scholarly journals Effect of Tai Chi Training on Plantar Loads during Walking in Individuals with Knee Osteoarthritis

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Zhiwang Zhang ◽  
Lingyan Huang ◽  
Yu Liu ◽  
Lin Wang
Keyword(s):  
Clinical Trials ◽  
Knee Osteoarthritis ◽  
Education Program ◽  
Tai Chi ◽  
Peak Pressure ◽  
Maximum Force ◽  
Control Group ◽  
Link Type ◽  
Wellness Education ◽  
Metatarsophalangeal Joints

Tai Chi is an available method for the treatment of knee osteoarthritis (KOA). The impacts of Tai Chi on plantar loads of individuals with KOA are not fully understood. 46 participants with knee osteoarthritis were randomly assigned into the Tai Chi group (n=23) or the control group (n=23). The Tai Chi group attended a 6-month Tai Chi program, and the control group participated in a wellness education program. Novel Pedar-X system was used to collect the peak pressure (PP) and maximum force (MF) during walking before and 6 months after the intervention. Significant higher peak pressure and maximum force were observed in the 4th and 5th metatarsophalangeal joints in the Tai Chi group. However, there were significant declines in the peak pressure of the whole foot and the 2nd and 3rd metatarsophalangeal joints and maximum force of the heel in the control group. These results suggested that individuals with KOA might change the pattern of plantar loads during walking through Tai Chi, and plantar loads would be useful as a parameter to assess the effect of Tai Chi on knee osteoarthritis. This trial is registered with Clinical Trials: CHiCTR-TRC-13003264.

scholarly journals Relieving distressed caregivers (ReDiCare study): study protocol of a randomized pragmatic trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Klaus Pfeiffer ◽  
◽  
Christina Theurer ◽  
Gisela Büchele ◽  
Ana Babac ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Long Term Care ◽  
Intervention Research ◽  
Care Quality ◽  
Control Group ◽  
Term Care ◽  
Link Type ◽  
Intervention Protocol ◽  
Secondary Outcomes

Abstract Background Providing care for someone with a disease or chronic condition can have a negative psychological, physical, social, and economic impact upon informal caregivers. Despite the socio-economic relevance and more than three decades of caregiver intervention research only very few translational efforts of successful interventions are reported. Still less of these interventions have been implemented into routine services. The aim of the ReDiCare study (German acronym BerTA) is to evaluate the effectiveness of a stepped counselling approach for burdened caregivers delivered by care counsellors of two long-term care insurances and registered psychotherapists. Methods/ design A pragmatic randomised controlled trial with 572 caregivers of older adults (≥ 60 years) receiving benefits of one of the two participating long-term care insurances. Participants are assigned (t0) to either the ReDiCare intervention or a control group receiving routine care and counselling. Data are collected at baseline (-t1), 3-month (t1), 9-month (t2) and 15-month (t3). The 9-month post-intervention assessment (t2) is the primary endpoint to evaluate the results on the primary and secondary outcomes, measured by self-reported questionnaires. Depressive symptoms measured with the CES-D are the primary outcome. The main secondary outcomes are physical complaints, utilization of psychosocial resources, caregiver self-efficacy and burden, positive aspects of caregiving and perceived care quality. A process evaluation, including audio tapes, self-report questionnaires and documentation will be conducted to examine internal and external validity of the intervention. Data on direct and indirect costs are collected for the (health) economic evaluation, using a health care perspective and a societal perspective. Discussion While comparable previous caregiver interventions have been developed and evaluated for specific caregiver groups (e.g. dementia caregivers, stroke caregivers), the ReDiCare study will indicate whether a stepped approach will be effective also in a broader group of caregivers. The intervention is one of the very few translational studies in caregiver intervention research and will provide valuable insights into relevant factors for training, intervention protocol adherence, effectiveness, and costs for future implementation steps. Trial registration Deutsches Register Klinischer Studien (German Clinical Trials Register), DRKS00014593 (www.drks.de, registered 14 May 2018) and International Clinical Trials Registry Platform, DRKS00014593  (https://apps.who.int/trialsearch/).

scholarly journals The Clinical Efficacy, Safety and Biomechanical Mechanism of Tai Chi in Patients with Knee Osteoarthritis: Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
PAN FUWEI ◽  
Min Zhang ◽  
Guoqing Du ◽  
Yuanchuan Chen ◽  
Guangyue Yang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Knee Osteoarthritis ◽  
Tai Chi ◽  
Controlled Trial ◽  
Joint Disease ◽  
Secondary Outcome ◽  
Control Group ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Biomechanical Effect

