scholarly journals A timed activity protocol to address sleep-wake disorders in home dwelling persons living with dementia: the healthy patterns clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Nancy A. Hodgson ◽  
Nalaka Gooneratne ◽  
Adriana Perez ◽  
Sonia Talwar ◽  
Liming Huang
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Trial Registration ◽  
Phase Iii ◽  
Poor Sleep ◽  
Sleep Wake Disorders ◽  
Clinical Trial Registration ◽  
Link Type ◽  
Home Based

Abstract Background Sleep-wake disorders occur in most persons living with dementia and include late afternoon or evening agitation, irregular sleep-wake rhythms such as daytime hypersomnia, frequent night awakenings, and poor sleep efficiency. Sleep-wake disorders pose a great burden to family caregivers, and are the principal causes of distress, poor quality of life, and institutionalization. Regulating the sleep-wake cycle through the use of light and activity has been shown to alter core clock processes and suggests that a combination of cognitive, physical, and sensory-based activities, delivered at strategic times, may be an effective mechanism through which to reduce sleep-wake disorders. Methods A definitive Phase III efficacy trial of the Healthy Patterns intervention, a home-based activity intervention designed to improve sleep-wake disorders and quality of life, is being conducted using a randomized two-group parallel design of 200 people living with dementia and their caregivers (dyads). Specific components of this one-month, home-based intervention involve 4 in-home visits and includes: 1) assessing individuals’ functional status and interests; 2) educating caregivers on environmental cues to promote activity and sleep; and 3) training caregivers in using timed morning, afternoon, and evening activities based on circadian needs across the day. The patient focused outcomes of interest are quality of life, measures of sleep assessed by objective and subjective indicators including actigraphy, subjective sleep quality, and the presence of neuropsychiatric symptoms. Caregiver outcomes of interest are quality of life, burden, confidence using activities, and sleep disruption. Salivary measures of cortisol and melatonin are collected to assess potential intervention mechanisms. Discussion The results from the ongoing study will provide fundamental new knowledge regarding the effects of timing activity participation based on diurnal needs and the mechanisms underlying timed interventions which can lead to a structured, replicable treatment protocol for use with this growing population of persons living with dementia. Clinical trial registration Clinicaltrials.gov # NCT03682185 at https://clinicaltrials.gov/; Date of clinical trial registration: 24 September 2018.

Rest or 30-Min Walk as Exercise Intervention (RESTOREX) in Myasthenia Gravis: A Randomized Controlled Trial

2021 ◽  
pp. 1-7
Author(s):  
Usha K. Misra ◽  
Jayantee Kalita ◽  
Varun K. Singh ◽  
Aditya Kapoor ◽  
Abhilasha Tripathi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Myasthenia Gravis ◽  
Controlled Trial ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Secondary Endpoints

<b><i>Introduction:</i></b> There is a lack of evidence about the usefulness of exercise or rest in myasthenia gravis (MG). This study is aimed to evaluate the efficacy and safety of exercise or rest in MG. <b><i>Methods:</i></b> In a single-center open-labeled randomized controlled trial, the patients with mild to moderate MG were randomized to 30-min walk or rest in addition to the standard treatment. The primary endpoint was 50% improvement in the MG Quality of Life (MG-QOL15), and secondary endpoints were change in the Myasthenic Muscle Score (MMS), MG Activities of Daily Living (MGADL), grip strength, dose of acetylcholine esterase inhibitor and prednisone, 6-min walk test (6MWT), decrement in trapezius on the low-rate repetitive nerve stimulation test, and adverse events. The outcomes were defined at 3 months, by &#x3e;50% improvement in these outcome parameters. <b><i>Results:</i></b> Forty patients with MG were randomized to the exercise or rest arm. The 2 arms were matched for demographic and clinical parameters. The patients in the exercise arm had significantly better QOL evidenced by MG-QOL15 (<i>p =</i> 0.02). The secondary endpoints, distance covered in 6MWT (<i>p =</i> 0.007), were also better in the exercise arm without any adverse event. <b><i>Conclusion:</i></b> Regular exercise for 30 min in mild and moderate MG improves quality of life and walking distance compared to rest and is safe. <b><i>Clinical Trial Registration:</i></b> The clinical trial registration number is CTRI/2019/11/021869.

