Pulsed Ultrasounds Reduce Pain and Disability, Increasing Rib Fracture Healing, in a Randomized Controlled Trial

AbstractIntroductionRib fractures are an important health issue worldwide, with significant, pain, morbidity, and disability for which only symptomatic treatment exists.ObjectivesBased on our previous experimental model, the objective of the current study was to assess for the first time whether pulsed ultrasound (PUS) application could have beneficial effects on humans.MethodsProspective, double-blinded, randomized, controlled trial of 51 patients. Four were excluded, and 47 were randomized into the control group (N = 23) or PUS group (N = 24). The control group received a PUS procedure without emission, and the PUS group received 1 Mhz, 0.5 W/cm2 for 1 min/cm2. Pain level, bone callus healing rate, physical and work activity, pain medication intake, and adverse events were blindly evaluated at baseline and one, three, and six months.ResultsThere were no significant differences at baseline between groups. PUS treatment significantly decreased pain by month 1 (P = 0.004), month 3 (P = 0.005), and month 6 (P = 0.025), significantly accelerated callus healing by month 1 (P = 0.013) and month 3 (P < 0.001), accelerated return to physical activity by month 3 (P = 0.036) and work activity (P = 0.001) by month 1, and considerably reduced pain medication intake by month 1 (P = 0.057) and month 3 (P = 0.017). No related adverse events were found in the PUS group.ConclusionsThis study is the first evidence that PUS treatment is capable of improving rib fracture outcome, significantly accelerating bone callus healing, and decreasing pain, time off due to both physical activity and convalescence period, and pain medication intake. It is a safe, efficient, and low-cost therapy that may become a new treatment for patients with stable rib fractures.

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The Effect of Lavender Oil on Perioperative Pain, Anxiety, Depression, and Sleep after Microvascular Breast Reconstruction: A Prospective, Single-Blinded, Randomized, Controlled Trial

Journal of Reconstructive Microsurgery ◽

10.1055/s-0041-1724465 ◽

2021 ◽

Author(s):

Ronnie L. Shammas ◽

Caitlin E. Marks ◽

Gloria Broadwater ◽

Elliot Le ◽

Adam D. Glener ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Adverse Events ◽

Breast Reconstruction ◽

Controlled Trial ◽

Depression Scale ◽

Control Group ◽

Lavender Oil ◽

Entire Cohort ◽

Randomized Controlled ◽

Anxiety Depression

Abstract Background Psychosocial distress, depression, or anxiety can occur in up to 50% of women after a breast cancer diagnosis and mastectomy. The purpose of this study was to assess the potential benefit of lavender oil as a perioperative adjunct to improve anxiety, depression, pain, and sleep in women undergoing microvascular breast reconstruction. Methods This was a prospective, single-blinded, randomized, controlled trial of 49 patients undergoing microvascular breast reconstruction. Patients were randomized to receive lavender oil or placebo (coconut oil) throughout their hospitalization. The effect of lavender oil on perioperative stress, anxiety, depression, sleep, and pain was measured using the hospital anxiety and depression scale, Richards–Campbell Sleep Questionnaire, and the visual analogue scale. Results Twenty-seven patients were assigned to the lavender group and 22 patients were assigned to the control group. No significant differences were seen in the perioperative setting between the groups with regard to anxiety (p = 0.82), depression (p = 0.21), sleep (p = 0.86), or pain (p = 0.30) scores. No adverse events (i.e., allergic reaction) were captured, and no significant differences in surgery-related complications were observed. When evaluating the entire cohort, postoperative anxiety scores were significantly lower than preoperative scores (p < 0.001), while depression scores were significantly higher postoperatively as compared with preoperatively (p = 0.005). Conclusion In the setting of microvascular breast reconstruction, lavender oil and aromatherapy had no significant adverse events or complications; however, there were no measurable advantages pertaining to metrics of depression, anxiety, sleep, or pain as compared with the control group.

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Water exchange-assisted vs. carbon dioxide-insufflated single-balloon enteroscopy: randomized controlled trial

Endoscopy ◽

10.1055/a-1459-4571 ◽

2021 ◽

Author(s):

Shaopeng Liu ◽

Tao Dong ◽

Yupeng Shi ◽

Hui Luo ◽

Xianmin Xue ◽

...

