Sustaining training effects through physical activity coaching (STEP): a randomized controlled trial.

BACKGROUND: Pulmonary rehabilitation (PR) programs improve physical fitness, symptoms and quality of life (QoL) of patients with COPD. However, improved physical activity (PA) is not guaranteed after PR and the clinical benefits fade off after PR discharge. We aimed to investigate whether a 9 months PA-telecoaching program is able to improve PA of patients with COPD, after 3 months of PR and if this leads to maintenance of PR-acquired benefits. METHODS: Patients with COPD enrolled in a 6-month PR program were randomized to a (semi-automated) PA-telecoaching program or usual care, 3 months after PR initiation. The intervention consisted of a smartphone application with individual targets and feedback (for 6 months) and self-monitoring with a step counter (for 9 months). Patients were followed up for 9 months after randomization. Primary outcome was PA (daily step count by accelerometery), secondary outcomes were exercise tolerance, quadriceps force, dyspnea and QoL. RESULTS: Seventy-three patients were included (mean ± SD: 65 ± 7 years, FEV1 49 ± 19%, 6MWD 506 ± 75 m, PA 5225 ± 2646 steps/day). The intervention group presented a significant improvement in steps/day at every visit compared to usual care (between-group differences mean ± SE: 1431 ± 555 steps/day at 9 months after randomization, p = 0.01). Secondary outcomes did not differ between the groups. CONCLUSION: The semi-automated PA-telecoaching program implemented after 3 months of PR was effective to improve the amount of PA (steps/day) during PR and after follow-up. However, this was not accompanied by the maintenance of other PR-acquired benefits. TRIAL REGISTRATION: ClinicalTrials.gov. Identifier: NCT02702791. Retrospectively registered on March 9, 2016. Start study October 2015. https://clinicaltrials.gov/ct2/show/NCT02702791?term=NCT02702791&draw=2&rank=1 .

Efficacy, durability, and tolerability of dolutegravir/lamivudine and dolutegravir/rilpivirine for the treatment of HIV in a real-world setting in Belgium.

OBJECTIVES: A paradigm shift from three-drug regimens to two-drug regimens (2DRs) is currently taking place in real-world clinical practice. This study aimed to describe the efficacy, durability, and tolerability of dolutegravir (DTG)/lamivudine (3TC) and DTG/rilpivirine (RPV) in a real-world setting. METHODS: This was a retrospective, observational, multicentre (ten centres in Belgium) study involving adult treatment-naïve and treatment-experienced people living with HIV on DTG/3TC or DTG/RPV between 1 January 2019 and 30 September 2020. The primary endpoint was rate of virological suppression (VS; plasma HIV-1 viral load [VL] <50 copies/ml) using an on-treatment analysis. Main secondary endpoints included the proportion of people that experienced loss of VS (LVS; defined as two consecutive HIV-1 VLs of >200 copies/ml after initially achieving VS) and a resistance analysis at the time of LVS; rate, incidence, and reasons for discontinuation of treatment (stopping treatment or changing any component of the 2DR); and change in weight, along with the proportion of people reporting a >10% weight gain. Ordinal logistic regression analysis examined associations between baseline variables and >10% on-treatment weight gain. RESULTS: Overall, 948 people were included, of whom 734 (77%) were on DTG/3TC and 214 (23%) were on DTG/RPV. Baseline characteristics included 54% aged ≥50 years, 31% female, 31% Black sub-Saharan African, 95% treatment-experienced, and 8% with HIV-1 VL ≥50 copies/ml. Through 48 weeks, the rate of VS for the overall cohort was 98.3% (99.1% with 3TC; 96.2% with RPV). LVS was observed in 0.5% (n = 5) of the overall population (n = 1 [3TC group], n = 4 [RPV group]). There were 40 treatment discontinuations (4.2%, n = 27 [3TC group]; n = 13 [RPV group]), corresponding to an incidence of 4.7 per 100 patient-years. The most common reason for discontinuation was an adverse event (1.4%), with neurotoxicity the most frequent (0.5%). Median on-treatment weight gain at week 48 was 1 kg (interquartile range [IQR] -1-3) overall, 1 kg (IQR -1-3) in the 3TC group, and 2 kg (IQR 0-4) in the RPV group. A >10% weight increase was observed in 6.3% of people. Regression analysis showed that being on a tenofovir disoproxil fumarate-based regimen prior to 2DR initiation was the only variable associated with a >10% increase in weight from baseline (odds ratio 3.48; 95% confidence interval 1.13-10.68; p = 0.038). CONCLUSION: In this real-world analysis, the 2DRs analysed were effective, durable, and safe for those who were treatment-naive and treatment-experienced. A slight increase in weight was associated with these regimens.

