• Title/Summary/Keyword: randomized clinical trial

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Effects of Bridge Exercise with Trunk Rotation on Trunk Muscle Thickness in Healthy Adults (몸통 회전을 이용한 교각운동이 정상 성인의 몸통 근육 두께에 미치는 영향)

  • Kwang Duk Park;Yong Nam Kim
    • Journal of Korean Physical Therapy Science
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    • v.30 no.3
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    • pp.41-48
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    • 2023
  • Background: This study examined the effects of the bridge exercise with trunk rotation on the thickness of body trunk muscles, including external oblique, internal oblique, and transverse abdominis in healthy male adults. Design: Randomized controlled trial Methods: Twenty-four men were evenly divided into a trunk rotation bridge exercise group and a basic bridge exercise group by drawing lots. The two groups performed the respective exercise for thirty minutes, three times a week for six weeks. repeated measure analysis of variance (ANOVA) was used after distinguishing between three different time points before the experiment, three weeks after the experiment, and six weeks after the experiment. The significance level was set at 0.05. In case an interaction between time and group existed, the paired t-test was used to examine the within-group difference. The independent-sample t-test was used to check the between-group difference. The significance level was set at 0.05. Results: All the men showed a significant change over time in their external oblique, internal oblique, and transverse abdominis muscles. An interaction between time and group was also found (p<0.05). Conclusion: The bridge exercise with trunk rotation causes a meaningful difference in the thickness of external oblique, internal oblique, and transverse abdominis muscles. Therefore, this study proposes the use of this exercise for lower-back stabilization in future research and clinical settings.

Effect of Thoracic Joint Mobilization and Breathing Exercise on The Thickness of The Diaphragm, Expansion of The Chest, Respiratory Function, and Endurance in Chronic Stroke Patients

  • Hyunmin Moon;Jang-hoon Shin;Wan-hee Lee
    • Physical Therapy Rehabilitation Science
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    • v.12 no.3
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    • pp.278-292
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    • 2023
  • Objective: This study was performed to investigate the effects of thoracic joint mobilization and breathing exercises on diaphragmatic thickness, chest expansion, respiratory function, and endurance in patients with chronic stroke. Design: Randomized controlled trial Methods: The study included 24 chronic stroke patients who were randomly divided into two groups. The experimental group (12 people) performed 15 minutes of thoracic joint mobility exercises and 15 minutes of breathing exercises, three times a week for 6 weeks, 30 minutes each time. The control group (12 people) received 15 minutes of conservative physical therapy and 15 minutes of breathing exercises, 3 times a week for 6 weeks, 30 minutes per session, the same as the experimental group. The experimental and control groups performed the same breathing exercises. To assess training effectiveness, changes in diaphragm thickness, chest expansion, respiratory function, and endurance were measured. Results: As a result, the experimental group exhibited significant improvements in diaphragm thickness, chest expansion, and respiratory function. The endurance mode also displayed significant enhancement (p<0.05), a finding consistent with the control group. However, the experimental group displayed more substantial improvements in non-affected diaphragm thickness and thoracic expansion compared to the control group (p<0.05). Conclusions: Drawing from these findings, breathing exercise which combine thoracic mobilization, will be actively utilized in addition to physical therapy interventions in clinical trials as an effective intervention method.

Effects of the Neurofeedback Program on Psychogenic Factors in Breast Cancer Patients (뉴로피드백 훈련이 유방암 환자의 심인성 변화에 미치는 영향)

  • SeungKeun Oh;JaeCheol Park
    • Journal of Korean Physical Therapy Science
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    • v.30 no.4
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    • pp.44-53
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    • 2023
  • Background: This report determines the effects of a neurofeedback program on patients with breast cancer through a study of psychogenic factors(distress, depression, anxiety). Design: Randomized controlled trial. Methods: The study selected 28 patients with breast cancer and divided them into two groups: 14 subjects in the neurofeedback program group and 14 subjects in the exercise intervention program group. Both groups conducted one-and-hour training per session five times a week for a total of five weeks. The experimental group performed neurofeedback, and the control group performed a exercise intervention. The distress was measured using the distress management Test. Beck's Depression Inventory was used to measure depression. Beck's Anxiety Inventory was used to measure Anxiety Results: Both the experimental and control groups showed significant differences in distress, depression, and anxiety after the intervention (p<0.05) in the within-group comparisons. It was found that the experimental group showed more significant differences in distress, depression, and anxiety than the control group (p<0.05) when the two groups were compared. Conclusion: The results obtained in this study show that the neurofeedback program had a positive effect on distress, depression, and anxiety of life in patients with breast cancer. The study thereby proposes that the neurofeedback program should be applied as an intervention method for clinical use on patients with breast cancer.