Keyword(s):

Carbon Dioxide ◽

Randomized Controlled Trial ◽

Adverse Events ◽

Water Exchange ◽

Controlled Trial ◽

Control Group ◽

Balloon Enteroscopy ◽

Randomized Controlled ◽

Single Balloon ◽

Single Balloon Enteroscopy

Background and study aims Single-balloon enteroscopy (SBE) is a valuable but difficult modality for the diagnosis and treatment of small-bowel diseases. The water exchange (WE) method has the advantage of facilitating intubation during colonoscopy. Here, we evaluated the effects of WE on procedure-related variables related to SBE. Patients and methods This randomized controlled trial was conducted in a tertiary-care referral center in China. Patients with attempt at total enteroscopy (ATE) were randomly allocated to undergo WE-assisted (WE group) or carbon dioxide-insufflated enteroscopy (CO2 group). All patients were planned to undergo both antegrade and retrograde procedures. The primary outcome was the total enteroscopy rate (TER). Secondary outcomes included maximal insertion depth, positive findings, procedural time and adverse events. Results In total, 110 patients were enrolled, with 55 in each group. Baseline characteristics between the two groups were comparable. TER was achieved in 58.2% (32/55) of the WE group and 36.4% (20/55) of the control group (p=0.022). The estimated intubation depth was 521.2±101.4 cm in the WE group and 481.6±95.2 cm in the CO2 group (p=0.037). The insertion time was prolonged in the WE group compared with CO2 group (178.9±45.1 min vs. 154.2±27.6 min, p<0.001). Endoscopic findings and adverse events were comparable between the two groups. Conclusions The WE method improved TER and increased intubation depth during SBE. The use of WE did not increase complications of enteroscopy. Clinical trial registation: https://clinicaltrials.gov/， NCT01942863.

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Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽

10.1186/s13063-021-05333-2 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Lena Violetta Krämer ◽

Nadine Eschrig ◽

Lena Keinhorst ◽

Luisa Schöchlin ◽

Lisa Stephan ◽

...

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Mixed Model ◽

Controlled Trial ◽

Control Group ◽

Web Based ◽

Intention To Treat ◽

Randomized Controlled ◽

Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

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Effect of Linear and Nonlinear Pedagogy Physical Education Interventions on Children’s Physical Activity: A Cluster Randomized Controlled Trial (SAMPLE-PE)

Children ◽

10.3390/children8010049 ◽

2021 ◽

Vol 8 (1) ◽

pp. 49

Author(s):

Matteo Crotti ◽

James R. Rudd ◽

Simon Roberts ◽

Lynne M. Boddy ◽

Katie Fitton Davies ◽

...

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Physical Education ◽

Primary Schools ◽

Controlled Trial ◽

Control Group ◽

Usual Practice ◽

Randomized Controlled ◽

Children’S Physical Activity ◽

Pedagogical Approaches

Background: School-based interventions are a key opportunity to improve children’s physical activity (PA); however, there is lack of evidence about how pedagogical approaches to motor learning in physical education (PE) might affect PA in children. Therefore, this study aimed to assess how different pedagogical approaches in PE might affect children’s PA. Methods: Participants (n = 360, 5–6 years) from 12 primary schools within the SAMPLE-PE randomized controlled trial were randomly allocated to either Linear Pedagogy (LP: n = 3) or Nonlinear Pedagogy (NP: n = 3) interventions, where schools received a 15-week PE intervention delivered by trained coaches, or to a control group (n = 6), where schools followed usual practice. ActiGraph GT9X accelerometers were used to assess PA metrics (moderate-to-vigorous PA, mean raw acceleration and lowest acceleration over the most active hour and half hour) over whole and segmented weeks at baseline, immediately post-intervention and 6 months follow-up. Intention to treat analysis employing multilevel modelling was used to assess intervention effects. Results: LP and NP interventions did not significantly affect children’s PA levels compared to the control group. Conclusion: PE interventions based on LP and NP alone might not be effective in improving habitual PA in children.

