Clinical Research Directory

IMST for Dementia Risk Reduction

Using a 2-arm, RCT approach, the primary goal of the study is to evaluate the feasibility and preliminary efficacy of Inspiratory Muscle Strength Training (IMST) as a non-pharmacologic intervention to reduce cardiovascular and cognitive risks in older adults. Next, investigators will examine secondary effects of IMST on mood, sleep quality, systemic inflammation, and physical/motor function. Finally, investigators will assess participant adherence and acceptability ratings of using an 8-week home-based IMST protocol in a diverse older adult sample.

Function and Lean Mass Preservation With Resistance Exercise During a GLP-1RA Treatment

This study aims to investigate the effect that a structured, progressive resistance exercise program may have on maintaining the muscle mass and physical function of overweight/ obese females whilst they experience a tirzepatide (GLP-1/GIP receptor agonist) induced weight loss. Overweight and obese females aged 25-50 will be recruited for the study, they will require a BMI of \>30 or \>27 with one obesity related comorbidity (excluding diabetes). They will be screened, prescribed tirzepatide and then randomly assigned to either the intervention (GLP-1/GIP + Exercise) or the control group (GLP-1/GIP). Groups will then be split into pre and peri menopausal groups to provide a further exploratory pathway looking analysing if the menopause transition may have any effect on our outcome variables. This was proposed as in the UK females are more likely to begin GLP-1RA treatment. Both groups will be given an industry standard treatment of tirzepatide over 20 weeks starting at a dose of 2.5mg/week and following the dose titration process of +2.5mg/week every four weeks outlined by its manufacturers. The Exercise Group (GLP-1 +EXC) will be given the same tirzepatide prescription alongside following a progressive resistance exercise program. The exercise program will follow a similar structure to previous work in which participants will complete a propriety 20-wk whole body, low impact resistance exercise training program four times a week. The exercise sessions will be up to an hour and will be instructor lead by video and supervised by a member of the research team at The University of Exeter.

A Digital Health Intervention to Improve Physical Function and Wellness of Lung Cancer Survivors

The rationale for the proposed project is to improve the experience and outcomes of individuals diagnosed with lung cancer treated for cure. Survival rates in patients with stages I-III lung cancer continue to increase given progress in early detection and more effective treatments. However, the survivorship needs of this population are considerable and too often overlooked, especially with respect to their health behaviors, such as physical activity and nutrition, as well as persistent symptoms and side effects, including breathing difficulties and sleep disturbance. To ensure that as many patients as possible can access the information, support, and skills they require to navigate the diagnosis and treatment of lung cancer, the investigators worked with a multidisciplinary team to create a digital health intervention, called "PROMOTE." The investigators designed the PROMOTE mobile app for lung cancer survivors undergoing treatment to help them improve physical function, manage breathlessness and insomnia, increase physical activity, maintain a healthy diet, and enhance their overall wellbeing. To achieve the long-term goal to have PROMOTE become widely available to all lung cancer survivors, the next step in this research program is to conduct a randomized trial to demonstrate the benefits of the digital health intervention. Specifically, the investigators hypothesize that, compared to patients receiving enhanced usual care, those assigned to PROMOTE will report improved physical function, less difficulty with breathlessness and sleep disturbance, increased physical activity, healthier eating behaviors, fewer symptoms of anxiety and depression, and better quality of life. The investigators also plan to examine whether PROMOTE leads to more effective coping and greater confidence in patients' ability to manage their health (i.e., self-efficacy). For this project, the investigators will enroll lung cancer survivors receiving care at an academic cancer center and two affiliated community sites that provide care for diverse patient populations to ensure the results apply to a wide range of individuals with lung cancer. Participants will be randomly assigned either to receive the PROMOTE app intervention for 12 weeks or to an enhanced usual care control group that includes health education materials. Participants will complete surveys at enrollment and again at 6, 12, and 24 weeks after enrollment. At the end of the study, those assigned to the control group will be permitted to receive the PROMOTE app as well.

Foot and Ankle Strengthening Program to Improve Physical Function in Menopausal Women

This randomized controlled trial will evaluate the effects of a 12-week foot and ankle strengthening program on physical function and health-related quality of life in menopausal women. Menopause is associated with hormonal changes that may negatively affect muscle strength, balance, and functional capacity, potentially leading to reduced mobility and increased risk of falls. Although exercise interventions have demonstrated benefits in this population, most programs focus on global lower-limb training and rarely target the foot and ankle complex, which plays a key role in postural stability and gait propulsion. Approximately 60 menopausal women aged 45-65 years will be randomly assigned to either an intervention group performing a structured foot and ankle strengthening program or a control group maintaining their usual physical activity. The intervention will last 12 weeks and will include one supervised weekly session and four home-based sessions. The primary outcome will be ankle plantarflexion isometric strength measured by hand-held dynamometry. Secondary outcomes will include ankle strength in other directions, intrinsic foot muscle function, gait speed, spatiotemporal gait parameters, balance, foot-related functional status, and health-related quality of life.

Effects of Adapted Sports on Balance, Physical Function, and Cognitive Function in Older Adults

This randomized controlled study aims to investigate the effects of adapted sports exercises on balance, physical function, and cognitive function in older adults. Participants will be randomly assigned to an intervention group and a control group. The intervention group will participate in a structured adapted sports exercise program, while the control group will maintain their usual daily activities. Balance, physical performance, and cognitive function will be assessed before and after the intervention period using standardized assessment tools. The findings of this study are expected to contribute to understanding the role of adapted physical activity in improving functional and cognitive health in older adults.

