• 제목/요약/키워드: Intervention trial

검색결과 551건 처리시간 0.025초

The Kuala Lumpur Qigong Trial for Women in the Cancer Survivorship Phase-Efficacy of a Three-Arm RCT to Improve QOL

  • Loh, Siew Yim;Lee, Shing Yee;Murray, Liam
    • Asian Pacific Journal of Cancer Prevention
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    • 제15권19호
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    • pp.8127-8134
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    • 2014
  • Background: Qigong is highly favoured among Asian breast cancer survivors for enhancing health. This study examined the hypothesis that quality of life (QoL) in the Qigong group is better than the placebo (aerobic) or usual care group. Materials and Methods: A total of 197 participants were randomly assigned to either the 8-week Kuala Lumpur Qigong Trial or control groups in 2010-2011. Measurement taken at baseline and post-intervention included QoL, distress and fatigue. Analysis of covariance (ANCOVA) and Kruskal Wallis were used to examine for differences between groups in the measurements. Results: There were 95 consenting participants in this 8week trial. The adherence rates were 63% for Qigong and 65% for the placebo group. The Qigong group showed significant marginal improvement in Quality of life scores compared to placebo (mean difference=7.3 unit; p=0.036), compared to usual care (mean difference=6.7 unit; p=0.048) on Functional Assessment Cancer Therapy-Breast measure. There were no significant changes between the placebo and usual care groups in fatigue or distress at post intervention (8-week). Conclusions: Cancer survivors who participated in the Qigong intervention showed slightly better QOL. Follow up studies are greatly needed to evaluate which subgroups may best benefit from Qigong. With a steep rise of cancer survivors, there is an urgent need to explore and engage more cultural means of physical activity to fight side effects of treatment and for cancer control in developing countries.

Daily walnut intake improves metabolic syndrome status and increases circulating adiponectin levels: randomized controlled crossover trial

  • Hwang, Hyo-Jeong;Liu, Yanan;Kim, Hyun-Sook;Lee, Heeseung;Lim, Yunsook;Park, Hyunjin
    • Nutrition Research and Practice
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    • 제13권2호
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    • pp.105-114
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    • 2019
  • BACKGROUND/OBJECTIVES: Several previous studies have investigated whether regular walnut consumption positively changes heart-health-related parameters. The aim of this study was to investigate the effects of daily walnut intake on metabolic syndrome (MetS) status and other metabolic parameters among subjects with MetS. SUBJECTS/METHODS: This study was a two-arm, randomized, controlled crossover study with 16 weeks of each intervention (45 g of walnuts or iso-caloric white bread) with a 6 week washout period between interventions. Korean adults with MetS (n = 119) were randomly assigned to one of two sequences; 84 subjects completed the trial. At each clinic visit (at 0, 16, 22, and 38 weeks), MetS components, metabolic parameters including lipid profile, hemoglobin A1c (HbA1c), adiponectin, leptin, and apolipoprotein B, as well as anthropometric and bioimpedance data were obtained. RESULTS: Daily walnut consumption for 16 weeks improved MetS status, resulting in 28.6%-52.8% reversion rates for individual MetS components and 51.2% of participants with MetS at baseline reverted to a normal status after the walnut intervention. Significant improvements after walnut intake, compared to control intervention, in high-density lipoprotein cholesterol (HDL-C) (P = 0.028), fasting glucose (P = 0.013), HbA1c (P = 0.021), and adiponectin (P = 0.019) were observed after adjustment for gender, age, body mass index, and sequence using a linear mixed model. CONCLUSION: A dietary supplement of 45 g of walnuts for 16 weeks favorably changed MetS status by increasing the concentration of HDL-C and decreasing fasting glucose level. Furthermore, consuming walnuts on a daily basis changed HbA1c and circulating adiponectin levels among the subjects with MetS. This trial is registered at ClinicalTrials.gov as NCT03267901.