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The Effects of Aerobic Versus Cognitively Demanding Exercise Interventions on Executive Functioning in School-Aged Children: A Cluster-Randomized Controlled Trial

Journal of Sport and Exercise Psychology ◽

10.1123/jsep.2020-0034 ◽

2020 ◽

pp. 1-13

Author(s):

Anna Meijer ◽

Marsh Königs ◽

Irene M.J. van der Fels ◽

Chris Visscher ◽

Roel J. Bosker ◽

...

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Executive Functioning ◽

Exercise Intervention ◽

Controlled Trial ◽

Vigorous Physical Activity ◽

Verbal Working Memory ◽

Control Group ◽

Exercise Interventions ◽

Randomized Controlled

The authors performed a clustered randomized controlled trial to investigate the effects of an aerobic and a cognitively demanding exercise intervention on executive functions in primary-school-age children compared with the regular physical education program (N = 856). They hypothesized that both exercise interventions would facilitate executive functioning, with stronger effects for the cognitively demanding exercise group. The interventions were provided four times per week for 14 weeks. Linear mixed models were conducted on posttest neurocognitive function measures with baseline level as covariate. No differences were found between the exercise interventions and the control group for any of the measures. Independently of group, dose of moderate to vigorous physical activity was positively related to verbal working memory and attention abilities. This study showed that physical exercise interventions did not enhance executive functioning in children. Exposure to moderate to vigorous physical activity is a crucial aspect of the relationship between physical activity and executive functioning.

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Health TAPESTRY Ontario: Protocol for a Randomized Controlled Trial to Test Reproducibility and Implementation

10.21203/rs.2.19032/v2 ◽

2020 ◽

Author(s):

Dee Mangin ◽

Larkin Lamarche ◽

Sivan Bomze ◽

Sayem Borhan ◽

Tracy Browne ◽

...

Keyword(s):

Physical Activity ◽

Health Care ◽

Randomized Controlled Trial ◽

Primary Health Care ◽

Controlled Trial ◽

Care Team ◽

Control Group ◽

Randomized Controlled ◽

Primary Health ◽

Diverse Communities

Abstract Background: Health TAPESTRY (Health Teams Advancing Patient Experience: STRengthening qualitY) aims to help people stay healthier for longer where they live by providing person-focused care through the integration of four key program components: 1) trained volunteers who visit clients in their homes, 2) an interprofessional primary health care team, 3) use of technology to collect and share information, and 4) improved connections to community health and social services. The initial randomized controlled trial of Health TAPESTRY found promising results in terms of health care use and patient outcomes, indicating a shift from reactive to preventive care. The trial was based on one clinical academic centre, thus limiting generalizability. The study objectives are: 1) to test reproducibility of the established effectiveness of Health TAPESTRY on physical activity and hospitalizations, 2) to test the feasibility of, and understand the contributing factors to, the implementation of Health TAPESTRY in six diverse communities across Ontario, Canada, and 3) to determine the value for money of implementing Health TAPESTRY. Methods : This planned study is a pragmatic parallel randomized controlled trial with a delayed intervention for control participants at six months. This trial will simultaneously assess effectiveness and implementation in a real world setting (Type II hybrid) in six diverse communities across Ontario. Participants 70 years of age and older will be randomized into the Health TAPESTRY intervention or the control group (usual care). Intervention clients will receive an individualized plan of care from an interprofessional care team. The plan will be based on a client’s goals and current health risks identified through volunteer visits. The study’s outcomes are mapped onto the RE-AIM framework, with levels of physical activity and number of hospitalizations as the co-primary outcomes. The main analysis will be a comparison at six months. Discussion: It is important to evaluate the effectiveness and implementation of Health TAPESTRY in multiple communities prior to scaling or widespread adoption. Trial registration: ClinicalTrials.gov: NCT03397836 (posted January 12, 2018). Keywords: Primary health care, Randomized controlled trial, Integrated care, Interdisciplinary health care teams, Health care volunteers, Older adults, Implementation

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Paternal Lifestyle-Related Parenting Practices Mediate Changes in Children’s Dietary and Physical Activity Behaviors: Findings From the Healthy Dads, Healthy Kids Community Randomized Controlled Trial

Journal of Physical Activity and Health ◽

10.1123/jpah.2014-0367 ◽

2015 ◽

Vol 12 (9) ◽

pp. 1327-1335 ◽

Cited By ~ 23

Author(s):