Effects of downhill walking in pulmonary rehabilitation for patients with COPD: a randomised controlled trial.

The development of contractile muscle fatigue (CMF) affects training responses in patients with chronic obstructive pulmonary disease (COPD). Downhill walking induces CMF with lower dyspnoea and fatigue than level walking. This study compared the effect of pulmonary rehabilitation (PR) comprising downhill walking training (DT) to PR comprising level walking (conventional training (CT)) in patients with COPD.In this randomised controlled trial, 35 patients (62±8 years; forced expiratory volume in 1 s (FEV1) 50±17% predicted) were randomised to DT or CT. Exercise tolerance (6-minute walk test distance (6MWD); primary outcome), muscle function, symptoms, quality-of-life and physical activity levels were assessed before and after PR. Absolute training changes and the proportion of patients exceeding the 30 m 6MWD minimally important difference (MID) were compared between groups. Quadriceps muscle biopsies were collected after PR in a subset of patients to examine physiological responses to long-term eccentric training.No between-group differences were observed in absolute 6MWD improvement (mean 6MWD change 77±46 m DT versus 56±47 m CT; p=0.45), however 94% of patients in DT exceeded the 6MWD MID compared to 65% in CT (p=0.03). Patients in DT tended to have larger improvements than CT in other outcomes. Muscle biopsy analyses did not differ between groups.PR incorporating downhill walking confers similar magnitudes of effects to PR with conventional walking across clinical outcomes in patients with COPD, however, offers a more reliable stimulus to maximise the achievement of clinically relevant gains in functional exercise tolerance in people with COPD.

Health status deterioration in subjects with mild to moderate airflow obstruction, a six years observational study.

BACKGROUND: Patients with COPD need to cope with a disabling disease, which leads to health status impairment. AIM: To investigate the long term change of health status in subjects with mild to moderate airflow obstruction and to compare this to subjects without airflow obstruction, with and without a smoking history. Second, to investigate the factors potentially associated to rapid health status decline in our total cohort. METHODS: Two hundred and one subjects were included. Generic [Short form 36 health survey (SF36) and EuroQol - 5 dimensions (EQ-5D)] and disease specific [Clinical COPD questionnaire (CCQ) and COPD Assessment Test (CAT)] health status questionnaires were regularly repeated over a six years period. Other functional outcomes comprised measures of lung function, physical fitness, physical activity and emotional state. RESULTS: On average, health status decline did not differ between groups with the exception of the EQ-5D index, which deteriorated faster in subjects with airflow obstruction compared to the never smoking control group [- 0.018(0.008) versus 0.00006(0.003), p = 0.03]. Subjects presenting at least one exacerbation had faster rate of deterioration measured with CAT [0.91(0.21) versus - 0.26(0.25), p < 0.01]. Characteristics of the fast declining group were older age, worse lung function, physical fitness, physical activity and disease specific baseline health status. Subjects with airflow obstruction had a 2.5 (95% CI 1.36-4.71) higher risk of presenting fast overall health status decline. Fast overall decline was associated with the presence of acute exacerbation(s) (44% of the subjects with exacerbation(s) versus 17% of subjects without exacerbation, p = 0.03). Changes in fat free mass, functional exercise capacity and in symptoms of anxiety and depression correlated weakly to changes in health status measured with all questionnaires. CONCLUSION: Subjects with mild airflow obstruction present a significant deterioration of health status, which is generally not much faster compared to smoking and never smoking controls. Subjects with fast decline in overall health status are older and more likely to have airflow obstruction, acute respiratory exacerbation(s), reduced physical fitness, physical activity and impaired COPD specific health status at baseline. TRIAL REGISTRATION: NCT01314807 - retrospectively registered on March 2011.