Abstract Background: Knee osteoarthritis (KOA), one of the most common degenerative joint disease, is the leading cause of disability among elder people. Many previous studies demonstrated that Tai chi is an effective treatment in the management of KOA, but there has been a lack of study evaluated the effect of Tai chi on both clinical and biomechanical outcomes in individuals with KOA. The purpose of the study is to identify the clinical and biomechanical effect of the Tai chi, the results will help to improve the understanding of possible underlying biomechanical effects of the Tai chi. Methods: We will conduct a prospective, randomized controlled trials of 72 individuals with medial KOA. The participants with medial KOA will be randomly divided into Tai chi group or a control group. The Tai chi group will participant in Tai chi twice a week for eight weeks. The control group will receive health care education. After the 8-week intervention period there will be a 16-week follow-period with no active intervention in either group. The primary and secondary outcomes will be assessed at baseline, 4 weeks, 8 weeks, 12 weeks and 24 weeks. The primary measure will be Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The secondary outcome measures will include the kinetics, kinematics changing of the knee joint at sagittal, frontal, and transverse plane, the muscle co-contraction.Discussion: This study aims to investigate the clinical and biomechanical effect of the Tai chi, and the results will help to improve the understanding of possible underlying biomechanical effects of the Tai chi in the management of KOA. Trail Registration: The study was approved by China registered clinical trial ethics review committee with No.ChiECRCT20200335. The study plan was registered on the website of China Registered Clinical Trial Registration Center with No.ChiCTR2000040769 .Registered 09 December 2020, http://www.chictr.org.cn/showprojen.aspx?proj=65571

scholarly journals Efficacy of bisphosphonates in specific knee osteoarthritis subpopulations: protocol for an OA Trial Bank systematic review and individual patient data meta-analysis

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e023889 ◽  
Author(s):  
Leticia A Deveza ◽  
Sita M A Bierma-Zeinstra ◽  
Willem Evert van Spil ◽  
Win Min Oo ◽  
Bruno T Saragiotto ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Bone Turnover ◽  
Knee Osteoarthritis ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Patient Data ◽  
Randomised Clinical Trials ◽  
Control Group ◽  
Cochrane Central Register ◽  
Mineral Density

IntroductionRandomised clinical trials to date investigating the efficacy of bisphosphonates in knee osteoarthritis (OA) have found divergent results, with a recent meta-analysis finding no superiority of these drugs over placebo. Whether particular patient subgroups are more likely to benefit from this therapy than others is still unclear. We aim to investigate the effects of bisphosphonates compared with a control group (placebo, no treatment, another active treatment) on clinical and structural outcomes in specific knee OA subpopulations with possible distinct rates of subchondral bone turnover.Methods and analysisMedline, Embase, Scopus, Web of Sciences and Cochrane Central Register of Controlled Trials will be searched from inception to February 2018. Randomised clinical trials will be eligible if they reported at least one potential treatment effect modifier at baseline: gender, menopausal status, age, body mass index, radiographic stage, knee pain severity, presence of bone marrow lesions, levels of biochemical markers of bone turnover (serum and/or urinary) and systemic bone mineral density status. Authors of original trials will be contacted to obtain individual patient data from each study. Risk of bias will be assessed using the Cochrane Collaboration’s tool. The primary outcomes will include pain and radiographic joint space width loss. Studies using other MRI-based assessment of disease progression will also be eligible. Outcomes will be grouped into short-term (≤3 months), intermediate-term (>3 months; ≤12 months) and long-term (>12 months). Regression models will be used, adding an interaction term for each subgroup of interest to determine possible subgroup effects. There was no source of funding for this study.Ethics and disseminationDissemination of our findings is planned to occur through conference presentations, publication in peer-reviewed journals and social media. No formal ethics approval is generally required as no new data collection will be undertaken.PROSPERO registration numberCRD42018093327.

scholarly journals The effect of letrozole versus artificial hormonal endometrial preparation on pregnancy outcome after frozen-thawed embryos transfer cycles: a randomized clinical trial

