scholarly journals Effects of Phase IV Pedometer Feedback Home-Based Cardiac Rehabilitation on Cardiovascular Functional Capacity in Patients With Myocardial Infarction: A Randomized Controlled Trial

2019 ◽  
Vol 4 (2) ◽  
pp. 75-80
Author(s):  
Mostafa Dehghani ◽  
Mostafa Cheraghi ◽  
Mehrdad Namdari ◽  
Valiollah Dabidi Roshan
Keyword(s):  
Myocardial Infarction ◽  
Randomized Controlled Trial ◽  
Cardiac Rehabilitation ◽  
Functional Capacity ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Control Groups ◽  
Randomized Controlled ◽  
Home Based

Introduction: Pedometer feedback home-based cardiac rehabilitation (PFHCR) programs have been effective in augmenting exercise tolerance. Our aim was to investigate the effects of PFHCR on cardiovascular functional capacity in patients with myocardial infarction (MI).Methods: Forty MI patients were divided into two intervention and two control groups (n=10)in a randomized controlled trial. The intervention group received a PFHCR program including routine medications along with continuous exercise program, whereas the control group received traditional care without PFHCR. Baseline evaluations and cardiovascular stresses were controlled during the 8-week follow-up rehabilitation program in all patients. Data analysis was conducted using one-way ANOVA and paired sample student’s t-test (P ≤ 0.05).Results: At baseline, no significant differences were observed between the groups. After eight weeks of PFHCR, the intervention groups had significantly higher metabolic equivalent(P = 0.001), VO2max (P = 0.001), total exercise times (P = 0.001), and total distance traveled(P = 0.003) when compared with the control groups. However, no significant intra-group or inter-group differences in variables were observed between the men and women.Conclusion: Our results showed that PFHCR exhibited significant optimal effects on the cardiovascular functional capacity in MI patients.

scholarly journals Effects of individualized follow-up with a smartphone-application after cardiac rehabilitation: protocol of a randomized controlled trial

2019 ◽  
Vol 11 (1) ◽  
Author(s):  
Pernille Lunde ◽  
Asta Bye ◽  
Astrid Bergland ◽  
Birgitta Blakstad Nilsson
Keyword(s):  
Randomized Controlled Trial ◽  
Cardiac Rehabilitation ◽  
Controlled Trial ◽  
Intervention Group ◽  
Smartphone Application ◽  
Control Group ◽  
Power Calculation ◽  
Large Sample Size ◽  
Randomized Controlled

Abstract Background Cardiac rehabilitation (CR) programs are evidence-based and widely recommended. However, benefits from CR are likely lost among individuals who discontinue their regular exercise routines and healthy habits. One possible approach to enhance adherence to lifestyle advice after completion of CR, may be individualized follow-up enabled by a smartphone application (app). Methods A protocol of a single-blinded, pragmatic randomized controlled trial. The study will take place in the eastern part of Norway, and will include heart patients who have completed CR. Participants will be recruited from two CR centers. Based on power calculation, 113 participants will be included. The intervention group will receive individualized follow-up through an app on a weekly basis throughout a year. The app will be set up with the participant’s own goals, and the follow-up will be based on these individual goals. The control group will receive usual care, including general advice regarding physical activity, exercise and diet. The participants will be assessed at baseline (at completion of CR) and 12 months after baseline. Primary outcome of the study will be peak oxygen uptake. Secondary outcomes include exercise performance, quality of life, health status, health literacy, self-perceived goal achievement, exercise habits, body weight, blood pressure as well as lipids and triglycerides. Discussion To our knowledge, this will be the first study to examine the effects of individualized follow-up with an app for one year, in patients completing CR. Hence, it is reasonable to assume that the study may be groundbreaking. Due to the large sample size and the theoretically based intervention, the study has the potential to generate new knowledge that may improve the design of future technology-based follow-up interventions of patients that have completed rehabilitation. Trial registration ClinicalTrials.gov. NCT03174106. First registration, 19/05/2017.

scholarly journals A Home-Based Individual Cognitive Stimulation Program for Older Adults With Cognitive Impairment: A Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Rosa Silva ◽  
Elzbieta Bobrowicz-Campos ◽  
Paulo Santos-Costa ◽  
Ana Rita Cruz ◽  
João Apóstolo
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Cognitive Impairment ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cognitive Stimulation ◽  
Attrition Rate ◽  
Control Group ◽  
Randomized Controlled ◽  
Home Based

