• Title/Summary/Keyword: Intervention trial

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Effect of Self-Complex Exercise Program on Pain, Function, Psychosocial, Balance Ability, and TrA Muscle in Patients with Lumbar Instability: A Randomized Controlled Trial (허리 불안정성이 있는 허리통증 환자에게 실시한 자가-복합 운동프로그램이 통증과 기능, 심리사회적, 균형 능력 그리고 배가로근에 미치는 효과)

  • Yoon, Jong-Hyuk;Jeong, Dae-Keun;Park, Sam-Ho
    • Journal of The Korean Society of Integrative Medicine
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    • v.10 no.2
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    • pp.73-83
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    • 2022
  • Purpose : Low back pain (LBP) is reported as a risk of experiencing musculoskeletal disorders due to muscle stiffness and hypokinetics. The lumbar spine in an unstable state causes imbalance and lumbar instability. Therefore, This study examined the effects of lumbar stabilization exercise and self-complex exercise program on pain, function, psychosocial level, static balance ability, and transverse abdominal muscle (TrA) thickness and contraction ratio in patients with lumbar instability. Methods : The design of this is a randomized controlled trial (RCT). Twenty-six LBP patients participated in this study. Screening tests were performed and assigned to the experimental group (n=13) and control group (n=13) using a random allocation program. Both groups underwent a lumbar stabilization exercise program. In addition, the experimental group implemented the self-complex exercise program. All interventions were applied three times per week for four weeks. The quadruple visual analog (QVAS), the Korean version of the Oswestry disability index (K-ODI), Korean version of fear-avoidance belief questionnaire (FABQ), static balance ability, TrA thickness, and contraction ratio were compared to evaluate the effect on intervention. Statistical significance was set at 𝛼=.05. Results : Both groups showed significant differences before and after the intervention in QVAS, K-ODI, FABQ, static balance ability, and TrA thickness in contraction (p<.05). In addition, significant differences in K-ODI and FABQ were observed between the experimental group and control group (p<.05). Conclusion : A lumbar stabilization exercise and self-complex exercise program resulted in reduced dysfunctions, psychosocial stability in patients with lumbar instability. Therefore, Lumbar stabilization exercise and self-complex exercise program for patients with lumbar instability are effective method with clinical significance in improving the function and psychosocial stability.

Muscle Mass Changes After Daily Consumption of Protein Mix Supplemented With Vitamin D in Adults Over 50 Years of Age: Subgroup Analysis According to the Serum 25(OH)D Levels of a Randomized Controlled Trial

  • Yeji Kang;Namhee Kim;Yunhwan Lee;Xiangxue An;Yoon-Sok Chung;Yoo Kyoung Park
    • Clinical Nutrition Research
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    • v.12 no.3
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    • pp.184-198
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    • 2023
  • Early prevention of sarcopenia can be an important strategy for muscle maintenance, but most studies target subjects at slightly pre-sarcopenic state. Our previous paper describes the effect of protein supplements rich in leucine and vitamin D on muscle condition, and in this paper, we performed a sub-analysis to evaluate who benefitted the most in terms of improvement in muscle health. A 12-week randomized clinical trial of 120 healthy adults (aged 50 to 80) assigned to an intervention group (n = 60) or control group (n = 60) were analyzed. Subjects in the intervention group received, twice per day, a protein supplement containing (per serving) 800 IU of vitamin D, 20 g of protein (3 g of total leucine), 300 mg of calcium, 1.1 g of fat, and 2.5 g of carbohydrate. The subjects were classified into 'insufficient' and 'sufficient' groups at 25-hydroxyvitamin D (25[OH]D) value of 30 ng/mL. The skeletal muscle mass index normalized to the square of the skeletal muscle mass (SMM) height (kg/m2) increased significantly in the 'insufficient group' difference value of change between weeks 0 and 12 (Δ1.07 ± 2.20; p = 0.037). The SMM normalized by body weight (kg/kg, %) was higher, but not significantly, in the insufficient group (Δ0.38 ± 0.69; p = 0.050). For people with insufficient (serum 25[OH]D), supplemental intake of protein and vitamin D, calcium, and leucine and adequate energy intake increases muscle mass in middle-aged and older adults and would be likely to exert a beneficial effect on muscle health.

