scholarly journals Task-oriented exercises improve disability of working patients with surgically-treated proximal humeral fractures. A randomized controlled trial with one-year follow-up

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marco Monticone ◽  
Igor Portoghese ◽  
Daniele Cazzaniga ◽  
Valentina Liquori ◽  
Giuseppe Marongiu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Group Differences ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
One Year ◽  
Task Oriented

Abstract Background General physiotherapy is a common means of rehabilitation after surgery for proximal humeral fracture (PHF). Better-targeted exercises seem worthy of investigation and the aim of this study was to assess the efficacy of a rehabilitation program including task-oriented exercises in improving disability, pain, and quality of life in patients after a PHF. Methods By means of a randomized controlled trial with one-year follow-up, 70 working patients (mean age of 49 ± 11 years; 41 females), who were selected for open reduction and internal fixation with plates caused by PHF, were randomized to be included in an experimental (n = 35) or control group (n = 35). There was a permuted-block randomization plan, and a list of program codes was previously created; subsequently, an automatic assignment system was used to conceal the allocation. The first group underwent a supervised rehabilitation program of task-oriented exercises based on patients’ specific job activities, and occupational therapy. The second group underwent general physiotherapy, including supervised mobility, strengthening and stretching exercises. Both groups individually followed programs of 60-min session three times per week for 12 weeks in the outpatient setting. The Disability Arm Shoulder Hand questionnaire (DASH; scores range from 0 to 100; primary outcome), a Pain intensity Numerical Rating Scale (scores range 0 to 10; secondary outcomes), and the Short-Form Health Survey (scores range from 0 to 100; secondary outcomes) assessed the interventions. Participants were evaluated before surgery, before and after rehabilitation (primary endpoint), and at the one-year follow-up (secondary endpoint). A linear mixed model analysis for repeated measures was carried out for each outcome measure (p < 0.05). Results Time, group and time by group showed significant effects for all outcome measures in favour of the experimental group. The DASH and the DASH work achieved clinically important between-group differences of 16.0 points (95% confidence interval [C.I.] 7.3 to 24.7) and 19.7 (95% C.I. 9.0 to 30.5) at follow-up, respectively. The NRS achieved a between-group difference of 2.9 (95% C.I. 1.0 to 3.9) at follow-up. As for SF-36, there were between-group differences ranging from 17.9 to 37.0 at follow-up. Conclusions A rehabilitation program based on task-oriented exercises was useful in improving disability, pain, and quality of life in working patients after PHFs. Improvements lasted for at least 12 months. Trial registration On 16/12/2019, the trial was retrospectively registered in the ISRCTN registry with the ID number 17996552.

Efficacy of task-specific circuit training on physical activity levels and mobility of stroke patients: A randomized controlled trial

2020 ◽  
Vol 47 (4) ◽  
pp. 451-462
Author(s):  
Júlia Caetano Martins ◽  
Sylvie Nadeau ◽  
Larissa Tavares Aguiar ◽  
Aline Alvim Scianni ◽  
Luci Fuscaldi Teixeira-Salmela ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Experimental Group

BACKGROUND: Impaired mobility is related to low physical activity (PA) levels observed after stroke. Therapeutic approaches, such as task-specific circuit training (TSCT), used to improve mobility in individuals with stroke, could also improve PA levels. OBJECTIVE: To investigate the efficacy of TSCT, focused on both upper (UL) and lower (LL) limbs, in improving PA levels and mobility (primary outcomes), as well as muscle strength, exercise capacity, and quality of life (secondary outcomes) in subjects with stroke. METHODS: A randomized controlled trial with 36 subjects with chronic stroke was conducted. Experimental group: TSCT, involving both UL and LL. Control group: global stretching, memory exercises, and education sessions. Both groups received 60 minute sessions/week over 12 weeks. Outcomes were measured at baseline, post-intervention and 16 week follow-up. RESULTS: No changes were found for primary and secondary outcomes (0.11≤p≤0.99), except for quality of life, which improved in the experimental group post-intervention and 16 week follow-up (p = 0.02). CONCLUSION: TSCT focused on both UL and LL was not effective on PA levels and mobility of individuals with chronic stroke, however, improvements in quality of life were observed. Since this is the first study to investigate this combined training aimed at improving PA levels, future studies are necessary to better understand the impact of this type of intervention.

