Single-blind Randomized Control Trial Research Articles

Stellarex Drug-Coated Balloon for the Treatment of Peripheral Artery Disease: Five-Year Results from the ILLUMENATE Pivotal Randomized Controlled Trial

This study aimed to report the 5-year outcomes from the ILLUMENATE Pivotal randomized controlled trial of the lower dose (2 µg/mm2) Stellarex drug-coated balloon (DCB) (Philips, formerly Spectranetics Corp, Colorado Springs, Colorado) compared with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic peripheral arterial disease. Long-term safety and effectiveness data for DCBs remains limited. The ILLUMENATE Pivotal was a prospective, randomized, multi-center, single-blinded study. Patients (Rutherford Clinical Category 2 to 4) were randomized 2:1 to Stellarex DCB or PTA. Follow-up was through 60 months. In total, 300 patients were enrolled. The mean age was 68.8 ± 10.2 years. At 60 months, freedom from a primary safety event was 69.2% in the Stellarex DCB arm and 68.2% in the PTA arm (log-rank, p = 0.623). The cumulative rate of major adverse events was 41.0% compared with 44.6% (p = 0.597), respectively. Freedom from clinically-driven target lesion revascularization was 70.3% in the Stellarex DCB arm compared with 68.2% in the PTA arm (p = 0.505). Time to first clinically-driven target lesion revascularization was 768.3 ± 478.9 days compared with 613.5 ± 453.4 days, respectively (p = 0.161). Kaplan-Meier estimates of freedom from all-cause mortality were 80.1% in the Stellarex DCB arm and 80.2% in the PTA arm (log-rank, p = 0.980). In conclusion, the 5-year results of the ILLUMENATE Pivotal randomized controlled trial add to the consistent safety data from the broader ILLUMENATE clinical program. These are the first data to report the 5-year safety and efficacy of a lower dose (2 µg/mm2) DCB for the treatment of symptomatic peripheral arterial disease. Clinicaltrials.gov Registration:NCT01858428.

Comparison of Milrinone with Sildenafil for the Treatment of Persistent Pulmonary Hypertension of the Newborn

Objective: To compare milrinone with sildenafil for the treatment of persistent pulmonary hypertension of the newborn. Methodology: A single blinded randomized control trial was conducted in Department of Pediatrics, Aziz Fatima Hospital Faisalabad from October 2022 to September 2023. 160 infants of persistent pulmonary hypertension were included through non probablity consecutive sampling. Group 1 infants (n = 80) received a loading dose of milrinone intravenously administered over a 60-minute period at a dose of 50 µg/kg. Group 2 infants (n = 80) received sildenafil (2mg per kg per dose three times a day). The medication was continued until extubation. The primary outcome variables were the mortality and duration of hospital stay. Results: Ninety two(57.5%) of the one hubdred & sixty newborns in total were male. 111(69.4%) of the total, were full-term babies. In 114(71.2%) infants, the mode of delivery was C-section. Mortality was observed in 7 (8.8%) patients in milrinone group and 17 (21.2%) patients in sildenafil group with p-value = 0.027. Duration of hospital stay was less in milrinone group as compared to sildenafil group (14.22±3.75 days vs 17.72±5.7 days) with p-value = 0.0001. Conclusion: Milrinone has been proven to be a promising therapeutic choice for persistent pulmonary hypertension in neonates, and it is effective in doing so in low resource settings.

Impact of Tai Chi and Aerobic Exercise on Cognitive Function, Balance, Cardiovascular Fitness, and Quality of Life in Older Adults: Randomized Control Trial.

