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Physical Disability clinical trials

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NCT ID: NCT06264895 Active, not recruiting - Chronic Disease Clinical Trials

Protocol for a Low Threshold Exercise Intervention for Women Experiencing Homelessness and Addiction.

LEAP-W
Start date: February 26, 2024
Phase: N/A
Study type: Interventional

Background: Frailty is a complex multi-dimensional state of increased vulnerability to adverse health outcomes and is usually associated with older age but there is growing evidence of accelerated ageing and frailty in non-geriatric populations, including those experiencing socio-economic deprivation and extreme social exclusion, such as people experiencing homelessness. Addiction, as a coping mechanism for prior trauma, is common among people who are homeless and can have a gendered dimension. Women experiencing homelessness and addiction have unique needs which require a gendered approach. The aim of this study is to explore the effectiveness of an exercise intervention to target the known physical functioning deficits and frailty which this population experiences. Methods: This mixed-methods study will explore physical functioning deficits and frailty in women experiencing homelessness and addiction, using a bespoke test battery and an exercise intervention. Physical function (10m Walk Test, 2 Minute Walk Test, Single Leg Stance Test, Chair Stand Test, hand grip dynamometry), frailty (Clinical Frailty Scale and the SHARE-FI) and nutritional status (Mini-Nutritional Status), pain (Numerical Pain Rating Scale) and quality of life (SF 12-V2) will be evaluated. The intervention will involve a 3-times weekly exercise programme with protein supplementation for 10 weeks. Following this, qualitative interviews, which will be thematically analysed using Braun & Clarke methodology, will be conducted. This study will be conducted in Dublin from February to July 2024. Discussion: Little is kn own about frailty-focussed interventions in women experiencing homelessness and addiction. This proposed study will help to increase the knowledge base regarding the physical health burden and frailty experienced by this extremely vulnerable population and will deliver a targeted intervention with a gendered dimension to mitigate its affects. The findings of this research will help narrow this research gap and will guide clinicians and policy makers to implement unique gender-based treatment strategies for this population.

NCT ID: NCT06242535 Active, not recruiting - Obesity Clinical Trials

Pilot Study of GLY-LOW Supplementation in Postmenopausal Women With Obesity

Start date: July 27, 2023
Phase: Early Phase 1
Study type: Interventional

A combination of generally regarded as safe (GRAS) compounds named GLY-LOW, which included: alpha lipoic acid, pyridoxamine, nicotinamide, piperine and thiamine, were examined in pre-clinical experiments. GLY-LOW supplementation reduced caloric intake and increased insulin sensitivity in mice. In female mice, GLY-LOW supplementation reversed aging-related declines in female hormones. Studies in humans are needed to examine the feasibility, utility and efficacy of GLY-LOW supplementation in post-menopausal women with obesity toward improving aging-related impairments. The effect of GLY-LOW supplementation on these obesity and biological age-related impairments in post-menopausal adult female humans with obesity is unknown. We aim to translate the findings of GLY-LOW supplementation in animals to a cohort of healthy, postmenopausal females at birth with obesity by conducting a one-group, no-placebo comparer, pre post intervention clinical trial. Additionally, we propose to examine the specific effect of supplementation by GLY-LOW on biological aging via retina scan. The objectives of the proposed pilot study are: I. Conduct a 6-month pilot study to examine the feasibility, utility and efficacy of GLY-LOW supplementation in a total of 40 postmenopausal female born adults > 55 years with obesity (> 30 BMI) Ia. Examine alterations in self-reported caloric intake and the following health and biological aging, parameters prior to and after 6 months of GLY-LOW supplementation: 1. Self-reported Caloric Intake 2. Metabolic disease risk 3. Cardiovascular disease risk 4. Metabolic assessments 5. Hormones 6. Physical Function and Fitness 7. Muscular strength 8. Cognitive Function and Depression assessments 9. Systemic inflammation 10. Biological aging 11. Safety parameters (also every 2 months during the intervention; ECG at baseline and 2 months only) 12, Compliance measures (pill counts and interviews every 2 months during the intervention)

NCT ID: NCT05940168 Active, not recruiting - Depression Clinical Trials

Internet-delivered ACT (I-Navigator ACT) for Parents of Children With Disabilities

