scholarly journals Effects of a Rehabilitation Program on Perceived Environmental Barriers in Older Patients Recovering from Hip Fracture: A Randomized Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Erja Portegijs ◽  
Merja Rantakokko ◽  
Johanna Edgren ◽  
Anu Salpakoski ◽  
Ari Heinonen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hip Fracture ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Community Dwelling ◽  
Outdoor Environment ◽  
Control Group ◽  
Environmental Barriers ◽  
Randomized Controlled ◽  
Link Type

Objectives. To study effects of a one-year multicomponent intervention on perceived environmental barriers in hip fracture patients.Design. Randomized controlled trial of a 12-month home-based rehabilitation aiming to improve mobility and function (ISRCTN53680197); secondary analyses.Subjects. Community-dwelling hip fracture patients on average 70 days after trauma (n=81).Methods. Assessments at baseline, 3, 6, and 12 months later included perceived entrance-related barriers (e.g., indoor/outdoor stairs, lighting, floor surfaces, and storage for mobility devices) and perceived barriers in the outdoor environment (poor street condition, hilly terrain, long-distances, and lack of resting places). Sum scores for entrance-related and outdoor barriers were analyzed using general estimating equation models.Results. At baseline, 48% and 37% of the patients perceived at least one entrance-related barrier, and 62% and 60% perceived at least one outdoor barrier in the intervention and control group, respectively. Over time, (P=0.003) the number of entrance-related barriers decreased in both groups (groupP=0.395; interactionP=0.571). For outdoor barriers, time (P=0.199), group (P=0.911), and interaction effect (P=0.430) were not significant.Conclusion. Our intervention had no additional benefit over standard care in hip fracture patients. Further study is warranted to determine whether perceived environmental barriers can be reduced by interventions targeted at the older individual. This trial is registered withISRCTN53680197.

scholarly journals Effects of a home-based rehabilitation program in community-dwelling older people after discharge from hospital: A subgroup analysis of a randomized controlled trial

2021 ◽  
pp. 026921552110016
Author(s):  
Turunen Katri Maria ◽  
Aaltonen-Määttä Laura ◽  
Portegijs Erja ◽  
Rantalainen Timo ◽  
Keikkala Sirkka ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Physical Performance ◽  
Standard Care ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Community Dwelling ◽  
Control Group ◽  
Randomized Controlled ◽  
Community Mobility

Objective: To examine whether pre-admission community mobility explains the effects of a rehabilitation program on physical performance and activity in older adults recently discharged from hospital. Design: A secondary analysis of a randomized controlled trial. Setting: Home and community. Participants: Community-dwelling adults aged ⩾60 years recovering from a lower limb or back injury, surgery or other disorder who were randomized to a rehabilitation ( n = 59) or standard care control ( n = 58) group. They were further classified into subgroups that were not planned a priori: (1) mild, (2) moderate, or (3) severe pre-admission restrictions in community mobility. Interventions: The 6-month intervention consisted of a motivational interview, goal attainment process, guidance for safe walking, a progressive home exercise program, physical activity counselling, and standard care. Measurements: Physical performance was measured with the Short Physical Performance Battery and physical activity with accelerometers and self-reports. Data were analysed by generalized estimating equation models with the interactions of intervention, time, and subgroup. Results: Rehabilitation improved physical performance more in the intervention ( n = 30) than in the control group ( n = 28) among participants with moderate mobility restriction: score of the Short Physical Performance Battery was 4.4 ± 2.3 and 4.2 ± 2.2 at baseline, and 7.3 ± 2.6 and 5.8 ± 2.9 at 6 months in the intervention and control group, respectively (mean difference 1.6 points, 95% Confidence Interval 0.2 to 3.1). Rehabilitation did not increase accelerometer-based physical activity in the aforementioned subgroup and did not benefit those with either mild or severe mobility restrictions. Conclusions: Pre-admission mobility may determine the response to the largely counselling-based rehabilitation program.