Introduction Tai chi, an ancient Chinese martial art, was originally developed for combat and self-defense. Over time, it has evolved into both a sport and a form of exercise. This gentle, low-impact exercise involves performing a series of deliberate, flowing motions while focusing on deep, slow breaths. This study investigates the effects of chen tai chi and aerobic exercises on cognition, balance, cardiopulmonary fitness, and quality of life in older adults. Methodology This study employed a single-blinded randomized control trial design, enrolling 60 participants aged between 60 and 75 years. Participants were divided into three groups: Group A (aerobics), Group B (chen tai chi), and Group C (control). Exercise sessions were held four days per week over a period of four weeks. Evaluations included the Montreal Cognitive Assessment for cognition, a one-leg stand test for static balance, a Timed Up and Go Test for dynamic balance, a six-minute walk test for cardiopulmonary fitness, and a health-related quality-of-life scale. Assessments were conducted at baseline, immediately after the intervention, and at follow-up was taken after eight weeks. Results Post-intervention, improvements were observed in cognition and static balance across all groups. Within-group analysis revealed that the aerobics group experienced statistically significant enhancements in cognition (p = 0.0001) and static balance (p = 0.01). Although no statistically significant differences were found between groups in terms of dynamic balance, cardiopulmonary fitness, and quality of life, the within-group analysis showed significant improvements in the aerobics group in dynamic balance (p = 0.0009), cardiopulmonary fitness (p = 0.03), and quality of life (p = 0.0001). Conclusion Compared to chen tai chi and no intervention, the study concludes that aerobic exercise has a more pronounced effect on improving cognition, balance, cardiopulmonary fitness, and quality of life in older adults. Aerobic exercise is recommended as an effective method to prevent frailty and promote independence among the elderly.

Neurofeedback training can increase the effectiveness of neuromuscular training on balance and limit of stability of athletes with chronic ankle instability: three arms and single-blind randomized control trial

Neurofeedback training can increase the effectiveness of neuromuscular training on balance and limit of stability of athletes with chronic ankle instability: three arms and single-blind randomized control trial

Protocol for a randomised controlled trial of ketamine versus ketamine and behavioural activation therapy for adults with treatment-resistant depression in the community

IntroductionAlthough short-term benefits follow parenteral ketamine for treatment-resistant major depressive disorder (TR-MDD), there are challenges that prevent routine use of ketamine by clinicians. These include acute dissociative effects of parenteral...

EFFECT OF ADDITION OF DEXAMETHASONE TO ROPIVACAINE ON POST-OPERATIVE ANALGESIA IN ULTRASOUND-GUIDED TRANSVERSE ABDOMINIS PLANE BLOCK FOR ANTERIOR ABDOMINAL WALL HERNIA REPAIR

Objective: The objective of the present study was to evaluate the adjuvant effect of dexamethasone to Ropivacaine in ultrasound-guided transverse abdominal plan block for anterior abdominal wall hernia repair. Methods: A single-blind randomized control trial was conducted by selecting patients undergoing anterior abdominal wall hernia and dividing them into two groups with Group A: received a total of 50 mL of 0.2% Ropivacaine (48 mL) with normal saline (2 mL) and Group B received a total 50 mL of 0.2% Ropivacaine (48 mL) with 8 mg dexamethasone (2 mL). Outcome was assessed on the basis of visual analog scale (VAS), the requirement of rescue analgesia, and adverse events. Results: Twenty-seven patients were recruited in each group, Group A and Group B had an average pain-free interval of 11.85±2.82 and 8.07±2.51, respectively (p<0.001). Mean VAS was lower in Group B at the end of 2 h (p<0.05). Both the groups had similar side effects with no significant difference. Total analgesia dose required in Groups B and A was 75 and 96 mg, respectively (p<0.001). Conclusion: A combination of 0.2% Ropivacaine (48 mL) with 8 mg dexamethasone (2 mL) significantly reduces the VAS in post-operative pain along with reduced quantity and frequency of rescue analgesia.

Randomized controlled trial of the CMR immersive virtual reality (IVR) headset training compared to e-learning for operating room configuration of the CMR versius robot

Robotic surgery offers potential advantages over laparoscopic procedures, but the training for configuring robotic systems in the operating room remains underexplored. This study seeks to validate immersive virtual reality (IVR) headset training for setting up the CMR Versius in the operating room. This single-blinded randomized control trial randomised medical students with no prior robotic experience using an online randomiser. The intervention group received IVR headset training, and the control group, e-learning modules. Assessors were blinded to participant group. Primary endpoint was overall score (OS): Likert-scale 1–5: 1 reflecting independent performance, with increasing verbal prompts to a maximum score of 5, requiring physical assistance to complete the task. Secondary endpoints included task scores, time, inter-rater reliability, and concordance with participant confidence scores. Statistical analysis was performed using IBM SPSS Version 27. Of 23 participants analysed, 11 received IVR and 12 received e-learning. The median OS was lower in the IVR group than the e-learning group 53.5 vs 84.5 (p < 0.001). VR recipients performed tasks independently more frequently and required less physical assistance than e-learning participants (p < 0.001). There was no significant difference in time to completion (p = 0.880). Self-assessed confidence scores and assessor scores differed for e-learning participants (p = 0.008), though not IVR participants (p = 0.607). IVR learning is more effective than e-learning for preparing robot-naïve individuals in operating room set-up of the CMR Versius. It offers a feasible, realistic, and accessible option in resource-limited settings and changing dynamics of operating theatre teams. Ongoing deliberate practice, however, is still necessary for achieving optimal performance. ISCRTN Number 10064213.

