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Aging clinical trials

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NCT ID: NCT05005208 Recruiting - Parkinson Disease Clinical Trials

SocIal ROBOTics for Active and Healthy Ageing

SI-ROBOTICS
Start date: May 19, 2022
Phase: N/A
Study type: Interventional

The study was designed to test the acceptability of the Si-Robotics system in a group of 20 subjects with Parkinson's Disease at an early stage, during a rehabilitation treatment based on Irish dancing. Assessments will be performed at the baseline and at the end of the treatment.

NCT ID: NCT05000515 Recruiting - Hypertension Clinical Trials

Inspiratory Muscle Strength Training for Lowering Blood Pressure and Improving Endothelial Function in Postmenopausal Women: Comparison With "Standard of Care" Aerobic Exercise

Start date: April 19, 2022
Phase: N/A
Study type: Interventional

High blood pressure (BP) is the major modifiable risk factor for cardiovascular diseases (CVD) and related health conditions, particularly among postmenopausal (PM) women. In adults age ≥50 years this risk is primarily driven by above-normal systolic BP (SBP ≥120 mmHg), as diastolic BP plateaus, then decreases in older adulthood. Although SBP is lower in premenopausal women vs. age-matched men, SBP reaches, then surpasses men after age 60. As such, >75% of PM women in the U.S. have above-normal SBP, which, in turn, is responsible for a 2-fold increase in risk of hypertension and corresponding increases in risk of CVD, chronic kidney disease and many other disorders. A key process linking high SBP to CVD and related conditions is vascular endothelial dysfunction, mediated by excessive reactive oxygen species (ROS)-induced oxidative stress and reductions in nitric oxide (NO) bioavailability. As the number of PM women is rapidly growing, further increases in SBP-related CV disorders are projected without effective intervention. - Aerobic exercise (AE) is a first-line, standard-of-care therapy for lowering BP. In PM women with baseline SBP ≥120 mmHg, AE reduces casual (resting) SBP by ~3 mmHg (back to baseline ≤4 weeks post-training), whereas 24-hour SBP is typically unchanged. However, only 25-30% of PM women meet guidelines for 150 min/week of moderate-intensity AE, citing the extensive time requirement, facility access and travel disruptions as major barriers. Another, far less recognized, limitation is that AE training consistently improves endothelial function in midlife/older men, but not in estrogen-deficient PM (PMe-) women, i.e., in >95% of the 60+million PM women in the U.S. Thus, establishing new lifestyle therapies that induce and sustain reductions in SBP and increases in endothelial function in PMe- women with above-normal SBP is an important public health goal. - High-resistance inspiratory muscle strength training (IMST) is a time-efficient (5 minutes per session) lifestyle intervention consisting of 30 inspiratory maneuvers performed against a high resistance. Preliminary data suggest 6-weeks of IMST performed 6 days/week reduces SBP by 9 mmHg in adults with above-normal SBP (i.e., greater than 120 mmHg) at baseline. Importantly, this reduction in SBP is equal to or greater than the reduction in blood pressure typically achieved with time- and effort-intensive healthy lifestyle strategies like conventional aerobic exercise. In addition, IMST improved endothelial function in the PMe- women in a small pilot study. - To translate these promising preliminary results towards clinical practice, this randomized clinical trial is being conducted to directly compare the efficacy of a longer, clinically relevant treatment duration of IMST (3 months) against home-based, moderate-intensity (standard-of-care) AE in PMe-women. The primary outcome will be the change in casual SBP (IMST vs. AE). Changes in 24-hour SBP and endothelial function will serve as secondary outcomes. Effects on NO bioavailability, ROS/oxidative stress, and the role of "circulating factors" will provide insight into mechanisms of action. The sustained effects on SBP and endothelial function also will be assessed. - Accordingly, a randomized, blinded, sham-controlled, parallel group design clinical trial will be conducted to assess the efficacy of 3-months of IMST (75 percent maximal inspiratory pressure) vs. brisk walking (40-60% heart rate reserve; an established healthy lifestyle strategy) for lowering SBP and improving endothelial function in PMe- women age 50 years and older with above-normal SBP. It is hypothesized that IMST will lower SBP and improve endothelial function by decreasing oxidative stress and increasing nitric oxide bioavailability. It is also expect that adherence to the intervention will be excellent (over 80 percent of all training sessions completed at the appropriate intensity). - To test this hypothesis, 90 PMe- women age 50 years and older who have SBP >/= 120 mmHg will be recruited. Participants will undergo baseline testing for casual (resting) SBP, 24-hour ambulatory SBP and endothelial function. Innovative mechanistic probes including pharmaco-dissection with vitamin C, analysis of biopsied endothelial cells, and high-throughput metabolomics, will be performed to assess oxidative stress and nitric oxide bioavailability at baseline. - After baseline testing, subjects will be randomized to perform either 3-months of high-resistance IMST or brisk walking. Subjects will train 6 days/week. Following 3 months of training, subjects will redo all the tests that were done during baseline testing to assess training-induced changes in SBP, physiological functions, and underlying mechanisms. Subjects will then cease training for 6 weeks before returning to the lab for follow-up testing to determine the persistent effects of IMST.