The Effects of Training with Immersive Virtual Reality Devices on Balance, Walking and Confidence in Chronic Stroke Patients

  • Hyun-min Moon;Ho-dong Gwak;Jang-hoon Shin;Na-eun Byeon;Wan-hee Lee
    • Physical Therapy Rehabilitation Science
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    • v.13 no.2
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    • pp.250-260
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    • 2024
  • Objective: This study aimed to explore the effects of balance training using fully immersive VR devices on the balance and walking abilities of stroke patients. Design: Randomized controlled trial Methods: This study involved 54 stroke patients divided into three groups: VRT(VR and traditional physical therapy), VR(VR only), and TPT(traditional physical therapy only). Interventions were administered twice daily for 30 minutes over eight weeks. Outcome measures included the Berg Balance Scale, Timed Up and Go Test, 10-meter walk test, gait analysis, and Activities-specific Balance Confidence Scale. Results: The VRT and VR groups showed significant effects on spatiotemporal variables and confidence compared to the TPT group (p<0.05). Specifically, the VR group demonstrated superior effects in TUG, 10MWT, velocity, stride length, single-leg support, and ABC compared to the other two groups (p<0.05). Conclusions: Fully immersive VR balance training had a positive impact on balance, walking, and confidence in chronic stroke patients. Traditional physical therapy alone showed limited effectiveness, highlighting the potential of VR-based interventions in stroke rehabilitation. These findings underscore the importance of integrating VR technology into clinical practice to enhance outcomes for stroke survivors.

Clinical Research of Warm Needle Acupuncture for Chronic Low Back Pain: A Protocol for Randomized, Controlled Pilot Study (온침이 만성요통에 미치는 효과에 대한 무작위배정 대조군 예비 임상연구 프로토콜)

  • Seo, Yeonho;Kim, Taeoh;Cho, Whisung;Ko, Junhyuk;Ahn, Jonghyun;Kim, Soo Jeon;Lee, Hansol;Chang, Hokyung;Kim, Hyungsuk;Kim, Koh-Woon;Cho, Jae-Heung;Chung, Wonseok;Song, Mi-Yeon
    • Journal of Korean Medicine Rehabilitation
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    • v.30 no.4
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    • pp.155-164
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    • 2020
  • Objectives This study is aimed to evaluate the feasibility of further clinical research of warm needle acupuncture as an effective and safe treatment for chronic low back pain. Methods Thirty participants will be randomly assigned to the Warm needle acupuncture group (n=15) and Dry needle acupuncture group (n=15). All patients will receive acupuncture therapy twice a week for 6 weeks, but only the experimental group will receive thermal stimulation. The primary outcome will be measured using the visual analogue scale for bothersomeness of low back pain, and the secondary outcome will be measured using the VAS for pain intensity, Oswestry disability index, 36-Item Short Form Health Survey, Beck's depression inventory, and amount of analgesics used. Conclusions The results of this study will be used to determine the feasibility of a future large-scale randomized controlled trial that provides clinical evidence for the efficacy and safety of warm needle acupuncture in the treatment of patients with chronic low back pain.

Effect of Acupuncture on Patients with Hypertension : A Review of Clinical Studies in the Republic of Korea (고혈압의 침치료에 대한 문헌고찰 : 국내 임상 연구를 중심으로)

  • Sang Yeon, Jung;Ye-Chae, Hwang;Seung-Yeon, Cho;Han-Gyul, Lee;Seungwon, Kwon;WooSang, Jung;Sang-Kwan, Moon;Jung-Mi, Park;Chang-Nam, Ko;Seong-Uk, Park
    • The Journal of the Society of Stroke on Korean Medicine
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    • v.23 no.1
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    • pp.25-40
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    • 2022
  • ■Objectives This study aimed to collect and analyze clinical studies on the significance of acupuncture in the treatment of hypertension among Korean patients. ■Methods Among Korean patients with a blood pressure (BP) of 120 mmHg or higher and a diastolic BP of 80 mmHg or higher, those, treated with acupuncture only, were included. A literature search was conducted through 'Embase', 'Medline', 'Science and Technology Information Integration Service (NDSL)', 'Traditional Korean Knowledge Portal (OASIS)', 'PubMed', and 'Scopus'. The search keywords were (hypertension OR 'blood pressure') AND acupuncture. The papers, published before the day of the search (02. January 2022), were included in this study. ■Results Among the 12 selected papers, seven involved randomized controlled trial (RCT), four before-and-after studies, and one case series. The number of RCTs has increased yearly. The treatment methods used in the studies included needle acupuncture in eight studies, auricular acupuncture in two, pharmacopuncture in one, and si-acupuncture in one. The average numbers of patients enrolled in RCTs, before-and-after studies, and case series were 21.1, 30, and 23 respectively. Six studies were conducted on prehypertensive patients, two on stage 1 hypertension patients, and four on stage 2 hypertension patients. The involved acupoints have been reported to be ST36 in eight papers, LI11 in four papers, and PC6 in three papers. The treatment period lasted for < 1 week in eight studies and 8 weeks in four studies. Acupuncture successfully lowered blood pressure in nine out of 12 studies ■Conclusions Acupuncture is a viable alternative treatment option for prehypertensive patients, who are not taking medications. Additionally, it is also useful in further lowering the BP of patients with stage 1 and stage 2 hypertension in the short term. Large-scale and long-term studies on acupuncture for hypertension should be conducted.