2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Azadeh Hosseini-Najarkolaei ◽  
Ashraf Moini ◽  
Ladan Kashani ◽  
Maryam Farid Mojtahedi ◽  
Elnaz Hosseini-Najarkolaee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Current Evidence ◽  
Control Group ◽  
Human Menopausal Gonadotropin ◽  
Widespread Application ◽  
Link Type ◽  
Endometrial Preparation

Abstract Background Considering that clinical trial studies are limited in polycystic ovary syndrome (PCOS) patients, and there is no consensus on an optimum endometrial preparation protocol for frozen embryo transfer (FET), the present study was designed as a randomized clinical trial to compare the reproductive outcomes following stimulated cycles with letrozole plus human menopausal gonadotropin (HMG) for endometrial preparation compared with routine AC-FET. Methods This randomized controlled trial was carried out on infertile PCOS patients who underwent IVF/ICSI and FET cycles in Arash Women’s Hospital affiliated to Tehran University of Medical Sciences between September 2018 and January 2020. PCOS diagnosis was based on the Rotterdam criteria. Eligible patients were randomly allocated into two groups: stimulated cycle with letrozole plus (HMG) (intervention group) and routine artificial hormonal endometrial preparation (control group). Results One hundred seventy-seven infertile patients were recruited for participation in the study. Of these, 57 women were excluded due to non-eligibility for entering the study, and a total of 120 patients were randomly assigned to two study groups. After follow up, the cycle outcomes of 57 patients in the intervention group and 59 patients in the control group were compared. The data analysis showed that the two groups did not have significant differences in fundamental and demographic characteristics. After the intervention, there were no significant differences in implantation rate, chemical, ectopic, and clinical pregnancy rates between groups. Moreover, the rates of miscarriage and ongoing pregnancy were similar between groups (P > 0.05). Conclusions We found similar pregnancy outcomes with two endometrial preparation methods. Noting that each treatment centre should select the most beneficial and cost-effective method with the least adverse effects for patients, letrozole preparations for FET could be incorporated into possible options; however, establishing this approach as first-line treatment is premature in light of current evidence, and future randomized clinical trials with larger sample sizes are required for widespread application. Trial registration The study was also registered in the Iranian Registry of Clinical Trials on March 20th, 2020. (IRCT20090526001952N12 at www.irct.ir, registered retrospectively).

scholarly journals Effects of nanomicelle curcumin capsules on prevention and treatment of oral mucosits in patients under chemotherapy with or without head and neck radiotherapy: a randomized clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Seyed Javad Kia ◽  
Maryam Basirat ◽  
Hamid Saeidi Saedi ◽  
Seyed Ali Arab
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Head And Neck ◽  
Oral Mucositis ◽  
Control Group ◽  
Study Group ◽  
Link Type ◽  
Prevention And Treatment ◽  
And Control ◽  
Head And Neck Radiotherapy

Abstract Background One of the most prevalent complications of chemotherapy and radiotherapy is oral mucositis (OM) and manifests as erythema and ulceration. Curcumin is one of the components of turmeric and possesses anti-inflammatory and anti-oxidative features. Some of studies have proved the effectiveness of Curcumin in OM. This study aimed to investigate the effects of nanomicelle Curcumin on OM related chemotherapy and head and neck radiotherapy. Methods In this clinical trial study, 50 patients underwent chemotherapy with or without head and neck radiotherapy were divided into study and control group. The study group was received Curcumin nanomicelle capsules 80 mg twice a day and the control group took placebo two times a day for 7 weeks and the severity and pain of OM was measured. Results Oral mucositis severity in control group in the first (P = 0.010), fourth (P = 0.022) and seventh (P < 0.001) weeks were significantly more than the study group. Pain grade in study group was lower than control group only in the seventh week. (P = 0.001) Additionally, NRS incremental gradient in control group was more than study group. OM severity in patients who underwent only chemotherapy in the control group were significantly more than the study group in all weeks. In patients who were under chemotherapy and head and neck radiotherapy, OM in control group was significantly more intense than the study group only in the fourth and seventh weeks. Conclusions Nabomicelle Curcumin capsules is effective on prevention and treatment of head and neck radiotherapy and especially chemotherapy induced OM. Trial registration Registered 12 February 2019 at Iranian Registry of Clinical Trials (IRCT). IRCT code: IRCT20100101002950N6. https://en.irct.ir/trial/36665. GUMS ethical code: IR.Gums.Rec.1397.296.