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

The purpose of the project is to evaluate the feasibility, acceptability, and effectiveness of the internet-delivered Acceptance and Commitment Therapy treatment (I-Navigator ACT) for parents who experience stress, distress, depression or anxiety that may be associated with being a parent of a child with disabilities. The project consists of three studies: Study 1: An open feasibility trial in which parents participate in an individual, clinician-supported internet-delivered Acceptance and Commitment Therapy treatment. Study 2: A randomized controlled trial in which participants are randomly assigned either: 1. Navigator ACT group treatment, where parents participate in an Acceptance and Commitment Therapy group together with other parents, led by two group leaders, or 2. I-Navigator ACT internet-delivered Acceptance and Commitment Therapy treatment, where the parent participates on their own, coached by a clinician via a message function. Study 3: A qualitative study in which a smaller sample of parents from the open feasibility trial participate in semi-structured interviews. The interviews take place after the parents have completed I-Navigator ACT. All three studies are conducted in a clinical health care context.

NCT ID: NCT04589988 Active, not recruiting - Physical Disability Clinical Trials

Aging With Long Term Physical Disabilities

Start date: November 4, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the feasibility and efficacy of an adapted evidence-based program (REBIL) to reduce barriers to community participation and remove fall hazards at home for adults aging with physical disabilities.

NCT ID: NCT04545593 Active, not recruiting - Depression Clinical Trials

Positive Minds Strong Bodies Implementation

PMSB-E
Start date: February 11, 2021
Phase: N/A
Study type: Interventional

This study aims to address treatment and service disparities and prevent disability among racial/ethnic and linguistic minority elders. It tests the effectiveness and implementation readiness of the Positive Minds-Strong Bodies Enhanced intervention (PMSB-E), a combined mental and physical health intervention designed to be implemented in low-resource community settings. This renewal grant project includes a streamlined intervention with new components designed to improve and maintain participant outcomes.

NCT ID: NCT04169620 Active, not recruiting - Parkinson Disease Clinical Trials

Effectiveness of a Program With Aquatic Therapy in Patients With Parkinson's Disease Clinical Trial

Start date: January 7, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to determine the effect of an aquatic Ai Chi training program on the perception of pain, the maintenance of balance and the functional independence of patients with Parkinson's disease. Fifteen patients diagnosed with Parkinson's disease (Hoehn and Yahr range: 1-3) participated in a program of Aquatic Ai Chi lasting ten weeks with sessions held twice weekly. These were compared to a group of 15 Parkinson patients (control group) who received therapy on dry land.

NCT ID: NCT04166422 Active, not recruiting - Clinical trials for Cardiovascular Diseases

Virtual Reality and Video Games in Cardiac Rehabilitation Programs

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

Cardiovascular diseases (CVD) are the leading cause of morbidity and mortality in developed countries. The consequent healthcare costs in Europe alone are estimated at 196,000 million euros annually, approximately 54% of the total investment in health, resulting in productivity losses of 24% [1-3]. In recent years, the impact of CVD in non-Western countries has been growing [4,5]; therefore, prevention is presented as a primordial tool to improve quality of life and patient survival [6,7]. Cardiac rehabilitation (CR) is defined as a multidisciplinary program of clinical application of preventive measures for risk reduction and global and long-term care of the cardiac patient. In secondary prevention, it is shown to reduce the morbimortality by almost 50% in patients with heart disease. However, the participation of patients in cardiac rehabilitation remains low, especially among the following groups: the elderly, women and patients with a low socioeconomic profile. According to the latest Euroaspire V data, participation in CR programs in Spain is around 50%. The Reureca registry reports that only 10% of patients with a CR indication attend the programs. Therefore, new technologies within the health field, specifically within cardiac rehabilitation programs through the use of virtual reality (VR) and video games, are shown as promising aids with the aim of increasing adherence, satisfaction with programs and participation rates, offering the ability to perform physical exercise [8-11]. Virtual reality is a simulation of a real or imaginary environment created by a computer system, which allows the user to feel immersed and to interact with objects in that environment [12-14]. Thus, the basic elements that constitute a VR system are simulation, interaction and immersion [15]. Moreover, the creation of more adaptable and accessible videogame platforms has meant that the phenomenon of technological expansion can be understood not only as a form of leisure but also as an important means of learning and skills training, especially in people with motor, cognitive and sensory (neurological and non-neurological) deficits [16]. In contrast to traditional CR procedures, which can be repetitive, causing a loss of interest on the part of patients, video games and VR systems offer the opportunity to participate in enjoyable tasks with a therapeutic purpose through physical interaction with the game. The design of exercise-based videogames (exergames) provides the possibility of practicing physical skills in an entertaining way and of adjusting the game according to the abilities of the subject and the level of intensity. In addition, it is known that the level of enjoyment of an activity has been identified as one of the predictive factors of the effectiveness of an exercise program, and for this reason, interactive technology based on exercise is becoming the all-time most popular strategy for the implementation of physical activity [17-23]. It is important to emphasize that VR allows the creation of environments suitable for activities related to CR. The users of these systems can develop simulated tasks and activities in a safe way, since the clinicians have the capacity to control the duration and intensity of the exercise and, in this way, to control and supervise the delivery of stimuli in the virtual environment [24]. Furthermore, knowledge of results regarding the performance of the task in real time, gained through extrinsic feedback, as well as the playful nature of the activities proposed through VR and videogame devices, generates a competitiveness and challenge component that further increases the degree of patient motivation. In this regard, Klasen et al. [25] point out that this increase in motivation is related to the influence of videogames on activation of the mesolimbic dopaminergic pathways and their repercussions on the reward system of the brain. All this promotes active participation on the part of the patient and thus increases adherence to the rehabilitation treatment. The aim of the present work is to carry out a RCT to provide information on the application of VR and videogame systems within CR programs in patients with cardiac diseases.

