Analysis of Effectiveness of a Supplement Combining Harpagophytum procumbens, Zingiber officinale and Bixa orellana in Healthy Recreational Runners with Self-Reported Knee Pain: A Pilot, Randomized, Triple-Blind, Placebo-Controlled Trial

Recreational running (RR) is becoming a popular way to increase physical activity for improving health, together with a higher incidence of knee injuries. The aim was to analyze the effect of a four-week supplementation with a mixture of Harpagophytum procumbens, Zingiber officinale and Bixa orellana on males, middle-aged, RR with an undiagnosed knee discomfort. A randomized triple-blind placebo-control trial was conducted among male RR aged 40–60 years suffering from self-declared knee discomfort after training. Participants were assigned to supplementation (2 g/day in 6 doses; n = 13; intervention group (IG)) or matched placebo (n = 15; control group (CG)) for 4 weeks. At pre- and post-intervention, assessment of routine blood biomarkers, body composition, running biomechanics and body temperature was performed using standardized procedures. Machine learning (ML) techniques were used to classify whether subjects belonged to IG or CG. ML model was able to correctly classify individuals as IG or CG with a median accuracy of 0.857. Leg fat mass decreased significantly (p = 0.037) and a deeper reduction in knee thermograms was observed in IG (p < 0.05). Safety evaluation revealed no significant differences in the rest of parameters studied. Subjects belonging to IG or CG are clearly differentiated, pointing into an effect of the supplement of ameliorating inflammation.

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Equol effects on AGE skin products, visceral fat and climacteric symptoms in post-menopausal women: A randomized controlled trial

10.21203/rs.3.rs-265906/v2 ◽

2021 ◽

Author(s):

Remi Yoshikata ◽

Khin Zay Yar Myint ◽

Hiroaki Ohta ◽

Yoko Ishigaki

Keyword(s):

Randomized Controlled Trial ◽

Visceral Fat ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Climacteric Symptoms ◽

Post Intervention ◽

Randomized Controlled ◽

Menopausal Women ◽

Post Menopausal

Abstract Introduction: Equol, an isoflavone derivative whose chemical structure is similar to estrogen, is considered as a potentially effective agent for relieving climacteric symptoms, for the prevention of the lifestyle-related diseases, and for aging care in post-menopausal women. We investigated the effect of an equol-containing supplement on metabolism and aging, and climacteric symptoms, with respect to internally-produced equol in post-menopausal women.Methods: A single center, randomized controlled trial (registration number: UMIN000030975) on 57 post-menopausal Japanese women (mean age: 56±5.37 years), was conducted. Twenty-seven women received the equol supplement, while the remaining received Control. Metabolic and aging-related biomarkers were compared before and after the 3-month intervention. Climacteric symptoms were assessed every month using a validated self-administered questionnaire in Japanese post-menopausal women. Results: Three months post intervention, the treatment group showed significant improvement in climacteric symptoms, when compared to the Control group (81% vs. 53% respectively, p=0.045). We did not observe any beneficial effect on metabolic and aging-related biomarkers in the intervention group. However, in certain populations significant improvement in skin auto-fluorescence, which is a measurement of AGE skin products, and visceral fat area was observed, especially among equol producers. Conclusion: Women receiving equol supplement showed improved climacteric symptoms. This study offered a new hypothesis that there may be a synergy between supplemented equol and endogenously-produced equol to improve skin aging and visceral fat in certain populations.

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Effectiveness of hamstring stretching using a pressure biofeedback unit for 4 weeks: A randomized controlled trial

Hong Kong Physiotherapy Journal ◽

10.1142/s1013702520500092 ◽

2020 ◽

Vol 40 (02) ◽

pp. 99-107

Author(s):