The likelihood of improving physical activity after pulmonary rehabilitation is increased in patients with COPD who have better exercise tolerance.

PURPOSE: Pulmonary rehabilitation (PR) enhances exercise tolerance in patients with COPD; however, improvements in physical activity (PA) are not guaranteed. This study explored the relationship between baseline exercise tolerance and changes in PA after PR. MATERIALS AND METHODS: Patient data from prospective clinical trials in the PR settings of Athens and Leuven (2008-2016) were analyzed. Validated PA monitors were worn for 1 week before and after a 12-week program. The proportion of patients who improved PA levels ≥1,000 steps/day ("PA responders") after PR was compared between those with initial 6-minute walk distance [6MWDi] <350 m and ≥350 m. Baseline predictors of PA change were evaluated via univariate and multivariate logistic regression analyses. RESULTS: Two hundred thirty-six patients with COPD (median [IQR] FEV1 44 [33-59] % predicted, age 65±8 years, 6MWDi 416 [332-486] m) were included. The proportion of "PA responders" after PR was significantly greater in those with higher vs lower 6MWDi (37.9% vs 16.4%, respectively; P<0.001). 6MWDi group classification was the strongest baseline independent predictor of PA improvement (univariate OR 3.10, 95% CI 1.51-6.36). CONCLUSION: The likelihood of improving PA after PR is increased with greater 6MWDi. Baseline exercise tolerance appears as an important stratification metric for future research in this field.

Six years progression of exercise capacity in subjects with mild to moderate airflow obstruction, smoking and never smoking controls.

BACKGROUND: Exercise capacity is an important feature in patients with COPD. Its impairment drives disability and dependency for daily activities performance. This study evaluated the six years change in exercise capacity in subjects with airflow obstruction and compared this to subjects without airflow obstruction, with and without a smoking history. METHODS: Cardiopulmonary exercise tests (CPET) were repeatedly performed during a six years follow up period. Peak oxygen uptake (VO2peak), work rate (WRpeak), heart rate (HRpeak), minute ventilation (VEpeak), respiratory exchange ratio (RERpeak) and ventilatory reserve (VE/MVV) were collected as effort dependent outcomes. The slopes of oxygen uptake, ventilatory and mechanical efficiency (OUES, ΔVE/ΔVCO2 and ΔVO2/ΔWR) were collected as effort independent outcomes. RESULTS: One hundred and thirty-eight subjects were included. Thirty-eight presented airflow obstruction (63±6 years, 74% men, FEV1 90±15%pred), 44 had a smoking history but no airflow obstruction (61±5 years, 61% men, FEV1 105±15%pred) and 56 had never smoked (61±7 years, 57% men, FEV1 117±18%pred). At baseline, the airflow obstruction group had slightly worse exercise capacity in comparison to the never smoking control group, in absolute terms and expressed as percentage of the predicted value (VO2peak = 27±5 versus 32±8 ml/min/kg, p<0.01; 112±29 versus 130±33%pred, p = 0.04). Most exercise variables showed a statistically significant yearly deterioration, with exception of VE/MVV, ΔVE/ΔVCO2 and ΔVO2/ΔWR. The yearly decline in VO2peak and OUES was not faster in subjects with airflow obstruction than in smoking and never smoking controls (VO2peak -67 (9) versus -76 (9) ml/min, p = 0.44 and versus -58 (9), p = 0.47; OUES -32 (11) versus -68 (10), p = 0.03 and versus -68 (13), p = 0.03). CONCLUSIONS: With exception of VO2peak, effort dependent variables deteriorated faster in subjects with airflow obstruction compared to never smoking controls. The deterioration of effort independent variables, however, was not accelerated in the airflow obstruction group compared to controls.