scholarly journals Safer cycling in older age (SiFAr): a protocol of a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Hanna Maria Siebentritt ◽  
Veronika Keppner ◽  
Sabine Britting ◽  
Robert Kob ◽  
Anja Rappl ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Community Dwelling ◽  
Older Age ◽  
Control Group ◽  
Positive Effects ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Cycling has positive effects on health and the proportion of older cyclists is rising. However, the risk for older adults to be injured or killed by a bicycle accident increases. The aim of the ongoing project “Safer Cycling in Older Age (SiFAr)” is to promote safer cycling in community-dwelling older adults with a structured, multi-component exercise training. Methods SiFAr is a randomized, controlled trial with a duration of 3 months for the intervention and a 6–9 months follow-up. We address community-dwelling persons aged 65 years and older living in the area Nürnberg-Fürth-Erlangen (Germany) who are either 1) beginners with the e-bike or 2) feeling self-reported unsteadiness when cycling or 3) uptaking cycling after a longer break. Long-term, experienced cyclists without subjectively reported limitations or worries when cycling are excluded. Participants are either randomized 1:1 to an intervention group (IG; receiving multi-component exercise program related to cycling, MEPC) or an active control group (aCG; receiving health and bicycle-related presentations, HRP). The purpose of this study is to investigate if the cycling competence of the IG will improve compared to the aCG. The cycling competence as primary outcome is tested not blinded in a standardized cycle course prior and after the intervention period, which consists of variant tasks requiring motor and cognitive skills related to traffic situations in daily life. Additional assessments such as physical functioning, quality of life, fear of falling, questionnaires regarding cycling behavior are obtained. To investigate the primary objective, regression analyses with difference of errors in the cycling course as independent variable and group as dichotomous dependent variable adjusted for covariates (sex, bicycle type) will be performed. The trial design is described in the present manuscript, using the extended CONSORT checklist for reporting pragmatic trials. Discussion Since there is a lack of cycling-related interventions for older people, SiFAr aims to evaluate a standardized intervention to enhance cycling safety. The results of the SiFAr trial could contribute to the implementation of an evaluated cycling course concept promoting mobility and independence of older adults. Trial registration This study was registered with clinicaltrials.gov: NCT04362514 on April 27, 2020

scholarly journals Frequency of repositioning for preventing pressure ulcers in patients hospitalized in ICU: protocol of a cluster randomized controlled trial

BMC Nursing ◽  
2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Olga L. Cortés ◽  
Mauricio Herrera-Galindo ◽  
Juan Carlos Villar ◽  
Yudi A. Rojas ◽  
María del Pilar Paipa ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Critical Care ◽  
Pressure Ulcers ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Link Type ◽  
Cluster Randomized ◽  
The Impact

Abstract Background Despite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients’ tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals. Methods A nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients’ level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study. Conclusion This study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk. Trial registration PENFUP phase-2 was Registered in Clinicaltrials.gov (NCT04604665) in October 2020.

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

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lena Violetta Krämer ◽  
Nadine Eschrig ◽  
Lena Keinhorst ◽  
Luisa Schöchlin ◽  
Lisa Stephan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Controlled Trial ◽  
Control Group ◽  
Web Based ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Link Type

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

Six Versus 12 Weeks of Outpatient Physical Therapy Including Progressive Resistance Training in Cognitively Intact Older Adults After Hip Fracture: A Multicenter Randomized Controlled Trial

2021 ◽  
Author(s):  
Jan A Overgaard ◽  
Thomas Kallemose ◽  
Kathleen K Mangione ◽  
Morten T Kristensen
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Hip Fracture ◽  
Physical Therapy ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Walking Distance ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Cognitively Intact