Efficacy of Early Intervention for Infants With Cerebral Palsy in an LMIC: An RCT.

To test efficacy of a parent-delivered multidomain early intervention (Learning through Everyday Activities with Parents [LEAP-CP]) for infants with cerebral palsy (CP) compared with equal-dose of health advice (HA), on (1) infant development; and (2) caregiver mental health. It was hypothesized that infants receiving LEAP-CP would have better motor function, and caregivers better mental health. This was a multisite single-blind randomized control trial of infants aged 12 to 40 weeks corrected age (CA) at risk for CP (General Movements or Hammersmith Infant Neurologic Examination). Both LEAP-CP and HA groups received 15 fortnightly home-visits by a peer trainer. LEAP-CP is a multidomain active goal-directed intervention. HA is based on Key Family Practices, World Health Organization. Primary outcomes: (1) infants at 18 months CA: Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT mobility); and (2) caregiver: Depression Anxiety and Stress Scale. Of eligible infants, 153 of 165 (92.7%) were recruited (86 males, mean age 7.1±2.7 months CA, Gross Motor Function Classification System at 18 m CA: I = 12, II = 25, III = 9, IV = 18, V = 32). Final data were available for 118 (77.1%). Primary (PEDI-CAT mobility mean difference = 0.8 (95% CI -1.9 to 3.6) P = .54) and secondary outcomes were similar between-groups. Modified-Intention-To-Treat analysis on n = 96 infants with confirmed CP showed Gross Motor Function Classification System I and IIs allocated to LEAP-CP had significantly better scores on PEDI-CAT mobility domain (mean difference 4.0 (95% CI = 1.4 to 6.5), P = .003) compared with HA. Although there was no overall effect of LEAP-CP compared with dose-matched HA, LEAP-CP lead to superior improvements in motor skills in ambulant children with CP, consistent with what is known about targeted goal-directed training.

Comparison of Nonimmersive Virtual Reality and Task-Oriented Circuit Training on Gait, Balance, and Cognition Among Elderly Population: A Single-Blind Randomized Control Trial.

Purpose: The purpose of this study was to determine the effects of nonimmersive virtual reality (VR) and task-oriented circuit training on gait, balance, cognitive domains, and quality of life among the elderly population. Methods: This is a single-blind randomized control trial in which 28 elderly individuals between 60 and 75 years were selected. The participants were divided into two groups, task-oriented circuit training and the other receiving nonimmersive VR treatment, with 14 participants in each group. To analyze the effects of both training on balance and gait time up and go test (TUGT), dynamic gait index (DGI), measures were used and for cognitive domains Montreal cognitive assessment (MoCA) scale was used. Short form 12 (SF-12) (along with two domains, Physical Component Summary and Mental Component Summary) was used for the measurement of quality of life. The treatment duration was 8 weeks for both groups. Both the pre-test and post-test readings were analyzed and compared. Results: The mean age of participants was 66.91 ± 3.79 years. Within-group comparison between the pre-test and post-test indicated that significant differences (P < 0.05) existed in all the outcome measures (TUGT, DGI, MoCA, and SF-12) in both groups. However, between-group comparison, significant differences were only found in TUGT and DGI in nonimmersive VR group. Conclusion: This study concluded that both interventions nonimmersive VR and task-oriented circuit training were beneficial for improving balance, gait, quality of life, and cognitive domains like memory, attention spans, executive functions, and so on in elderly population. However nonimmersive virtual reality training is a more effective, feasible, and safe alternative and can be proposed as a form of fall prevention exercise for the older adults. ClinicalTrials.gov Identifier: NCT05021432.

