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Changes in Body Mass Index and Physical Activity Predict Changes in Vitality During a Weight Loss Trial in Breast Cancer Survivors.
Kenzik, KM, Demark-Wahnefried, W, Ganz, PA, Colditz, G, Rock, CL, Rogers, LQ
Annals of behavioral medicine : a publication of the Society of Behavioral Medicine. 2018;(12):999-1009
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Abstract
BACKGROUND Breast cancer survivors rank fatigue (e.g., decreased vitality) as their number one concern affecting quality of life. Excess adiposity is associated with decreased vitality in breast cancer survivors, yet weight loss intervention trials report inconsistent effects on this parameter. METHODS This is a secondary analysis of the Exercise and Nutrition to Enhance Recovery and Good Health for You trial, in which 692 overweight or obese breast cancer survivors ≤5 years from diagnosis, initiated weight loss interventions, and completed assessments semi-annually for 2 years. Assessments included the Godin Leisure-Time Exercise Questionnaire and the SF-36 MOS vitality subscale as an inverse measure of fatigue. Multilevel structural equation models estimated the direct effects of physical activity on vitality and indirect effects through body mass index (BMI) changes. RESULTS Within-person findings show that at assessments with greater physical activity, BMI was significantly lower (B = -0.07, p < 0.001) and vitality was higher (B = 0.22, p < 0.001). However, there was no direct relationship between lower BMI and higher vitality (B = -0.11, p = 0.262) after controlling for the relationship of physical activity with BMI and physical activity with vitality. The between-person indirect effect of physical activity change through BMI change to vitality was significant (B = 0.03, p < 0.001). Participants whose physical activity was above the mean (B = 0.37, p < 0.001) and whose BMI was below the mean (B = -1.05, p < 0.001) were more likely to report greater vitality. CONCLUSION Improvements in vitality are primarily associated with increases in physical activity rather than BMI changes in this trial. Vitality was lower among survivors with higher BMI, although within-individual changes in BMI had no effect on vitality. Physical activity and weight loss share mechanistic links to vitality with physical activity potentially increasing (e.g., in an additive or synergistic manner) the effect of BMI reduction on vitality.
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Efficacy and Safety of "URSA Complex" in Subjects with Physical Fatigue: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial.
Kim, KM, Kim, MJ, Song, SW, Cho, DY, Park, KC, Yang, SW, Kim, YS, Kim, KS
Chinese medical journal. 2016;(2):129-34
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Abstract
BACKGROUND Fatigue is a common symptom both in diseases status and in healthy subjects. Various supplements and nutraceuticals for relieving of fatigue have been used. However, there are a few studies to evaluate the efficacy and the safety of the drug for fatigue alleviation, we conducted using URSA Complex to evaluate the efficacy on physical fatigue via score changes in the checklist individual strength (CIS). METHODS The study was designed as a multicenter, randomized, double-blind, placebo-controlled trial, with subjects randomized to one of the two arms, receiving either placebo or URSA Complex administered as identical capsules. The primary efficacy endpoints of this clinical trials are the ratio of improving CIS scores < 76 points in patients at the end (4 weeks). Secondary efficacy variables are as follows one is an improvement of fatigue and the other is an improvement of the liver enzyme. RESULTS The fatigue recovery rate in who had improved CIS scores of < 76 points were 70.0%, 50.9% in the therapy group and placebo group, respectively (P = 0.019). The fatigue recovery rate in CIS score was higher in URSA Complex therapy group than placebo group. The difference between therapy group and placebo group was statistically significant at 4 weeks later, but not 2 weeks. CONCLUSIONS Our results provided that the URSA Complex was effective in alleviating physical fatigue. The adverse event frequency in the therapy groups was similar to that in the placebo group.
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Effects of an 18-week exercise programme started early during breast cancer treatment: a randomised controlled trial.
Travier, N, Velthuis, MJ, Steins Bisschop, CN, van den Buijs, B, Monninkhof, EM, Backx, F, Los, M, Erdkamp, F, Bloemendal, HJ, Rodenhuis, C, et al
BMC medicine. 2015;:121
Abstract
BACKGROUND Exercise started shortly after breast cancer diagnosis might prevent or diminish fatigue complaints. The Physical Activity during Cancer Treatment (PACT) study was designed to primarily examine the effects of an 18-week exercise intervention, offered in the daily clinical practice setting and starting within 6 weeks after diagnosis, on preventing an increase in fatigue. METHODS This multi-centre controlled trial randomly assigned 204 breast cancer patients to usual care (n = 102) or supervised aerobic and resistance exercise (n = 102). By design, all patients received chemotherapy between baseline and 18 weeks. Fatigue (i.e., primary outcome at 18 weeks), quality of life, anxiety, depression, and physical fitness were measured at 18 and 36 weeks. RESULTS Intention-to-treat mixed linear model analyses showed that physical fatigue increased significantly less during cancer treatment in the intervention group compared to control (mean between-group differences at 18 weeks: -1.3; 95 % CI -2.5 to -0.1; effect size -0.30). Results for general fatigue were comparable but did not reach statistical significance (-1.0, 95%CI -2.1; 0.1; effect size -0.23). At 18 weeks, submaximal cardiorespiratory fitness and several muscle strength tests (leg extension and flexion) were significantly higher in the intervention group compared to control, whereas peak oxygen uptake did not differ between groups. At 36 weeks these differences were no longer statistically significant. Quality of life outcomes favoured the exercise group but were not significantly different between groups. CONCLUSIONS A supervised 18-week exercise programme offered early in routine care during adjuvant breast cancer treatment showed positive effects on physical fatigue, submaximal cardiorespiratory fitness, and muscle strength. Exercise early during treatment of breast cancer can be recommended. At 36 weeks, these effects were no longer statistically significant. This might have been caused by the control participants' high physical activity levels during follow-up. TRIAL REGISTRATION Current Controlled Trials ISRCTN43801571, Dutch Trial Register NTR2138. Trial registered on December 9th, 2009.