Jin-Oh Ahn ◽

Jong-Hyuck Weon ◽

Eun-Kyung Koh ◽

Do-Young Jung

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Knee Extension ◽

Control Group ◽

Post Intervention ◽

Lower Back ◽

Hamstring Muscles ◽

Before And After ◽

The Difference ◽

Pressure Biofeedback

Background: Stretching and length test of hamstring muscles have been performed commonly to manage lower back pain (LBP) in sports rehabilitation. Previous literatures addressed that stretching techniques and length test of hamstring muscles should be performed with the pelvic maintained in an anterior tilt position. However, there is no study to determine the effectiveness of pressure biofeedback unit (PBU) to maintain in anterior pelvic tilting (APT) on length test and stretching of hamstring muscles. Objective: To determine the effectiveness of hamstring muscles stretching using a PBU. Methods: Forty participants with shortness of hamstrings randomized into two groups. Participants performed the active knee extension (AKE) stretching without (control group) or with PBU (intervention group) for four weeks. AKE tests without and with PBU were administered three times before and after hamstrings stretching by each group. Results: The AKE test without PBU showed a significant main effect of time ([Formula: see text]) but not of group ([Formula: see text]) on the AKE angle. The AKE test with PBU showed a significant increase in the AKE angle in the post-intervention compared to the pre-intervention assessments in both groups ([Formula: see text]). The difference of AKE angle between the pre- and post-intervention results was significantly greater in the intervention group than in the control group ([Formula: see text]). Conclusion: We recommend the use of a PBU to maintain the pelvic anterior tilting position when performing the AKE test or AKE stretching.

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Robot-assisted gait training to reduce pusher behavior

Neurology ◽

10.1212/wnl.0000000000006276 ◽

2018 ◽

Vol 91 (14) ◽

pp. e1319-e1327 ◽

Cited By ~ 6

Author(s):

Jeannine Bergmann ◽

Carmen Krewer ◽

Klaus Jahn ◽

Friedemann Müller

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Gait Training ◽

Class Ii ◽

Control Group ◽

Robot Assisted ◽

Post Intervention ◽

Subacute Stroke ◽

Post Test

ObjectiveTo determine the effects of 2 weeks of intensive robot-assisted gait training (RAGT) on pusher behavior compared to nonrobotic physiotherapy (nR-PT).MethodsIn a single-blind, randomized, controlled trial with 2 parallel arms, we compared 2 weeks of daily RAGT (intervention group) with the same amount of nR-PT (control group). Patients with subacute stroke who had pusher behavior according to the Scale for Contraversive Pushing (SCP) were included. The primary research questions were whether changes in pusher behavior would differ between groups post intervention, and at a follow-up 2 weeks afterward (SCP and Burke Lateropulsion Scale, Class II evidence). Secondary outcomes included the Performance-Oriented Mobility Assessment, the Functional Ambulation Classification, and the Subjective Visual Vertical.ResultsThirty-eight patients were randomized. Thereof, 30 patients received the allocated intervention and were included in the analyses. RAGT led to a larger reduction of pusher behavior than nR-PT at post test (SCP: U = 69.00, r = −0.33, p = 0.037; Burke Lateropulsion Scale: U = 47.500, r = −0.50, p = 0.003) and at follow-up (SCP: U = 54.00, r = −0.44, p = 0.008). Pusher behavior had ceased in 6 of 15 participants in the intervention group and 1 of 15 participants in the control group at post test. At follow-up, 9 of 15 and 5 of 15 participants, respectively, no longer exhibited the behavior.ConclusionsTwo weeks of RAGT seems to persistently reduce pusher behavior, possibly by recalibrating the disturbed inner reference of verticality. The potential benefits of RAGT on pusher behavior and verticality perception require further investigation.Trial registrationGerman Clinical Trials Register (registration number: DRKS00003444).Classification of evidenceThis study provides Class II evidence that RAGT is beneficial to reduce pusher behavior in patients with stroke.

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Randomised controlled trial of the new short-term online emotion focused training for self-compassion and self-protection in a nonclinical sample

Current Psychology ◽

10.1007/s12144-018-9933-4 ◽

2018 ◽

Vol 40 (1) ◽

pp. 333-343 ◽

Cited By ~ 1

Author(s):

Júlia Halamová ◽

Martin Kanovský ◽

Karolína Varšová ◽

Nuriye Kupeli

Keyword(s):