Atracurium for Rapid Sequence Induction; A dose determining Randomized Control Trial at a Tertiary Care Hospital.

Introduction: Expert airway management is one of the essential anesthetic skills. Rapid Sequence induction is a technique of providing rapid securement of airway with endotracheal tube in patients who are at risk of aspiration. Objective: To find out the efficacy of 3-4 ED95 dose of Atracurium in providing optimal intubating conditions for Rapid Sequence Induction. Methodology: Single-blind randomized control trial was carried out Department of Anesthesia and Critical Care Medicine, Pakistan Institute of Medical Sciences (PIMS), Islamabad. 118 patients were included and divided into two groups by help of computer-generated random numbers. All the patients were pre-medicated with 8 mg of IV Dexamethasone. Group A patients received 1 mg/kg while group B patients received 0.75 mg/kg of Atracurium. Intubating conditions were assessed on the basis of number of coughing episodes along with degree of vocal cord movement or paralysis. Results: Patients who received 0.75 mg/kg of Atracurium had statistically significant better intubating conditions as compared to those receiving 1 mg/kg of Atracurium (p value &lt; 0.05). Coughing episodes were more common among patients receiving higher dose of Atracurium while degree of vocal cord paralysis was similar in both groups. Furthermore 75% of histamine related adverse effects such as erythema and bronchospasm were observed in higher dose group. The difference was statistically significant with a p value of &lt;0.05. Conclusion: Atracurium at a dose of 0.75 mg/kg along with pre-medication with 8 mg of IV Dexamethasone provided better and safer intubating conditions for rapid sequence induction.

The Influence of Honey and Hydrogel Products Therapy on Healing Time in Diabetic Foot.

Diabetic foot ulcer is a serious and common complication of diabetes that often leads to significant morbidity and even amputation if not properly treated. Current treatment options, such as wound dressing, have limitations in promoting efficient healing. There is a need for effective interventions that can expedite the healing process and enhance the time required for complete healing. This prospective single-blinded randomized control trial studied diabetic mellitus type 2 patients with ulcer in their second-degree feet from February 2019 to February 2023 in the Diabetic Foot Center, King Fahad Specialist Hospital Al Qassim-KSA. This study involved 120 patients with a mean age of 59.64 ± 10.21. And 63% to 52.5% of them were males and 57% to 47.5% were females. The mean healing time was about 12.76 ± 4.08 days. Cases were divided into 4 equal groups with altered treatment procedures: honey alone, hydrogel alone, honey, and hydrogel combination alternately (3 intervention groups), and fucidin ointment or cream alone (1 control group), with 30 participants in each group. We revealed that the mean healing times for honey alone, hydrogel alone, and honey and hydrogel alternately were 12.20, 13.97, and 10.83 days, respectively. While it was 14.03 days in the control Fucidin ointment or cream [significantly P < .05 (P = .004)]. From the findings of the present study, we noticed that faster healing time among diabetic foot cases could be accomplished by treatment with a combination of honey and hydrogel alternately. Therefore, this therapy is effective in reducing the risk of diabetic foot ulcers.

The Effectiveness of Photobiomodulation Using 940-nm Diode Laser for Reducing Pain, Swelling and Trismus After Third Molar Surgery: A Single-Blinded Randomized Control Trial

The Effectiveness of Photobiomodulation Using 940-nm Diode Laser for Reducing Pain, Swelling and Trismus After Third Molar Surgery: A Single-Blinded Randomized Control Trial

Effects of Decompression therapy in leg pain and straight leg rise in patient with lumbar radiculopathy due to disc protrusion

One among many disc problems is disc protrusion, which has more prevalence in outpatient department physical therapy management Centre globally. The purpose of this study was to compare the effect of lumbar spine decompression therapy and standard physical therapy treatment in patients with lumbar radiculopathy due to disc protrusion. The single-blind randomized control trial of 71 patients was conducted at Max Rehab &amp; Physical Therapy Centre Islamabad, Pakistan. After setting inclusion criteria all the patients were randomly allocated into treatment and control group. Both group received standard physical therapy treatment including, Moist Hot pack, Lumbar Mobilization, Stretching &amp; strengthening exercises. The only difference was that Decompression Group received additional Decompression therapy. The data included demographics and Numeric Pain Rating Scale score in supine lying position for the painful leg and Straight Leg Raise Range for the painful side. The values for leg pain for control group decreased from 6 to 3 and the value for straight leg raise increased from 15° to 49°. The values for leg pain for the Decompression Group decreased from 6 to 2 and the value for the straight leg raise increased from 10° to 48°, the p value for both the variables was &lt;.001 showing statistically significant difference between pre and post values in treating patients leg pain and straight leg raise range of motion. It is concluded that decompression therapy is more effective in managing lumbar radiculopathy.