Smartphone-Based Physical Activity Telecoaching in Chronic Obstructive Pulmonary Disease: Mixed-Methods Study on Patient Experiences and Lessons for Implementation.

BACKGROUND: Telecoaching approaches can enhance physical activity (PA) in patients with chronic obstructive pulmonary disease (COPD). However, their effectiveness is likely to be influenced by intervention-specific characteristics. OBJECTIVE: This study aimed to assess the acceptability, actual usage, and feasibility of a complex PA telecoaching intervention from both patient and coach perspectives and link these to the effectiveness of the intervention. METHODS: We conducted a mixed-methods study based on the completers of the intervention group (N=159) included in an (effective) 12-week PA telecoaching intervention. This semiautomated telecoaching intervention consisted of a step counter and a smartphone app. Data from a project-tailored questionnaire (quantitative data) were combined with data from patient interviews and a coach focus group (qualitative data) to investigate patient and coach acceptability, actual usage, and feasibility of the intervention. The degree of actual usage of the smartphone and step counter was also derived from app data. Both actual usage and perception of feasibility were linked to objectively measured change in PA. RESULTS: The intervention was well accepted and perceived as feasible by all coaches present in the focus group as well by patients, with 89.3% (142/159) of patients indicating that they enjoyed taking part. Only a minority of patients (8.2%; 13/159) reported that they found it difficult to use the smartphone. Actual usage of the step counter was excellent, with patients wearing it for a median (25th-75th percentiles) of 6.3 (5.8-6.8) days per week, which did not change over time (P=.98). The smartphone interface was used less frequently and actual usage of all daily tasks decreased significantly over time (P<.001). Patients needing more contact time had a smaller increase in PA, with mean (SD) of +193 (SD 2375) steps per day, +907 (SD 2306) steps per day, and +1489 (SD 2310) steps per day in high, medium, and low contact time groups, respectively; P for-trend=.01. The overall actual usage of the different components of the intervention was not associated with change in step count in the total group (P=.63). CONCLUSIONS: The 12-week semiautomated PA telecoaching intervention was well accepted and feasible for patients with COPD and their coaches. The actual usage of the step counter was excellent, whereas actual usage of the smartphone tasks was lower and decreased over time. Patients who required more contact experienced less PA benefits. TRIAL REGISTRATION: ClinicalTrials.gov NCT02158065; http://clinicaltrials.gov/ct2/show/NCT02158065 (Archived by WebCite at http://www.webcitation.org/73bsaudy9).

Principles of rehabilitation and reactivation.

Skeletal muscle dysfunction and physical inactivity are two clinically important features of a wide range of acute and chronic respiratory conditions. Optimisation of both of these features is important in order to improve physical function, prevent clinical deterioration and maximise community participation. One of the most potent and evidence-based interventions to address these physical deficits is pulmonary rehabilitation (PR). Whilst the majority of PR research has been conducted in patients with chronic obstructive pulmonary disease, there is widespread recognition that PR can benefit many other respiratory patient groups. These include patients with interstitial lung diseases, asthma, pulmonary hypertension, pre-/post-lung surgery (e.g. lung cancer, transplantation) and cystic fibrosis to name a few. Exercise training must be appropriately prescribed by a skilled healthcare professional with comprehensive knowledge of the pathology and physiology of these conditions, as well as a sound understanding of the exercise physiology and core principles of exercise prescription, monitoring and progression. It has also become increasingly recognised that people with respiratory conditions, particularly those with chronic disease, are considerably less active than those of good health. PR should therefore aim to induce behavioural change to facilitate the adoption and maintenance of an active lifestyle. In addition, PR should pay attention to the psychological well-being of patients and self-management of their lung disease in all its aspects. To that end, multidisciplinary individualised programs should be offered. This review sets the scene of PR principles for a series of papers that will focus on specific diseases other than chronic obstructive pulmonary disease where rehabilitation may offer a clinically important aspect of care over and above conventional pharmacological treatment.