scholarly journals MEBO versus topical Diltiazem versus a combination of both ointments in the treatment of acute anal fissure: a randomized clinical trial protocol

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mohamad Hadi El Charif ◽  
Samer Doughan ◽  
Rawya Kredly ◽  
Sara Kassas ◽  
Rayan Azab ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Wound Healing ◽  
Anal Fissure ◽  
Topical Therapy ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Anal Fissures ◽  
Link Type ◽  
Anorectal Region ◽  
Registration Date

Abstract Background Anal fissure is a common complication of the anorectal region and one of the most reported causes of anal pain. Acute anal fissure can be cured by surgery or medical treatment. There is an increase in the use of topical therapy for the treatment of anal fissures. A common topical drug used is Diltiazem (DTZ), a calcium-channel blocker, which relaxes the anal sphincter and thus promotes healing of the anal fissure. Moist exposed burn ointment (MEBO) is an ointment that is effective for the treatment of burns and wound healing and is becoming popular in the treatment of anal fissures. Methods This is a 1:1:1 randomized, controlled, parallel design, with endpoint measures of change in pain score, wound healing, defecation strain score and patient’s global impression of improvement. The study will be conducted at AUBMC over a 10-week period. Patients will be randomized to three treatment arms: MEBO, Diltiazem, and a combination of MEBO and Diltiazem ointments. Discussion The results of this study will allow physicians to assess the efficacy and safety of MEBO in the treatment of acute anal fissure, and also in comparison to Diltiazem. This trial will generate evidence-based conclusions regarding the use of a herbal/natural-based product (MEBO ointment) for the treatment of anal fissures. Trial registration ClinicalTrials.gov Identifier NCT04153032. Clinical Trial Registration Date: 06-NOVEMBER-2019.

scholarly journals Zytux in Refractory Myasthenia Gravis: A Multicenter, Open-Labeled, Clinical Trial Study of Effectiveness and Safety of a Rituximab Biosimilar

2021 ◽  
Vol 12 ◽  
Author(s):  
Farzad Fatehi ◽  
Kamyar Moradi ◽  
Ali Asghar Okhovat ◽  
Ghazaleh Shojatalab ◽  
Behnaz Sedighi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Myasthenia Gravis ◽  
Clinical Status ◽  
Neuromuscular Disorder ◽  
Clinical Trial Registration ◽  
Prednisolone Dose ◽  
Immune Mediated ◽  
Post Infusion

Objectives: Myasthenia gravis (MG) is an immune-mediated neuromuscular disorder responsive to immunomodulatory treatments. 10–20% of MGs are not responsive to conventional first-line therapies. Here, we sought to investigate the efficacy and safety of rituximab therapy in the treatment of patients with refractory MG.Methods: In a 48-week, multicenter, open-labeled, prospective cohort setting, 34 participants with refractory MG were assigned to receive infusions of Zytux, which is a rituximab biosimilar, according to a validated protocol. Clinical, functional, and quality of life (QoL) measurements were recorded at baseline, and seven further visits using the Myasthenia Gravis Foundation of America (MGFA), Myasthenia Gravis Composite (MGC), Myasthenia Gravis Activities of Daily Living profile (MG-ADL), and Myasthenia Gravis Quality of Life (MGQoL-15) scales. Besides, the post-infusion side effects were systematically assessed throughout the study.Results: The correlation analysis performed by generalized estimating equations analysis represented a significant reduction of MGC, MG-ADL, and MGQoL-15 scores across the trial period. The subgroup analysis based on the patients' clinical status indicated a significant effect for the interaction between time and MGFA subtypes on MG-ADL score, MGC score, and pyridostigmine prednisolone dose, reflecting that the worse clinical condition was associated with a better response to rituximab. Finally, no serious adverse event was documented.Conclusions: Rituximab therapy could improve clinical, functional, and QoL in patients with refractory MG in a safe setting. Further investigations with larger sample size and a more extended follow-up period are warranted to confirm this finding.Clinical Trial Registration: The study was registered by the Iranian Registry of Clinical Trials (IRCT) (Code No: IRCT20150303021315N18).

