Post-surgical physical activity enhancing program for elderly patients after hip fracture: a randomized controlled trial

AbstractBackground: Hip fracture seriously influences an elderly person’s life and mobility, independent living, and causes earlier mortality. Although surgery is generally successful, many of the elderly suffer from decreased physical ability after surgery for hip fracture.Objectives: To determine the effects of a physical activity enhancing program (PEP) on the level of physical activity of elderly patients after surgical treatment of hip fracture.Methods: A randomized controlled trial of 46 elderly patients was conducted at King Chulalongkorn Memorial Hospital from January 2012 to February 2013 to evaluate the effectiveness of the Resnick self-efficacy model (2009) compared with standard care in improving physical activity. The participants were enrolled on a criteria basis and were block randomized into two groups. The intervention group attended four phases of physical training and efficacy based intervention comprising assessment, preparation, practicing, and evaluation phases with face-to-face contact and five telephone calls during seven weeks post-surgery.Results: Six weeks after discharge, the physical activity of the intervention group increased by significantly more than the control group (F1,43= 9.63, P < 0.01), with an effect size of 0.18 after controlling for preoperative physical activity. The ratio of the effect on physical activity induced by the PEP was higher than that induced by usual care (65.2% vs. 47.8%).Conclusion: PEP is effective at improving physical activity. Efforts to follow up for longer periods and with studies using larger populations are recommended.

Download Full-text

Effectiveness of the Healthy Start-Départ Santé approach on physical activity, healthy eating and fundamental movement skills of preschoolers attending childcare centres: A randomized controlled trial

10.21203/rs.2.12703/v4 ◽

2020 ◽

Author(s):

Anne Leis ◽

Stéphanie Ward ◽

Hassan Vatanparast ◽

Louise Humbert ◽

Amanda Froehlich Chow ◽

...

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Food Intake ◽

Healthy Eating ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Movement Skills ◽

Randomized Controlled ◽

Fundamental Movement Skills

Abstract Background: Since young children spend approximately 30 hours per week in early childcare centres (ECC), this setting is ideal to foster healthy behaviors. This study aimed to assess the effectiveness of the Healthy Start-Départ Santé (HSDS) randomized controlled trial in increasing physical activity (PA) levels and improving healthy eating and fundamental movement skills in preschoolers attending ECC. Methods: Sixty-one ECC were randomly selected and allocated to either the usual practice (n=30; n=433 children) or intervention group (n=31; n=464 children). The HSDS intervention group was provided a 3-hour on-site training for childcare educators which aimed to increase their knowledge and self-efficacy in promoting healthy eating, PA and development of fundamental movement skills in preschoolers. PA was measured during childcare hours for five consecutive days using the Actical accelerometer. Preschoolers’ fundamental movement skills were assessed using the standard TGMD-II protocol and POMP scores. Food intake was evaluated using digital photography-assisted weighted plate waste at lunch, over two consecutive days. All data were collected prior to the HSDS intervention and again 9 months later. Mixed-effect models were used to analyse the effectiveness of the HSDS intervention on all outcome measures. Results: Total number of children who provided valid data at baseline and endpoint for PA, food intake and fundamental movement skills were 259, 670 and 492, respectively. Children in the HSDS intervention group had, on average, a 3.33 greater point increase in their locomotor motor skills scores than children in the control group (β=3.33, p=0.009). No significant differences in effects were observed for object control, PA and food intake. However, results demonstrated a marginal increase in portions of fruits and vegetables served in the intervention group compared to control group (β=0.06, p=0.05).Conclusion: Of the 12 outcome variables investigated in this study, 10 were not different between the study groups and two of them (locomotor skills and vegetables and fruits servings) showed a significant improvement. This suggests that HSDS is an effective intervention for the promotion of some healthy behaviours among preschoolers attending ECC.