scholarly journals A community-centric multi-disciplinary education program with the 8-section brocade Tai Chi therapy for patients with osteoarthritis of the knee – a pilot study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Kevin Ki-Wai Ho ◽  
Gerald Pong ◽  
Queena Wai-Chin Poon ◽  
Jojo Yan-Yan Kwok ◽  
Wai-Wang Chau ◽  
...  
Keyword(s):  
Education Program ◽  
Tai Chi ◽  
Program Effectiveness ◽  
Dropout Rate ◽  
Activity Level ◽  
Control Group ◽  
Osteoarthritis Of The Knee ◽  
Womac Pain ◽  
Knee Oa ◽  
Tai Chi Exercise

Abstract Background Osteoarthritis (OA) of the knee is one of the most common chronic degenerative joint diseases, and a multi-disciplinary approach to educating patients with OA knee are effective in symptoms management. Tai Chi exercise is a novel approach to relieving knee OA symptoms. Combining both educational program and Tai Chi has not yet been explored. Methods Multi-disciplinary education program included a total of 4-week 2-h weekly talks delivered by different health professionals with live demonstrations. This was then followed by a 1-h Tai Chi class (Baduanjin). Results from IPAQ (Physical activity level), WOMAC (evaluate knee OA conditions), and SF-36v2 (quality of life) were collected at the first class of education program, 3 and 6 months after the end of Tai Chi class. CSQ-8 (program effectiveness) was administered on the last day of Tai Chi class. Results One hundred and twelve patients joined the program. The overall attendance was over 90% with close-to-zero dropout rate. Satisfaction scored high in 85% of patients. WOMAC pain scores (p = 0.04) and SF-36v2 emotional role (p = 0.02) were statistically decreasing (improving) at 6 months after the program. SF-36v2 physical role and mental health tended to improve with time. Conclusions Combining both multidisciplinary education program program and Tai Chi exercise for knee OA patients was proven feasible. This program received high satisfaction, high attendance and very low dropout rates without any adverse event. Patients’ pain and emotion were significantly improved. A large-scale randomized trial introducing a control group is recommended. Trial registration Registry: ClinicalTrials.gov Registration number: NCT04204213 Date of registration: 18/12/2019 (Retrospectively registered)

scholarly journals Study on efficacy and safety of Tong-luo Qu-yu plaster treatment for knee osteoarthritis: study protocol for a randomised, double-blind, parallel positive control, multi-center clinical trial

2019 ◽  
Author(s):  
Bao-ping Xu ◽  
Min Yao ◽  
Zi-rui Tian ◽  
Long-yun Zhou ◽  
Long Yang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Knee Osteoarthritis ◽  
Clinical Symptoms ◽  
Positive Control ◽  
Control Group ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Experimental Group

Abstract Background: Knee osteoarthritis (KOA) is a common chronic musculoskeletal disorder that seriously affect quality of life. Patients with KOA frequently develop one or more of the typically following symptoms: joint pain, stiffness, joint friction noise, impaired functionality. Traditional Chinese medicines (TCM) have showed a superior effect and peculiar advantage on the treatment of KOA, among TCMs, the Tong-luo Qu-yu plaster is the convenient and most commonly used method in China to improve symptoms including pain, stiffness and limited mobility in patients with KOA, as it causes few adverse effects. But there is a lack of high quality of clinical evidences to support the therapeutic effect that Chinese adhesive plaster can relieve pain and stiffness. The purpose of this study will be to evaluate the efficacy and safety of Tong-luo Qu-yu plaster in patients with KOA. Methods: This study will be a randomised, double-blind, parallel positive control, multi-center clinical trial. A total of 2000 participants older than 40 years with KOA, will be randomly allocated into a experimental group (n=1500) and a control group (n=500). All participants will receive a conventional conservative treatment lasted for 14 days as two courses, daily 1 time. Tong-luo Qu-yu plaster will be administered externally to participants in the experimental group, while the control group will receive a Qi-zheng Xiao-tong plaster. The outcome of the total Western Ontario and McMaster Universities Arthritis Index scores, TCM syndrome quantitative score, visual analog scale scores will be measured during the assessment visits (baseline and 1-, 2-week follow-up). In addition, adverse events concerning clinical symptoms and signs as well as laboratory tests will be documented during clinical trials. Discussion: This study will be a randomized, double-blind, parallel positive control trial to further evaluate the effectiveness and safety of Tong-luo Qu-yu plaster for patients with KOA in nine medical centers compared with control group, it is expected that the patients with KOA will benefit from this study. Trial Registration: ClinicalTrials.gov, NCT03309501. Registered on 08 November 2017. Keywords: Clinical trials, Knee osteoarthritis, Tong-luo Qu-yu plaster, Randomized, Protocol