Mental Health Professionals ◽

Controlled Trial ◽

Intervention Group ◽

Clinical Population ◽

Control Group ◽

Short Term ◽

Post Intervention ◽

Self Compassion ◽

Self Protection

AbstractThe Emotion Focused Training for Self-Compassion and Self-Protection (EFT-SCP) is an intervention developed to increase skills of self-compassion and protective anger with the aim to decrease self-criticism. This novel intervention was developed on the basis of the latest findings on self-criticism from Emotion-focused therapy and previous programs cultivating compassion (namely Compassion Mind Training and Mindful Self-Compassion Program). According to existing research, simply cultivating self-compassion is not always sufficient in reducing self-criticism. Therefore, the EFT-SCP was designed to build self-compassion whilst developing protective anger to combat self-criticism. Our goal was to investigate the efficacy of this new, short-term, online EFT-SCP program in a non-clinical population. A randomized control trial was conducted with pre- and post-intervention measurements and two-month follow-up of self-compassion and self-criticism/reassurance. Convenience sampling was used to recruit participants through a snowballing technique on social media. A total of 123 participants were randomly allocated to the EFT-SCP intervention or to a control condition. The intervention group were instructed through emails to complete an EFT-SCP task every day for 14 consecutive days. The control group did not complete any tasks. Out of 123 participants, 31 from intervention group and 20 from control group completed all measurements. There was a significant effect of the EFT-SCP on increasing self-compassion and self-reassurance scores as reported at two-month follow-up. The EFT-SCP was also effective at reducing self-uncompassionate responding and self-criticism (specifically Hated self) with changes evident at two months post-intervention. These findings are encouraging and suggest that interventions designed to enhance self-compassion and decrease self-criticism can be delivered to broader populations without the direct contact with mental health professionals.

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Consumption of melatonin supplement improves cardiovascular disease risk factors and anthropometric indices in type 2 diabetes mellitus patients: A double-blind, randomized, placebo-controlled trial

10.21203/rs.3.rs-18733/v2 ◽

2020 ◽

Author(s):

Hadi Bazyar ◽

Ahmad Zare Javid ◽

Hossein Bavi Behbahani ◽

Fardin Moradi ◽

Bahman Moradi Poode ◽

...

Keyword(s):

Diabetes Mellitus ◽

Disease Risk ◽

Controlled Trial ◽

Cardiovascular Disease Risk ◽

Intervention Group ◽

Control Group ◽

Post Intervention ◽

Anthropometric Indices ◽

Double Blind ◽

Conicity Index

Abstract Background: Diabetes mellitus is a common chronic disease. Dyslipidemia and hypertension are two complications that may develop in diabetic patients if hyperglycemia, insulin resistance, and weight gain are not controlled. This study investigated the effects of melatonin supplementation on some cardiovascular disease risk factors and anthropometric indices in patients with type 2 diabetes mellitus (T2DM).Materials and Methods: In this double-blind, randomized, placebo-controlled trial, 50 T2DM patients were randomly allocated to intervention and control groups which received two tablets of either melatonin or placebo (250 mg) once a day for eight weeks. Mean arterial pressure (MAP), pulse pressure (PP), the atherogenic index of plasma (AIP), weight, body mass index (BMI), waist and hip circumference (WC, HC), body shape index (ABSI), abdominal volume index (AVI), body adiposity index (BAI), lipid accumulation product (LAP), conicity index, and waist-to-height ratio (WHR) were evaluated in all the patients pre- and post-intervention.Results: Melatonin supplementation for eight weeks significantly decreased the mean levels of MAP, PP, weight, BMI, WC, HC, BAI, AVI, conicity index, and WHR post-intervention (p<0.05). Also, the median changes of MAP, PP, weight, BMI, WC, HC BAI, AVI, and conicity index were significantly lower in the intervention group compared with the control group (p<0.05). A significant increase (p<0.001) was observed in the mean levels of ABSI in the intervention group. The median changes of ABSI were significantly greater in the intervention group compared with the control group (p<0.001).Conclusions: Consumption of melatonin supplement may be effective in controlling arterial pressure and anthropometric indices (as predictors of obesity) in T2DM patients.Trial registration: This trial was registered in the Iranian Registry of Clinical Trials website at 2019/5/17. (IRCT20190303042905N1).

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The efficacy of a resilience-enhancement program for mothers in Japan based on emotion regulation: study protocol for a randomized controlled trial

BMC Psychology ◽

10.1186/s40359-019-0344-6 ◽

2019 ◽

Vol 7 (1) ◽

Cited By ~ 1

Author(s):

Hiromi Tobe ◽

Mariko Sakka ◽

Kiyoko Kamibeppu

Keyword(s):

Emotion Regulation ◽

Child Maltreatment ◽

Parental Stress ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Self Report ◽