Abstract Background Recovery of function and regaining muscle strength are challenging after hip fracture. We compared the effectiveness of a 12- versus 6-week outpatient physical therapy program with progressive resistive training (PRT) to increase strength and physical performance. Methods This parallel, superiority, 2-group randomized controlled trial was conducted in 4 clinics that enrolled community-dwelling, cognitively intact older adults (+60 years) with a surgical repair of a hip fracture and no major medical conditions. Participants received 12 or 6 weeks of PRT and standardized physical therapy, twice weekly. Pain was monitored throughout. Primary outcome was the change in the 6-minute walk test (6MWT) from baseline to 12-week follow-up. Randomization via a computer-generated allocation sequence was implemented using sealed, sequentially numbered opaque envelopes and assessors were blinded to group assignment. Results Participants (81% women) with a mean (SD) age of 77 (8.1) years were enrolled at an average of 18 days after hip fracture surgery and randomized into a 12-week group (n = 50) or a 6-week group (n = 50). Mean (SD) change scores in the 6MWT were 143.8 (81.1) and 161.5 (84.1) m in the 12- and 6-week groups, respectively (both exceeding the minimal clinically important difference of 55 m). The mean between-group difference was −17.7 m (95% CI −50.1, 14.8). Pain during training did not exceed moderate levels nor increase as training intensity increased. Conclusion Twelve weeks of physical therapy with PRT was not superior to 6 weeks in improving walking distance. Hip fracture-related pain was relatively low and indicated strength testing and training was well tolerated. Clinical Trials Registration Number: NCT01174589

scholarly journals Effects of an Interactive Computer Game Exercise Regimen on Balance Impairment in Frail Community-Dwelling Older Adults: A Randomized Controlled Trial

2011 ◽  
Vol 91 (10) ◽  
pp. 1449-1462 ◽  
Author(s):  
Tony Szturm ◽  
Aimee L. Betker ◽  
Zahra Moussavi ◽  
Ankur Desai ◽  
Valerie Goodman
Keyword(s):  
Randomized Controlled Trial ◽  
Video Game ◽  
Dynamic Balance ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Control Group ◽  
Day Hospital ◽  
Randomized Controlled ◽  
Balance Exercises ◽  
Experimental Group

Background Due to the many problems associated with reduced balance and mobility, providing an effective and engaging rehabilitation regimen is essential to progress recovery from impairments and to help prevent further degradation of motor skills. Objectives The purpose of this study was to examine the feasibility and benefits of physical therapy based on a task-oriented approach delivered via an engaging, interactive video game paradigm. The intervention focused on performing targeted dynamic tasks, which included reactive balance controls and environmental interaction. Design This study was a randomized controlled trial. Setting The study was conducted in a geriatric day hospital. Participants Thirty community-dwelling and ambulatory older adults attending the day hospital for treatment of balance and mobility limitations participated in the study. Interventions Participants were randomly assigned to either a control group or an experimental group. The control group received the typical rehabilitation program consisting of strengthening and balance exercises provided at the day hospital. The experimental group received a program of dynamic balance exercises coupled with video game play, using a center-of-pressure position signal as the computer mouse. The tasks were performed while standing on a fixed floor surface, with progression to a compliant sponge pad. Each group received 16 sessions, scheduled 2 per week, with each session lasting 45 minutes. Measurements Data for the following measures were obtained before and after treatment: Berg Balance Scale, Timed “Up & Go” Test, Activities-specific Balance Confidence Scale, modified Clinical Test of Sensory Interaction and Balance, and spatiotemporal gait variables assessed in an instrumented carpet system test. Results Findings demonstrated significant improvements in posttreatment balance performance scores for both groups, and change scores were significantly greater in the experimental group compared with the control group. No significant treatment effect was observed in either group for the Timed “Up & Go” Test or spatiotemporal gait variables. Limitations The sample size was small, and there were group differences at baseline in some performance measures. Conclusion Dynamic balance exercises on fixed and compliant sponge surfaces were feasibly coupled to interactive game-based exercise. This coupling, in turn, resulted in a greater improvement in dynamic standing balance control compared with the typical exercise program. However, there was no transfer of effect to gait function.

scholarly journals Study Protocol for a Randomized Controlled Trial Evaluating the Efficacy of an Evidence-Based iPad-App for Cognitive Rehabilitation in Patients with Primary Brain Tumors

