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NCT ID: NCT04091308 Completed - Rehabilitation Clinical Trials

Individualized Physical Exercise Training and Enhanced Protein Intake in Older Citizens During Municipality-based Rehabilitation

Start date: January 10, 2020
Phase: N/A
Study type: Interventional

The study will investigate if: 1) individualized physical exercise training in combination with extra protein intake can increase measures on all three ICF-levels? 2) extra protein intake alone increases outcomes of usual care treatment?

NCT ID: NCT04090905 Completed - Atrial Fibrillation Clinical Trials

Incidence of Post-operative Atrial Fibrillation Secondary to Abdominal Surgery

SECAFIB-SURG
Start date: June 13, 2020
Phase:
Study type: Observational

Background and purpose Post-operative AF (POAF) is considered a phenomenon rather than a definite diagnosis and the current clinical guidelines have no specific recommendations regarding its management. Few prospective studies have been performed in non-cardiac conditions and the consequences of POAF in patients without known heart disease are not well described. However, recent data suggest an association between POAF in relation to non-cardiac surgery and increased post-operative mortality and stroke. POAF in relation to abdominal surgery seems common (incidence: 8-18%); however, the true incidence is uncertain. The available studies are few, heterogeneous, and often methodologically inadequate. The study aims at reporting the incidence of atrial fibrillation (AF), and associated complications, in relation to abdominal surgery. Material and methods Designed as a prospective, single-centre, cohort study of consecutive adult patients undergoing acute* abdominal surgery at the Department of Abdominal Surgery at Bispebjerg Hospital. Patients who are pregnant or where follow-up is not possible will be excluded. Patients will be examined pre-operatively by ECG and signal processed surface ECG (wavECG). A subset of patients admitted to the Department in the time interval of 7 AM to 11 PM$, will be offered heart rhythm monitoring from admission and until discharge (preferably ≥72 hours post-operatively). Additional follow-up will be based on a review of patient charts at discharge and one# month postoperatively. The primary endpoint is the occurrence/recurrence of AF. The study will include 400-500 patients of which an estimated 2/3 will wear heart rhythm monitoring corresponding to 264-330 patients. Perspective If more thorough heart rhythm monitoring of patients undergoing abdominal surgery leads to the identification of more patients with AF, routine continuous heart rhythm monitoring should be considered recommended in upcoming guidelines to prevent associated complications. Footnote(s): See 'Detailed Description' below.

NCT ID: NCT04090333 Completed - Migraine Clinical Trials

Endocrinological Profile in Patients With Medication-overuse Headache Before and After Withdrawal Therapy

ENDOMOH
Start date: August 1, 2019
Phase:
Study type: Observational

The project will be conducted to investigate the hormonal homeostasis in men and women, with a special emphasis on sex hormones in men and AMH level in women, before and after withdrawal of the overused analgesics among MOH patients. Additionally, a more broad endocrine profile will be explored before and after withdrawal. It is hypothesized that patients with MOH have disturbed hormone levels, which is normalized after withdrawal of the medication-overuse.

NCT ID: NCT04089462 Completed - Clinical trials for Diabetes Mellitus, Type 1

Effects of Frequency and Duration of Exercise in People With Type 1 Diabetes A Randomized Crossover Study

