scholarly journals Effects of Volume Training on Strength and Endurance of Back Muscles: A Randomized Controlled Trial

2018 ◽  
Vol 27 (4) ◽  
pp. 340-347
Author(s):  
Leonardo Shigaki ◽  
Cynthia Gobbi Alves Araújo ◽  
Mariane Guizeline Calderon ◽  
Thais Karoline Cezar Costa ◽  
Andreo Fernando Aguiar ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Resistance Training ◽  
Controlled Trial ◽  
Control Group ◽  
Functional Evaluation ◽  
Back Muscles ◽  
Endurance Time ◽  
Randomized Controlled ◽  
Dynamic Endurance ◽  
Single Set

Context: Strength/resistance training volume has historically been supported in the American College of Sports Medicine recommendations. However, for the back muscles, exercise prescription related to the number of sets, such as single versus multiple, is not well established in the literature. Objective: The purpose of this study was to compare the effects of 2 training volumes on strength and endurance of back-extensor muscles in untrained young participants with regard to a repeated-measures design. Design: Randomized controlled trial. Setting: Laboratory of functional evaluation and human motor performance. Participants: Forty-four untrained young participants (mean age = 21 y) were randomized into single-set (n = 14), multiple-set (MSG, n = 15), and untrained control (n = 15) groups. Intervention: The single-set group and MSG underwent a 10-week progressive resistance training program (2 d/wk) using a 45° Roman chair. Main Outcome Measures: Back maximal strength (dynamometer) and isometric and dynamic endurance (time limit, trunk extension–flexion cycles, and electromyography muscle fatigue estimates). Results: The results showed differences between the MSG and control group for isometric endurance time (mean = 19.8 s; 95% confidence interval, −44.1 to 4.8), but without time intervention significance. Significant improvement after training (P < .05) was found predominantly during dynamic endurance (number of repetitions) for both the MSG (+61%) and single-set group (+26%) compared with preintervention, whereas the control group reported no benefit. There was no significant (P > .05) difference in either strength or electromyography estimates after training. Conclusions: Both multiple and single volume training were efficient in promoting better back endurance during dynamic performance based on mechanical variables (time and number of repetitions).

Resistance Training Impact on Mobility, Muscle Strength and Lean Mass in Pancreatic Cancer Cachexia: A Randomized Controlled Trial

2020 ◽  
Vol 34 (11) ◽  
pp. 1391-1399
Author(s):  
FatmaAlzahraa H Kamel ◽  
Maged A Basha ◽  
Ashwag S Alsharidah ◽  
Amr B Salama
Keyword(s):  
Pancreatic Cancer ◽  
Randomized Controlled Trial ◽  
Resistance Training ◽  
Muscle Strength ◽  
Lean Body Mass ◽  
Body Mass ◽  
Controlled Trial ◽  
Training Group ◽  
Control Group ◽  
Randomized Controlled

Objective: To determine the efficacy of a three-month resistance training programme on the mobility, muscle strength and lean body mass of patients with pancreatic cancer-induced cachexia. Design: Randomized controlled trial. Setting: Elsahel Teaching Hospital, outpatient clinic of the Faculty of Physical Therapy, Cairo, Egypt. Participants: Patients with pancreatic cancer-induced cachexia. Interventions: Participants were randomized to the resistance training group ( n = 20) and control group ( n = 20). Main measures: Outcomes including mobility, muscle strength and lean body mass were measured at baseline, three months after surgical resection and 12 weeks after intervention. Results: The mean (SD) age was 51.9 (5.03) years and body mass index was 21.1 (1.13) kg/m²; 65% of patients were male. Compared to the control group, the resistance training group showed significant improvement in mobility: 400-m walk performance (270.3–256.9 seconds vs 266.4–264.2 seconds, respectively) and chair rise (13.82–12.53 seconds vs 13.77–13.46 seconds, respectively). Similarly, muscle strength was also significantly improved in the resistance training group than in the control group; we observed increase in peak torque of knee extensors ( P = 0.004), elbow flexors ( P = 0.001) and elbow extensors, improvement in lean mass of the upper limb (6.28–6.46 kg vs 6.31–6.23 kg, respectively) and lower limb (16.31–16.58 kg vs 16.4–16.31 kg, respectively). Conclusion: A three-month resistance training improved the mobility of patients with pancreatic cancer-induced cachexia. Muscle strength and lean body mass also improved.

scholarly journals Efficacy of preoperative progressive resistance training in patients undergoing total knee arthroplasty: 12-month follow-up data from a randomized controlled trial

2019 ◽  
Vol 34 (1) ◽  
pp. 82-90 ◽  
Author(s):  
Birgit Skoffer ◽  
Thomas Maribo ◽  
Inger Mechlenburg ◽  
Christian Gaarden Korsgaard ◽  
Kjeld Søballe ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Resistance Training ◽  
Muscle Strength ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Significant Group ◽  
Randomized Controlled ◽  
Patient Reported