Home-based dance exercise for adults with moderate Parkinson’s disease: Protocol with a pilot study for a non-randomized clinical trial using video-dances in a DVD format (Preprint)

2022 ◽  
Author(s):  
Manoela de Paula Ferreira ◽  
Adriano Zanardi da Silva ◽  
Bruna Yamaguchi ◽  
Sunita Mathur ◽  
Taina Ribas Melo ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Parkinson’S Disease ◽  
Clinical Trial ◽  
Parkinson's Disease ◽  
Cognitive Function ◽  
Pilot Study ◽  
Functional Mobility ◽  
Contemporary Dance ◽  
Home Based

BACKGROUND Many people with Parkinson’s disease (PD) have never received rehabilitation care due to lack of accessibility and transportation and high therapy costs for in-person rehabilitation. Home-based dance exercise is an innovative, low-cost therapy that may reduce accessibility barriers to exercise. Especially since the COVID-19 pandemic, home-exercise programs are a highly relevant, alternative approach for people with PD OBJECTIVE This clinical trial protocol aims to explore the effects of a Home-Based contemporary dance exercise program for people with moderate Parkinson’s Disease (PD), focusing on balance, functional mobility, quality of life (QOL), cognitive function, and depression. METHODS This protocol is for a non-randomized clinical trial for adults with moderate PD divided into control group (CG) and Experimental Group (EG). Participants from the EG will perform video-dances of the contemporary dance, delivered in a DVD format. The video-dances will be executed 16 weeks, three times per week, 30 minutes each day at home, with exercise intensity controlled by the BORG scale. Participants from the CG will not receive any new exercise therapy. As primary outcomes, the signs and symptoms of the PD assessed by the Unified Parkinson’s Disease Rating Scale – UPDRS II and III, Hoehn and Yahr for the PD severity, and health-related quality of life (HRQL), measured by the Parkinson’s Disease Questionnaire – PDQ-39) will be tested. Secondary outcomes include cognitive function by the Montreal Cognitive Assessment – MoCA, balance by the Mini-BESTest, functional mobility by the Timed “Up and Go” test – TUG and depression by the Geriatric Depression Scale – GDS. All outcomes will be assessed in an in-person evaluation by a blinded assessor before and after the 16 weeks of the program. RESULTS This protocol has a pilot study that included 10 participants (5 in each group). It was observed positive results favoring the EG over cognitive function (p = 0.034). In addition, HRQL, balance, and depression were improved after the pilot program in the EG, however, without significant difference. CONCLUSIONS This clinical trial has the potential to be a safe alternative exercise approach under COVID restrictions and travel-free therapy with effects on PD symptoms. CLINICALTRIAL RBR-58T68W (Brazilian Clinical Trials Registry)

scholarly journals Effects of home-based mirror therapy and cognitive therapeutic exercise on the improvement of the upper extremity functions in patients with severe hemiparesis after a stroke: a protocol for a pilot randomised clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e035768
Author(s):  
Josefa Gonzalez-Santos ◽  
Raul Soto-Camara ◽  
Paula Rodriguez-Fernández ◽  
Maria Jimenez-Barrios ◽  
Jeronimo Gonzalez-Bernal ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Upper Extremity ◽  
Randomised Clinical Trial ◽  
Therapeutic Exercise ◽  
Mirror Therapy ◽  
Link Type ◽  
Home Based ◽  
Study Results ◽  
Task Oriented