The clinical efficacy of thoracolumbar fascia release for shoulder pain

  • Choi, Don Mo;Jung, Ji Hye
    • Physical Therapy Rehabilitation Science
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    • 제4권1호
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    • pp.55-59
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    • 2015
  • Objective: This study aimed to elucidate the effects of thoracolumbar fascia release (TLFR) on the degree of pain and disability in patients with shoulder pain. Design: Randomized control trial. Methods: Thirty subjects with shoulder pain participated in this study. They were allocated to TLFR group (n=15) and manual physical therapy (MPT) group (n=15). Shoulder pain and disability index (SPADI) and the score on the visual analogue scale (VAS) were measured before and after TLFR. Results: In the TLFR group, the degree of shoulder pain as indicated by SPADI measured after the intervention significantly differed from that before the intervention (p<0.05); moreover, in the MPT group, the degree of shoulder pain was significantly lower (p<0.05). The data of the 2 groups before the intervention significantly differed from those after the intervention (p<0.05). SPADI significantly differed within the groups (p<0.05), but not between the groups. The sum of SPADI did not differ significantly between the groups. The VAS scores of shoulder pain measured before the intervention significantly differed from those measured after the intervention (p<0.05) in the both groups. After the intervention, shoulder pain decreased significantly in the TLFR group as compared to that in the MPT group. Conclusions: TLF release was effective in reducing shoulder pain. The results of this study can be applied in clinical practice for TLFR performed to reduce shoulder pain. Further studies will need to be performed to elucidate the effects of TLFR on functional recovery.

Individualized Traditional Korean Acupuncture for Knee Osteoarthritis : a Protocol for a Randomized Controlled Trial

  • Byun, Hyuk;Baek, Seung-Tae;Park, In-Shik;Kim, Kap-Sung;Kim, Sun-Woong;Choi, Sun-Mi;Lee, Seung-Deok
    • 대한한의학회지
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    • 제27권4호
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    • pp.225-232
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    • 2006
  • Objective : To test the hypotheses that individualized traditional Korean acupuncture improves pain and disability in patients with osteoarthritis of the knee and that benefits remain after stopping treatment more so than is the case for standardized minimal acupuncture. Design : Randomized single blind controlled trial with two intervention arms (individualized traditional Korean acupuncture, standardized minimal acupuncture) of six weeks' duration and three months follow-up. Setting : Acupuncture interventions were applied by two training doctors in the Department of Acupuncture and Moxibustion in a 1000-bed hospital. Assessment of the result was performed in a university-based laboratory. Participants : 50 patients with symptoms of knee osteoarthritis as diagnosed by an orthopedist. Intervention : Individualized traditional Korean acupuncture or standardized minimal acupuncture for six weeks. Main outcome measures: Primary outcome measure was pain as measured by the visual analogue scale. Secondary measures of pain and disability included the Western Ontario and McMaster Universities (WOMAC) index, Short Form-36 (SF-36), Lequesne Functional Index (LFI) score and Korean version of Health Assessment Questionnaire (KHAQ). Discussion : This paper presents detail on the rationale, design, methods and operational aspects of the trial.

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The effect of single trial transcutaneous electrical nerve stimulation on balance and gait function in elderly people with dementia: a pilot study

  • Jung, Ju Yeon;Jung, Jin-Hwa;Hahm, Suk-Chan;Jung, Kyoungsim;Kim, Sung-Jin;Suh, Hye Rim;Cho, Hwi-young
    • Physical Therapy Rehabilitation Science
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    • 제6권2호
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    • pp.59-64
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    • 2017
  • Objective: Elderly people with dementia experience not only cognitive dysfunction but also motor function deficits, such as balance and gait impairments. Recently, transcutaneous electrical nerve stimulation (TENS) has been used to reduce pain as well as to control muscle spasm, spasticity and motor performance in various types of subjects. The purpose of this study determined the effect of a single trial TENS on balance and gait function in elderly people with dementia. Design: A randomized controlled trial. Methods: Twenty-two subjects with dementia were assigned to the TENS group (n=12) and ten subjects were assigned to the control group (n=10) randomly. Subjects were classified into two groups: the TENS group (n=12) and the placebo-TENS group (n=10). The TENS group had electrical stimulation applied on the calf muscle for 15 minutes, while the placebo-TENS group had not received real electrical stimulation. The timed up and go test (TUG) and functional reach test (FRT) were used to measure the balance function, and the 10 meters walk test (MWT) and 6MWT were used to assess gait ability. All tests were performed before and after intervention under a single-blinded condition. Results: After intervention, there were significant improvements in TUG, FRT, 10MWT, and 6MWT results in the TENS group (p<0.05), while the placebo-TENS group did not show significant changes in all outcome measurements. There were also differences in all tests between the two groups at post-measurements (p<0.05). Conclusions: This study demonstrated that a single trial TENS application on the calf may be used to improve balance and gait function in elderly people with dementia.

