy subjects, Nordic walking (NW) generates higher oxygen uptake (V˙O2) than standard walking at an equal rate of perceived exertion (RPE). The feasibility and positive outcomes of NW in patients with chronic obstructive pulmonary disease (COPD) have been reported. Objectives: The aim of the current study is to assess the physiological responses and RPE during NW in COPD patients. Methods: In 15 COPD patients [mean (SD) age 67 (9) years] with a forced expiratory volume in the 1st s of 55% (15)], V˙O2, minute ventilation and heart rate were measured with a portable system during the 6-min walking test (6MWT), incremental shuttle walking test (SWT), 6-min NW on solid ground (6mNWground) and 6-min NW on soft dry beach sand (6mNWsand). The RPE using a modified Borg scale was assessed after each test. Results: 6mNWground and 6mNWsand showed a higher V˙O2 plateau compared with the 6MWT and peak V˙O2 measured during SWT [mean (SD) V˙O2 21 (3), 22 (4), 18 (4) and 19 (5) ml·kg-1·min-1, respectively; p < 0.05 each]. However, no differences in RPE were observed among 6mNWground, 6MWT and SWT [modified Borg scale score for dyspnea 4.2 (2.0), 4.1 (1.8) and 4.3 (1.7), respectively; nonsignificant]. However, RPE in 6mNWsand was significantly higher than in all the other exercise protocols [modified Borg scale score for dyspnea 5.2 (2.2); p < 0.05]. Conclusions: In COPD patients, the use of Nordic poles generates higher V˙O2 than standard walking with no differences in the dyspnea score. The results indicate the potential to enhance community-based training programs in these patients

Effects of a combined community exercise program in obstructive sleep apnea syndrome : a randomized clinical trial

Physical activity is associated with a decreased prevalence of obstructive sleep apnea and improved sleep efficiency. Studies on the effects of a comprehensive exercise program in a community setting remain limited. Our objective was to investigate the effects of a combined physical and oropharyngeal exercise program on the apnea-hypopnea index in patients with moderate to severe obstructive sleep apnea. This was a randomized clinical trial where the intervention group followed an eight-week urban-walking program, oropharyngeal exercises, and diet and sleep recommendations. The control group followed diet and sleep recommendations. A total of 33 patients were enrolled and randomized and, finally, 27 patients were included in the study (IG, 14; CG, 13) Obstructive sleep apnea patients were analyzed with a median age of 67 (52–74) and median apnea-hypopnea index of 32 events/h (25–41). The apnea-hypopnea index did not differ between groups pre- and post-intervention. However, in intervention patients younger than 60 (n = 6) a reduction of the apnea-hypopnea index from 29.5 (21.8–48.3) to 15.5 (11–34) events/h (p = 0.028) was observed. While a comprehensive multimodal program does not modify the apnea-hypopnea index, it could reduce body weight and increase the walking distance of patients with moderate to severe obstructive sleep apnea. Patients younger than 60 may also present a decreased apnea-hypopnea index after intervention

Long-term efficacy and effectiveness of a behavioural and community-based exercise intervention (Urban Training) to increase physical activity in patients with COPD: a randomised controlled trial

There is a need to increase and maintain physical activity in patients with chronic obstructive pulmonary disease (COPD). We assessed 12-month efficacy and effectiveness of the Urban Training intervention on physical activity in COPD patients.This randomised controlled trial (NCT01897298) allocated 407 COPD patients from primary and hospital settings 1:1 to usual care (n=205) or Urban Training (n=202). Urban Training consisted of a baseline motivational interview, advice to walk on urban trails designed for COPD patients in outdoor public spaces and other optional components for feedback, motivation, information and support (pedometer, calendar, physical activity brochure, website, phone text messages, walking groups and a phone number). The primary outcome was 12-month change in steps·day-1 measured by accelerometer.Efficacy analysis (with per-protocol analysis set, n=233 classified as adherent to the assigned intervention) showed adjusted (95% CI) 12-month difference +957 (184-1731) steps·day-1 between Urban Training and usual care. Effectiveness analysis (with intention-to-treat analysis set, n=280 patients completing the study at 12 months including unwilling and self-reported non-adherent patients) showed no differences between groups. Leg muscle pain during walks was more frequently reported in Urban Training than usual care, without differences in any of the other adverse events.Urban Training, combining behavioural strategies with unsupervised outdoor walking, was efficacious in increasing physical activity after 12 months in COPD patients, with few safety concerns. However, it was ineffective in the full population including unwilling and self-reported non-adherent patients