IntroductionNeuroplasticity is defined as the capacity of the brain to reorganise new neuronal pathways. Mirror therapy (MT) and cognitive therapeutic exercise (CTE) are two neurorehabilitation techniques based on neuroplasticity and designed to improve the motor functions of the affected upper extremity in patients with severe hemiparesis after a stroke. Home-based interventions are an appropriate alternative to promote independence and autonomy. The objective of this study is to evaluate which of these techniques, MT and CTE, combined with task-oriented training, is more effective in functional recovery and movement patterns of the upper extremities in patients with severe hemiparesis after a stroke.Methods and analysisThis is a home-based, single-blind, controlled, randomised clinical trial with three parallel arms, including 154 patients who had a stroke aged above 18 years. The primary outcome will be the functionality of the affected upper extremity measured using the Fugl-Meyer Assessment. Secondary variables will include cognitive performance, emotional state, quality of life and activities of daily living. During 6 weeks, one of the intervention groups will receive a treatment based on MT and the other one on CTE, both combined with task-oriented training. No additional interventions will be provided to the control group. To assess the progress of patients who had a stroke in the subacute phase, all variables will be evaluated at different visits: initial (just before starting treatment and 4 weeks post-stroke), post-intervention (6 weeks after initial) and follow-up (6 months).Ethics and disseminationThis protocol has been approved by the Institutional Review Board (CEIm-2.134/2.019) and registered at ClinicalTrials.gov (NCT04163666). The results will be disseminated through open-access peer-reviewed journals, conference presentation, broadcast media and a presentation to stakeholders. These study results will provide relevant and novel information on effective neurorehabilitation strategies and improve the quality of intervention programmes aimed at patients after a stroke.Trial registration numberClinicalTrials.gov (NCT04163666).

scholarly journals Quality assessment of clinical trial registration with traditional Chinese medicine in WHO registries

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e025218 ◽  
Author(s):  
Xuan Zhang ◽  
Ran Tian ◽  
Zhen Yang ◽  
Chen Zhao ◽  
Liang Yao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Reporting Quality ◽  
Reporting Rate ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Data Set

ObjectiveThis study aimed to assess the registration quality of clinical trials (CTs) with traditional Chinese medicine (TCM) in the WHO International Clinical Trials Registry Platform (ICTRP) and identify the common problems if any.MethodsThe ICTRP database was searched for all TCM CTs that were registered up to 31 December 2017. Registered information of each trial was collected from specific registry involved in ICTRP through hyperlink. The primary analysis was to assess the reporting quality of registered trials with TCM interventions, which is based on the minimum 20 items of WHO Trial Registration Data Set (TRDS, V.1.2.1) plus optional additional three items recommended by ICTRP, and some specific items for TCM information (including TCM intervention, diagnosis, outcome and rationale). Descriptive statistics were additionally used to analyse the baseline characteristics of TCM trial registrations.ResultsA total of 3339 records in 15 registries were examined. The number of TCM registered trials has increased rapidly after the requirement of mandatory trial registration proposed by International Committee of Medical Journal Editors on 1 July 2005, and the top two registries were Chinese Clinical Trial Registry and ClincialTrials.gov. Of 3339 trials, 61% were prospective registration and 12.8% shared resultant publications. There were 2955 interventional trials but none of them had a 100% reporting rate of the minimum 20 items and additional three items. The reporting quality of these 23 items was not optimal due to 11 of them had a lower reporting rate (<65%). For TCM details, 49.2% lacked information on description of TCM intervention(s), 85.9% did not contain TCM diagnosis criteria, 92.6% did not use TCM outcome(s) and 67.1% lacked information on TCM background and rationale.ConclusionThe registration quality of TCM CTs should be improved by prospective registration, full completion of WHO TRDS, full reporting of TCM information and results sharing. Further full set of trial registration items for TCM trials should be developed thus to standardise the content of TCM trial registration.

scholarly journals A feasibility study to investigate the utility of a home–based exercise intervention during and after neo-adjuvant chemotherapy for oesophago-gastric cancer – the ChemoFit study protocol