Immunogenicity and safety of a 12-valent pneumococcal conjugate vaccine in infants aged 6-10 weeks: a randomized double-blind active-controlled trial

  • Shin, Jonghoon;Teeratakulpisarn, Jamaree;Puthanakit, Thanyawee;Theerawit, Tuangtip;Ryu, Ji Hwa;Shin, Jinhwan;Lee, Seulgi;Lee, Hayoung;An, Kyungjun;Kim, Hun
    • Clinical and Experimental Pediatrics
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    • v.63 no.7
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    • pp.265-271
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    • 2020
  • Background: Pneumococcal diseases among children aged <5 years worldwide are associated with high annual mortality rates. Purpose: This study aimed to evaluate the immunogenicity and safety of GBP411, a 12-valent pneumococcal conjugant vaccine, with a dosing schedule of 2 primary doses plus 1 booster dose (2p+1) in healthy infants. Methods: This randomized active-controlled (Prevnar 13) double-blind phase 2 trial enrolled healthy subjects aged 6-10 weeks. Three serum concentrations of pneumococcal serotype-specific immunoglobulin G (IgG) were evaluated using the pneumococcal serotype-specific pneumonia polysaccharide enzyme-linked immunosorbent assay at 1 month after the primary doses and before and 1 month after the booster dose. The pneumococcal serotype-specific IgG titer was evaluated using a multiplex opsonophagocytic assay in a subset of 15 subjects per group. Results: After administration of the primary doses, the proportion of subjects who achieved pneumococcal serotype-specific IgG concentrations of >0.35 ㎍/mL was lower for some serotypes in the GBP411 group than in the comparator group (6B: 20.83% vs. 39.22%, P=0.047 and 19A: 58.33% vs. 90.20%, P<0.001). However, after administration of the booster dose, >97% of the subjects in each group achieved IgG concentrations of ≥0.35 ㎍/mL for all 12 serotypes. Increased immunogenicity was observed for some serotypes that showed significant intergroup differences after administration of the primary doses but not after the booster dose. We also found no significant intergroup difference in the overall incidence of solicited local adverse events. Furthermore, the overall incidence of solicited systemic adverse events was significantly lower in the GBP411 group than in the comparator vaccine group (79.59% vs. 98.04%; P=0.003). Conclusion: The GBP411 vaccine with a dosing schedule of 2p+1 may be immunogenic and safe for healthy infants.

Short-Term Effects of Mahuang on State-Trait Anxiety According to Sasang Constitution Classification : A Double-Blind Randomized Controlled Trial (마황 단기복용이 사상체질인의 불안에 미치는 영향 : 이중맹검 임상시험)

  • Hsing, Li-Chang;Yang, Chang-Sop;Lee, Tae-Ho;Kim, Lak-Hyung;Kwak, Min-Jung;Seo, Eui-Seok;Jang, In-Soo
    • The Journal of Internal Korean Medicine
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    • v.28 no.1
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    • pp.106-114
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    • 2007
  • Background : Mahuang (Ephedrae Herba, Ephedra sinica $S_{TAPE}$) has been widely used to treat respiratory disease in Asian over the past thousand years. The main ingredient of Mahuang is ephedrine, whose affects on the autonomic nervous system induce some adverse effects like vasoconstriction, hypertension, tachycardia, miosis, insomnia, dizziness, headache, etc. Although there were lots of reports about adverse effects of Mahuang, there were no clinical studies which evaluated the adverse effects of Mahuang on the autonomic nervous system by objective numerical value in the past decade. Objectives : The purpose of this report was to provide an objective assessment of state-trait anxiety that is caused by Mahuang, and to identify anxiety of Mahuang according to different Sasang constitution classifications. Methods : The study design was a double-blind randomized placebo-controlled trial. The subjects of this study were 79 adults aged between 20 to 40 who agreed to participate. Because 8 adults dropped out, a total of 71 subjects entered the study. They were allocated through randomization to a Mahuang group (N=50) and placebo group (N=21). Each group took three opaque capsules (every opaque capsule containing 2g of Mahuang or none) twice a day. To compare the state and trait anxiety before and after taking Mahuang, we checked the anxiety by using STAI-KYZ. Results : The following results were obtained. Short-term administration of Mahuang significantly increased state-anxiety, but in the placebo group, there were no significant changes in state-anxiety. In the Mahuang group except females, there was more significant increase in state-anxiety of Soeumin than Soyangin and Taeumin in the 2nd measurement. Conclusion : It is suggested that the ingestion of Mahuang can increase sympathetic activity and induce anxiety. There was a significant difference among Sasang constitution classification. Especially, the response is stronger in Soeumin than other constitutions. If we use Mahuang according to the Sasang constitution classification in clinic, we could not only minimize the anxiety but maximize the potential curative value.