NCT ID: NCT04997577 Recruiting - Aging Clinical Trials

Speech Perception and High Cognitive Demand

Start date: September 27, 2021
Phase: N/A
Study type: Interventional

With advancing age, adults experience increasing speech understanding difficulties in challenging situations. Currently, speech-in-noise difficulties are rehabilitated by providing hearing aids. For older normal-hearing adults, however, hearing devices do not provide much benefit since these adults do not have decreased hearing sensitivity. The goal of the "Speech Perception and High Cognitive Demand" project is to evaluate the benefit of a new auditory-cognitive training paradigm. In the present study neural (as measured by pupillometry and magnetoencephalography) and behavioral changes of speech-in-noise perception from pretest to posttest will be examined in older adults (age 65 - 85 years) assigned to one of three training groups: 1) Active Control Group: sessions of watching informational videos, 2) Auditory Training Group: sessions of auditory training listening to one of two speakers in everyday scenarios (e.g., driving directions) and needing to recall what one speaker said in the previous sentence, and 3) Auditory-cognitive training group: identical to the auditory training group, except participants will be asked to remember information from two previous sentences. Changes in speech-in-noise perception will be examined for the three groups of older adults and gains will be compared to a control group of young, normal hearing adults (18-30 years) that is not part of the clinical trial and will not undergo any training.

NCT ID: NCT04985877 Recruiting - Aging Clinical Trials

Effect of Fermented Milk Containing Lactobacillus Casei Strain Shirota in Sarcopenia Elderly

Start date: March 23, 2021
Phase: N/A
Study type: Interventional

Sarcopenia, which refers to the progressive loss of skeletal muscle mass and strength, shares many characteristics with other disease states typically associated with risks of falling and fracture, including osteoporosis, frailty, and obesity. Sarcopenia often is linked to an increase in connective tissue, muscle steatosis, impaired muscle metabolism, an increase in inflammatory markers (e.g., TNF-a and IL-6), an increased stiffness of myofibers, slower kinetics in establishing myosin-actin crossing bridges, increased oxidative stress, mitochondria dysfunction, hormonal imbalance, and decreased capillary flow. In addition to the Lactobacillus casei strain, Shirota is a well-known probiotic strain that has been approved and is generally recognized as safe by the United States Food and Drug Administration. L. casei strain Shirota (LCS) has been suggested to confer health benefits. Investigators found that LCS decelerated age-related muscle loss via ensuring mitochondrial function in Senescence-Accelerated Mouse Prone 8 (SAMP8) mice. Investigators also found that 3-Indolepropionic Acid (IPA) is a microbiota-derived metabolite from a healthy intestinal gut. IPA is also a protective factor for the progression of chronic kidney disease in the Chinese population. This clinical trial focuses on the effect of fermented milk containing LCS on sarcopenia in elderly Taiwanese individuals. Investigators focus on the topic of the interaction of LCS with the diversity of the gut microbiota, microbiota-derived metabolites, and protein utilization. The proposal will have four research goals. First, investigators try to investigate whether long term supplementation LCS could restructure the gut microbiota composition and gut microbial metabolites to against Aging related -Gut Dysbiosis in elderly. Second, investigators also try to link the LCS play an important role on muscle loss and alternation of gut microbiota composition. Third, investigators try to study the LCS effect of muscle deterioration with aging, and highlight the two underpinning mechanisms (ROS and protein utilization) regulating declines in muscle mass and function. Fourth, Since IPA is important Microbiota-derived metabolites in health gut, investigators try to investigate whether LCS could play an important role on modulation of IPA production in GI. Fifth, investigators hope that investigators can through gut microbiota composition found some selective microbiota clusters perform positively correlation with IPA.

