| ObjectiveThe study is on the basis of standardizing and modifying the nourishing Spleen and replenishing Kidney medicated diet Ci Ji Zhou,to apply the Ci Ji Zhou in frail elderly in community,to explore the medicated diet to improve frailty status,nutritional status,fhysical activity,and quality of life in frail elderly,and to lay a theoretical foundation for further mechanism research.The study also aimed to provide an economical and effective nutrition supplement method for the frail elderly,to give full play to the characteristics and advantages of Chinese medicated diet in preventing and treating diseases,health care and rehabilitation,promoting the development of the Chinese medicated diet.MethodThe study was a randomized controlled trial.From February to Octorber 2017 in Hua chuan community,Long quan yi district,Chengdu,72 consecutive frail elderly was recruited according to the inclusion and exclusion criteria.They were randomly divided into experimental group(n=36)and control group(n=36)according to random number table.The control group was performed health education,Lectures in combination with individual instructions were performed for 8 weeks of healthy education in the control group.The themes of lectures including frailty and life style,nutrition and healthy,exercise and healthy,lectures were held every two weeks and each time lasted 40~50min.Individual instructions including face to face,phone,We Chat forms,and were held per week and lasted 10 ~ 15 min each time.The experimental group was performed Ci Ji Zhou on the baisis of the control group.By refercncing a great deal of documents,consulting specialists(2 Chinese Medical specialists,1Chinese medicinal diet specialist and 1 geriatrician,1 nutrition specialist)and basing on the pilot study results,scientific adjustment and modification was did for the Ci Ji Zhou from dosage,edible method,course of treatment to cooking method before the clinical study.The experimental group was performed Ci Ji Zhou for 8 weeks on the baisis of the control group.Ci Ji Zhou was taken on an empty stomach in the morning alternate dose,300~400ml each time.To evaluate the clinical effects,several scales such as Frailty Pheynotype(FP),Frailty index(FI),Mini Nutritional Assessment(MNA),Body Mass Index(BMI),Short Physical Performance Battery(SPPB),Activity of Daily Living Scale(ADL)and The MOS 36-item short form health survey(SF-36)were used to evaluate the participations before and after the intervention.Meanwhile,the whole research period to whether the adverse effects of the occurrence of the object were observed to assess its safety.ResutlsA total of 72 subjects were included in this study,ultimately,64 subjects finished the whole study,the experimental group were 32 cases(three cases lossed,1 cases excluded),while the control group 32 cases(4 cases lossed).Results showed that: 1.Frailty Status(1)Frailty Pheynotype(FP):(1)The total scores of FP in experimental group after the intervention were lower than the same period in the control group(P<0.05),The incidence of items of slow walking speed,grip strength,low physical activity,weekness were lower than the same period in the control group(P<0.05),except the incidence of unintentional weight loss item(P>0.05).(2)Compared with prior intervention,the scores of FP and the incidence of items of slow walking speed,grip strength,weekness and unintentional weight loss in experimental group were lower after intervention(P<0.05),except the incidence of item of low physical activity(P>0.05).(2)Frailty Index(FI):(1)The total score of FI in experimental group after the intervention were lower than the same period in the control group(P<0.05).(2)Compared with prior intervention,the score of FI in experimental group were lower after intervention(P<0.05).2.Nutritional Status(1)Mini Nutritional Assessment(MNA):(1)Human body measurement,dietary assessment,subjective evaluation dimensions and the total scores of MNA in experimental group after the intervention were higher than the same period in the control group(P<0.05),except the comprehensive evaluation dimension(P>0.05).(2)Compared with prior intervention,three dimensions and the total scores of MNA in experimental group were higher after intervention(P<0.05),except the comprehensive evaluation dimension(P>0.05).(2)Body Mass Index(BMI):(1)The BMI of experimental group after the intervention were higher than the control group,but no statistically significant(P>0.05).(2)The BMI in experimental group were lower after intervention,but no statistically significant(P>0.05).3.Fhysical activity(1)Activities of daily living(ADL):(1)There were no significant difference between experimental group and control group in the PSMS and IADL dimension and the total score of ADL after the intervention(P>0.05).(2)Compared with prior intervention,PSMS and IADL dimension and the total score of ADL in experimental group showed statistically significant after intervention(P<0.05).(2)Short Physical Performance Battery(SPPB):(1)The pace test,Five Times Sit to Stand Test and the total score of SPPB in experimental group after the intervention were higher than the same period in the control group(P<0.05),except the balance test showed no statistically(P>0.05).(2)Three dimensions and the total scores of SPPB in experimental group were higher after intervention(P<0.05).4.Quality of Life The MOS 36-item short form health survey(SF-36): Physical function,overall health,body pain,energy,social function,emotional function,physiological and emotional function dimensions of SF-36 in experimental group after the intervention were higher than the same period in the control group(P<0.05).Compared with prior intervention,eight dimensions of SF-36 in experimental group were higher after intervention(P<0.05).5.Safety There was no clinical adverse events during the whole experiment.ConlusionThe nourishing Spleen and replenishing Kidney Chinese medicated diet Ci Ji Zhou is an effective and safety complementary and alternative medicine method,it can improve frailty status,nutritional status,functional status and quality of life in the frail elderly.As an unique traditional Chinese medicated diet therapy,it is necessary to explore the mechanism of the Ci Ji Zhou further,and to promote the clinical application of it. |
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