Effects of a Partially Supervised Conditioning Program in Cystic Fibrosis: An International Multicenter, Randomized Controlled Trial (ACTIVATE-CF).

Rationale: The long-term effects of vigorous physical activity (PA) on lung function in cystic fibrosis are unclear. Objectives: To evaluate effects of a 12-month partially supervised PA intervention using motivational feedback. Methods: In a parallel-arm multicenter randomized controlled trial (ACTIVATE-CF), relatively inactive patients aged at least 12 years were randomly assigned (1:1 ratio) to an intervention group or control group. The intervention group consented to add 3 hours of vigorous PA per week, whereas the control group was asked not to change their PA behavior. Primary endpoint was change in percent predicted FEV1 (ΔFEV1) at 6 months. Secondary endpoints included PA, exercise capacity, exercise motives, time to first exacerbation and exacerbation rates, quality of life, anxiety, depression, stress, and blood glucose control. Data were analyzed using mixed linear models. Measurements and Main Results: A total of 117 patients (40% of target sample size) were randomized to an intervention (n = 60) or control group (n = 57). After 6 months, ΔFEV1 was significantly higher in the control group compared with the intervention group (2.70% predicted [95% confidence interval, 0.13-5.26]; P = 0.04). The intervention group reported increased vigorous PA compared with the control group at each study visit, had higher exercise capacity at 6 and 12 months, and higher PA at 12 months. No effects were seen in other secondary outcomes. Conclusions: ACTIVATE-CF increased vigorous PA and exercise capacity, with effects carried over for the subsequent 6 months, but resulted in better FEV1 in the control group.

Effects of a partially supervised conditioning programme in cystic fibrosis: an international multi-centre randomised controlled trial (ACTIVATE-CF): study protocol.

BACKGROUND: Physical activity (PA) and exercise have become an accepted and valued component of cystic fibrosis (CF) care. Regular PA and exercise can positively impact pulmonary function, improve physical fitness, and enhance health-related quality of life (HRQoL). However, motivating people to be more active is challenging. Supervised exercise programs are expensive and labour intensive, and adherence falls off significantly once supervision ends. Unsupervised or partially supervised programs are less costly and more flexible, but compliance can be more problematic. The primary objective of this study is to evaluate the effects of a partially supervised exercise intervention along with regular motivation on forced expiratory volume in 1 s (FEV1) at 6 months in a large international group of CF patients. Secondary endpoints include patient reported HRQoL, as well as levels of anxiety and depression, and control of blood sugar. METHODS/DESIGN: It is planned that a total of 292 patients with CF 12 years and older with a FEV1 ≥ 35% predicted shall be randomised. Following baseline assessments (2 visits) patients are randomised into an intervention and a control group. Thereafter, they will be seen every 3 months for assessments in their centre for one year (4 follow-up visits). Along with individual counselling to increase vigorous PA by at least 3 h per week on each clinic visit, the intervention group documents daily PA and inactivity time and receives a step counter to record their progress within a web-based diary. They also receive monthly phone calls from the study staff during the first 6 months of the study. After 6 months, they continue with the step counter and web-based programme for a further 6 months. The control group receives standard care and keeps their PA level constant during the study period. Thereafter, they receive the intervention as well. DISCUSSION: This is the first large, international multi-centre study to investigate the effects of a PA intervention in CF with motivational feedback on several health outcomes using modern technology. Should this relatively simple programme prove successful, it will be made available on a wider scale internationally. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01744561 ; Registration date: December 6, 2012.

Skeletal Muscle Function in Young Patients With Cystic Fibrosis.

PURPOSE: Defects in the gene encoding the cystic fibrosis (CF) transmembrane conductance regulator (CFTR) cause CF. Absence of the CFTR may result in skeletal muscle dysfunction. Here, we tested skeletal muscle function in male adolescent patients with CF. METHODS: Ten CF and 10 control participants (age: 16.8 ± 0.6 years) performed 7 repetitive sets of maximum voluntary contractions (MVCs) and underwent an isometric fatigue test of the knee extensors. Electromyography (EMG) activity was recorded from the m. vastus lateralis (VL) and m. vastus medialis (VM). RESULTS: In CF, the MVC torque was lower and correlated with the predicted forced expiratory volume in one second (r = .73, p = .012, n = 10). The M-wave in the VL was shorter in CF than in controls (18.6 ± 0.5 vs. 20.3 ± 0.5 ms, p < .028). In the VM, both the M-wave (4.96 ± 0.61 vs. 7.97 ± 0.60 mV, p = .001) and the EMG (0.29 ± 0.04 vs. 0.47 ± 0.04 mV, p = .004) amplitudes were smaller in CF. CONCLUSION: The differences in the VL and VM EMG signals between the groups indicate that the lower MVC torque in CF did not result from the direct impact of a CFTR defect on the sarcolemmal excitability; the differences more likely resulted from the less developed musculature in the patients with CF.