Download Full-text

Effect of accelerometer-based feedback on physical activity in hospitalized patients with ischemic stroke: a randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215518755841 ◽

2018 ◽

Vol 32 (8) ◽

pp. 1047-1056 ◽

Cited By ~ 11

Author(s):

Masashi Kanai ◽

Kazuhiro P Izawa ◽

Miki Kobayashi ◽

Akira Onishi ◽

Hiroki Kubo ◽

...

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Ischemic Stroke ◽

Controlled Trial ◽

Intervention Group ◽

Hospitalized Patients ◽

Control Group ◽

Baseline Measurement ◽

Randomized Controlled

Objective: To evaluate the effect of accelerometer-based feedback on physical activity in hospitalized patients with ischemic stroke. Design: Randomized controlled trial. Setting: Acute care hospital. Subjects: A total of 55 patients with ischemic stroke who could walk without assistance were randomly assigned to the intervention group ( n = 27) or the control group ( n = 28). Interventions: At the baseline measurement, patients did not receive accelerometer-based feedback. At follow-up, a physical therapist provided instruction on accelerometer-based feedback, discussed physical activity targets and encouraged the patients to walk more until discharge. Main measures: The average daily number of steps taken was used as the index of daily hospitalized physical activity. Results: The study sample consisted of 48 patients, of whom 23 patients comprised the intervention group and 25 patients comprised the control group. Although there were no significant differences in physical activity values between the two groups at the baseline measurement, the values in the intervention group at follow-up were significantly higher than those in the control group (5180.5 ± 2314.9 vs. 3113.6 ± 1150.9 steps/day, P = 0.0003). The effect size of physical activity values (Cohen’s d = 1.15) at follow-up was large between the two groups. Conclusion: Exercise training combined with accelerometer-based feedback effectively increased physical activity in hospitalized patients with ischemic stroke.

Download Full-text

Preliminary Results of the Planet Nutrition Program on Obesity Parameters in Mexican Schoolchildren: Pilot Single-School Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18020790 ◽

2021 ◽

Vol 18 (2) ◽

pp. 790

Author(s):

Diana L. Ramírez-Rivera ◽

Teresita Martínez-Contreras ◽

Rosa C. Villegas-Valle ◽

Gricelda Henry-Mejia ◽

Trinidad Quizán-Plata ◽

...

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Nutrition Education ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Z Score ◽

Fat Percentage ◽

Nutrition Program ◽

Randomized Controlled

School-based obesity prevention programs are key to promoting healthy habits. The aim of this study was to evaluate the effect of the Planet Nutrition program on BMI z-score and other parameters compared to a control group of Mexican schoolchildren after 9 weeks of intervention. The effect of the summer holidays on the BMI z-score was also evaluated at 23 weeks. A pilot randomized controlled trial design was used and 41 schoolchildren were randomized (21 intervention group and 20 control). The program included 18 nutrition education sessions, 20 physical activity classes and six brochures for parents. At 9 weeks, no significant differences were found between the intervention and control groups in the change in BMI z-score (−0.11, 95% CI −0.23, 0.01). Significant differences were observed in some secondary outcomes: body fat percentage (−1.72, 95% CI −3.42, −0.02), waist circumference (−3.45, 95% CI −5.55, −1.36), physical activity (0.44, 95% CI 0.01, 0.88) and nutrition knowledge (1.15, 95% CI 0.27, 2.03). Summer holidays negatively affected the BMI z-score in both groups, reducing the difference observed between groups at 9 weeks (−0.07, 95% CI −0.22, 0.07). The Planet Nutrition program showed favorable effects in some obesity and lifestyle parameters in the short term.