Baseline Survey ◽

Control Group ◽

Post Intervention

Abstract Background The demands of daily life often cause mothers high levels of distress and other negative emotions. Anger, including harsh verbal discipline, has been linked to child maltreatment, with long-term adverse effects on a child’s well-being. It is critically important to teach mothers stress management and emotion regulation in addition to parenting skills, but this is yet to be conducted in a formalized manner. Strengthening the multiple protective factors that constitute resilience helps reduce distress. The aim of this study is to evaluate the efficacy of a resilience-enhancement program for mothers. Methods We designed a two-arm, parallel, randomized trial with an active control. Mothers and their partners with children between three and six years old will be recruited. Following an online baseline survey, 140 mothers will be randomly allocated to either an intervention or control group. Self-report assessment will be conducted online post-intervention and at a two-month follow-up. The control group will participate in a serious of group discussions. The intervention group will participate in four bi-weekly 120-min sessions of a Cognitive Behavior Therapy-based program designed to enhance resilience, focusing on emotion regulation through cognitive reappraisal. Participants will be encouraged to apply and share the skills they acquire with their partner and children at home. Partners will also be assessed to explore their indirect influence from the mothers. Intention-to-treat analysis will be conducted and the two groups will be compared, applying covariate analysis. The primary outcome of the intervention is improved resilience. Secondary outcomes include improved anger control, self-esteem, cognition of children’s misbehavior, and reduced parental stress. Discussion To the best of our knowledge, this study will evaluate the first resilience-enhancement program focused on emotion regulation for mothers in Japan. It will contribute to the existing body of knowledge on building emotional resilience. If the program is found to be effective, it will provide an alternative means to enhance mothers’ resilience against stress and improve their ability to regulate emotion. In so doing, it will offer a way to prevent child maltreatment and protect the mental health of children and families. Trial registration UMIN000027232, May 3, 2017.

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Feasibility of a Mindfulness-Based Intervention for Caregivers of Veterans: A Pilot Study

Journal of Holistic Nursing ◽

10.1177/0898010119831580 ◽

2019 ◽

Vol 37 (4) ◽

pp. 322-337

Author(s):

Sandraluz Lara-Cinisomo ◽

Elinor M. Fujimoto ◽

Ryan L. Santens

Keyword(s):

Pilot Study ◽

Controlled Trial ◽

Intervention Group ◽

Effect Sizes ◽

Group Method ◽

Control Group ◽

Five Facet Mindfulness Questionnaire ◽

Post Intervention ◽

Difference Scores ◽

Group Type

Purpose: This pilot study aimed to assess the feasibility of conducting an 8-week mindfulness-based intervention with caregivers of veterans and to examine the effectiveness of the intervention to improve mindfulness using the Five Facet Mindfulness Questionnaire compared with waitlist controls. Design: In this randomized controlled trial, 23 caregivers of veterans were assigned to either the intervention or waitlist group. Method: Compliance with mindfulness instruction and attendance was assessed among those in the intervention. Wilcoxon signed-rank tests compared within group pre- and post-intervention scores and Mann–Whitney U tests compared difference scores (post–pre) by group type. Effect sizes were also calculated. Compliance variables were correlated with difference scores in the intervention group only. Findings: Of the 23 participants, 11 were assigned to the intervention; 100% of participants were retained. There was significant improvement from pre- to post-intervention in four of the five facets of mindfulness ( p < .05) in the intervention group. Significant between-group differences ( p < .05) were also observed in two of the five facets. Effect sizes ranged from small (.44) to large (.89). No significant improvement was observed in the waitlist control group. Conclusions: A mindfulness-based intervention is feasible and acceptable to improve mindfulness in caregivers of veterans.

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Assessing effective methods to educate caregivers on fever in children aimed at reducing input to the paediatric emergency department

Proceedings of Singapore Healthcare ◽

10.1177/2010105817733271 ◽

2017 ◽

Vol 27 (2) ◽

pp. 73-84 ◽

Cited By ~ 1

Author(s):

Tessa E-Lin Ong ◽

Jade Phek Hui Kua ◽

Luther Jinmian Yiew ◽

Zi Ying Lim ◽

Michelle Xing Hui Thia ◽

...

Keyword(s):

Emergency Department ◽

Controlled Trial ◽

Significant Proportion ◽

Intervention Group ◽

Control Group ◽

P Value ◽

Post Intervention ◽

Paediatric Emergency Department ◽

Paediatric Emergency ◽

Fever Management

Introduction: Many paediatric emergency departments face a significant proportion of non-urgent attendances, leading to problems for both patients and healthcare systems. Our primary aim was to compare the effectiveness of pamphlet versus video in educating caregivers regarding fever management in children. Our secondary aim was to assess caregivers’ sentiments towards these methods. Methods: A randomized controlled trial was conducted with 50 participants over a four-week period (May–June 2015) in the KK Hospital Paediatric Emergency Department. The control group was exposed to the standard pamphlet available in the KK Hospital Paediatric Emergency Department, which provided basic information on fever management. The intervention group watched a video produced by our team, containing similar content. The same five-question questionnaire assessing fever management knowledge was issued to participants before and immediately following exposure to intervention. Results: The pamphlet group had a mean pre-intervention score=2.8 (out of five), post-intervention score=3.84, amounting to an improvement of 1.04. The video group had a mean pre-intervention score=2.56, post-intervention score=4.12, giving an improvement of 1.36. The study was powered at 80%, with calculated p-value=0.111, hence the results were statistically insignificant. Both groups had increased self-reported awareness post-exposure, found the intervention useful, would rely on it for future management and would recommend it to others. Conclusion: While the sample size was limited, this study demonstrates the potential that both pamphlet and video interventions have in educating caregivers, as participants reported favourable sentiments towards the methods. It would be worthwhile to conduct the study on a larger scale to yield statistically significant results.

