Animal-Assisted Intervention Improves Pain Perception in Polymedicated Geriatric Patients with Chronic Joint Pain: A Clinical Trial

Abstract Abstract Background: Allergic rhinitis (AR) is a common allergic disease which affects people worldwide and traditional Chinese medicine is getting popular among AR patients for definite clinical effect and less adverse reactions. Lung qi deficiency and cold syndrome (LQDCS) is a frequent type of AR, and Chinese herbal medicine Bimin Decoction (BMD) was generated for AR patients with LQDCS. This study aimed to compare the clinical efficacy of BMD for AR patients with LQDCS to conventional medicine loratadine and fluticasone nasal spray. Methods/Design: The study was designed as an open-label, non-inferiority, randomized controlled trial. A total of 108 AR patients with LQDCS aged 19 to 60 were 1:1 randomly allocated to BMD group and control group by central computer system in Beijing Hospital of Traditional Chinese Medicine from January 2017 to April 2018. 98 completed the study (n=51; n=47). Patients in BMD group received Bimin Decoction while the control group received fluticasone nasal spray and loratadine tablets for a 4-week treatment. The primary outcome was change of the Total Nasal Symptom Score (TNSS) at baseline and the end of treatment. Alterations in Rhinoconjunctivitis Quality Life quality Questionnaire (RQLQ), nasal resistance (NR) and acoustic rhinometry parameters were second outcomes. Any side effect of treatment was observed and recorded. Results: After the 4-week treatment the TNSS total score was significantly reduced in both groups from baseline ( P < 0.05), no significant between-groups differences were observed for the changes of TNSS scores [-0.298 (95% CI -0.640 to 0.140)], which was within the defined non-inferiority margin. RQLQ in both groups decreased significantly ( P < 0.001) from baseline and more obvious reduction in BMD group was observed ( P < 0.001). There was no significant difference in the nasal resistance, the nasal volume and the nasal minimum cross-sectional area after treatment between groups ( P > 0.05). Conclusions: These findings indicated that BMD helps relieve PAR symptoms and improve rhinitis-related life quality. Our study indicated that BMD is non-inferior to loratadine tablets and fluticasone nasal spray for AR patients with LQDCS. Trial registration: Chinese Clinical Trial Registry, ChiCTR-INR-16010063. Registered on 2 December, 2016 Keywords: Perennial allergic rhinitis, Chinese traditional medicine, Randomized controlled trial, Clinical efficacy

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EFFECTS OF MINDFUL FELDENKRAIS EXERCISES AND STRENGTH TRAINING ON COGNITIVE EXECUTIVE FUNCTION IN OLDER ADULTS

Innovation in Aging ◽

10.1093/geroni/igz038.2410 ◽

2019 ◽

Vol 3 (Supplement_1) ◽

pp. S649-S649

Author(s):

Gerhild Ullmann ◽

Yuhua Li ◽

Meredith A Ray

Keyword(s):

Older Adults ◽

Executive Function ◽

Cognitive Function ◽

Strength Training ◽

Group Intervention ◽

Independent Living ◽

Low Cost ◽

Controlled Trial ◽

Control Group ◽

Post Intervention

Abstract Decline in cognitive function associated with aging is one of the greatest concerns of older adults and often leads to significant burden for individuals, families, and the health care system. This 3-arm randomized controlled trial (RCT) responds to the urgent need to identify strategies which can enhance and/or maintain cognitive vitality in older adults. The study is funded by the National Institute on Aging, and aims to examine the effects of both the mind-body exercise Feldenkrais and strength training on cognitive executive function in independent living older adults (N=90) age 65 to 85. Participants of the first wave (n=45) were randomized to a (1) Feldenkrais group, (2) strength training and (3) no-intervention control group. Intervention groups met twice a week for 12 weeks. Cognitive and physical performance measures of the NIH-Toolbox were used at baseline, post-intervention and at a 3-month follow-up. Results of changes in cognitive executive functions within and across groups will be presented. The findings will suggest if such interventions would be a viable low-cost option for older adults to maintain cognitive vitality and thereby impact the development of programs and guidelines for combatting decline in cognitive function.