Start date: September 30, 2019
Phase: N/A
Study type: Interventional

According to the Standards of Medical Care in Diabetes by the American Diabetes Association, people with diabetes should aim for 30 minutes of moderate-to-vigorous intensity aerobic exercise at least 5 days a week or a total of 150 minutes per week and doing some type of strength training at least 2 times per week in addition to aerobic activity. However, the effects of different forms and intervals of exercise on glycemic control are not well established. Exercise increases the risk of hypoglycemia both during and several hours after exercise. There are several strategies to avoid hypoglycemia during exercise. The most common strategy is to reduce insulin and to take carbohydrates before the exercise starts. Short-acting insulin analogs have a duration of approximately four hours, thus reductions need to be planned and done well in advance before the exercise starts. Since different types of exercise (aerobic, strength training or high intensity training) affect blood glucose in different ways and most exercise sessions include a combination of the types, these strategies are often associated with difficulties in obtaining stable blood glucose. The American Diabetes Association guidelines do not explicitly recommend a daily workout routine but outline recommendations for weekly amounts of exercise as there is currently insufficient evidence on the ideal timing, frequency and duration of exercise for preventing hypoglycemia. Hypothesis: in people with type 1 diabetes, time in hypoglycemia can be reduced if exercise is performed daily over five consecutive days compared to the same total amount of exercise performed at 2 days with at least 2 days interval. Aim: to evaluate the impact of the same total amount of exercise split into either five consecutive sessions or two sessions with at least 2 days in between on percentage of time spent in hypoglycemia and other glycemic parameters in people with type 1 diabetes.

NCT ID: NCT04086667 Completed - Low Back Pain Clinical Trials

What Determines a Positive Outcome of Spinal Manipulation for Persistent Low Back Pain: Stiffness or Pain Sensitivity? A Randomized Trial

POPS
Start date: November 1, 2017
Phase: N/A
Study type: Interventional

Introduction Several treatment methods have been proposed to ease the burden of low back pain (LBP) but none are clearly superior. Spinal manipulative therapy (SMT) is a guideline recommended treatment, but the effect is moderate to low. Previous publications suggest that acute LBP patients with who are more stiff are more likely to improve with SMT. However, as LBP persists changes in the central nervous system which modulates the pain experience becomes hypersensitive and possible stiffness is not as important an factor. Experimentally SMT may have a reversible effect of this sensitization. Objective The primary objective of this study is, to examine whether SMT is more effective in regards to short term pain relief when directed at level in the lower back characterized by spinal stiffness or pain hypersensitivity in persistent LBP. Methods A double blinded randomized clinical trial of up to 155 participants with persistent LBP included at a multidisciplinary Spinecenter. spinal stiffness (Global Stiffness Score) is measured using the VerteTracker, a novel device that can quantify stiffness. Pain sensitivity is measured as pain threshold, tolerance, temporal summation (TS) and conditioned pain modulation(CPM). Participants receive SMT at either "the stiffest" or "the most sensitive" segment, a total of four times over a 14-day period. The quantitative measures are recorded at baseline, post treatment and at 4-weeks follow-up along with a numerical pain rating (NRS) and the a disability index (ODI). Discussion These novel findings could improve clinical decision rules - specifically at which level in the lower back to direct SMT. Furthermore, the results will potentially shed light on the underlying mechanisms of SMT - are treatment effects mediated primarily by changes in stiffness or central hypersensitivity?

NCT ID: NCT04085692 Completed - Clinical trials for Out-Of-Hospital Cardiac Arrest

