Background This prospective, randomized controlled clinical trial compared changes in exercise performance and daily ambulatory activity in peripheral artery disease (PAD) patients with intermittent claudication following a home-based exercise program, a supervised exercise program, and usual care control. Methods and Results Of 119 patients randomized, 29 completed home-based exercise, 33 completed supervised exercise, and 30 completed usual care control. Both exercise programs consisted of intermittent walking to near maximal claudication pain for 12 weeks. Patients wore a step activity monitor during each exercise session. Primary outcome measures included claudication onset time (COT) and peak walking time (PWT) obtained from a treadmill exercise test, and secondary outcome measures included daily ambulatory cadences measured during a 7-day monitoring period. Adherence to home-based and supervised exercise was similar (p = 0.712) and exceeded 80%. Both exercise programs increased COT (p < 0.001) and PWT (p < 0.01), whereas only home-based exercise increased daily average cadence (p < 0.01). No changes were seen in the control group (p > 0.05). The changes in COT and PWT were similar between the two exercise groups (p > 0.05), whereas the change in daily average cadence was greater with home-based exercise (p < 0.05). Conclusions A home-based exercise program, quantified with a step activity monitor, has high adherence and is efficacious in improving claudication measures similar to that seen with a standard supervised exercise program. Furthermore, home-based exercise appears more efficacious in increasing daily ambulatory activity in the community setting than supervised exercise.

BackgroundThis prospective, randomized, controlled clinical trial compared changes in primary outcome measures of claudication onset time (COT) and peak walking time (PWT), and secondary outcomes of submaximal exercise performance, daily ambulatory activity, vascular function, inflammation, and calf muscle hemoglobin oxygen saturation (StO2) in patients with symptomatic peripheral artery disease (PAD) following new exercise training using a step watch (NEXT Step) home‐exercise program, a supervised exercise program, and an attention‐control group.Methods and ResultsOne hundred eighty patients were randomized. The NEXT Step program and the supervised exercise program consisted of intermittent walking to mild‐to‐moderate claudication pain for 12 weeks, whereas the controls performed light resistance training. Change scores for COT (P<0.001), PWT (P<0.001), 6‐minute walk distance (P=0.028), daily average cadence (P=0.011), time to minimum calf muscle StO2 during exercise (P=0.025), large‐artery elasticity index (LAEI) (P=0.012), and high‐sensitivity C‐reactive protein (hsCRP) (P=0.041) were significantly different among the 3 groups. Both the NEXT Step home program and the supervised exercise program demonstrated a significant increase from baseline in COT, PWT, 6‐minute walk distance, daily average cadence, and time to minimum calf StO2. Only the NEXT Step home group had improvements from baseline in LAEI, and hsCRP (P<0.05).ConclusionsNEXT Step home exercise utilizing minimal staff supervision has low attrition, high adherence, and is efficacious in improving COT and PWT, as well as secondary outcomes of submaximal exercise performance, daily ambulatory activity, vascular function, inflammation, and calf muscle StO2 in symptomatic patients with PAD.Clinical Trial RegistrationURL: ClinicalTrials.gov. Unique Identifier: NCT00618670.

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Intermittent claudication is associated with lower total daily ambulatory activity owing both to less time ambulating and to fewer strides taken while ambulating, particularly at moderate and high cadences.

Objective Green tea (Camellia sinensis) has shown to exert cardio-protective benefits in observational studies. The objective of this clinical trial was to assess the effects of green tea on features of metabolic syndrome and inflammation in obese subjects. Methods We conducted a randomized controlled trial in obese subjects with metabolic syndrome. Thirty-five subjects [age (mean±SE) 42.5±1.7 years, BMI 36.1±1.3 kg/m2] completed the 8-week study and were randomly assigned to receive green tea (4 cups/day), green tea extract (2 capsules and 4 cups water/day), or no treatment (4 cups water/day). Both the beverage and extract groups had similar dosing of epigallocatechin-3-gallate (EGCG), the active green tea polyphenol. Fasting blood samples were collected at screening, four, and eight weeks of the study. Results Green tea beverage or extract supplementation did not significantly alter features of metabolic syndrome or biomarkers of inflammation including adiponectin, C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-1β (IL-1β), soluble vascular cell adhesion molecule-1 (sVCAM-1), soluble intercellular adhesion molecule-1 (sICAM-1), leptin, or leptin:adiponectin ratio. However, both green tea beverage and extracts significantly reduced plasma serum amyloid alpha (SAA) versus no treatment (p<0.005). Conclusion This study suggests that the daily consumption of green tea beverage or extracts for 8 weeks was well tolerated but did not affect the features of metabolic syndrome. However, green tea significantly reduced plasma SAA, an independent CVD risk factor, in obese subjects with metabolic syndrome.