Personalized Behavioral Nutrition Intervention in Older Asian Americans with Type 2 Diabetes during COVID-19 Pandemic: Study Protocol for a Pilot, Hybrid, Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Jisook Ko ◽  
Yan Du ◽  
Rozmin Jiwani ◽  
Chengdong Li ◽  
Jing Wang
Keyword(s):  
Type 2 Diabetes ◽  
Clinical Trials ◽  
Pilot Study ◽  
Glycemic Control ◽  
Asian Americans ◽  
Control Group ◽  
Management Approach ◽  
Self Monitoring ◽  
Behavioral Nutrition

BACKGROUND The COVID-19 pandemic has challenged the in-person-based self-management approach (i.e., face-to-face or group approach) of type 2 diabetes (T2D). Older adults with T2D, including Asian Americans (AAs), have experienced worsening of diabetes control due to various reasons, including uncertainty of continuous access to essential diabetes medications, devices, education, limited health literacy, as well as constant anxiety and stress. Hybrid clinical trials that incorporate virtual elements into the in-person-based study could provide these vulnerable populations with accessible and timely interventions OBJECTIVE The primary aims of this pilot study are to determine (1) the effect of personalized behavioral nutrition (PBN) intervention on glycemic control, weight control, and metabolites profiles; and (2) the acceptability of PBN. to enhance glycemic control using personalized behavioral nutrition. METHODS Participants will be recruited with a web-based registry, advertisements in ethnic newspapers, and social network services popular among AAs. A total of 60 AAs, aged 65 years or older, who are descendants of Chinese, Korean, or South Asian, and have a diagnosis of T2D will be randomized into two groups: a PBN group (n=30) and a control group (n=30). A 4-week PBN intervention comprises three components: 1) digital self-monitoring; 2) personal nutrition change goals and recommendations; and 3) diabetes nutrition educations. All participants will complete digital self-monitoring on diet, physical activity, and blood glucose. In addition, all participants will access an interactive digital platform to track their self-monitoring data and communicate with the research team. The effectiveness and acceptability of implementing the intervention will be assessed. RESULTS Funding support and institutional review board approval for this study have been secured. Data collection started in August 2020 and is ongoing. CONCLUSIONS To our knowledge, this is the first study to determine the effectiveness and acceptability of PBN utilizing a metabolomics approach and digital-assisted intervention with hybrid RCT among older AAs. The findings of this pilot study will inform the development of a full-scale PBN protocol and hybrid clinical trials that can be adapted for people with T2D in the ongoing pandemic.

The impact of a music education program on meta-musical awareness, logical-mathematical, and notational skills in preschoolers

2021 ◽  
pp. 025576142110272
Author(s):  
Oriana Incognito ◽  
Laura Scaccioni ◽  
Giuliana Pinto
Keyword(s):  
Music Education ◽  
Education Program ◽  
Cognitive Abilities ◽  
Musical Training ◽  
Control Group ◽  
Transfer Of Knowledge ◽  
General Domain ◽  
Music Program ◽  
Before And After ◽  
The Impact

A number of studies suggest a link between musical training and both specific and general cognitive abilities, but despite some positive results, there is disagreement about which abilities are improved. This study aims to investigate the effects of a music education program both on a domain-specific competence (meta-musical awareness), and on general domain competences, that is, cognitive abilities (logical-mathematical) and symbolic-linguistic abilities (notational). Twenty 4- to 6-year-old children participated in the research, divided into two groups (experimental and control) and the measures were administered at two different times, before and after a 6-month music program (for the experimental group) and after a sports training program (for the control group). Children performed meta-musical awareness tasks, logical-mathematical tasks, and emergent-alphabetization tasks. Non-parametric statistics show that a music program significantly improves the development of notational skills and meta-musical awareness while not the development of logical-mathematical skills. These results show that a musical program increases children’s meta-musical awareness, and their ability to acquire the notational ability involved in the invented writing of words and numbers. On the contrary, it does not affect the development of logical skills. The results are discussed in terms of transfer of knowledge processes and of specific versus general domain effects of a musical program.

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