Challenges of Telemonitoring Programs for Complex Chronic Conditions: A Randomized Controlled Trial with an Embedded Qualitative Study (Preprint)

2021 ◽  
Author(s):  
Patrick Ware ◽  
Amika Shah ◽  
Heather Joan Ross ◽  
Alexander Gordon Logan ◽  
Phillip Segal ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Decision Support ◽  
Chronic Conditions ◽  
Controlled Trial ◽  
Self Care ◽  
Randomized Controlled ◽  
Complex Patients ◽  
Secondary Outcomes

BACKGROUND Despite the growing prevalence of people with complex conditions and evidence of the positive impact of telemonitoring for single conditions, little research exists on the use of telemonitoring in this population, particularly those with multiple chronic conditions (MCCs). OBJECTIVE This randomized controlled trial (RCT) and embedded qualitative study aimed to evaluate the impact and experiences of patients and healthcare providers (HCPs) using a telemonitoring system with decision support to manage complex patients, including those with MCCs, compared to the standard of care. METHODS A pragmatic 6-month RCT sought to recruit 146 patients with a diagnosis of heart failure (HF), uncontrolled hypertension (HT), and/or insulin requiring diabetes (DM) from outpatient specialty settings in Toronto, Canada. Participants were randomized into the control and telemonitoring groups with the latter being instructed to take readings relevant to their condition(s). The telemonitoring system contained an algorithm that generated decision support in the form of actionable self-care directives to patients and alerts to HCPs. The primary outcome was health status as measured by the SF-36. Secondary outcomes included anxiety and depression, self-efficacy in chronic disease management, and self-reported healthcare utilization. HF-related quality of life and self-care measures were also collected from patients followed for HF. Within- and between-group change scores were analyzed for statistical significance (P<.05). A convenience sample of HCPs and patients in the intervention group were interviewed about their experiences RESULTS A total of 96 patients were recruited and randomized. Recruitment was terminated early due to implementation challenges and the onset of COVID-19. No significant within- and between-group differences were found for the main primary and secondary outcomes. However, a within-group analysis of HF patients found improvements in self-care maintenance (P=.036) and physical quality of life (P= .046). Opinions expressed by the 5 HCPs and 13 patients interviewed differed based on the condition(s) monitored. Although HF patients reported benefitting from actionable self-care guidance and meaningful interactions with their HCPs, patient and HCP users of the DM and HT modules did not think telemonitoring improved the clinical management of those conditions to the same degree. These differing experiences were largely attributed to the siloed nature of specialty care, and the design of the decision support whereby it was indicated that fluctuations in HT and DM patient status typically required less urgent intervention compared to HF. CONCLUSIONS Consistent with previous studies, we recommend that future research conceive telemonitoring as a program and that self-management and clinical decision support are necessary, but not sufficient components of such programs for complex patients with lower acuity. We conclude that a multidisciplinary model of care that includes care coordination must accompany telemonitoring systems which may best be operationalized through novel models of care, such as nurse-led models. CLINICALTRIAL ClinicalTrials.gov NCT03127852, ISRCTN (41238563) INTERNATIONAL REGISTERED REPORT RR2-10.2196/resprot.8367

scholarly journals Evaluation of a Brief Intervention for Promoting Mental Health among Employees in Social Enterprises: A Cluster Randomized Controlled Trial

2018 ◽  
Vol 15 (10) ◽  
pp. 2107 ◽  
Author(s):  
Benedicte Deforche ◽  
Jasmine Mommen ◽  
Anne Hublet ◽  
Winnie De Roover ◽  
Nele Huys ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Health Promotion ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Social Enterprises ◽  
Randomized Controlled ◽  
Cluster Randomized

Evidence on the effectiveness of workplace mental health promotion for people with disabilities is limited. This study aimed to evaluate the effectiveness of a brief mental health promotion intervention in social enterprises. It had a non-blinded cluster randomized controlled trial design with follow-up one and four months after the intervention. In total 196 employees agreed to participate (86 intervention and 110 control). Empowerment was the main outcome; secondary outcomes were resilience, palliative behavior, determinants of four coping strategies of mental health, quality of life, and life satisfaction. A brief participant satisfaction survey was conducted after the intervention. No significant intervention effect on empowerment was found. However, at one month follow-up, significant favorable effects were found on perceived social support for coping strategies for mental health and on palliative behavior. At four months follow-up, favorable intervention effects were found on quality of life, but unfavorable effects were found on unjustified worrying. In addition, the intervention was well received by the employees. This brief intervention might be a promising first step to improve mental health in people with disabilities working in social enterprises. Nevertheless, additional monitoring by professionals and managers working in the organizations might be needed to maintain these effects.