간암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰 (Analysis of Existing Guidelines and Randomized, Controlled, Clinical Trials for Development of [Guideline of Clinical Trial on Herbal Medicinal Product for Liver Cancer])

  • 한가진;김동훈;박은주;성신;김성수;임정태
    • 대한한방내과학회지
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    • 제40권1호
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    • pp.89-116
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    • 2019
  • Objective: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer," by analyzing existing guidelines and clinical trials. Methods: Committee for the development of a guideline, consisting of 6 Korean medicine doctors, reviewed guidelines and clinical trials on using herbal medicine for treating liver cancer. The trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparators, outcomes, and trial design. We then compared the results of our analysis with the guidelines to identify issues we must to consider when following the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer." Several guidelines for antitumor agents and clinical trials on herbal medicine were obtained from the Ministry of Food and Drug Safety homepage, etc. The search terms were as follows: "liver neoplasms"; "herbal medicine"; "medicine, Korean traditional"; and "medicine, Chinese Traditional.". Results: Ten articles were obtained from pubmed and Embase. There was no guideline for clinical trials on using herbal medicine for treating liver cancer. All the participants in the reviewed articles had primary liver cancer, and the type of intervention varied (e.g., decoction, patches, and capsules. The comparators included placebos and conventional treatments such as chemotherapy. The outcome assessment methods were tumor response, quality of life, survival, and liver function tests. Adverse events occuring during the trial were also evaluated. Conclusion: Findings were derived by reviewing existing guidelines and comparing them with clinical trials on liver cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer."

Immediate Effect of Pressure Pain Threshold and Flexibility in Tensor Fascia Latae and Iliotibial Band According to Various Foam Roller Exercise Methods

  • Kim, Ho;Shin, Wonseob
    • 국제물리치료학회지
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    • 제10권4호
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    • pp.1879-1888
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    • 2019
  • Background: The treatment of pain in the iliotibial band friction syndrome has been difficult to determine, according to studies to date. However, recent studies have suggested that flexibility in the subacute stage of pain in the iliotibial band friction syndrome may help reduce pain. Objective: To investigate the immediate effect on pressure pain threshold and flexibility of the tensor fascia latae and iliotibial band by applying static and dynamic myofascial release foam rolling and self-stretching to adults with shortening iliotibial band. Design: Randomized controlled trial Methods: In this study, 50 subjects who were selected in advance as a randomized controlled trial were randomly allocated using a R Studio program. The included subjects were randomly allocated to three intervention groups. The static self-myofascial release 18 people, dynamic self-myofascial release group 16 people separated the self-stretching group 16 people and conducted a homogeneity check in advance. Before the start of the experiment, after of the experiment, 5 minutes after the end of the experiment, the pressure pain threshold and flexibility change for each part were measured. Results: The results of this study showed that the static self-myofascial release showed a significant difference in the pressure pain threshold in the tensor fascia latae and middle, lower part of the iliotibial band, compared with the other intervention groups (p<.05). In change of flexibility, the static self-myofascial release was significantly different than the other intervention groups (p<.05). Conclusion: The result of this study suggest that static self-myofascial release using foam roller may help to improve the pain and flexibility of the iliotibial band and to apply it as a more discerning intervention.

Effects of a School-based Intervention Program on Attitude and Knowledge of Household Members Towards a Smoke-free Home: a Cluster Controlled Trial

  • Intarut, Nirun;Chongsuvivatwong, Virasakdi;McNeil, Edward
    • Asian Pacific Journal of Cancer Prevention
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    • 제17권3호
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    • pp.1235-1242
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    • 2016
  • Background: A school-based smoke free home (SFH) program is useful in empowering the mother and child to reduce secondhand smoke exposure but the effects of pretesting on knowledge and attitude has been largely ignored. We aimed to test whether such a program can be effective in Southern Thailand with an additional assessment of the net effect of the pretest. Materials and Methods: A Solomon four-group design was used. Twelve rural primary schools were assigned to one of the four conditions (each with 3 schools): intervention with and without a pretest, control with and without the same pretest. The intervention was performed in the classroom and home over a period of 1 month. Outcomes were assessed at baseline and 3 months after the intervention on whether the home was smoke free and related knowledge and attitude. Results: The intervention could lead to a smoke-free home without statistical significance. Attitude, knowledge and self-confidence on creating a smoke-free home, and self-confidence in avoidance of secondhand smoke exposure and persuading smokers to not smoke in their home were significantly improved. No pretest effect was observed. Conclusions: Gain in attitude, knowledge and self-confidence among family members from the brief school-based education should be enhanced by other measures.