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Weekly group tummy time classes are feasible and acceptable to mothers with infants: a pilot cluster randomized controlled trial

Pilot and Feasibility Studies ◽

10.1186/s40814-020-00695-x ◽

2020 ◽

Vol 6 (1) ◽

Author(s):

Lyndel Hewitt ◽

Samantha Stephens ◽

Abbe Spencer ◽

Rebecca M. Stanley ◽

Anthony D. Okely

Keyword(s):

Randomized Controlled Trial ◽

Motor Development ◽

Group Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Post Intervention ◽

Time Duration ◽

Randomized Controlled ◽

Tummy Time

Abstract Background The World Health Organization recommends 30 min of tummy time daily for improved motor development and reduced likelihood of plagiocephaly. As only 30% of infants meet this recommendation, parents require strategies and support to increase this proportion. Methods The aim of this study was to determine the feasibility, acceptability, and potential efficacy of a group intervention to promote tummy time. The design is a cluster randomized controlled trial with concealed allocation, assessor blinding, and intention-to-treat analysis. Five groups of healthy infants (N = 35, baseline mean (SD) age 5.9 (2.8) weeks) and their mothers attending local mother’s groups (Australia) were randomly allocated to the intervention or control group. The intervention group received group tummy time classes in addition to usual care. The control group received usual care with their child and family health nurse. Primary outcomes were intervention feasibility and acceptability. Secondary outcomes were tummy time duration (accelerometry), adherence to physical activity guidelines, head shape, and motor development. Measures were taken at baseline, post-intervention, and when infants were 6 months of age. Analyses were by linear mixed models and Cohen’s d statistic. Results Recruitment, retention, and collection of objective data met feasibility targets. Acceptability was also met with intervention mothers reporting the information, goal planning, and handouts significantly more useful and relevant than control group mothers (p < 0.01). Moderate effect sizes were also found at post-intervention for tummy time duration, adherence to physical activity guidelines and infant ability in prone and supine favoring the intervention group (intervention infants had a mean of 30 min and 30% adherence to guidelines (95% CI 0 to 60.6 min) compared to the control infants who had a mean of 16.6 min and 13% adherence to the guidelines (95% CI 0 to 42.1 min, Cohen’s d = 0.5). Limitations were the small sample size, 4-week intervention, limited accelerometer use, and a homogenous sample of participants. Conclusion Group tummy time classes delivered in a mother’s group setting were shown to be feasible and acceptable. A larger randomized controlled trial is warranted. Trial registration ANZCTR, ACTRN12617001298303p. Registered 11 September 2017

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Teaching and Practicing Cognitive-Behavioral and Mindfulness Skills in a Web-Based Platform among Older Adults through the COVID-19 Pandemic: A Pilot Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph182010563 ◽

2021 ◽

Vol 18 (20) ◽

pp. 10563

Author(s):

Stav Shapira ◽

Ella Cohn-Schwartz ◽

Daphna Yeshua-Katz ◽

Limor Aharonson-Daniel ◽

Avram Mark Clarfield ◽

...

Keyword(s):

Social Support ◽

Older Adults ◽

Group Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Post Intervention ◽

Web Based ◽

Wait List Control

The outbreak of the COVID-19 pandemic has led to an acceleration in the development of web-based interventions to alleviate related mental health impacts. The current study explored the effects of a short-term digital group intervention aimed at providing cognitive behavioral and mindfulness tools and skills to reduce loneliness and depression and to increase social support among older adults in Israel. This pilot randomized controlled trial included community-dwelling older adults (n = 82; aged between 65–90 years; 80% female) who were randomized either to an intervention group (n = 64) or a wait-list control group (n = 18). The intervention included seven online sessions, over 3.5 weeks. Depression, loneliness, and social support measures were administered at baseline, immediately post-intervention, and at 1-month follow-up. Repeated measures ANOVA revealed statistically and clinically significant reductions in depression in the intervention group, with results maintained at one-month follow-up. Loneliness levels also significantly decreased post-intervention; however, this benefit was not maintained at one-month follow-up. Social support slightly increased both post-intervention and 1-month follow-up—but these changes were not statistically significant. There were no overall changes for the wait-list control group. Our intervention provided promising evidence regarding the effectiveness of an online group intervention to alleviate mental health effects and to promote the coping of older adults during the COVID-19 pandemic. This relatively simple model can be effectively utilized by communities globally to help connect lonely and isolated older inhabitants, both during the pandemic and in more routine times.