NCT ID: NCT04982497 Recruiting - Aging Clinical Trials

Development and Evaluation of a Psychological Intervention in Videogame Format for the Promotion of Active Aging

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

The social and health challenges of the aging population have led to the recommendation of active aging programs to increase the number of healthy and independent elderly people. These interventions have been shown to offer benefits in terms of quality of life, wellbeing, dietary and physical exercise habits, and cultural and social activity. However, there is a current need to investigate more-effective alternative means to disseminate these interventions beyond in-person formats such as serious videogames, aimed at promoting behavioral changes and providing education for purposes such as health or learning. The main objective of this project is to improve on a videogame intervention for the promotion of aging and to evaluate its efficacy via a randomized controlled trial. It is expected that after the intervention and in the follow-ups (at 3, 6, and 12 months), participants in the videogame arm of the study will have higher health status compared to the control group subjects. The first months of the study will be devoted to revising the materials and fine-tuning the intervention tested in a previous pilot study. After that, the randomized controlled trial will be conducted. Participants will be recruited through clinics and health care centers in the Autonomous Community of Galicia (Spain). To participate in the study, participants must: (a) be at least 45 years old, (b) have normal cognitive functioning, and (c) reside in Galicia. Participants will be excluded if they: (a) have serious mental or medical disorders; (b) have been receiving psychological or psychopharmacological treatment during the two months prior to the study or are participating in other studies related to active aging; and finally, (c) do not have the appropriate devices to play the game, cannot communicate in Spanish, or have problems that make it impossible to play the videogame. Information on various sociodemographic and clinical variables will be collected during the pre-intervention evaluation. The main outcome will be perceived health status, as evaluated using the SF-36 health questionnaire. A total of 574 participants will be randomly assigned to a cognitive-behavioral intervention administered through a serious online interactive multimedia game with a complementary App (CBI-V, experimental group) or to a control group that will receive information on active aging in an online format (CG). The randomization sequence will be generated automatically by the evaluation platform (concealment or blinding of randomization), and the participants in the CBI-V group will be given access to the first module of the intervention, while those in the CG will receive the first informational module. The participants in both groups will then complete the next seven modules for each condition. After the intervention, the participants will be evaluated in the postintervention assessment and follow-up assessments at 3, 6 and 12 months. In terms of its impact, this study will contribute to the development and rigorous evaluation of the worlds first psychological intervention to promote active aging managed through an interactive online multimedia videogame with a complementary app. In addition, confirmation of the programs clinical validity will be of great relevance in terms of health, social and economic benefits.

NCT ID: NCT04973124 Recruiting - Anesthesia Clinical Trials

The Neuroprotective Effect of Dexmedetomidine Preserving Brain Functional Connectivity in Elderly Patients

DEXPM
Start date: November 16, 2021
Phase: N/A
Study type: Interventional

Older patients are more prone to adverse cognitive outcomes such as postoperative delirium (POD) and postoperative cognitive dysfunction (POCD). Both conditions are associated with an increased risk of death, functional decline, and health care costs. The presence of pro-inflammatory cytokines in the central nervous system has detrimental effects on the regulation of neurotransmitter signaling in different areas of the brain, especially the hippocampus, ultimately resulting in neuronal dysfunction and cognitive decline. Neuroimaging studies have provided important information on the structural and functional networks involved in the pathogenesis of POD and POCD. Strong evidence has shown a decrease in the integrity of the default mode network (DMN), along a continuum from normal aging to mild cognitive impairment and Alzheimer's disease. Dexmedetomidine is a highly selective alpha-2 adrenergic agonist with sedative and analgesic properties but minimal respiratory effects. Several studies have shown that dexmedetomidine reduces serum pro-inflammatory cytokines and POCD. The expected results are to analyze the change in the integrity of the DMN from the preoperative period to the first weeks after discharge given by the two anesthetic strategies (SEVO vs SEVODEX). In addition, it seeks to evaluate (1) Changes in the integrity of the DMN at 3 months. (2) Modulation of structural changes in white matter integrity as measured by DTI. (3) Patient performance in specific cognitive function tests and serum inflammation biomarkers between the pre- and postoperative period. For the analysis, the Generalized Linear Model (GLM) will be used, in which the integrity of the DMN is the dependent variable. As predictors will use the anesthetic groups (SEVO and SEVODEX) and the measurement time (preoperative, 1 to 3 weeks after discharge and 3 months later as levels). With this work we aim to provide a mechanistic explanation of the observed neuroprotective effects of dexmedetomidine in anesthesia protocols for elderly patients. Furthermore, this work will possibly promote functional connectivity as a possible clinical biomarker of cognitive impairment in this vulnerable population.