Neurosurgery ◽  
2018 ◽  
Vol 85 (2) ◽  
pp. 273-279 ◽  
Author(s):  
Sophie Dorothee van der Linden ◽  
Margriet Maria Sitskoorn ◽  
Geert-Jan Maria Rutten ◽  
Karin Gehring
Keyword(s):  
Randomized Controlled Trial ◽  
Brain Tumor ◽  
Brain Tumors ◽  
Cognitive Rehabilitation ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Control Group ◽  
Tumor Patients ◽  
Primary Brain Tumors ◽  
Randomized Controlled

Abstract BACKGROUND Many patients with primary brain tumors suffer from cognitive deficits, which negatively impact their quality of life. However, cognitive rehabilitation programs for these patients are scarce. We developed an iPad-based cognitive rehabilitation program for brain tumor patients, which was based on our effective face-to-face cognitive rehabilitation program. After successful completion of a feasibility study, a randomized controlled trial has been started. OBJECTIVE To evaluate the immediate and long-term effects of the iPad-based program on cognitive performance and patient-reported outcome measures (PROMs) in patients with primary brain tumors in an early stage of the disease. METHODS Prior to surgery, patients with presumed low-grade glioma and meningioma are included. Before surgery and 3 mo after surgery, neuropsychological assessments are conducted. After the second neuropsychological assessment, patients are assigned to the intervention group or waiting-list control group. The intervention consists of psychoeducation, compensation training, and retraining. Patients are advised to spend 3 h per week on the program for 10 wk. Immediately after completion of the program and a half-year thereafter, postintervention assessments take place. Patients in the control group are offered the opportunity to follow the program after all study assessments. EXPECTED OUTCOMES We expect that early cognitive rehabilitation has beneficial effects on cognitive performance and PROMs in brain tumor patients. DISCUSSION The iPad-based program allows brain tumor patients to follow a cognitive rehabilitation program from their homes. Forthcoming results may contribute to further improvement of supportive care for brain tumor patients.

scholarly journals Pharmacist-guided pre-emptive pharmacogenetic testing in antidepressant therapy (PrePGx): study protocol for an open-label, randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Céline K. Stäuble ◽  
Markus L. Lampert ◽  
Samuel Allemann ◽  
Martin Hatzinger ◽  
Kurt E. Hersberger ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Antidepressant Treatment ◽  
Controlled Trial ◽  
Response Rates ◽  
Control Group ◽  
Open Label ◽  
Randomized Controlled ◽  
Link Type ◽  
Increased Risk ◽  
Antidepressant Pharmacotherapy

Abstract Background It is known that only 50% of patients diagnosed with major depressive disorders (MDD) respond to the first-line antidepressant treatment. Accordingly, there is a need to improve response rates to reduce healthcare costs and patient suffering. One approach to increase rates of treatment response might be the integration of pharmacogenetic (PGx) testing to stratify antidepressant drug selection. The goal of PGx assessments is to identify patients who have an increased risk to experience adverse drug reactions or non-response to specific drugs. Especially for antidepressants, there is compiling evidence on PGx influencing drug exposure as well as response. Methods This study is an open-label, randomized controlled trial conducted in two study centers in Switzerland: (1) the Psychiatric Clinic of Solothurn and (2) the Private Clinic Wyss in Münchenbuchsee. Adult inpatients diagnosed with a unipolar moderate or severe depressive episode are recruited at clinic admission and are included in the study. If the adjustment to a new antidepressant pharmacotherapy is necessary, the participants are randomized to either Arm A (intervention group) or Arm B (control group). If no new antidepressant pharmacotherapy is introduced the participants will be followed up in an observational arm. The intervention is the service of pharmacist-guided pre-emptive PGx testing to support clinical decision making on antidepressant selection and dosing. As a comparison, in the control group, the antidepressant pharmacotherapy is selected by the treating physician according to current treatment guidelines (standard of care) without the knowledge of PGx test results and support of clinical pharmacists. The primary outcome of this study compares the response rates under antidepressant treatment after 4 weeks between intervention and control arm. Discussion The findings from this clinical trial are expected to have a direct impact on inter-professional collaborations for the handling and use of PGx data in psychiatric practice. Trial registration ClinicalTrials.govNCT04507555. Registered on August 11, 2020. Swiss National Clinical Trials Portal SNCTP000004015. Registered August 18, 2020.

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