• Title/Summary/Keyword: Intervention trial

Search Result 551, Processing Time 0.026 seconds

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
    • /
    • v.15 no.19
    • /
    • pp.8127-8134
    • /
    • 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
    • /
    • v.13 no.2
    • /
    • pp.105-114
    • /
    • 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
    • /
    • v.4 no.1
    • /
    • pp.55-59
    • /
    • 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
    • The Journal of Korean Medicine
    • /
    • v.27 no.4
    • /
    • pp.225-232
    • /
    • 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.

  • PDF

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
    • /
    • v.6 no.2
    • /
    • pp.59-64
    • /
    • 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.

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

  • Han, Ga-jin;Kim, Dong-hun;Park, Eun-joo;Seong, Sin;Kim, Sung-su;Leem, Jung-tae
    • The Journal of Internal Korean Medicine
    • /
    • v.40 no.1
    • /
    • pp.89-116
    • /
    • 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
    • Journal of International Academy of Physical Therapy Research
    • /
    • v.10 no.4
    • /
    • pp.1879-1888
    • /
    • 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
    • /
    • v.17 no.3
    • /
    • pp.1235-1242
    • /
    • 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.

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

  • Bae, Hansol;Lee, Eunnam
    • Journal of Korean Critical Care Nursing
    • /
    • v.14 no.3
    • /
    • pp.73-86
    • /
    • 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.

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

  • Jo, Eun-Ju;Kam, Kyung-Yoon;Chang, Moon-Young
    • The Journal of Korean society of community based occupational therapy
    • /
    • v.8 no.3
    • /
    • pp.77-89
    • /
    • 2018
  • Objective : The purpose of this study was to analyze occupational therapy intervention on the community mobility for stroke patients, and to provide evidence of intervention in the clinical fields. Methods : A systematic review was executed according to the PRISMA checklist. The accessed database was PubMed, EMBASE, Cochrane Library (CENTRAL), ProQuest Dissertations & thesis (PQDT), RISS, and KoreaMed. We included the articles published from 2005 to September 2018. RoBANS checklist was used to evaluate the quality of the articles. Included articles, totally eight, were categorized according to the type of intervention. Results : The study design of the literature was varied from two-group randomized trial, quasi-experimental study, case-control trial, one group pre-post comparison study, and cross-sectional study. In the evidence level, 6 articles were included in level II (75%). The percentage of low risk of bias in each article ranged from 52.5%~87.5%. Four studies (50%) provided intervention based on virtual reality or virtual environment. The three (37.5%) provided intervention based on the protocol, and the other (12.5%) did wheelchair training. All studies reported significant effects of the intervention. Conclusion : This systematic review provided evidences to use proper intervention in the clinical fields. Various type of studies should be conducted to prove the effect of occupational therapy intervention for community mobility.