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Efficacy of Bimin Decoction on patients with perennial allergic rhinitis: an open-label non-inferiority randomized controlled trial

10.21203/rs.2.173/v1 ◽

2019 ◽

Author(s):

Jingyi Zhao ◽

Xinyu Yan ◽

Jianqing Gai ◽

Jinshuai Han ◽

Hong Zhang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Allergic Rhinitis ◽

Nasal Spray ◽

Controlled Trial ◽

Life Quality ◽

Control Group ◽

Nasal Resistance ◽

Perennial Allergic Rhinitis ◽

Open Label ◽

Randomized Controlled

Abstract Background: Allergic rhinitis (AR) is a common allergic disease which affects people worldwide and traditional Chinese medicine is getting popular among AR patients for definite clinical effect and less adverse reactions. Lung qi dificiency and cold syndrome (LQDCS) is a frequent type of AR, and Chinese herbal medicine Bimin Decoction (BMD) was generated for AR patients with LQDCS. This study aimed to compare the clinical efficacy of BMD for AR patients with LQDCS to conventional medicine loratadine and fluticasone nasal spray. . Methods/Design: The study was designed as an open-label, non-inferiority, randomized controlled trial. A total of 108 AR patients with LQDCS aged 19 to 60 were 1:1 randomly allocated to BMD group and control group by central computer system in Beijing Hospital of Traditional Chinese Medicine from January 2017 to April 2018. 98 completed the study (n=51; n=47). Patients inBMD group received Bimin Decoction while the control group received fluticasone nasal spray and loratadine tablets for a 4-week treatment. The primary outcome was change of the Total Nasal Symptom Score (TNSS) at baseline and the end of treatment. Alterations in Rhinoconjunctivitis Quality Life quality Questionnaire (RQLQ), nasal resistance (NR) and acoustic rhinometry parameters were second outcomes. Any side effect of treatment was observed and recorded. Results: After the 4-week treatment the TNSS total score was significantly reduced in both groups from baseline (P < 0.05), no significant between-groups differences were observed for the changes of TNSS scores [-0.08 (95% CI -0.56 to 0.40)], which was within the defined non-inferiority margin. RQLQ in both groups decreased significantly (P < 0.001) from baseline and more obvious reduction in BMD group was observed (P < 0.001). There was no significant difference in the nasal resistance, the nasal volume and the nasal minimum cross-sectional area after treatment between groups (P > 0.05). Conclusions: These findings indicated that BMD helps relieve PAR symptoms and improve rhinitis-related life quality. Our study indicated that BMD is non-inferior to loratadine tablets and fluticasone nasal spray for AR patients with LQDCS. Trial registration: Chinese Clinical Trial Registry, ChiCTR-INR-16010063. Registered on 2 December, 2016 Keywords: Perennial allergic rhinitis, Chinese traditional medicine, Randomized controlled trial, Clinical efficacy

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Efficacy of Bimin Decoction on patients with perennial allergic rhinitis: an open-label non-inferiority randomized controlled trial

10.21203/rs.2.173/v3 ◽

2019 ◽

Author(s):

Jingyi Zhao ◽

Xinyu Yan ◽

Jianqing Gai ◽

Jinshuai Han ◽

Hong Zhang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Allergic Rhinitis ◽

Nasal Spray ◽

Controlled Trial ◽

Life Quality ◽

Control Group ◽

Nasal Resistance ◽

Perennial Allergic Rhinitis ◽

Open Label ◽

Randomized Controlled

Abstract Abstract Background: Allergic rhinitis (AR) is a common allergic disease which affects people worldwide and traditional Chinese medicine is getting popular among AR patients for definite clinical effect and less adverse reactions. Lung qi deficiency and cold syndrome (LQDCS) is a frequent type of AR, and Chinese herbal medicine Bimin Decoction (BMD) was generated for AR patients with LQDCS. This study aimed to compare the clinical efficacy of BMD for AR patients with LQDCS to conventional medicine loratadine and fluticasone nasal spray. Methods/Design: The study was designed as an open-label, non-inferiority, randomized controlled trial. A total of 108 AR patients with LQDCS aged 19 to 60 were 1:1 randomly allocated to BMD group and control group by central computer system in Beijing Hospital of Traditional Chinese Medicine from January 2017 to April 2018. 98 completed the study (n=51; n=47). Patients in BMD group received Bimin Decoction while the control group received fluticasone nasal spray and loratadine tablets for a 4-week treatment. The primary outcome was change of the Total Nasal Symptom Score (TNSS) at baseline and the end of treatment. Alterations in Rhinoconjunctivitis Quality Life quality Questionnaire (RQLQ), nasal resistance (NR) and acoustic rhinometry parameters were second outcomes. Any side effect of treatment was observed and recorded. Results: After the 4-week treatment the TNSS total score was significantly reduced in both groups from baseline ( P < 0.05), no significant between-groups differences were observed for the changes of TNSS scores [-0.298 (95% CI -0.640 to 0.140)], which was within the defined non-inferiority margin. RQLQ in both groups decreased significantly ( P < 0.001) from baseline and more obvious reduction in BMD group was observed ( P < 0.001). There was no significant difference in the nasal resistance, the nasal volume and the nasal minimum cross-sectional area after treatment between groups ( P > 0.05). Conclusions: These findings indicated that BMD helps relieve PAR symptoms and improve rhinitis-related life quality. Our study indicated that BMD is non-inferior to loratadine tablets and fluticasone nasal spray for AR patients with LQDCS. Trial registration: Chinese Clinical Trial Registry, ChiCTR-INR-16010063. Registered on 2 December, 2016 Keywords: Perennial allergic rhinitis, Chinese traditional medicine, Randomized controlled trial, Clinical efficacy

