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Lung Diseases, Obstructive clinical trials

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NCT ID: NCT04704479 Active, not recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Russian Current and Expiratory Muscle Training in COPD Patients

Start date: March 15, 2021
Phase: N/A
Study type: Interventional

Respiratory muscles are essential to alveolar ventilation. In COPD, these muscles work against increased mechanical loads due to airflow limitation and geometrical changes of the thorax derived from pulmonary hyperinflation. Respiratory muscle fibers show several degrees of impairment in cellular and subcellular structures which translates, from the functional point of view, to a loss of strength (capacity to generate tension) and an increased susceptibility to failure in the face of a particular load. Expiratory Muscle Training was recommended to strengthen expiratory muscles and minimize exacerbations in addition to delaying deterioration with better functional capacity. Neuromuscular electrical stimulation (NMES) is emerging as a new rehabilitation modality for muscle strengthening that does not evoke dyspnea to obtain a benefit in patients who are unable to participate in a traditional rehabilitation program

NCT ID: NCT04668599 Active, not recruiting - Heart Failure Clinical Trials

Cardio-pulmonary Rehabilitation and Sleep Quality

Start date: May 11, 2020
Phase:
Study type: Observational

In this prospective cohort study the investigators aim to evaluate the effect of pulmonary rehabilitation on sleep quality. Disturbed sleep is associated with, frequent exacerbations, increase in the severity of disease and increased mortality in chronic obstructive pulmonary disease (COPD). Sleep quality is a good predictor of quality of life in patients with stable COPD. However, there has been little investigation into non-pharmacological methods to improve sleep quality in patients with COPD and heart failure. It is also uncertain, how long the beneficial effects of cardio-pulmonary rehabilitation on sleep quality, if any, usually last. Due to lack of robust data, the investigators sought to find the effect of cardio-pulmonary rehabilitation on sleep quality.

NCT ID: NCT04645732 Active, not recruiting - Hypertension Clinical Trials

Personalized Exercise Therapy and Self-management Support for Patients With Multimorbidity

MOBILIZE
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Chronic conditions such as knee or hip osteoarthritis (OA), chronic obstructive pulmonary disease (COPD), heart failure (HF), coronary heart disease (CHD), hypertension, type 2 diabetes mellitus (T2DM) and depression are among the leading causes of global disability and affect hundreds of millions of people around the world. In recent years, multimorbidity, commonly defined as the co-occurrence of at least two chronic conditions, has also gained interest due to its substantial impact on the person and society. Despite the significant burden of multimorbidity, little is known about how to treat this effectively. A 2016 Cochrane systematic review found that interventions targeting populations with specific combinations of conditions and addressing specific problems such as functional difficulties may be more effective. Exercise therapy is a treatment addressing functional limitations that is a safe and effective treatment of at least 26 chronic conditions, including OA, HF, CHD, hypertension, T2DM, COPD and depression. Furthermore, self-management support is increasingly recognized as an essential component of interventions to improve outcomes in patients living with multimorbidity and to support the long-term adherence to exercise. A new systematic review found that exercise seems effective in people with multimorbidity (the conditions included in the current study), however highlighting the need for further high-quality RCTs. The aim of this randomized controlled trial (RCT) is to investigate the effects of a personalized exercise therapy and self-management support program in addition to usual care on self-reported, objectively measured and physiological outcomes in people with multimorbidity (i.e. at least two of the following conditions: OA (knee or hip), heart condition (HF or CHD), hypertension, T2DM, COPD and depression). The primary endpoint is 12 months, but 4- and 6-month follow-ups are included as well and a 12-month health economic evaluation of the program will be conducted. Prior to the RCT, a feasibility trial of 20 people with multimorbidity, all undergoing the personalized exercise therapy and self-management support program, will be conducted using the same methods as in the RCT, but primarily focusing on feasibility outcomes (recruitment, retention, adherence to treatment, burden of outcomes, improvements in outcomes, adverse events). This will start recruitment in Feb 2021 and end August 2021. The MOBILIZE project has received funding from several foundations, including the European Research Council (ERC) under the European Union's Horizon 2020 research and innovation program (grant agreement No 801790).

NCT ID: NCT04534062 Active, not recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Effects of PNF D2 Technique With Resistance on Pulmonary Function, Exercise Capacity and Health Status of COPD Patients

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Chronic Obstructive Pulmonary Disease (COPD) is the third leading cause of morbidity and disability with 251 million cases per anum reported worldwide. COPD ranks fourth among the common causes of mortality with an estimated 3 million annual deaths worldwide that is projected to be third by 2020. COPD deaths are more prevalent among the low socio-economic developing countries, estimated up to 90% of the total mortality rate across the globe. In Asia, 13.5% of the total population suffers with COPD. Particularly, in Pakistan every 10th individual suffers with COPD out of which 19.4% are of age above 40 years. Moreover, the problem has been identified as a growing public health concern and a challenge for the clinicians of 21st century. Consequently, the severity of the condition of patients is contributed by exacerbations or co-morbidities, and significant economic burden due to the hospitalizations, absence from work and disability; and its management cost from $1544 to $2335 in Asian countries, annually. However, specific data economic burden for Pakistan is not reported yet. A number of pharmaceutical and non-pharmaceutical treatment options are utilized in the management of COPD; however, pulmonary rehabilitation has been conferred as the corner stone in management of COPD. NICE guidelines emphasize upon the importance of pulmonary rehabilitation for all individuals presenting with COPD; even those who have acutely suffered an exacerbation or underwent recent hospitalization. Moreover, pulmonary rehabilitation consisting of structured exercises regimes and education regarding self-care has been reported to improve COPD symptoms and exercise tolerance; and reduce expenditure of resources on recurrent hospitalization and length of stay. Study has reported that resistance training demonstrated in better improvement in muscular strength than endurance exercise and causes lesser chances of dyspnea while performing activities and is more tolerable than endurance exercise regime. Literature is evident upon that the combination of resistance and endurance training has shown significant improvement in the respiratory parameters. Hence the present study is aimed to incorporate Proprioceptive Neuromuscular Facilitation (PNF) D2 pattern including different types of resistance training in order to determine the response of adjunct therapies on the outcome measures.