NCT ID: NCT04046471 Active, not recruiting - Physical Disability Clinical Trials

Weight Loss Physical Disabilities

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

The objective of this study is to compare weight loss (6 mos.) and maintenance (18 mos.) between an individual home visit intervention (IH) and an intervention delivered remotely via video conferencing to groups of overweight/obese adults with Mobility Related Disabilities (MRDs) in their homes (GR). The primary aim will be to compare weight loss (0-6 mos.) between the two interventions (IH vs. GR). Secondarily, the study team will compare the mean weight loss from 0-18 mos., the proportion of participants achieving >=5% weight loss from baseline, changes in cardiovascular risk factors and quality of life, and conduct a cost analysis. In addition, factors that will be explored include the influence of behavioral session attendance, compliance with the recommendations for diet (energy intake, number of entrees/shakes, servings of fruits/vegetables), Physical Activity (PA, min of moderate vigorous PA, min sedentary time), and self-monitoring of diet and PA, self-efficacy for dietary change and PA, dietary self-regulation, social support for diet/PA, barriers to PA, sleep and medications on weight loss at 6 and 18 mos.

NCT ID: NCT03807115 Active, not recruiting - Stroke Clinical Trials

Effects of an Educational Intervention on Rehabilitation Clinicians' Practices for Health-related Outcomes After Stroke

Start date: February 24, 2020
Phase: N/A
Study type: Interventional

The overall aim of this pilot study is to evaluate the feasibility of a study protocol for a future stepped wedge cluster randomized clinical trial (c-RCT) that will investigate the effects of an innovative KT intervention on 1) walking capacity and independence in ADL in patients undergoing rehabilitation after stroke (patient outcomes); and 2) clinicians' practice (i.e. use of 4 evidence-based stroke rehabilitation interventions: motor imagery/mental practice, rhythmic auditory stimulation gait therapy, task oriented training including fitness and mobility exercises and aerobic training) (provider outcome) aimed at improving walking capacity. The specific objectives are: 1) To evaluate the feasibility (effectiveness of clinician recruitment strategies, extent of losses to follow-up across sites, and data analysis plans) of the study protocol in terms of methodology (stepped wedge design is an innovative methodology); 2) To estimate intervention effect sizes on study outcomes (patient and clinician); 3) To evaluate the secondary outcome (clinicians' use of the 4 interventions) with regard to reliability and validity.

NCT ID: NCT03427099 Active, not recruiting - Surgery Clinical Trials

The Effect of a Developed Perioperative Rehabilitation Pathway Following Lumbar Arthrodesis

Start date: January 3, 2018
Phase: N/A
Study type: Interventional

To compare the current rehabilitation pathway with the implementation of a newly developed rehabilitation pathway for patients with a single and double level lumbar arthrodesis.