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Efficacy of Bimin Decoction on patients with perennial allergic rhinitis: an open-label non-inferiority randomized controlled trial

10.21203/rs.2.173/v4 ◽

2019 ◽

Author(s):

Jingyi Zhao ◽

Xinyu Yan ◽

Jianqing Gai ◽

Jinshuai Han ◽

Hong Zhang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Allergic Rhinitis ◽

Nasal Spray ◽

Controlled Trial ◽

Life Quality ◽

Control Group ◽

Nasal Resistance ◽

Perennial Allergic Rhinitis ◽

Open Label ◽

Randomized Controlled

Abstract Abstract Background: Allergic rhinitis (AR) is a common allergic disease which affects people worldwide and traditional Chinese medicine is getting popular among AR patients for definite clinical effect and less adverse reactions. Lung qi deficiency and cold syndrome (LQDCS) is a frequent type of AR, and Chinese herbal medicine Bimin Decoction (BMD) was generated for AR patients with LQDCS. This study aimed to compare the clinical efficacy of BMD for AR patients with LQDCS to conventional medicine loratadine and fluticasone nasal spray. Methods/Design: The study was designed as an open-label, non-inferiority, randomized controlled trial. A total of 108 AR patients with LQDCS aged 19 to 60 were 1:1 randomly allocated to BMD group and control group by central computer system in Beijing Hospital of Traditional Chinese Medicine from January 2017 to April 2018. 98 completed the study (n=51; n=47). Patients in BMD group received Bimin Decoction while the control group received fluticasone nasal spray and loratadine tablets for a 4-week treatment. The primary outcome was change of the Total Nasal Symptom Score (TNSS) at baseline and the end of treatment. Alterations in Rhinoconjunctivitis Quality Life quality Questionnaire (RQLQ), nasal resistance (NR) and acoustic rhinometry parameters were second outcomes. Any side effect of treatment was observed and recorded. Results: After the 4-week treatment the TNSS total score was significantly reduced in both groups from baseline ( P < 0.05), no significant between-groups differences were observed for the changes of TNSS scores [-0.298 (95% CI -0.640 to 0.140)], which was within the defined non-inferiority margin. RQLQ in both groups decreased significantly ( P < 0.001) from baseline and more obvious reduction in BMD group was observed ( P < 0.001). There was no significant difference in the nasal resistance, the nasal volume and the nasal minimum cross-sectional area after treatment between groups ( P > 0.05). Conclusions: These findings indicated that BMD helps relieve PAR symptoms and improve rhinitis-related life quality. Our study indicated that BMD is non-inferior to loratadine tablets and fluticasone nasal spray for AR patients with LQDCS. Trial registration: Chinese Clinical Trial Registry, ChiCTR-INR-16010063. Registered on 2 December, 2016 Keywords: Perennial allergic rhinitis, Chinese traditional medicine, Randomized controlled trial, Clinical efficacy

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Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

Otolaryngology ◽

10.1177/0194599821994742 ◽

2021 ◽

pp. 019459982199474

Author(s):

Maggie Xing ◽

Dorina Kallogjeri ◽

Jay F. Piccirillo

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Training ◽

Mixed Model ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Functional Index ◽

Open Label ◽

Randomized Controlled ◽

The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

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A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting

Healthcare ◽

10.3390/healthcare9070910 ◽

2021 ◽

Vol 9 (7) ◽

pp. 910

Author(s):

Dorthe Djernis ◽

Mia S. O’Toole ◽

Lone O. Fjorback ◽

Helle Svenningsen ◽

Mimi Y. Mehlsen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Effect Sizes ◽

Medium Effect ◽

Control Group ◽

Post Intervention ◽

Pilot Randomised Controlled Trial ◽

Self Compassion ◽

Randomised Controlled

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

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