Objective: This study aims to assess the feasibility and meaningfulness of a home-based individual cognitive stimulation (iCS) program delivered by caregivers to persons with cognitive impairment (PwCIs). It also aims to assess whether the older adults receiving this program improved their cognitive, neuropsychiatric, and depressive symptoms and quality of life and whether their caregivers improved their mental and physical health.Methods: A randomized controlled trial (RCT) was conducted with PwCI-caregiver dyads recruited from the community. Participants were allocated to two groups: intervention (n = 28) and control (n = 24). The intervention group received the European Portuguese version of the Individual Cognitive Stimulation Program—Making a Difference 3 (MD3-P). The control group received usual care. The iCS therapy program was implemented three times a week for 12 weeks. Caregivers were supported by the researchers to deliver the sessions at home. Participants were assessed at baseline and at the end of the intervention (week 13). Feasibility and meaningfulness were assessed through the attrition rate, adherence, and degree of satisfaction with the sessions. Four interviews were conducted (after week 13) to understand participants’ experiences.Results: The attrition rate was 23.1%. The dyads reported that they did not have high expectations about the iCS program before starting the study. Nevertheless, as the program evolved, caregivers noted that their family members had improved some areas of functioning. Intention-to-treat analysis based on group differences revealed a significant improvement in PwCIs’ cognition, specifically in their orientation and ability to follow commands. The intervention had no impact on other variables such as caregivers’ physical and mental health.Conclusion: The iCS program implemented by caregivers showed promising results in improving PwCIs’ cognition. The participants who completed the intervention attributed a positive meaning to the MD3-P, confirming it as a valid non-pharmacological therapeutic approach to reducing frailty in PwCIs in community settings.Clinical Trial Registration:www.ClinicalTrials.gov, identifier [NCT03514095].

scholarly journals Did awarding badges increase data sharing in BMJ Open ? A randomized controlled trial

2020 ◽  
Vol 7 (3) ◽  
pp. 191818 ◽  
Author(s):  
Anisa Rowhani-Farid ◽  
Adrian Aldcroft ◽  
Adrian G. Barnett
Keyword(s):  
Randomized Controlled Trial ◽  
Data Sharing ◽  
Controlled Trial ◽  
Intervention Group ◽  
Open Data ◽  
Research Articles ◽  
Control Group ◽  
Control Groups ◽  
Randomized Controlled ◽  
And Control

Sharing data and code are important components of reproducible research. Data sharing in research is widely discussed in the literature; however, there are no well-established evidence-based incentives that reward data sharing, nor randomized studies that demonstrate the effectiveness of data sharing policies at increasing data sharing. A simple incentive, such as an Open Data Badge, might provide the change needed to increase data sharing in health and medical research. This study was a parallel group randomized controlled trial (protocol registration: doi:10.17605/OSF.IO/PXWZQ ) with two groups, control and intervention, with 80 research articles published in BMJ Open per group, with a total of 160 research articles. The intervention group received an email offer for an Open Data Badge if they shared their data along with their final publication and the control group received an email with no offer of a badge if they shared their data with their final publication. The primary outcome was the data sharing rate. Badges did not noticeably motivate researchers who published in BMJ Open to share their data; the odds of awarding badges were nearly equal in the intervention and control groups (odds ratio = 0.9, 95% CI [0.1, 9.0]). Data sharing rates were low in both groups, with just two datasets shared in each of the intervention and control groups. The global movement towards open science has made significant gains with the development of numerous data sharing policies and tools. What remains to be established is an effective incentive that motivates researchers to take up such tools to share their data.

scholarly journals Home-based Palliative Intervention to Improve Quality of Life in Children with Cancer: A Randomized Controlled Trial

2019 ◽  
Author(s):  
Murti Andriastuti ◽  
Pricilia G Halim ◽  
Elnino Tunjungsari ◽  
Dwi P Widodo
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Children With Cancer ◽  
Randomized Controlled ◽  
Home Based ◽  
Significant Difference

Abstract Background: In these last few years, an integrated approach between palliative care (PC) and chronic and/or life-threatening conditions care have been widely used. Home-based PC service is developed to meet the needs of the patients at home, but hasn’t been applied widely. This study is aimed to determine the benefit of integrated home-based PC in the quality of life (QOL) and symtomps intensity of Indonesian children with malignancies. Method: A randomized controlled trial to compare the quality of life between patients who were given PC (a 3-month home visit) and those who were not (intervention vs control group) was conducted, each group containing 30 children with cancer aged 2-18 years old who were consulted to palliative team. Participants were randomly assigned into each group. In the first and twelfth week of the intervention, all patients were assessed with the Pediatric Quality of Life Inventory (PedsQLTM) questionnaire cancer module 3.0 (report by proxy or self-report). Symptoms intensity (pain, anorexia, sleep disturbance) were scored by using Edmonton Symptoms Assessment Scale (ESAS). Mean score and each dimension score of both group were compared and analyzed using bivariate analysis. Results: A total 50 participants were included in analysis. Significant difference was found between two groups with average total score in control group 62.39 and intervention group 81.63 (p<0.001). In the intervention group QoL tends to improve, whereas in the control group, those did not get palliative intervention, quality of life tends to decrease as the disease progress. The most improved aspect in QoL is pain and nausea (p<0.001), followed by procedural anxiety (p=0.002), treatment anxiety (p=0.002), and worry (p=0.014). Palliative intervention was found to be able to reduce sleep disturbances (p=0.003) and anorexia (p<0.001) significantly. Conclusion: Home-based PC improved several aspects of the QOL and provide better symptoms management of children with malignancies. An early intervention concurrent with the underlying treatment is believed to be able to improve their quality of life. Trial Registration: This study has been retrospectively registered in ClinicalTrials.gov ID: NCT04067687 (August, 22nd 2019).