NCT ID: NCT04458038 Active, not recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Does Chronic Obstructive Lung Disease Influence the Cognitive Function

Start date: December 7, 2020
Phase: N/A
Study type: Interventional

Studies have documented impaired cognitive function in patients with COPD. The possible reasons for this and correlation to the severity of the disease are not well described. This explorative study examines the cognitive skills of COPD patients, quantified by their ability to drive a vehicle and other cognitive test. Furthermore, we want to study the cognitive skills in COPD patients before and after they are diagnosed with and treated for obstructive sleep apnoea (OSA). The overall hypothesis is that chronic lung patients´ cognitive skills correlate with the severity of their disease. We expect that their ability to drive a vehicle drops in relation to the severity of the disease and to comorbidities.

NCT ID: NCT04457843 Active, not recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

The Mobile COPD Status Test (mCST)

Start date: August 21, 2020
Phase:
Study type: Observational

Up tp now, disease activity of COPD patients in their home environment has usually been recorded by questionnaires (e.g. COPD assessment test). Digital multifactorial measurements, via the "mobile COPD Status test" app, offer a new way of displaying disease activity. However, there is no independent study that has examined whether digitally collected parameters correlate with the common used measurement instruments for COPD patients (both in cross-sectional and longitudinal course). The aim of this exploratory study is to investigate the correlation between the mobile COPD Status test (mCST App, KAIA Health) and a conventional collected clinical data set of routine measurements as well as the subjective symptoms and activity perception of COPD patients in their home environment, with and without exacerbation.

NCT ID: NCT04456673 Active, not recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate to Severe COPD With Type 2 Inflammation

NOTUS
Start date: July 6, 2020
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by - Annualized rate of acute moderate or severe COPD exacerbation (AECOPD) Secondary Objectives: To evaluate the effect of dupilumab administered every 2 weeks on - Pre-bronchodilator forced expiratory volume in 1 second (FEV1) over 12 weeks compared to placebo - Health related quality of life, assessed by the change from baseline to Week 52 in the St. George's Respiratory Questionnaire (SGRQ) - Pre-bronchodilator FEV1 over 52 weeks compared to placebo - Lung function assessments - Moderate and severe COPD exacerbations - To evaluate safety and tolerability - To evaluate dupilumab systemic exposure and incidence of antidrug antibodies (ADA)

NCT ID: NCT04415788 Active, not recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Inspiratory Muscle Training and COPD

Start date: May 1, 2021
Phase: N/A
Study type: Interventional

Subjects with chronic obstructive pulmonary disease (COPD) frequently develop considerable deterioration in exercise capacity in association with weakness and deconditioning of the respiratory muscles, which can be corrected with specific therapies. While pulmonary rehabilitation is a central component in the rather complex manangement of COPD, there is currently a lack of centers able to provide appropriate rehabilitation services in the Czech Republic. The main objective of this study will be to fully evaluate the utility of the Test of Incremental Respiratory Endurance (TIRE) as an at-home inspiratory muscle training method in subjects with COPD, while comparing the effectiveness of this novel training approach to the outcomes of more traditional ispiratory muscle training protocols. This prospective, randomized controlled trial will include 2 treatment groups and 1 sham intervention group in a 1:1:1 ratio. All participants will undergo a certain type of IMT regardless of group assignment, which will be perfomed via two different devices. The trial will comprise of an 8-week at-home training period with remote supervision followed by 4 months of unsupervised, independent inspiratory muscle training. Study outcomes will include measures of inspiratory muscle strength and endurance, pulmonary function, COPD-specific symptomatology, functional exercise capacity, surrogate markers of mortality risk, mental health status and health-related quality of life of participants. While investigators acknowledge the value of standard inspiratory muscle training protocols which use Threshold devices, investigators believe that the TIRE training has the potential to provide additional clinical benefits since it is able to modulate all aspects of muscular performance, including strength, endurance and work capacity. Investigators hypothesize that, as a home-based stand-alone rehabilitative therapy, TIRE will be superior to standard IMT in improving COPD-related measures.

NCT ID: NCT04354220 Active, not recruiting - Critical Illness Clinical Trials

Capnography Monitoring in Ventilated Children

Start date: June 9, 2020
Phase:
Study type: Observational

End-tidal CO2 measurements in children will be assessed for their accuracy with arterial CO2 measurements.

NCT ID: NCT04301700 Active, not recruiting - COPD Clinical Trials

Effects of Progressive Muscle Relaxation and Mindfulness Meditation in Patients With Chronic Obstructive Pulmonary Disease

Start date: April 20, 2018
Phase: N/A
Study type: Interventional

Patients with COPD will be entered. Participants will be randomized to one of three study arms: Arm 1: meditation; Arm 2: relaxation; Arm 3: Control. Hypothesis: Progressive muscle relaxation and mindfulness meditation will decrease severity of dyspnea, fatigue and care dependency.