Comparative evaluation of different oil pulling agents and 0.2% chlorhexidine mouthwash as an adjunct to full-mouth scaling and root planing in plaque-induced gingivitis: A single-blind randomized control trial

Abstract Introduction: Oil pulling is old Indian natural daily practice which has been written in Ayurveda texts such as Charak and Sushruta Samhita. The act of swishing oil around the mouth removes microbes. Therefore, oil pulling reduces plaque-induced gingivitis. Naturally occurring products like coconut oil and sesame oil are enriched with antimicrobial activity. These oils are cheaper and easily available. Therefore, the aim of this article is to compare the efficacy of coconut, sesame oil, and chlorhexidine mouthwash as an adjunct to full-mouth scaling and root planing (SRP) in patients with plaque-induced gingivitis. Aim and Objectives: This study aimed to compare the efficacy of coconut oil sesame oil and chlorhexidine mouthwash as an adjunct to SRP in patients with plaque-induced gingivitis. Materials and Methods: Sixty patients of plaque-induced gingivitis were randomly divided into four groups: SRP, coconut oil, sesame oil, and chlorhexidine mouthwash. Clinical measurements included plaque index, gingival index (GI), and simplified oral hygiene index at baseline, 7 days, 15 days, 1 month, and 3 months. Microbial analysis was carried out. Results: There was a significant reduction in plaque and gingival scores from baseline to 3 months for the chlorhexidine group. Intragroup comparison shows a statistically significant reduction in plaque and GI. Conclusion: Oil pulling considers to affect microbes to treat plaque-induced gingivitis.

Effects of additional functional strength training on mobility in children with hemiplegic cerebral palsy

Background: Cerebral palsy (CP) affects the mobility and functional strength of children which leads to a decline in the quality of life of children. Functional strength training may considered objective-oriented to achieve some specific activity level and improve the overall performance of children. Objective: To determine the effects of additional functional strength training on mobility in Children with Hemiplegic Cerebral Palsy (HCP). Method: A single-blind randomized control trial (NCT05878756) was conducted on (n=40) children with hemiplegic cerebral palsy (HCP) at the National Institute of Rehabilitation Science, Islamabad. Children who can follow commands, not using assistive devices, and are not being treated in any other rehabilitation services were included. Children aged 4-12 years were recruited through a non-probability convenient sampling technique and a total of n=40 participants were randomly divided into Group A (n=20) which received conventional therapy along with functional strength training for 4 weeks, while Group B (n=20) only received conventional physical therapy. Both groups received intervention for 4weeks. The tools, Gross Motor Function Measure (GMFM) used for the severity of mobility and, five times sit to stand (FTSST) to assess functional lower extremity strength, transitional movement balance, and fall risk in older adults, were used at baseline and post-treatment assessment. Results: Both groups had improvements in strength and mobility but there was significant improvement in strength and mobility in Group A after 4th week (p≤ 0.05). However, no significant increase in the dimension of lying and kneeling was observed. Comparison between both groups (pre and post-treatment) for dimensions of walking, running, and jumping in both groups showed significant improvement (p=0.045). According to the result of GMFM scoring, a significant improvement in the interventional group (A) as compared to Group B (p=0.003). So, there is a considerable increase in GMFM score for Group A than Group B group. Conclusion: It is concluded that additional functional therapy has a better outcome as compared to conventional therapy on mobility and strength of children with CP. Keywords Cerebral palsy; functional strength training; mobility; Gross Motor Function Measure; Gross Motor Function Classification System

Effect of optimized transcranial direct current stimulation on motor cortex activation in patients with sub-acute or chronic stroke: a study protocol for a single-blinded cross-over randomized control trial.