Download Full-text

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

10.2196/preprints.16141 ◽

2019 ◽

Author(s):

Jan van Lieshout ◽

Joyca Lacroix ◽

Aart van Halteren ◽

Martina Teichert

Keyword(s):

Randomized Controlled Trial ◽

Medication Adherence ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Community Pharmacies ◽

Web Based ◽

Randomized Controlled ◽

Tailored Interventions ◽

Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

Download Full-text

Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

Journal of Nursing Education and Practice ◽

10.5430/jnep.v10n2p70 ◽

2019 ◽

Vol 10 (2) ◽

pp. 70

Author(s):

Samah Nasser Abd El-Aziz El-Shora ◽

Amina Mohamed Rashad El-Nemer

Keyword(s):

Randomized Controlled Trial ◽

Cesarean Section ◽

Controlled Trial ◽

Intervention Group ◽

Cost Effective ◽

Control Group ◽

Induced Hypotension ◽

Randomized Controlled ◽

Significant Difference ◽

Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

Download Full-text

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.

Download Full-text

Community Health Workers as a Strategy to Tackle Psychosocial Suffering Due to Physical Distancing: A Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18063097 ◽

2021 ◽

Vol 18 (6) ◽

pp. 3097

Author(s):

Dorien Vanden Bossche ◽

Susan Lagaert ◽

Sara Willems ◽

Peter Decat

Keyword(s):

Randomized Controlled Trial ◽

Community Health ◽

Health Workers ◽

Psychosocial Support ◽

Controlled Trial ◽

Intervention Group ◽

Psychosocial Health ◽

Control Group ◽

Randomized Controlled ◽

The Impact

Background: During the COVID-19 pandemic, many primary care professionals were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psychosocial support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW interventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

Download Full-text

Influence of physical activity on periodontal health in patients with type 2 diabetes mellitus. A blinded, randomized, controlled trial

Clinical Oral Investigations ◽

10.1007/s00784-021-03908-6 ◽

2021 ◽

Author(s):

K. Wernicke ◽

J. Grischke ◽

M. Stiesch ◽

S. Zeissler ◽

K. Krüger ◽

...

Keyword(s):

Physical Activity ◽

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Periodontal Health ◽

Randomized Controlled ◽

Hba1c Levels

Abstract Objectives The aim was to investigate the effect of physical activity on periodontal health and HbA1c levels in patients with type 2 diabetes mellitus (T2DM) over a period of 6 months. Materials and methods Thirty-seven patients with non-insulin-dependent T2DM were included in the study. The intervention group (n=20) performed physical activity over a period of 6 months. The control group (n=17) did not receive any intervention. Baseline and final examinations included dental parameters and concentrations of glycosylated hemoglobin (HbA1c) and high-sensitivity C-reactive protein (hsCRP). Results Physical activity showed a positive effect on periodontal health. Both the BOP (p= 0.005) and the severity of periodontitis (p= 0.001) were significantly reduced in the intervention group compared to the control group. Furthermore, HbA1c levels were reduced (p= 0.010) significantly in the intervention group while hsCRP levels significantly increased in the control group (p= 0.04). Conclusions Within the limitations of this randomized, controlled trial, physical activity over a period of 6 months is a health-promoting measure for patients with T2DM and improves both periodontal health and HbA1c concentrations.

Download Full-text

Methylprednisolone or dexamethasone, which one is superior corticosteroid in the treatment of hospitalized COVID-19 patients: a triple-blinded randomized controlled trial

BMC Infectious Diseases ◽

10.1186/s12879-021-06045-3 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Keivan Ranjbar ◽

Mohsen Moghadami ◽

Alireza Mirahmadizadeh ◽

Mohammad Javad Fallahi ◽

Vahid Khaloo ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Clinical Status ◽