The Effect of Vit-D Supplementation on the Side Effect of BioNTech, Pfizer Vaccination and Immunoglobulin G Response Against SARS-CoV-2 in the Individuals Tested Positive for COVID-19: A Randomized Control Trial

  • Hawal Lateef Fateh;Goran Kareem;Shahab Rezaeian;Jalal Moludi;Negin Kamari
    • Clinical Nutrition Research
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    • v.12 no.4
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    • pp.269-282
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    • 2023
  • Vitamin D participates in the biological function of the innate and adaptive immune system and inflammation. We aim to specify the effectiveness of the vitamin D supplementation on the side effects BioNTech, Pfizer vaccination, and immunoglobulin G response against severe acute respiratory syndrome coronavirus 2 in subjects tested positive for coronavirus disease 2019 (COVID-19). In this multi-center randomized clinical trial, 498 people tested positive for COVID-19 were divided into 2 groups, receiving vitamin D capsules or a placebo (1 capsule daily, each containing 600 IU of vitamin D) over 14-16 weeks. Anthropometric indices and biochemical parameters were measured before and after the second dose of vaccination. Fourteen to 16 weeks after supplementation, the intervention group had an immunoglobulin G (IgG) increase of 10.89 ± 1.2 g/L, while the control group had 8.89 ± 1.3 g/L, and the difference was significant between both groups (p = 0.001). After the second dose of vaccination, the supplement group significantly increased their 25-hydroxy vitamin D from initially 28.73 ± 15.6 ng/mL and increased to 46.48 ± 27.2 ng/mL, and the difference between them was significant. Those with a higher body mass index (BMI) had the most of symptoms, and the difference of side effects according to BMI level was significantly different. In 8 weeks after supplementation obese participants had the lowest IgG levels than overweight or normal subjects. The proportion of all types of side effects on the second dose was significantly diminished compared with the first dose in the intervention group. Supplementation of 600 IU of vitamin D3 can reduce post-vaccination side effects and increase IgG levels in participants who received BioNTech, Pfizer vaccine.

Diet intervention to improve cardiovascular risk factors among Iranian postmenopausal women

  • Abedi, Parvin;Lee, Mary Huang-Soo;Kandiah, Mirnalini;Yassin, Zaitun;Shojaeezade, Davood;Hosseini, Mostafa;MSc, Reza Malihi
    • Nutrition Research and Practice
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    • v.4 no.6
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    • pp.522-527
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    • 2010
  • Cardiovascular disease is a leading cause of death and disability and remains so in the future. The aim of this study was to detect the impact of a 6-month diet intervention on cardiovascular risk factors in postmenopausal Iranian women. It was a randomized controlled trial that carried out in the East Health Clinic in Ahvaz-Iran. This study started on June 2007 and was completed on May 2008. A total 64 healthy postmenopausal women recruited and randomly assigned to the intervention group (35) and control (29). Over the six months follow-up, the intervention group received five educational sessions (two face to face and three lecture discussion classes with slide demonstration) at the first month. These sessions were about menopause, cardiovascular disease and healthy diet. Every participant in the intervention group received one face to face education session at the $3^{rd}$ month, and also received a telephone call at the end of each month starting with the second month to remain on the diet. Pre-intervention and post-intervention anthropometric measurements, blood pressure, blood lipids and dietary intake were assessed. Data analyzed using the SPSS version 15. Descriptive (means and SD), univariate (paired-t test, Chi-Square and Independent T-test) and multivariate (GLM Repeated Measure) statistics were used. Participants in the diet group had significantly lower weight (-0.9 kg), body mass index (-0.4 $kg/m^2$), and fasting blood sugar (-4.5 mg/dl). The diet group significantly increased their daily intake of fiber (+2.3 g, P=0.05), decreased their intake of sodium (-28 mg, P=0.04), and consumption of fruit and vegetable ${\geq}$ 5 serving a day (80%, P=0.03) compared to the control group. Post menopausal women are at a greater risk for cardiovascular disease. Healthy diet using educational intervention can be an effective means of reducing cardiovascular risk in postmenopausal women.