Adam B. Lloyd ◽

David R. Lubans ◽

Ronald C. Plotnikoff ◽

Philip J. Morgan

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Parenting Practices ◽

Controlled Trial ◽

Control Group ◽

Intervention Effect ◽

Wait List Control ◽

Randomized Controlled ◽

Logistic Support ◽

Children’S Physical Activity

Background:This study examined potential parenting-related mediators of children’s physical activity and dietary behavior change in the Healthy Dads, Healthy Kids (HDHK) community program.Methods:A randomized controlled trial was conducted with 45 overweight/obese (mean [SD] age = 39.8 [5.4] years; BMI = 32.4 [3.8]) fathers and their children (n = 77; 58% boys; mean [SD] age = 7.7 [2.5] years). Families were randomized to either the HDHK program or wait-list control group. The program involved 7 sessions. Fathers and their children were assessed at baseline and at 14 weeks for physical activity (pedometery) and core food intake (Questionnaire). Fathers’ lifestyle-related parenting practices included; self-efficacy, beliefs, modeling, logistic support, rules, cophysical activity, shared mealtime frequency and intentions.Results:Significant intervention effects were found for cophysical activity and modeling physical activity. Cophysical activity mediated children’s physical activity in the intervention (‘mediated effect,’ AB = 653, 95% CI = 4–2050) and was responsible for 59.5% of the intervention effect. Fathers’ beliefs mediated children’s percent energy from core foods (AB = 1.51, 95% CI = 0.05–5.55) and accounted for 72.9% of the intervention effect.Conclusions:Participation in the HDHK program positively impacted on fathers’ cophysical activity with their child and beliefs about healthy eating which mediated changes in children’s diet and physical activity behaviors.

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Effects of the Preschool-Based Family-Involving DAGIS Intervention Program on Children’s Energy Balance-Related Behaviors and Self-Regulation Skills: A Clustered Randomized Controlled Trial

Nutrients ◽

10.3390/nu12092599 ◽

2020 ◽

Vol 12 (9) ◽

pp. 2599 ◽

Cited By ~ 1

Author(s):

Carola Ray ◽

Rejane Figuereido ◽

Henna Vepsäläinen ◽

Reetta Lehto ◽

Riikka Pajulahti ◽

...

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Energy Balance ◽

Repeated Measures ◽

Screen Time ◽

Controlled Trial ◽

Self Regulation ◽

Control Group ◽

Randomized Controlled ◽

Multicomponent Intervention

The study examines the effects of a preschool-based family-involving multicomponent intervention on children’s energy balance-related behaviors (EBRBs) such as food consumption, screen time and physical activity (PA), and self-regulation (SR) skills, and whether the intervention effects differed among children with low or high parental educational level (PEL) backgrounds. The Increased Health and Wellbeing in Preschools (DAGIS) intervention was conducted as a clustered randomized controlled trial, clustered at preschool level, over five months in 2017–2018. Altogether, 802 children aged 3–6 years in age participated. Parents reported children’s consumption of sugary everyday foods and beverages, sugary treats, fruits, and vegetables by a food frequency questionnaire, and screen time by a 7-day diary. Physical activity was assessed by a hip-worn accelerometer. Cognitive and emotional SR was reported in a questionnaire by parents. General linear mixed models with and without repeated measures were used as statistical methods. At follow-up, no differences were detected in EBRBs or SR skills between the intervention and control group, nor did differences emerge in children’s EBRBs between the intervention and the control groups when stratified by PEL. The improvement in cognitive SR skills among low PEL intervention children differed from low PEL control children, the significance being borderline. The DAGIS multicomponent intervention did not significantly affect children’s EBRBs or SR. Further sub-analyses and a comprehensive process evaluation may shed light on the non-significant findings.