Dispatcher-Assisted CPR: Low-Dose, High-Frequency Simulation-Based Training

Start date: September 12, 2019
Phase: N/A
Study type: Interventional

Clear, concise, yes, and no answers can be challenging to achieve in the assessment of consciousness and breathing in out-of-hospital cardiac arrest (OHCA) calls. Often callers will provide an unclear response, and this can lead to hesitation on the part of the Emergency Medical Dispatcher (EMD). Further, the relatively small proportion OHCA calls represent might demand the need for simulation training in the dispatcher-assisted cardiopulmonary resuscitation (DA-CPR) guiding itself. Therefore, the investigators investigate whether low-dose, high-frequency (LDHF) simulation-based training of EMDs can increase the quality of DA-CPR in a simulation setting. Additionally, the investigators measure whether the effect of the training will be transferred to real OHCA calls. The study is a randomised controlled trial comparing LDHF simulation-based training to standard quality improvement of the EMD in a single centre. The study protocol is structured according to the SPIRIT 2013 statement, and the study will be reported in compliance with the CONSORT 2010 Statement. The investigators chose EMDs receiving standard quality improvement as the comparator group, to reflect a representative cohort of the EMDs not exposed to the LDHF simulation-based training program. The aims of this study are: 1. To measure the effect of LDHF simulation-based training on the quality of DA-CPR in a simulation setting. 2. To measure the effect of LDHF simulation-based training on the quality of DA-CPR in real OHCA calls. The investigators hypothesise that LDHF simulation-based training will increase the quality of DA-CPR in the intervention group in a simulation setting and that this improvement is transferred to real OHCA calls - although the effect in real OHCA calls might be smaller due to the complexity of some calls. The investigators hypothesise that this improvement can be detected as a decrease in time to first bystander compression (TTFC), an increase in clarification of consciousness and breathing without asking additional questions, a decrease in time to recognition of cardiac arrest, and an increase in calls where the EMD provide DA-CPR instructions on patients in cardiac arrest.

NCT ID: NCT04085458 Completed - Hemophilia A Clinical Trials

Study to Gain More Information on How Safe and Effective Jivi Works in Patients With Severe Hemophilia A (Post-marketing Investigation)

Start date: September 23, 2019
Phase: Phase 4
Study type: Interventional

The goal of this study is to give gather more information on how safe and well Jivi works in patients with severe hemophilia A. Jivi has been approved by various regulatory agencies, including the FDA, Health Canada, Japanese Health Authority and the European Medicinal Agency. 25 patients will be enrolled and will stay for 1 to 2 years in this study depending on their treatment frequency. Researcher will monitor during the course of the study whether patients are developing antibodies (a protein made by the body in response to the drug) affecting the effectiveness of Jivi. In addition information on bleedings and patient's wellbeing will be collected.

NCT ID: NCT04082923 Completed - Obesity Clinical Trials

Effect of Meal Texture on Glucose-metabolism and Gut Hormone Response After Bariatric Surgery

Obesity
Start date: October 3, 2019
Phase: N/A
Study type: Interventional

The investigators want to evaluate the difference in glucose metabolism and intestinal hormonal response after a liquid meal versus a solid meal in patients after bariatric surgery.

NCT ID: NCT04081493 Completed - Clinical trials for Total Knee Replacement

The Efficacy of Low-load Blood Flow Restricted Resistance Before TKR

Start date: September 17, 2019
Phase: N/A
Study type: Interventional

The primary aim of this study is to investigate the efficacy of 8 weeks of Low-load blood flow restricted exercise (BFRE) compared to receiving standard care only (no preoperative training) before total knee replacement (TKR) on postoperative 30-seconds chair stand test (30s-CST). We hypothesize that 8 weeks of preoperative BFRE will increase chair stand performance 3 months postoperatively. Secondary aims are to investigate the efficacy of 8 weeks of preoperative BFRE compared to receiving standard care only on changes in muscle strength 3 months after TKR and investigate associations to functional capacity and quality of life. Furthermore, it will be investigated if 8 weeks of BFRE induces muscle hypertrophy and increases satellite cell and myonuclei content of the vastus lateralis muscle.

NCT ID: NCT04079894 Completed - Low Back Pain Clinical Trials

Physical Activity in the Elderly Spine Patient

PAESP
Start date: June 26, 2019
Phase:
Study type: Observational [Patient Registry]

Purpose Physical activity reduces the risk of several diseases of the body and the mind1, 2 and can help the elderly maintain physical abilities and self-efficacy in daily life1. The overall purpose of the project is to provide clinicians with a tool to objectively assess physical activity in daily life and thus provide an informed basis for individualized care of elderly patients with spine disease. We would like to introduce this tool to a broad population of elderly patients with low back pain to give an overview of the range and variability in physical activity. We will also look into a method for accurate step count in spine disorders where patients have severe walking impairment due to affected lumbar nerve roots.