Intervention Group ◽

Length Of Hospital Stay ◽

Ordinal Scale ◽

Control Group ◽

Randomized Controlled ◽

Group Data ◽

Significant Difference

Abstract Background Although almost a year has passed since the Coronavirus disease 2019 (COVID-19) outbreak and promising reports of vaccines have been presented, we still have a long way until these measures are available for all. Furthermore, the most appropriate corticosteroid and dose in the treatment of COVID-19 have remained uncertain. We conducted a study to assess the effectiveness of methylprednisolone treatment versus dexamethasone for hospitalized COVID-19 patients. Methods In this prospective triple-blinded randomized controlled trial, we enrolled 86 hospitalized COVID-19 patients from August to November 2020, in Shiraz, Iran. The patients were randomly allocated into two groups to receive either methylprednisolone (2 mg/kg/day; intervention group) or dexamethasone (6 mg/kg/day; control group). Data were assessed based on a 9-point WHO ordinal scale extending from uninfected (point 0) to death (point 8). Results There were no significant differences between the groups on admission. However, the intervention group demonstrated significantly better clinical status compared to the control group at day 5 (4.02 vs. 5.21, p = 0.002) and day 10 (2.90 vs. 4.71, p = 0.001) of admission. There was also a significant difference in the overall mean score between the intervention group and the control group, (3.909 vs. 4.873 respectively, p = 0.004). The mean length of hospital stay was 7.43 ± 3.64 and 10.52 ± 5.47 days in the intervention and control groups, respectively (p = 0.015). The need for a ventilator was significantly lower in the intervention group than in the control group (18.2% vs 38.1% p = 0.040). Conclusion In hospitalized hypoxic COVID-19 patients, methylprednisolone demonstrated better results compared to dexamethasone. Trial registration The trial was registered with IRCT.IR (08/04/2020-No. IRCT20200204046369N1).

Download Full-text

Japanese health and safety information for overseas visitors: protocol for a randomized controlled trial

BMC Public Health ◽

10.1186/s12889-021-10627-w ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Mariko Nishikawa ◽

Masaaki Yamanaka ◽

Akira Shibanuma ◽

Junko Kiriya ◽

Masamine Jimba

Keyword(s):

Health Care ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Safety Information ◽

Intervention Group ◽

Health And Safety ◽

Trial Registration ◽

Control Group ◽

Internet Portal ◽

Randomized Controlled

Abstract Background Before the COVID-19 pandemic occurred in January 2020, the number of overseas visitors to Japan had increased threefold over the last decade. To minimize the risk of health problems, visitors should be able to access information on the health care systems of the places they visit. Most short-term overseas visitors are young adults. Although they are not very likely to get sick from noncommunicable diseases, they are at high risk for injury and often experience stomach ailments, fever, or nausea when travelling. The objective of this study is to evaluate culturally and linguistically appropriate health information on preventive health behaviours and the health care system in Japan. We will examine the level of satisfaction of overseas visitors to Japan with health care-related educational materials using a five-minute digital game named Sa-Chan Japan. Methods Our study is a randomized controlled trial (RCT). We will assess both satisfaction and motivation before, during, and after the interventions and examine the changes over time. The intervention group will comprise overseas visitors who will view and answer questions in an animation named Sa-Chan Japan. The control group will comprise overseas visitors who will watch an English digital animation named Mari Info Japan. We will recruit 1002 participants through the Macromill Internet portal. We will contact overseas visitors who have either visited or wish to visit Japan from the United Kingdom, United States, and Australia. The participants will fill out a self-administered questionnaire online in the first quarter of 2021. We will determine the participants’ levels of satisfaction with the CSQ-8 (8-item Client Satisfaction Questionnaire). We will analyse the median score of the overseas visitors with both the Wilcoxon rank-sum and the Wilcoxon signed-rank tests. Our protocol of randomized controlled trials follows the SPIRIT guidelines. Discussion Our research will utilize unique digital education strategies in a game that promotes health and safety among overseas visitors to Japan. We believe the results of this study will be useful in overcoming the current challenges regarding pretravel health requirements for overseas visitors worldwide. Trial registration Version 1 of this trial was registered in the UMIN-CTR (University Hospital Medical Information Network Center Clinical Trials Registry), and the trial registration data are available on UMIN000042483, November 17, 2020.

Download Full-text