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Effectiveness of a mindfulness-oriented substance use prevention program for boys with mild to borderline intellectual disabilities: study protocol for a randomised controlled trial

BMC Public Health ◽

10.1186/s12889-020-09878-w ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Lucie Waedel ◽

Anne Daubmann ◽

Antonia Zapf ◽

Olaf Reis

Keyword(s):

Substance Use ◽

Randomised Controlled Trial ◽

Intellectual Disabilities ◽

Controlled Trial ◽

Intervention Group ◽

Secondary Outcome ◽

Control Group ◽

Post Intervention ◽

Randomised Controlled

Abstract Background Boys with mild to borderline intellectual disabilities (MBID) are at particular risk to drink in harmful ways once they start to consume alcohol. Interventions based on mindfulness have been proven to be effective in preventing substance use, but mostly for adults with MBID. A mindfulness oriented intervention targeting 11–17 years old boys will be tested in a randomised controlled trial. Study aim is to investigate the benefits of this new intervention compared to an active control condition within a 12 months follow-up. Methods In this randomised controlled proof of concept study, 82 boys with MBID who consumed any alcohol during the last year will be randomised either to the 6 week mindfulness oriented intervention or the control group receiving a control intervention equal in dose and length. The intervention group undergoes mindfulness training combined with interactive drug education, while the control group completes a health training combined with the same education. In the intention-to-treat analysis the primary outcome is the self-reported delay of first post-intervention drunkeness within a 12 months follow-up time span, measured weekly with a short app-based questionnaire. Secondary outcome is the use of alcohol, tobacco and other drugs within 30 days post-intervention. Changes in neurobiological behavioural parameters, such as impulse control, reward anticipation, and decision making, are also investigated. Other secondary outcomes regard trait mindfulness, emotion regulation, psychopathological symptoms, peer networks, perceived stress, and quality of life. In addition, a prospective registry will be established to record specific data on the population of 11–17 year old boys with MBID without any alcohol experience. Discussion This study offers the opportunity to gain first evidence of the effectiveness of a mindfulness-oriented program for the prevention of substance use for boys with MBID. Trial registration German Clinical Trials Register, DRKS00014042. Registered on March 19th 2018.

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Effects of the Conceptual Model of Health Literacy as a Risk: A Randomised Controlled Trial in a Clinical Dental Context

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph15081630 ◽

2018 ◽

Vol 15 (8) ◽

pp. 1630 ◽

Cited By ~ 4

Author(s):

Linda Stein ◽

Maud Bergdahl ◽

Kjell Sverre Pettersen ◽

Jan Bergdahl

Keyword(s):

Health Literacy ◽

Conceptual Model ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Post Intervention ◽

Convenience Sample ◽

Communication Techniques ◽

The Mean ◽

Randomised Controlled

Numerous conceptual models of health literacy have been proposed in the literature, but very few have been empirically validated in clinical contexts. The aim of this study was to test the effects of the conceptual model of health literacy as a risk in a clinical dental context. A convenience sample of 133 Norwegian-speaking adults was recruited. Participants were randomly allocated to an intervention group (n = 64, 54% women, mean age = 50 years) and a control group (n = 69, 49% women, mean age = 46 years). Clinical measurements were conducted pre-intervention and six months post-intervention. In the intervention group, communication regarding patients’ oral health was tailored to their health literacy levels using recommended communication techniques, whereas the control group received brief information not tailored to health literacy levels. The ANCOVA showed significant between-group effects, finding reduced post-intervention mean gingival (p < 0.000) and mean plaque (p < 0.000) indices in the intervention group when controlling for baseline index scores. The adjusted Cohen’s d indicated large effect sizes between the intervention group and the control group for both the mean gingival index (−0.98) and the mean plaque index (−1.33). In conclusion, the conceptual model of health literacy as a risk had a large effect on important clinical outcomes, such as gingival status and oral hygiene. The model may be regarded as a suitable supplement to patient education in populations.

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