The Effect of Alcohol-related Harm Preventing Intervention on Drinking Frequency and Problem Behaviors of Adolescent: A Meta-analysis (청소년의 음주폐해 예방 중재가 음주 빈도와 문제행동에 미치는 효과: 메타분석)

  • Song, A-Young;Song, Ye-Won;Lee, Jae-Shin
    • The Journal of the Korea Contents Association
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    • v.17 no.2
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    • pp.687-695
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    • 2017
  • This study tried to confirm the effective intervention to reduce drinking frequency and problem behaviors among the three interventions; school based, feedback, and behavior change. Meta-analysis was conducted targeting at 16 studies of randomized controlled trial in which alcohol intervention has been applied to adolescent. The drinking frequency and problem behaviors were analyzed by follow up period. There was a significant difference in the feedback intervention to reduce the frequency of drinking under 3 months of follow up period. Also, there was a significant difference in the feedback intervention to reduce the problematic behaviors of drinking between 4 and 12 months of follow up period(p<.05). The study confirmed that feedback intervention is effective in reducing the frequency of drinking during the follow up period under 3 months, and it is effective in reducing the problem behaviors of drinking during the 4~12 months of follow up period. Also, the study confirmed that school-based intervention and feedback intervention were useful in reducing and preventing harmful effects of drinking by adolescents.

Effects of Self-Care Intervention Study on Chronic Obstructive Pulmonary Disease: Focusing on a Systematic Review of a Randomized Controlled Trials (만성폐쇄성폐질환의 자가간호 중재연구(RCT) 효과에 관한 체계적 문헌고찰)

  • Kyoung Mi Moon;Inhee Park;Hyun Joo Kim
    • Journal of Industrial Convergence
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    • v.21 no.8
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    • pp.97-110
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    • 2023
  • This study presents a systematic literature review aimed at integrating and analyzing the research findings regarding the components of various self-care intervention programs conducted for individuals with chronic obstructive pulmonary disease (COPD) both domestically and internationally. The paper selection criteria were established based on materials from PubMed, CINAHL, EMBASE, /MEDLINE, RISS, DBpia, KISS, and KMbase databases, covering the period from January 1, 2000, to September 30, 2022. The inclusion criteria included controlled pre-post experimental study designs. A total of 23 studies were included in this systematic review. The intervention-related factors examined included the sample size, type of intervention mediator, intervention frequency, and duration. Additionally, factors associated with intervention effects, such as measurement tools and variables, were analyzed. The findings of the analysis support the notion that self-care intervention programs for COPD can contribute to the prevention of symptom exacerbation and hospital readmissions among patients. Consequently, the development of a tailored self-care intervention program specifically designed for COPD patients in South Korea is warranted, considering aspects such as patient accessibility, convenience, and motivation for long-term sustainability.

Effects of a Multi-disciplinary Approached, Empowerment Theory Based Self-management Intervention in Older Adults with Chronic Illness (만성질환 노인에서 임파워먼트 이론에 근거한 다학제적 자기관리 프로그램의 효과)

  • Park, Chorong;Song, Misoon;Cho, Belong;Lim, Jaeyoung;Song, Wook;Chang, HeeKyung;Park, Yeon-Hwan
    • Journal of Korean Academy of Nursing
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    • v.45 no.2
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    • pp.192-201
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    • 2015
  • Purpose: The purpose of this study was to develop a multi-disciplinary self-management intervention based on empowerment theory and to evaluate the effectiveness of the intervention for older adults with chronic illness. Methods: A randomized controlled trial design was used with 43 Korean older adults with chronic illness (Experimental group=22, Control group=21). The intervention consisted of two phases: (1) 8-week multi-disciplinary, team guided, group-based health education, exercise session, and individual empowerment counseling, (2) 16-week self-help group activities including weekly exercise and group discussion to maintain acquired self-management skills and problem-solving skills. Baseline, 8-week, and 24-week assessments measured health empowerment, exercise self-efficacy, physical activity, and physical function. Results: Health empowerment, physical activity, and physical function in the experimental group increased significantly compared to the control group over time. Exercise self-efficacy significantly increased in experimental group over time but there was no significant difference between the two groups. Conclusion: The self-management program based on empowerment theory improved health empowerment, physical activity, and physical function in older adults. The study finding suggests that a health empowerment strategy may be an effective approach for older adults with multiple chronic illnesses in terms of achieving a sense of control over their chronic illness and actively engaging self-management.