Transcranial direct current stimulation (tDCS) has shown positive but inconsistent results in stroke rehabilitation. This could be attributed to inter-individual variations in brain characteristics and stroke lesions, which limit the use of a single tDCS protocol for all post-stroke patients. Optimizing the electrode location in tDCS for each individual using magnetic resonance imaging (MRI) to generate three-dimensional computer models and calculate the electric field (E-field) induced by tDCS at a specific target point in the primary motor cortex may help reduce these inconsistencies. In stroke rehabilitation, locating the optimal position that generates a high E-field in a target area can influence motor recovery. Therefore, this study was designed to determine the effect of personalized tDCS electrode positions on hand-knob activation in post-stroke patients. This is a crossover study with a sample size of 50 participants, who will be randomly assigned to one of six groups and will receive one session of either optimized-active, conventional-active, or sham tDCS, with 24 h between sessions. The tDCS parameters will be 1 mA (5 × 5 cm electrodes) for 20 min. The motor-evoked potential (MEP) will be recorded before and after each session over the target area (motor cortex hand-knob) and the MEP hotspot. The MEP amplitude at the target location will be the primary outcome. We hypothesize that the optimized-active tDCS session would show a greater increase in MEP amplitude over the target area in patients with subacute and chronic stroke than conventional and sham tDCS sessions.Clinical trial registration: https://cris.nih.go.kr, identifier KCT0007536.

Digital Therapeutic Intervention for Women in the UK Armed Forces Who Consume Alcohol at a Hazardous or Harmful Level: Protocol for a Randomized Controlled Trial.

Alcohol misuse is common in the United Kingdom Armed Forces (UKAF), with prevalence significantly higher than in the general population. To date, digital health initiatives to support alcohol misuse have focused on male individuals, who represent approximately 89% of the UKAF. However, female veterans drink disproportionally more than female members of the public. This 2-arm participant-blinded (single-blinded) confirmatory randomized controlled trial (RCT) aims to assess the efficacy of a brief alcohol intervention (DrinksRation) in reducing weekly self-reported alcohol consumption between baseline and a 3-month follow-up (day 84) among women who have served in the UKAF. In this 2-arm single-blinded RCT, a smartphone app that includes interactive user-focused features tailored toward the needs of female veterans and designed to enhance participants' motivations to reduce the amount of alcohol they consume is compared with the UK Chief Medical Officer guidance on alcohol consumption. The trial will be conducted among women who have served at least 1 day of paid service in the UKAF. Recruitment, consent, and data collection will be carried out automatically through the DrinksRation app or the BeAlcoholSmart platform. The primary outcome is change in self-reported weekly alcohol consumption between baseline (day 0) and the 3-month follow-up (day 84) measured using the Timeline Follow Back for alcohol consumption. The secondary outcome is the change in the Alcohol Use Disorders Identification Test score measured at baseline and 3-month follow-up between the control and intervention groups. The process evaluation measures include (1) app use and (2) usability ratings as measured by the mHealth App Usability Questionnaire. RCT recruitment will begin in January 2024 and last for 5 months. We aim to complete all data collection, including interviews, by May 2024. This study will assess whether a smartphone app tailored to the needs of women who have served in the UKAF is efficacious in reducing self-reported alcohol consumption. If successful, the digital therapeutics platform could be used not only to support women who have served in the UKAF but also for other conditions and disorders. ClinicalTrials.gov NCT05970484; https://www.clinicaltrials.gov/study/NCT05970484. PRR1-10.2196/51531.

Effects of a multilevel intervention of resistance training with or without beta-hydroxy-beta-methylbutyrate in medical ICU patients during entire hospitalisation: a four-arm multicentre randomised controlled trial