Intensive versus minimalist follow-up in patients treated for endometrial cancer: A multicentric randomized controlled trial (The TOTEM study—NCT00916708).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5506-5506
Author(s):  
Paolo Zola ◽  
Giovannino Ciccone ◽  
Elisa Piovano ◽  
Luca Fuso ◽  
Elena Peirano ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Overall Survival ◽  
Endometrial Cancer ◽  
Cancer Patients ◽  
Early Recognition ◽  
Controlled Trial ◽  
Physical And Mental Health ◽  
Randomized Controlled

5506 Background: Intensive follow-up in cancer patients, which absorbs a lot of health system resources and can be a source of increased stress for patients, are often proposed on the assumption that an early recognition of relapse will translate in better outcomes. In endometrial cancer few randomized controlled trials were conducted to assess the role of a reduced number of the scheduled visits and of different settings of the follow-up, but did not investigate the contribution of routine serum, cytological or imaging follow-up investigations in improving overall survival or quality of life. The TOTEM study was planned to compare an intensive (INT) vs minimalist (MIN) 5- year follow-up regimen in endometrial cancer patients in terms of overall survival (OS). Methods: Patients surgically treated for endometrial cancer, in complete clinical remission confirmed by imaging, FIGO stage I-IV, were stratified by center and in low (LoR) or high (HiR) risk of recurrence and then randomized to INT or MIN hospital-based follow-up regimens. The main study hypothesis was to demonstrate an improvement from 75% to 80% (expected hazard ratio, HR = 0.78) of the 5-year OS with the INT regimen. Secondary objectives were to compare relapse free survival (RFS), health-related quality of life (HRQL) assessed at baseline, at 6 and 12 months and then yearly (with the SF-12 Physical and Mental Health Summary Scale) and costs. Results: 1884 patients were randomized in 42 centers between 2008 and 2018, and 1847 patients were available for the final analysis (60% LoR). Compliance with the follow-up scheduled visits was 75.3%, similar between INT (74.7%) and MIN (75.9%) arms, whereas the mean number of recorded exams (laboratory or imaging) was markedly higher in the INT than in the MIN arms (9.7 vs 2.9, p < 0.0001). After a median follow-up of 66 months, the overall 5-year OS was 91.3%, 90.6% in the INT and 91.9% in the MIN arms, respectively (HR = 1.12, 95%CI 0.85-1.48, p = 0.429). Comparing the INT vs MIN arms, the 5-year OS were 94.1% and 96.8% (HR = 1.48, 0.92-2.37, p = 0.104) in the LoR and 85.3% and 84.7% (HR = 0.96, 0.68-1.36, p = 0.814) in the HiR group. No relevant differences emerged in RFS between INT and MIN regimens, (HR = 1.13, 0.87-1.48, p = 0.365). At the time of the relapse most women were asymptomatic (146/228, 64.0%), with a tendency of higher proportions in the INT than in the MIN arm, both in the LoR group (78.8% vs 61.1%, p = 0.070) and in the HiR one (64% vs 60%, p = 0.754). HRQL was available only for a subgroup of patients (50% at baseline) and did not differ between arms. Conclusions: Intensive follow-up in endometrial cancer treated patients showed a weak and uncertain advantage in detecting earlier asymptomatic relapses but did not improve OS, even in HiR patients, nor influenced HRQL. Frequent routine use of imaging and laboratory exams in these patients should be discouraged. Clinical trial information: NCT00916708.

scholarly journals Effects of Virtual Reality Associated With Serious Games for Upper Limb Rehabilitation in Patients With Multiple Sclerosis. a Randomized Controlled Trial

2020 ◽  
Author(s):  
Alicia Cuesta-Gómez ◽  
Patricia Sanchez-Herrera Baeza ◽  
Edwin Daniel Oña-Simbaña ◽  
Alicia Martínez-Medina ◽  
Carmen Ortiz-Comino ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Randomized Controlled Trial ◽  
Serious Games ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Experimental Group

Abstract Background: Dexterity and activities of daily living limitations on the upper limb (UL) represent one of the most common problems in patients with multiple sclerosis (MS). The aim of this study was to evaluate the effectiveness of the specially developed Serious Games that make use of the Leap Motion Controller (LMC) as main user interface for improving UL grip muscle strength, dexterity, fatigue, quality of life, satisfaction and compliance. Methods: A single-blinded randomized controlled trial was conducted. The sample was randomized into two groups: an experimental group who received treatment based on serious games designed by the research team using the developed LMC based Serious Games for the UL plus conventional rehabilitation, and a control group who received the same conventional rehabilitation for the UL. Both groups received two 60 min sessions per week over a ten-week period. Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, fatigue, quality of life, satisfaction and compliance were assessed in both groups pre-treatment, post-treatment and in a follow-up period of one month without receiving any treatment. Results : In the experimental group compared to the control group, significant improvements were observed in the post-treatment assessment for coordination, speed of movements, fine and gross UL dexterity. Also, significant results were found in the follow-up in coordination, speed of movements, fine and gross for the more affected side. Conclusions: An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance.

scholarly journals Pulmonary rehabilitation to improve physical capacity, dyspnea and quality of life following pulmonary embolism (the PeRehab study): Study protocol for a two-centre randomized controlled trial