Cystic fibrosis related diabetes is not associated with maximal aerobic exercise capacity in cystic fibrosis: a cross-sectional analysis of an international multicenter trial.

BACKGROUND: Previous studies have reported differences in aerobic exercise capacity, expressed as peak oxygen uptake (VO2peak), between people with and without cystic fibrosis (CF) related diabetes (CFRD). However, none of the studies controlled for the potential influence of physical activity on VO2peak. We investigated associations between CFRD and VO2peak following rigorous control for confounders including objectively measured physical activity. METHODS: Baseline data from the international multicenter trial ACTIVATE-CF with participants ≥12 years performing up to 4 h per week of vigorous physical activity were used for this project. Multivariable models were computed to study associations between CFRD and VO2peak (mL.min-1) adjusting for a set of pre-defined covariates: age, sex, weight, forced expiratory volume in 1 s (FEV1), breathing reserve index, Pseudomonas aeruginosa infection, and physical activity (aerobic step counts from pedometry). Variables were selected based on their potential confounding effect on the association between VO2peak and CFRD. RESULTS: Among 117 randomized individuals, 103 (52% female) had a maximal exercise test and were included in the analysis. Participants with (n = 19) and without (n = 84) CFRD did not differ in FEV1, physical activity, nutritional status, and other clinical characteristics. There were also no differences in VO2peak (mL.min-1 or mL.kg-1.min-1 or% predicted). In the final multivariable model, all pre-defined covariates were significant predictors of VO2peak (mL.min-1), however CFRD [coefficient 82.1, 95% CI -69.5 to 233.8, p = 0.28] was not. CONCLUSIONS: This study suggests no meaningful differences in VO2peak between people with and without CFRD given comparable levels of physical activity.

Sinus-like versus random vibration: Acute effects on elderly people with a high risk of falling.

BACKGROUND: Whole-body vibration (WBV) could be an alternative training method for elderly with a high risk of falling. RESEARCH QUESTION: What acute effects of sinus-like and random WBV intervention occur in this risk group and how do they differ? METHODS: This prospective pilot study was performed on two days separated by a one-week wash-out phase. Twelve subjects (10 women and 2 men, age 77.7 ± 5.3; 162.3 ± 7.4 cm; 82.4 ± 15.2 kg; BMI 31.2 ± 5.1 kg/m²) undertook sinus-like WBV intervention. One week later random WBV were performed. This consisted of six intervals each lasting 60 s, with heart and respiratory rates monitored. Feasibility outcomes involved safety and compliance. The primary endpoint was postural control, measured by a static posturography before and after the first interval and complete intervention. Secondary outcomes measured before and after the intervention were a Timed-Up-and-Go-Test (TUGT) and an instrumental gait analysis. RESULTS: Random WBV intervention showed positive acute effect on postural control (Standard deviation (SD) Ellipse area p = 0.007; SD of the Center of force (CoF) independent from direction p = 0.017; SD of the CoF in the antero-posterior direction p = 0.011). There were no significant acute effects on TUGT or gait analysis (comparison between sinus-like and random WBV: Single Task: ΔVelocity p = 0.373, ΔStep time p = 0.077, ΔStep length p = 0.369, ΔStride length p = 0.408, ΔDouble-support-time p = 0.492; Dual task: ΔVelocity p = 0.580, ΔStep-time p = 0.559, ΔStep length p = 0.626, ΔStride length p = 0.584, ΔDouble-support-time p = 0.550). During sinus-like WBV, heart rate increased significantly from rest 69.7 ± 20.9bpm to max.146.0 ± 24.9bpm (p = 0.025). Respiratory rate increased significantly from 10.0 ± 1.0 to max.32.0 ± 6.0 (p = 0.011) during random WBV. No undesirable side effects were observed. SIGNIFICANCE: Findings demonstrate that random WBV improves acute functional ability of postural control, but not gait for elderly people with a high risk of falling. Intervention with WBV seems safe and well accepted by participants. Monitoring of heart and respiratory rate offers protection for subjects with heart disease.

Influence of Officially Ordered Restrictions During the First Wave of COVID-19 Pandemic on Physical Activity and Quality of Life in Patients after Kidney Transplantation in a Telemedicine Based Aftercare Program-A KTx360° Sub Study.