연하장애를 가진 급성기 뇌졸중환자의 캡사이신을 이용한 구인두 감각 자극의 효과 (Effect of Oropharyngeal Sensory Stimulation Using Capsaicin in Acute Stroke Patients with Dysphagia)

  • 배한솔;이은남
    • 중환자간호학회지
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    • 제14권3호
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    • pp.73-86
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    • 2021
  • Purpose : This study aimed to investigate the effects of oropharyngeal sensory stimulation using low-temperature capsaicin on dysphagia, dietary level, aspiration pneumonia, and nutritional status in acute stroke patients with dysphagia admitted to a stroke intensive care unit. Methods : This study used a randomized controlled trial design and 43 participants were randomly assigned to the experimental group (n=21) or control group (n=22). An oropharyngeal sensory stimulation intervention program was constructed based on previous studies. The intervention was provided before meals twice a day for seven days and started with the first meal after hospitalization. In the control group, a solution was made using only bottled water without adding capsaicin solution, and the intervention was provided at the same time, method, and number of times as the experimental group. Results : As a result of the study, dysphagia and dietary level improved in the experimental group that received oropharyngeal sensory stimulation using capsaicin. There were no effects on the nutritional status or aspiration pneumonia. Conclusion : This study provides basic data for the development of an intervention program for patients with dysphagia by presenting a theoretical basis that oropharyngeal sensory stimulation intervention using capsaicin improves dysphagia and dietary levels.

뇌졸중 환자의 지역사회이동을 위한 작업치료 중재: 체계적 고찰 (Occupational Therapy for Community Mobility in Stroke Patients : Systematic review)

  • 조은주;감경윤;장문영
    • 대한지역사회작업치료학회지
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    • 제8권3호
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    • pp.77-89
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    • 2018
  • 목적 : 본 연구는 뇌졸중 환자에게 적용한 지역사회이동을 위한 작업치료적 중재를 분석한 논문으로, 임상에서 지역사회이동에 대한 중재를 사용하는데 있어 근거를 제시하고자 한다. 연구방법 : PRISMA checklist와 diagram을 통해 체계적 고찰을 시행하였고, 데이터베이스는 PubMed, EMBASE, Cochrane library (CENTRAL), ProQuest Dissertations & thesis (PQDT), 한국교육학술정보원(RISS)과 코리아메드(KoreaMed)를 이용하였다. 검색기간은 2005년부터 2018년 9월까지로 하였다. 연구에 선택된 문헌의 질 평가는 RoBANS (Riks of Bias Assessment tool for Non-randomized Study)를 사용하였다. 연구에 포함된 문헌은 총 8개이었다. 문헌에서 사용된 중재들은 종류에 따라 분류하였다. 결과 : 문헌의 연구디자인은 무작위배정 실험연구, 유사실험연구, 전후비교연구, 환자-대조군연구, 횡단적 연구로 다양하게 나타났다. 포함된 문헌의 질적수준은 level I이 1편(12.5%), level II가 6편(75%), level III가 1편(12.5%)으로 나타났다. 문헌의 '편향 위험 낮음' 비율은 62.5%~87.5%로 각 문헌마다 다르게 나타났다. 문헌에 사용된 중재는 가상 현실 및 가상환경을 기반으로 한 중재가 4편(50%)으로 가장 많았고, 프로토콜을 이용한 중재가 3편(37.5%), 휠체어 사용훈련이 1편(12.5%)으로 나타났다. 각 중재의 효과는 전반적으로 유의미하게 나타났다. 결론 : 본 연구는 지역사회이동에 대한 작업치료의 중재효과를 체계적으로 보고하여 임상적 적용근거를 제공하였다. 추후 지역사회이동성에 대해 다양한 형태로 중재를 적용한 연구가 이루어져야 할 것이다.