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A Randomized Controlled Trial Comparing Clinical Outcomes and Toxicity of Lobaplatin- Versus Cisplatin-Based Concurrent Chemotherapy Plus Radiotherapy and High-Dose-Rate Brachytherapy for FIGO Stage II and III Cervical Cancer

  • Wang, Ji-Quan;Wang, Tao;Shi, Fan;Yang, Yun-Yi;Su, Jin;Chai, Yan-Lan;Liu, Zi
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.14
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    • pp.5957-5961
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    • 2015
  • Background: We designed this randomized controlled trial (RCT) to assess whether lobaplatin-based concurrent chemotherapy might be superior to cisplatin-based concurrent chemotherapy for FIGO stage II and III cervical cancer in terms of efficacy and safety. Materials and Methods: This prospective, open-label RCT aims to enroll 180 patients with FIGO stage II and III cervical cancer, randomly allocated to one of the three treatment groups (cisplatin $15mg/m^2$, cisplatin $20mg/m^2$ and lobaplatin $35mg/m^2$), with 60 patients in each group. All patients will receive external beam irradiation (EBRT) and high-dose-rate intracavitary brachytherapy (HDR-ICBT). Patients in cisplatin $15mg/m^2$ and $20mg/m^2$ groups will be administered four cycles of $15mg/m^2$ or $20mg/m^2$ cisplatin intravenously once weekly from the second week to the fifth week during EBRT, while patients inthe lobaplatin $35mg/m^2$ group will be administered two cycles of $35mg/m^2$ lobaplatin intravenously in the second and fifth week respectively during pelvic EBRT. All participants will be followed up for at least 12 months. Complete remission rate and progression-free survival (PFS) will be the primary endpoints. Overall survival (OS), incidence of adverse events (AEs), and quality of life will be the secondary endpoints. Results: Between March 2013 and March 2014, a total of 61 patients with FIGO stage II and III cervical cancer were randomly assigned to cisplatin $15mg/m^2$ group (n=21), cisplatin $20mg/m^2$ group (n=21) and lobaplatin $35mg/m^2$ group (n=19). We conducted a preliminary analysis of the results. Similar rates of complete remission and grades 3-4 gastrointestinal reactions were observed for the three treatment groups (P=0.801 and 0.793, respectively). Grade 3-4 hematologic toxicity was more frequent in the lobaplatin group than the cisplatin group. Conclusions: This proposed study will be the first RCT to evaluate whether lobaplatin-based chemoraiotherapy will have beneficial effects, compared with cisplatin-based chemoradiotherapy, on complete remission rate, PFS, OS, AEs and quality of life for FIGO stage II and III cervical cancer.

Preoperative Chemotherapy in Gastric Cancer (위암의 선행화학 요법)

  • Hong, Young-Seon;Park, Cho-Hyun
    • Journal of Gastric Cancer
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    • v.5 no.3 s.19
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    • pp.139-145
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    • 2005
  • Gastric cancer is the most prevalent cancer in Korea and comprises the second cause of cancer death. Surgery only can provide chance of cure, but most locally advanced cancers recur after a curative resection, even though important advances in the surgical and nonsurgical treatments of gastric cancer have taken place. Preoperative chemotherapy theoretically can provide the advantages of reducing the bulk of tumor, which might improve the R0 resection rate, and of treating micrometastases early. Also, preoperative chemotherapy is expected to render unresectable tumors resectable without increasing postoperative morbidity and mortality. There are many new chemo-therapeutic agents available for the treatment of advanced gastric cancer, but still the most effective agent, the optimal time and number of cycle for administration are still not known. The addition of postoperative chemotherapy through an intraperitoneal route and/or radiotherapy might affect the outcome of surgery favorably, but that hasn't been proved yet. A multicenter prospective randomized phase III trial should be peformed to answer for those questions and to improve the curability of gastric cancer treatment.

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