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Impact of a Knowledge Translation Intervention on Physical Activity and Mobility in Older Adults (the Move4Age Study): Randomized Controlled Trial (Preprint)

10.2196/preprints.15125 ◽

2019 ◽

Author(s):

Sarah Neil-Sztramko ◽

Jenna Smith-Turchyn ◽

Julie Richardson ◽

Maureen Dobbins

Keyword(s):

Physical Activity ◽

Older Adults ◽

Randomized Controlled Trial ◽

Knowledge Translation ◽

Controlled Trial ◽

Rapid Assessment ◽

Control Group ◽

Self Rated Health ◽

Randomized Controlled

BACKGROUND The McMaster Optimal Aging Portal (the Portal) was launched in 2014 as a knowledge translation (KT) tool to increase access to evidence-based health information. OBJECTIVE The purpose of this study was to understand if and how dissemination of mobility information through the Portal impacts physical activity (PA) in older adults. METHODS In this randomized controlled trial, participants (n=510) were assigned to a 12-week mobility-focused KT intervention or self-serve control group. The intervention included weekly email alerts and a study-specific social media hashtag linking to mobility-focused Portal materials. The control group was able to access the Portal on their own but did not receive targeted KT strategies. Participants completed questionnaires (including the Rapid Assessment of Physical Activity to quantify PA) at baseline, end of the study, and 3-month follow-up. RESULTS Participants were predominantly female (430/510, 84.3%), mean age 64.7 years, with no baseline differences between groups. Over half (277/510, 54.3%) of the participants were classified as “active” at baseline. There was no significant between-group difference in the PA category. Overall, both groups increased their PA with improvements maintained at 3-month follow-up (P<.001). In planned subgroup analyses, the KT intervention had a significant effect for those with poor or fair baseline self-rated health (P=.03). CONCLUSIONS No differences were found between those who received the targeted intervention and a control group with self-serve access to the Portal, except in subgroups with low self-rated health. Both groups did report increases in PA that were sustained beyond participation in a research study. Findings suggest that different KT strategies may be needed for different types of users, with more intense interventions being most impactful for certain groups (ie, those with lower self-rated health). CLINICALTRIAL ClinicalTrials.gov NCT02947230; https://clinicaltrials.gov/ct2/show/NCT02947230

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Comparison of a new versus standard removable offloading device in patients with neuropathic diabetic foot ulcers: a French national, multicentre, open-label randomized, controlled trial

BMJ Open Diabetes Research & Care ◽

10.1136/bmjdrc-2019-000954 ◽

2020 ◽

Vol 8 (1) ◽

pp. e000954

Author(s):

Louis Potier ◽

Maud François ◽

Dured Dardari ◽

Marilyne Feron ◽

Narimene Belhatem ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Adverse Events ◽

Diabetic Foot ◽

Primary Outcome ◽

Controlled Trial ◽

Control Group ◽

Foot And Ankle ◽

End Points ◽

Randomized Controlled ◽

Ankle Joints

IntroductionThe offloading is crucial to heal neuropathic diabetic foot ulcer (DFU). Removable offloading are the most used devices. Orthèse diabète is a new customized removable knee-high offloading device immobilizing foot and ankle joints, with some specific and innovative features that may improve offloading. We aimed to evaluate the efficiency of this device in DFU healing.Research, design and methodsThe evaluation of Offloading using a new removable ORTHOsis in DIABetic foot study is a French multicenter (13 centers) randomized controlled trial with blinded end points evaluation. Adults with neuropathic DFU were randomly assigned to either Orthèse Diabète (experimental device), or any type of conventional (usually used in France) removable offloading devices (control group). The primary outcome was the 3-month proportion of patients with fully healed DFU.ResultsAmong 112 randomized patients (men 78%, age 62±10 years), the primary outcome occurred in 19 (33%) participants using conventional device vs 19 (35%) Orthèse Diabète users (p=0.79). Study groups were also comparable in terms of prespecified secondary end points including occurrence of new DFU (25% vs 27% in conventional and experimental groups), ipsilateral lower-limb amputation (4% vs 10%) or infectious complications (14% vs 13%) (p>0.05 for all). Adverse events were comparable between groups, including 4 deaths unrelated to study allocation (1 sudden death, 2 ventricular arrhythmias and 1 pancreatic cancer). Adverse events believed to be related to the device were higher in the Orthèse Diabète group than in the control group (15% vs 4%). Orthèse Diabète was less frequently worn than conventional devices (46% vs 66%, p=0.04).ConclusionsOrthèse Diabète, a new removable offloading orthosis immobilizing foot and ankle joints did not show superiority compared with conventional removable devices in neuropathic DFU healing and cannot be recommended to heal DFU.Trial registration numberNCT01956162.

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