Development of Clinical Protocol for Acquisition of Change of Radial Pulse Wave Signal in the Cold-Heat Intervention: Explanatory, Randomized, 2×2 cross-over design (냉온 부하에 따른 요골동맥 맥파의 변화 특성을 파악하기 위한 무작위 배정·2×2교차설계 탐색적 임상시험계획서 개발)

  • Yu, Hana;Kim, Jihye;Ku, Boncho;Kim, Hyunho;Jeon, Youngju
    • The Journal of the Society of Korean Medicine Diagnostics
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    • v.19 no.2
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    • pp.91-100
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    • 2015
  • Objectives The aim of this study is to develop a structured clinical protocol related with acquisition of radial pulse wave in the randomized, $2{\times}2$ cross-over design, and cold-heat intervention trial for a pilot and preliminary study. Methods The protocol was contrived based on wide ranging literature searches for cold-heat intervention experiments and radial pulse diagnoses. Results Sample size of 60 subjects was calculated based on an effect size derived from the previous study designed to detect the pre-post cold-heat differences in the radial pulse. Each subjects will be randomly assigned to the cold (first) to heat (last) group (n=30) or heat (first) to cold (last) group (n=30). All subjects will fill out a case report form and questionnaires related with pattern identification, dietary patterns, sleep quality, and physical activity will be surveyed and used as a secondary outcomes. Safety assessment will be reported at the final stage. Conclusions This protocol will provide an additional reference to future studies related with observation of radial pulse during any interventions and also expect to be used as a guideline for acquisition of reliable radial pulse wave data.

The Effects of Communication Training Applying Gagné's Nine Events of Instruction and Video Clips upon Communication Competency and Interpersonal Relations in Nursing Students (가네의 9가지 수업사태와 비디오 클립을 적용한 의사소통 훈련이 간호대학생의 의사소통 능력과 대인관계에 미치는 효과)

  • Cha, Jin-Gyung;Kim, Hyang-Ha
    • Journal of East-West Nursing Research
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    • v.23 no.2
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    • pp.115-123
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    • 2017
  • Purpose: The purpose of this study was to determine the effects of teaching communication training using $Gagn{\acute{e}}^{\prime}s$ 9 events of instruction and video clip on communication competency and interpersonal relations of nursing students. Methods: The participants were 79 nursing students (41 in the intervention group, 38 in the control group). A nonequivalent control group design was used. The research was carried out from September 7 to November 20, 2015. Teaching communication skills using $Gagn{\acute{e}}^{\prime}s$ 9 events of instruction and video clip were provided to the intervention group 180 minutes/session once a week for 9 weeks. Data were analyzed using chi-square test, independent t-test and ANCOVA with SPSS/PC version 21.0. Results: The intervention group reported significantly higher scores of communication competency(F=8.41, p=.005) and interpersonal relations(F=8.97 p=.004) compared to those of the control group at the completion of the intervention. Conclusion: The findings of this study show that $Gagn{\acute{e}}^{\prime}s$ 9 events of instruction and video clip is an effective communication training for improving communication competency and interpersonal relations in nursing students. A randomized clinical trial is needed to confirm the value of communication training using $Gagn{\acute{e}}^{\prime}s$ 9 events of instruction and video clip for nursing students.

Effects of Smoking Cessation Intervention among Female Smokers: Systematic Review (여성 흡연자의 금연 중재 효과: 체계적 문헌고찰)

  • Kim, Da Hye;Choe, Yu Hyeon;Ham, Ok Kyung;Im, Boae;Kim, Na Kyeong
    • Journal of Korean Public Health Nursing
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    • v.34 no.2
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    • pp.263-276
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    • 2020
  • Purpose: This paper systematically reviewed the effects of smoking cessation (SC) intervention among female smokers. Methods: A systematic search was performed targeting articles published on eight electronic databases, from January 1, 2010, to February 25, 2020. Nine studies were included in the systematic review. The risk of bias (RoB) tool was used to evaluate the quality of scientific evidence. Results: A randomized controlled trial (RCT) was performed in all nine studies. Interventions were classified as exercise (n=4), cognitive behavioral counseling (n=2), motivational counseling (n=1), group counseling with self-help group (n=1), and pharmacotherapy (n=1). The SC rates were measured using a 7-days point prevalence abstinence in 55.6% of the studies. Exercise studies showed higher SC rates in the experimental groups than control groups after the intervention, but the differences were not significant. Other interventions were employed in two or fewer studies or did not conduct long-term follow-up, thus we were unable to examine effects of these interventions. Conclusion: It is necessary to develop SC programs for female smokers by carefully considering the characteristics of female smokers. Further research will be needed to confirm the effects of SC programs in certain subgroups among females. Also more experimental studies on SC intervention should be carried out with scientific rigor.