BackgroundIntensive care unit-acquired weakness (ICU-AW) is a prevalent and severe issue among ICU patients. Resistance training and beta-hydroxy-beta-methylbutyrate (HMB) intervention have demonstrated the potential to enhance muscle function in patients with sarcopenia and in older adults. The purpose of this study was to determine whether resistance training and/or HMB administration would improve physical function, muscle strength, and quality of life in medical ICU patients.MethodsIn this multicentre, four-arm, single-blind randomised control trial, a total of 112 adult patients with internal medical diagnoses admitted to the ICU were enrolled. These participants were then randomly assigned to one of four treatment groups: the resistance training group received protocol-based multilevel resistance exercise, the HMB group received 3 g/day of HMBCa, combination group and control groups received standard care, from the ICU to the general ward until discharge. The primary outcomes assessed at discharge included six-minute walking distance (6MWD) and short physical performance battery (SPPB). Secondary outcomes measured included muscle mass, MRC score, grip strength, and health reports quality of life at different time points. Data analysis was performed using a generalised linear mixed model, adhering to the principles of intention-to-treat analysis.ResultsResistance training and combination treatment groups exhibited significant increases in SPPB scores (3.848 and 2.832 points, respectively) compared to the control group and substantial improvements in 6WMD (99.768 and 88.577 m, respectively) (all with P < 0.01). However, no significant changes were observed in the HMB group. Muscle strength, as indicated by MRC and grip strength tests conducted at both ICU and hospital discharge, showed statistically significant improvements in the resistance training and combination groups (P < 0.05). Nevertheless, no significant differences were found between the treatment groups and usual care in terms of 60-day mortality, prevalence of ICU-AW, muscle mass, quality of life, or other functional aspects.ConclusionsResistance training with or without beta-hydroxy-beta-methylbutyrate during the entire hospitalisation intervention improves physical function and muscle strength in medical ICU patients, but muscle mass, quality of life, and 60-day mortality were unaffected.Trial registrationChiCTR2200057685 was registered on March 15th, 2022.

Effect of prepared herbal mouthwash in maintaining the oral health of school children: A single-blind randomised control trial

Background and aimOral health is a vital indicator of overall well-being, quality of life, and general health, with historical roots in Unani medicine (i.e. preventive measures, oral hygiene, and treatment). This study aims to assess the efficacy and safety of prepared herbal mouthwash in maintaining oral health among school children. Experimental procedure110 schoolchildren were randomly assigned to the test group (treated with herbal mouthwash -Anacyclus pyrenthrum DC, Punica granutum (pericarp), Capparis spinosa (root bark), and Quercus infectoria Oliv (galls)) and the control group (treated with 0.2 % Chlorhexidine Mouthwash) for 30-days. The response was assessed by DMFT, Salivary pH, Oral hygiene index-simplified (OHI-S), Plaque index (Loe & Silness) (PI), Plaque index simplified (O'Leary et al., 1972) (PI-S), Gingival Index (Löe-Silness) (GI), and Bleeding on probing (BOP) on baseline and 30th day GI and PI were further assessed on 60th, 90th and 120th days to determine the sustainable effect of the intervention. ResultsAfter treatment, Mean OHI-S, PI, PI-S, GI and BOP significantly reduced on the 30th day from baseline (p ≤ 0.001) in both groups. After discontinuing intervention, both groups showed significantly lower PI and GI scores on the 120th day from baseline. (p < 0.001). ConclusionThis study revealed that prepared mouthwash is safe and significantly effective in maintaining oral health, and it could be used as an adjunct to mechanical oral hygiene measures.

Avatar Intervention for Cannabis Use Disorder in a Patient with Schizoaffective Disorder: A Case Report

Considering the harmful effects of cannabis on individuals with a severe mental disorder and the limited effectiveness of current interventions, this case report showcases the beneficial results of a 10-session Avatar intervention for cannabis use disorder (CUD) on a polysubstance user with a comorbid schizoaffective disorder. Virtual reality allowed the creation of an Avatar representing a person significantly related to the patient’s drug use. Avatar intervention for CUD aims to combine exposure, relational, and cognitive behavioral therapies while practicing real-life situations and learning how to manage negative emotions and cravings. Throughout therapy and later on, Mr. C managed to maintain abstinence from all substances. Also, an improvement in the severity of CUD, as well as a greater motivation to change consumption, was observed after therapy. As observed by his mother, his psychiatrist, and himself, the benefits of Avatar intervention for CUD extended to other spheres of his life. The drastic results observed in this patient could be promising as an alternative to the current treatment available for people with a dual diagnosis of cannabis use disorder and psychotic disorder, which generally lack effectiveness. A single-blind randomized control trial comparing the treatment with a classical intervention in a larger sample is currently underway to evaluate whether the results are reproducible on a larger sample.