Guidelines recommend a healthy lifestyle and regularly physical activity (PA) after kidney transplantation (KTx). The KTx360° program is a multicenter, multisectoral, multimodal, telemedicine-based follow-up care program. Effects of the first COVID-19 wave restrictions on health-related quality of life and PA of supervised KTx360° patients were evaluated using an online questionnaire. Six hundred and fifty-two KTx360° patients were contacted via email and were asked to complete the Freiburg questionnaire of physical activity and the Short form 12 Health Survey (SF-12) online. Pre-pandemic and lockdown data were compared in 248 data sets. While sporting activity decreased during the COVID-19 pandemic, basic and leisure activity increased, resulting in increased overall activity. The physical component scale of the SF-12 was in the low normal range before as well as during the pandemic, with a small but significant increase during the pandemic. The mental component scale showed normal values before and during pandemic with a small but statistically significant decrease. Our study supports the effectiveness of a telemedicine based program for KTx patient care in maintaining PA and quality of life during the first peak of the COVID-19 pandemic. However, further research and observation during the ongoing pandemic are required.

Deviations in frequency and mode of vibration in whole-body vibration training devices with long-term and regular use.

Research regarding whole body vibration training (WBVT) and its practical use may be hindered by the fact that WBVT devices generate frequencies and/or modes of vibration different from their preset adjustments. This research aimed to clarify whether prolonged regular use can generate such deviations in frequency and mode of vibration. Three WBVT devices, each used for approximately 13 months in two research projects, were tested with an accelerometer before start of the 1st study, after four months, and after 13 months (the completion of the 2nd study). Divergences between the preset and measured frequencies were calculated for all measurements. Furthermore, the total harmonic distortion (THD), an index for signal deviations from a perfect sine wave, and the sum signal-to-modulation-noise-ratio (SMNR), an indicator of fidelity, were recorded. One device had a significantly larger machine run time than the other two, and it displayed the most pronounced signs of impaired function concerning frequency, mode of vibration, and random variability (SMNR) after prolonged use. These results indicate that prolonged use will result in divergences between the preset and actual applied frequencies as well as in the mode of vibration and other accuracy measurements.

Low-dose, non-supervised, health insurance initiated exercise for the treatment and prevention of chronic low back pain in employees. Results from a randomized controlled trial.

OBJECTIVE: Back pain is a major problem requiring pragmatic interventions, low in costs for health care providers and feasible for individuals to perform. Our objective was to test the effectiveness of a low-dose 5-month exercise intervention with small personnel investment on low back strength and self-perceived pain. METHODS: Two hundred twenty-six employees (age: 42.7±10.2 years) from three mid-size companies were randomized to 5-month non-supervised training at home (3 times/week for 20 minutes) or wait-list-control. Health insurance professionals instructed the participants on trunk exercises at the start and then supervised participants once a month. RESULTS: Muscle strength for back extension increased after the 5-month intervention with a significant between-group difference (mean 27.4 Newton [95%CI 2.2; 60.3]) favoring the exercise group (p = 0.035). Low back pain was reduced more in subjects after exercise than control (mean difference -0.74 cm [95%CI -1.17; -0.27], p = 0.002). No between-group differences were observed for back pain related disability and work ability. After stratified analysis only subjects with preexisting chronic low back pain showed a between-group difference (exercise versus controls) after the intervention in their strength for back extension (mean 55.7 Newton [95%CI 2.8; 108.5], p = 0.039), self-perceived pain (mean -1.42 cm [95%CI -2.32; -0.51], p = 0.003) and work ability (mean 2.1 points [95%CI 0.2; 4.0], p = 0.032). Significant between-group differences were not observed in subjects without low back pain: strength for back extension (mean 23.4 Newton [95%CI -11.2; 58.1], p = 0.184), self-perceived pain (mean -0.48 cm [95%CI -0.99; 0.04], p = 0.067) and work ability (mean -0.1 points [95%CI -0.9; 0.9], p = 0.999). An interaction between low back pain subgroups and the study intervention (exercise versus control) was exclusively observed for the work ability index (p = 0.016). CONCLUSION: In middle-aged employees a low-dose, non-supervised exercise program implemented over 20 weeks improved trunk muscle strength and low back pain, and in those with preexisting chronic low back pain improved work ability.

Using ICT to Support Individual Guidance in Health Promotion Programs for Increased Physical Activity.

INTRODUCTION: We report on experiences in implementing a system to support the individual guidance of training in health promotion programs aiming to increase participants' regular level of physical activity. METHODS: We used an iterative development approach considering data privacy and security aspects, followed by a phase of field testing and continuous further development. RESULTS: Our preliminary results comprise identified clinically relevant parameters, suitable data collection methods, experienced privacy and security challenges and a glance on our developed prototype system. DISCUSSION: We consider our results to be of interest for others doing related research. The most important requirements for a simple supporting system can be fulfilled with established solutions in the short run. A more adaptable and flexible system with an increased level of support in analysing the data, which we aim to achieve, leads to currently open research challenges.