NCT ID: NCT04971954 Recruiting - Aging Clinical Trials

Using Nicotine to Reverse Age-related Auditory Processing Deficits

Nicotine
Start date: February 1, 2022
Phase: N/A
Study type: Interventional

The present study will evaluate the effects of both aging and nicotine on psychophysical tasks and electrophysiological measures. Nicotine will be administered to study participants in the form of gum that is available as an over-the-counter medication. The hypothesis is that nicotine will reverse the detrimental effects of aging on auditory processing. The proposed experiments will characterize the effects of nicotine and may eventually lead to improved treatments of hearing loss in a variety of patient populations and in healthy aging.

NCT ID: NCT04970888 Recruiting - Aging Clinical Trials

Comparing the Effects of Cognitive Training and Physical Exercise on Cognition, Cerebral Autoregulation and Cerebral Vasoreactivity in Men and Women With Heart Failure

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

The objective of this project is to assess the effects of combined physical exercise and cognitive training interventions on cognitive and brain health in patients with heart failure (HF). Also, the role of sex on the effects of the interventions will be assessed.

NCT ID: NCT04964999 Recruiting - Aging Clinical Trials

Understanding the Negative Effects of Bed Rest and Using Exercise as Countermeasure

Start date: July 12, 2021
Phase: N/A
Study type: Interventional

Physical activity appears to be an important lifestyle habit to achieve healthy aging by promoting autonomy and quality of life. Interestingly, the dramatic changes that the human body undergoes due to bedrest for illnesses and hospitalization are similar to those seen over decades of normal aging. Bedrest in otherwise healthy older individuals can lead to a reduction of muscle size and strength, changes in bone strength and function of the heart and blood vessels. Bedrest can also lead to changes in keeping proper balance as well as changes in processing and understanding information. All of these factors negatively affect activities of daily living leading to physical function impairment and development of frailty, a clinical condition associated with an increased risk for disease and death. The purpose of this study is to investigate whether exercise can counteract the negative effects of 2-week head tilt down bed rest on muscle function and metabolism, postural control, bone structure, orthostatic tolerance and cognitive function in adults. For this study the investigators will recruit 24 healthy men and women between 55 - 65 years of age. All subjects will spend a total of 26 days (5 days of adaption period, 14 days of bed rest with 6 degrees of downward inclination, and 7 days of recovery period) at the McGill University Health Centre (MUHC). During this study, 12 subjects will randomly undergo an exercise intervention as countermeasure during the 14 days of bed rest period and 12 will serve as control. Each subjects participation in this study will involve 1 telephone call (pre-screening) and 4 visits at the MUHC: 1 screening visit (Visit 1) followed by a 26-day long visit (Visit 2) and 2 follow-up visits (Visit 3 and Visit 4). During Visits 2 - 4 various measurements will be performed to assess sensorimotor control, muscle function and metabolism, bone structure, cardiovascular function, cognitive performance and function, and specimen collection (blood, urine, saliva, feces and muscle tissue).

NCT ID: NCT04962061 Recruiting - Aging Clinical Trials

A Combined Multidomain Intervention to Prevent Cognitive Decline Associated With Cardiovascular Risk Factors.

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

The ACTIONcardioRisk trial is designed to investigate the effect of aerobic and progressive resistance training exercises combined with cognitive training, on neurocognitive functioning of sedentary older adults with and without cardiovascular risk factors.