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Objective

To evaluate the effect of quadriceps functional electrical stimulation (FES)-cycling on exertional oxygen uptake (V˙o2) compared with placebo FES-cycling in patients with chronic obstructive pulmonary disease (COPD).

Design

A randomized, single-blind, placebo-controlled crossover trial.

Setting

Pulmonary rehabilitation department.

Participants

Consecutive patients (N=23) with COPD Global Initiative for Chronic Obstructive Lung Disease stage 2, 3, or 4 (mean forced expiratory volume during the first second, 1.4±0.4L [50.3% predicted]) who had recently begun a respiratory rehabilitation program.

Intervention

Two consecutive 30-minute sessions were carried out at a constant load with active and placebo FES-cycling.

Main Outcome Measures

The primary outcome was mean V˙o2 during the 30-minute exercise session. The secondary outcomes were respiratory gas exchange and hemodynamic parameters averaged over the 30-minute endurance session. Lactate values, dyspnea, and perceived muscle fatigue were evaluated at the end of the sessions.

Results

FES-cycling increased the physiological response more than the placebo, with a greater V˙o2 achieved of 36.6mL/min (95% confidence interval [CI], 8.9–64.3mL/min) (P=.01). There was also a greater increase in lactate after FES-cycling (+1.5mmol/L [95% CI, .05–2.9mmol/L]; P=.01). FES-cycling did not change dyspnea or muscle fatigue compared with the placebo condition.

Conclusions

FES-cycling effectively increased exercise intensity in patients with COPD. Further studies should evaluate longer-term FES-cycling rehabilitation programs.  相似文献   

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Introduction

The superiority of tiotropium/olodaterol is demonstrated in improvement of lung function, dyspnea, lung hyperinflation, and quality of life compared with either monotherapy in patients with chronic obstructive pulmonary disease (COPD). Japanese Respiratory Society Guidelines for COPD management include improvement of exercise tolerance and daily physical activity as the treatment goals; however, there is limited evidence in Japanese patients with COPD.

Methods

A protocol is developed for the VESUTO® study that investigates the efficacy of tiotropium/olodaterol fixed-dose combination (FDC) compared with tiotropium alone on inspiratory capacity (IC, volume from functional residual capacity to total lung capacity), exercise capacity, and daily physical activity in Japanese patients with COPD.

Results

A total of 180 Japanese patients with COPD, aged ≥40 years will be enrolled into the double-blind, multicenter, active-controlled, crossover study (NCT02629965) and will be randomized to receive either tiotropium/olodaterol FDC or tiotropium for 6 weeks each [two puffs via RESPIMAT® (Boehringer Ingelheim, Ingelheim, Germany) inhaler in the morning]. The primary endpoint is IC at rest measured at 60 min post-dose after 6 weeks treatment. The secondary endpoints include the 6-min walk distance (6MWD) at 90 min post-dose and physical activity measured by the activity monitor in the last 2 weeks of the 6-week treatment periods. Lung function tests will also be assessed after 6 weeks treatment. A mixed-effects model repeated measures approach will be used for the primary and secondary endpoints.

Conclusion

The VESUTO® study is the first randomized interventional study to investigate exercise capacity (6MWD) and physical activity measured by a 3-axis accelerometer in Japanese patients with COPD. The study could provide additional evidence of long-acting muscarinic antagonist (LAMA) + long-acting β2-agonist (LABA) combination therapy on patients’ physical activities as well as lung function.

Trial registration

ClinicalTrials.gov: NCT02629965 (registered on December 1, 2015).

Funding

The VESUTO study was funded by Nippon Boehringer Ingelheim Co., Ltd., Tokyo, Japan.
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OBJECTIVE

To compare the effectiveness of diabetes prevention strategies addressing postpartum weight retention for women with gestational diabetes mellitus (GDM) delivered at the health system level: mailed recommendations (usual care) versus usual care plus a Diabetes Prevention Program (DPP)–derived lifestyle intervention.

RESEARCH DESIGN AND METHODS

This study was a cluster randomized controlled trial of 44 medical facilities (including 2,280 women with GDM) randomized to intervention or usual care. The intervention included mailed gestational weight gain recommendations plus 13 telephone sessions between 6 weeks and 6 months postpartum. Primary outcomes included the following: proportion meeting the postpartum goals of 1) reaching pregravid weight if pregravid BMI <25.0 kg/m2 or 2) losing 5% of pregravid weight if BMI ≥25.0 kg/m2; and pregravid to postpartum weight change.

RESULTS

On average, over the 12-month postpartum period, women in the intervention had significantly higher odds of meeting weight goals than women in usual care (odds ratio [OR] 1.28 [95% CI 1.10, 1.47]). The proportion meeting weight goals was significantly higher in the intervention than usual care at 6 weeks (25.5 vs. 22.4%; OR 1.17 [1.01, 1.36]) and 6 months (30.6 vs. 23.9%; OR 1.45 [1.14, 1.83]). Condition differences were reduced at 12 months (33.0 vs. 28.0%; OR 1.25 [0.96, 1.62]). At 6 months, women in the intervention retained significantly less weight than women in usual care (mean 0.39 kg [SD 5.5] vs. 0.95 kg [5.5]; mean condition difference −0.64 kg [95% CI −1.13, −0.14]) and had greater increases in vigorous-intensity physical activity (mean condition difference 15.4 min/week [4.9, 25.8]).

CONCLUSIONS

A DPP-derived lifestyle intervention modestly reduced postpartum weight retention and increased vigorous-intensity physical activity.  相似文献   

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