Effects on shoulder pain and disability of teaching patients with shoulder pain a home-based exercise program: a randomized controlled trial

2020 ◽  
Vol 34 (10) ◽  
pp. 1245-1255
Author(s):  
Giovanna Santello ◽  
Denise Martineli Rossi ◽  
Jaqueline Martins ◽  
Thiele de Cássia Libardoni ◽  
Anamaria Siriani de Oliveira
Keyword(s):  
Randomized Controlled Trial ◽  
Shoulder Pain ◽  
Effect Size ◽  
Controlled Trial ◽  
Intervention Group ◽  
Exercise Program ◽  
Control Group ◽  
Randomized Controlled ◽  
Medication Intake ◽  
Home Based

Objective: To investigate the effect on shoulder pain and disability of teaching patients with shoulder pain how to undertake a home-based exercise program. Design: A randomized controlled trial conducted from September 2015 to January 2016. Setting: Participants’ home. Participants: Sixty participants with shoulder pain who were waiting for physiotherapeutic treatment. Interventions: The control group ( n = 30) received minimal education about their shoulder condition and instructions to continue their activities as normal. The intervention group ( n = 30) received a two-month home exercise program with one-hour sessions delivered by a physiotherapist to begin and one month after the program for exercise instructions. Main measures: The primary outcome was change in the Shoulder Pain and Disability Index (SPADI). The secondary outcomes included change in the numeric pain rating scale and medication intake for pain relief. Results: The patients’ average age was 54.3 (13.8) years. SPADI scores at baseline were 60.9 (16.5) in the intervention and 64.7 (15.3) in the control group. After two months, the SPADI scores decreased to 18.8 (28.6) and to 61.4 (24.0), respectively, in the intervention and control groups with an estimated mean difference of 40.0, effect size: 1.61. The intervention group showed a reduced pain intensity (estimated mean difference: 3.7, effect size: 2.43) and medication intake (chi-square: 0.001). The number needed to treat was 1.2 for one patient to have a SPADI score <20. Conclusion: Teaching patients with shoulder pain how to undertake a home-based exercise program improved shoulder function and reduced pain intensity and medication intake over two months.

The Impact of Home-Based Exercise Rehabilitation on Functional Capacity in Patients With Acute Ischemic Stroke: A Randomized Controlled Trial

2019 ◽  
Vol 32 (3) ◽  
pp. 141-147
Author(s):  
Mohammad Saadatnia ◽  
Hossein Shahnazi ◽  
Fariborz Khorvash ◽  
Fatemeh Esteki-Ghashghaei
Keyword(s):  
Randomized Controlled Trial ◽  
Ischemic Stroke ◽  
Daily Living ◽  
Controlled Trial ◽  
Intervention Group ◽  
Rehabilitation Program ◽  
Control Group ◽  
Exercise Rehabilitation ◽  
Randomized Controlled ◽  
Home Based

One of the major consequences of stroke impairments is hemiparesis, which affects activities of daily living and contributes sedentary lifestyle. The purpose of this study was evaluation of the effectiveness of home-based exercise rehabilitation incentive on daily living activities and functional capacity among acute ischemic patients. This randomized controlled trial was done from August 2017 to September 2018. Iranian subjects with unilateral ischemic stroke were recruited from inpatient wards at educational hospital. Patients were randomly assigned to the home-based rehabilitation program (intervention group) or usual care (control group). National Institute of Health Stroke Scale (NIHSS), Barthel Index Score (BI), Modified Rankin Scale (MRS), and Fugl-Meyer Upper and Lower Extremity Sensorimotor Score were evaluated in both groups at baseline and 3 months later. Intervention group received home-based rehabilitation exercise program for 3 months. Control group did not receive home-based rehabilitation program and incentive telephone call. All data were collected and analyzed by SPSS software (Version 20.0; SPSS Inc., Chicago, Illinois) using chi-square test to compare demographic variables, and independent and paired t-tests to between- and within-group assessment, respectively. Forty ischemic stroke patients (20 intervention group and 20 control group) were examined. Results showed BI, Fugl-Meyer Upper and Lower Extremity Score, and MRS score in the interventional group were significantly higher than the control group after 3-month home-based exercise rehabilitation ( p < .001). Providing a home rehabilitation program in this study resulted in a motor recovery on ischemic stroke survivors in the acute phase of recovery. This was assumed to be cost-effective intervention in low-income countries

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.

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.

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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