2020 ◽  
Author(s):  
Jakub Chmelo ◽  
Alexander William Phillips ◽  
Alastair Greystoke ◽  
Sarah Jane Charman ◽  
Leah Avery ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adjuvant Chemotherapy ◽  
Gastric Adenocarcinoma ◽  
Exercise Intervention ◽  
Locally Advanced ◽  
Trial Registration ◽  
High Morbidity ◽  
Home Based ◽  
Neo Adjuvant Chemotherapy

Abstract Background Treatment of locally advanced oesophago-gastric adenocarcinoma usually entails neo-adjuvant chemotherapy (NAC), and surgery. Surgery is associated with high morbidity and mortality. Cardiopulmonary reserve of patients having major surgery is related to postoperative outcomes. Complications are associated with poorer quality of life and may affect prognosis. Preventing complications may be beneficial to both of these and have cost implications. Prehabilitation may improve recovery from surgery by increasing a patients’ fitness before surgery. Designing a potentially cost and resource effective regimen which improves cardiopulmonary reserve may have a beneficial impact on patient outcomes after surgery. Methods The ChemoFit study is a non-randomised, single-arm and single-centre pilot study designed to investigate the feasibility of a home-based prehabilitation exercise intervention for patients receiving neoadjuvant treatment prior to oesophago-gastric surgery. Forty patients will be recruited at a single high-volume centre. The simple, home-based exercise intervention involves patients increasing their daily step-count during and after NAC and in the weeks leading up to surgical resection of the cancer. Additionally, quality of life assessments (QLQ-C30 and QLQ-OG25), oncological treatment delivery and participant perceptions of the study assessed by focus groups and questionnaires will be performed. The primary outcomes are to assess feasibility of the exercise intervention. The secondary outcomes will evaluate changes in cardiopulmonary reserve, sarcopenia and fat composition. Discussion It is anticipated that during an important teachable moment, the diagnosis and treatment of cancer, our patients will be open to the possibility of improving their fitness during chemotherapy and before major cancer surgery. It is possible that the negative impact of NAC on cardiopulmonary fitness could be prevented by implementing a home-based prehabilitation programme during and after NAC, prior to surgery for oesophago-gastric adenocarcinoma. Trial registration This study has been approved by the Health Research Authority (REC 18/WA/0427). Newcastle upon Tyne Hospitals NHS Foundation Trust (NUTH) will act as the study sponsor and the work is funded by a grant awarded by The Jon Moulton Charitable Foundation, supported by a research post funded by the Sir Bobby Robson Foundation. Trial registration: Clinicaltrials.gov, NCT04194463. Registered 11 th December 2019 – retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04194463.

International Perspective on Health-Related Quality-of-Life Research in Cancer Clinical Trials: The European Organisation for Research and Treatment of Cancer Experience

2007 ◽  
Vol 25 (32) ◽  
pp. 5082-5086 ◽  
Author(s):  
Andrew Bottomley ◽  
Neil K. Aaronson
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Phase Iii ◽  
Cancer Clinical Trials ◽  
Health Related Quality ◽  
European Organisation ◽  
Related Quality ◽  
Health Related

Over recent decades, health-related quality of life (HRQOL) research has been increasingly integrated into cancer clinical trials. The purpose of this review is to examine the overall approach taken towards clinical trial–based HRQOL investigations within the European Organisation for Research and Treatment of Cancer (EORTC). This article reports a literature review of clinical trial–based HRQOL investigations and provides selective examples of HRQOL studies in phase III clinical trials in various disease sites. The findings of this review highlight that, historically, assessing HRQOL was a challenge. However, as EORTC has become more experienced in the assessment of HRQOL and has developed a portfolio of appropriate tools, HRQOL has become a more accepted end point in large-scale trials. The trials reviewed in this article show that, in general, HRQOL data do provide information that can both inform clinicians about the effectiveness of the treatments and also serve as an invaluable source of information for patients to make informed decisions regarding the treatment choice.

Sign in / Sign up

Export Citation Format

Share Document