Objective: The aim of this study was to investigate the effect of adding four weeks preoperative progressive resistance training (PRT) to four weeks postoperative PRT on patient function, muscle strength, and other outcomes 12 months after total knee arthroplasty (TKA). Design: Twelve-month follow-up data from a previously published randomized controlled trial. Setting: Aarhus University Hospital, Silkeborg Regional Hospital, and Aarhus University. Subjects: A total of 59 patients scheduled for TKA were enrolled in a single-blinded, clinical randomized controlled trial. Interventions: Participants were randomized to preoperative PRT (intervention group) or to a control group who “lived as usual” the last four weeks before TKA. The intervention group completed four weeks preoperative and four weeks postoperative PRT, whereas the control group only completed four weeks postoperative PRT. Main follow-up measures were as follows: the 30-second Chair Stand Test (primary outcome), Timed Up and Go Test, walk tests, knee extensor, and knee flexor muscle strength and patient-reported outcomes. Statistical analyses were performed according to the intention-to-treat principle. Results: No significant group differences were observed for the primary outcome 30-second Chair Stand Test (4.0 repetitions versus 2.4 repetitions, P = 0.067) or for other functional performance outcomes. The intervention group had significantly higher weight-normalized knee extensor muscle strength (0.5 Nm/kg versus 0.2 Nm/kg, P = 0.002) and knee flexor muscle strength (0.3 Nm/kg versus 0.2 Nm/kg, P = 0.042) in the operated leg when compared to the control group. No significant group differences for patient-reported outcomes. Conclusion: The study supports the use of short-term high-intensity resistance training before TKA as it induces a long-lasting effect on muscle strength, while it may have no discernible effect on functional performance.

Evaluation of a collaborative protocolized approach by community pharmacies and general medical practitioners for an Australian minor ailments scheme: study protocol for a cluster-randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Sarah Dineen-Griffin ◽  
Victoria Garcia Cardenas ◽  
Kylie Williams ◽  
Shalom Isaac Benrimoj
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Care ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Community Pharmacies ◽  
Randomized Controlled ◽  
Minor Ailments ◽  
Cluster Randomized

BACKGROUND Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MAS) promote efficiencies within the healthcare system. The cost savings and health outcomes demonstrated in the UK and Canada opens up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE This trial is evaluating the clinical, economic and humanistic impact of an Australian minor ailments service (AMAS), compared with usual pharmacy care in a cluster-randomized controlled trial in Western Sydney, Australia. METHODS The cluster-randomized controlled trial design has an intervention and a control group, comparing individuals receiving a structured intervention with those receiving usual care for specific common ailments. Participants will be community pharmacies, general practices and patients located in Western Sydney Primary Health Network region. 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients seeking, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain). Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The co-primary outcomes are rates of appropriate use of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, time to resolution of symptoms, health services resource utilization and EQ VAS. Differences in the primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost analysis compared with usual care. RESULTS The study began in July 2018. At the time of submission, 30 community pharmacies have been recruited. Pharmacists from the 15 intervention pharmacies have been trained. 27 general practices have consented. Pharmacy patient recruitment began in August 2018 and is ongoing and monthly targets are being met. Recruitment will be completed March 31st, 2019. CONCLUSIONS This study may demonstrate the utilization and efficacy of a protocolized intervention to manage minor ailments in the community, and will assess the clinical, economic and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and self-medication may contribute greater efficiency of healthcare resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a MAS national service, with protocolized care for common ailments using a robust framework for management and referral. CLINICALTRIAL Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.

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

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)

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

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.

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

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.

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

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.

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

Endoscopy ◽  
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

<b>Background and study aims</b> 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. <b>Patients and methods</b> 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 (CO<sub>2</sub> 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. <b>Results</b> 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 CO<sub>2</sub> group (p=0.037). The insertion time was prolonged in the WE group compared with CO<sub>2</sub> 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. <b>Conclusions</b> 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.

scholarly journals Primary dementia care based on the individual needs of the patient: study protocol of the cluster randomized controlled trial, DemStepCare

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Isabella Bablok ◽  
◽  
Harald Binder ◽  
Dominikus Stelzer ◽  
Klaus Kaier ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Dementia Care ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Care Model ◽  
Randomized Controlled ◽  
Individual Needs ◽  
Cluster Randomized ◽  
The Individual

Abstract Background Most people with dementia (PwD) are cared for at home, with general practitioners (GPs) playing a key part in the treatment. However, primary dementia care suffers from a number of shortcomings: Often, diagnoses are made too late and therapies by GPs do not follow the guidelines. In cases of acute crises, PwD are too often admitted to hospital with adverse effects on the further course of the disease. The aim of this study is to implement and evaluate a new GP-based, complex dementia care model, DemStepCare. DemStepCare aims to ensure demand-oriented, stepped care for PwD and their caregivers. Methods/design In a cluster randomized controlled trial, the care of PwD receiving a complex intervention, where the GP is supported by a multi-professional team, is compared to (slightly expanded) usual care. GPs are clustered by GP practice, with 120 GP practices participating in total. GP practices are randomized to an intervention or a control group. 800 PwD are to be included per group. Recruitment takes place in Rhineland-Palatinate, Germany. In addition, a second control group with at least 800 PwD will be formed using aggregated routine data from German health insurance companies. The intervention comprises the training of GPs, case management including repeated risk assessment of the patients’ care situation, the demand-oriented service of an outpatient clinic, an electronic case record, external medication analyses and a link to regional support services. The primary aims of the intervention are to positively influence the quality of life for PwD, to reduce the caregivers’ burden, and to reduce the days spent in hospital. Secondary endpoints address medication adequacy and GPs’ attitudes and sensitivity towards dementia, among others. Discussion The GP-based dementia care model DemStepCare is intended to combine a number of promising interventions to provide a complex, stepped intervention that follows the individual needs of PwD and their caregivers. Its effectiveness and feasibility will be assessed in a formative and a summative evaluation. Trial registration German Register of Clinical Trials (Deutsches Register Klinischer Studien, DRKS), DRKS00023560. Registered 13 November 2020 - Retrospectively registered. HTML&TRIAL_ID=DRKS00023560.

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

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.

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