2020 ◽  
Author(s):  
Stacey Haukeland-Parker ◽  
Øyvind Jervan ◽  
Hege Hølmo Johannessen ◽  
Jostein Gleditsch ◽  
Knut Stavem ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pulmonary Embolism ◽  
Pulmonary Rehabilitation ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Physical Capacity ◽  
Control Group ◽  
Walk Test ◽  
Randomized Controlled

Abstract Background: Recently, a large group of patients with persistent dyspnea, poor physical capacity and reduced health-related quality of life (HRQoL) following pulmonary embolism (PE) has been identified and clustered under the name “post pulmonary embolism syndrome” (PPS). These patients seem good candidates for pulmonary rehabilitation. The aim of the study is to explore whether a pulmonary rehabilitation program can improve physical capacity, dyspnea and HRQoL in PPS patients.Methods: A two-centre randomized controlled trial (RCT) is being performed at Østfold Hospital and Akershus University Hospital in Norway. Patients with PPS are 1:1 randomized into an intervention or a control group. The intervention consists of a supervised, outpatient rehabilitation program twice weekly (1 hour) for 8 weeks provided by experienced physiotherapists. The intervention involves individually adapted exercises based on existing pulmonary rehabilitation programs (relaxation, interval and resistance training), and an educational session including topics such as normal anatomy and physiology of the respiratory and circulatory system, information on PE/PPS, breathing strategies, and benefits of exercise/physical activity. Patients randomized to the control group receive usual care without specific instructions to exercise.Participants in the intervention and control groups will be compared based on assessments conducted at baseline, 12 weeks and 36 weeks after inclusion using the incremental shuttle walk test (primary outcome) and endurance shuttle walk test (exercise capacity), Sensewear activity monitor (daily physical activity), the Modified Medical Research Council scale, the Shortness of Breath questionnaire (dyspnea), and EQ-5D-5L and the Pulmonary Embolism Quality of Life Questionnaire (HRQoL).Recruitment of 190 patients is currently ongoing.Discussion: Results from this study may provide a currently untreated group of PPS patients with an effective treatment resulting in reduced symptoms of dyspnea, improved exercise capacity and better HRQoL following PE.Trial registration: NCT03405480, Clinical Trials (registered prospectively.Protocol version 1 (from original protocol September 2017).The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 1).

One-year follow-up of health-related quality of life in the Swedish PREDIX HER 2 trial, evaluating docetaxel, trastuzumab sc, pertuzumab versus trastuzumab emtansine as neoadjuvant treatment of HER2 positive breast cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 590-590
Author(s):  
Yvonne Brandberg ◽  
Theodoros Foukakis ◽  
Anne Andersson ◽  
Judith Bjohle ◽  
Ana Bosch ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Neoadjuvant Treatment ◽  
Group Differences ◽  
Standard Group ◽  
Her2 Positive ◽  
One Year ◽  
Eortc Qlq ◽  
Experimental Group

590 Background: Neoadjuvant therapy combining docetaxel, trastuzumab and pertuzumab (DTP) was compared to trastuzumab emtansine (T-DM1) in the randomised phase II PREDIX HER2 trial. Patients, ≥18 years with HER2 positive breast cancer, ≥20mm or with verified lymph node metastases, were randomised to six courses of DTP (Standard group) or T-DM1 (Experimental group) before surgery. After operation patients in the Standard arm received two, and those in the Experimental arm four courses of EC. Since there were no differences in proportions of complete response at surgery and in the event-free survival between the groups, health-related quality of life (HRQoL) is of special interest. Methods: HRQoL was measured, using European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 + EORTC QLQ-BR23, before randomisation, after six courses before surgery, at three months and one year after surgery. Results: Response rate for the questionnaires varied between 87% and 99% for the 198 included patients. There were no between-group differences at baseline. Results after six courses revealed statistically significant differences (p≤0.01), favouring the Experimental group on 12 out of 21 of the EORTC QLQ-C30 and BR23 variables (Physical-, Role-, and Social- functioning, Global quality of Life, Fatigue, Dyspnea, and Diarrhea, Body image, Sexual functioning, Sexual enjoyment, Systemic therapy side effects and Upset by hair loss). Three months after surgery, however, statistically significant differences in favour of the Standard group were found for six variables (Physical functioning, Nausea/vomiting, Dyspnea, Constipation, Systemic therapy side effects, Upset by hair loss). No other between group differences were found with one exception: lower levels of Breast symptoms in the Experimental group. One possible explanation is that patients in the Experimental group were still on chemotherapy at that assessment point, whereas the majority in the Standard group had terminated their treatment. No differences were found between the groups at the one-year after surgery follow-up, where the levels on most variables had returned to baseline values. Conclusions: HRQoL was better in the Experimental group during neoadjuvant treatment. Three months after surgery, however, HRQoL was in favour or the Standard arm. HRQoL returned to baseline levels for most variables at the one-year follow-up and no between-group differences were found. Clinical trial information: NCT02568839 .

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