Neurocognitive Deficit After Paediatric Transplantation: Understanding the Role of Environment and Physical Function

Hematopoietic stem cell transplantation (HSCT) is a potentially life-saving treatment for children with relapsed or resistant leukemia and other life-threatening hematological and hereditary disorders. In Denmark, around 25 children undergo allogeneic HSCT every year, of these approximately 85-90% survive into adulthood. The goal of this observational study is to learn about neurocognitive outcomes in children undergoing (HSCT) and to understand which clinical, physical, and environmental factors may affect neurocognitive development during the first year after transplant. The main questions it aims to answer are: How does neurocognitive function change from before HSCT to one year after transplantation in pediatric patients? Which clinical, physical, and environmental factors are linked to better or worse neurocognitive outcomes? Participants will: Complete neurocognitive tests before HSCT and at 1-year follow-up, covering intelligence, memory, attention, executive function, processing speed, and motor skills. Undergo physical tests before HSCT, at hospital discharge, at 6-months follow-up, and at 1-year follow-up, including muscle strength, mobility, endurance, balance, and cardiopulmonary fitness (only at 1-year follow-up). Wear activity trackers to measure physical activity and sedentary time during hospitalization at 6 months and 1-year post-HSCT. Complete questionnaires about sleep, pain, quality of life, fatigue, family background, and exposure to outdoor and green spaces. Have medical records reviewed for treatment-related side effects, immune recovery, inflammation, and pain management. This study will help understand how neurocognitive function develops after HSCT in children and which factors (clinical, physical, or environmental) may support better recovery and well-being.

Preventing Hospital Associated Disability in Older Patients: Individualized Nutrition and Exercise Strategy

Aproximately a third of persons older than 70 years lose physical function and ability to take care of themselves during a stay at a hospital. This is associated to an increased risk of readmission and mortality. Earlier research has shown that insufficient nutrition and physical activity during hospital stay, leading to a loss in muscle mass and strength, plays an important role in this fall in functionality. This study aims to examine if a structured and supervised resistance and mobility exercise intervention, can prevent this fall in functional ability during hospital stay among older patients. The Impact of nutritional status will be investigated by registrering caloric, protein and hydtrational intake during the study period.

Preventing Hospital Associated Disability in Older Patients: Individualized Nutrition and Exercise Strategy, a Feasibility Study

Aproximately a third of persons older than 70 years lose physical function and ability to take care of themselves during a stay at a hospital. This is associated to an increased risk of readmission and mortality. Earlier research has shown that insufficient nutrition and physical activity during hospital stay, leading to a loss in muscle mass and strength, plays an important role in this fall in functionality. This study aims to examine if a structured and supervised resistance exercise, with or without an individualized nutritional plan and intervention, can prevent this fall in functional ability during hospital stay among older patients. Furthermore, this study seeks to investigate if it is feasible to carry out such a exercise and nutritional intervention in a hospital setting, and to obtain viewpoints regarding exercise and nutrition during hospital stay from older patients. This study aims to produce experience for at bigger randomized controlled study expected later in 2025

The Effects of MediDrink Platinum+ and Fava Bean Protein Hydrolysate on Fitness in an Aged Population

Examining the effects of MediDrink Platinum+ containing novel protein blend SRP-01 alone or when combined with PeptiStrong on clinical responses in elderly adults with sarcopenia

Therapeutic Effects of Instrument-assisted Versus Sound-assisted Soft Tissue Mobilization in Chronic Non-specific Low Back Pain

Chronic low back pain (CLBP) is the most common medical problem observed among musculoskeletal pain and spinal pain problems. It can reduce the movements due to muscular imbalances, decreased activity of daily living, and effects on health-related quality of life. It is the major cause of activity limitation, work absence, and reported clinical issues. Most of the cases of low back pain remained undiagnosed and received only symptomatic management.

Effects of Resistance and Dual-Task Training on Physical, Oculomotor, and Executive Functions in Older Adults With MCI

The goal of this clinical trial is to determine the effect of a combined therapeutic intervention program with anaerobic exercises (resistance exercises) and dual tasks on the physical, oculomotor, and executive functions of older adults with mild cognitive impairment. The main questions it aims to answer are: • How effective will a therapeutic intervention program combining resistance exercises with dual tasks be in improving the physical, oculomotor, and executive functions of older adults with mild cognitive impairment living in the community? Researchers will compare the effectiveness of a resistance exercise training program combined with dual tasks versus a resistance-only exercise training program to see if it improves the physical, oculomotor, and executive functions of older adults with mild cognitive impairment Participants Will: * Receive resistance exercises, resistance exercises combined with dual tasks. or the standard health care. The intervention programs will consist of 3 weekly sessions over 8 weeks. * Before the start and after the completion of the programs, they will be evaluated using a battery of tests. This includes sociodemographic and general health background, physical fitness tests, as well as assessments of executive functions and oculomotor Saccadic movements and anti-saccadic error. * be required to sign a consent form.

Time Restricted Eating in Survivors Trial 2.0

After chemotherapy, older breast cancer survivors experience a faster decline in brain function. This can make it harder to enjoy life, stay social, and maintain independence. Chemotherapy can lead to poorer lifestyle habits, like unhealthy eating, less exercise, high stress, and poor sleep. Chemotherapy can also affect important health markers like blood sugar and cholesterol. Over time, these changes can damage blood vessels, which might lead to heart and brain issues. The investigators do not fully understand why brain function declines faster after chemotherapy, especially in older survivors, because there are many factors involved. In this study, the investigators will look at how lifestyle habits (like diet, exercise, stress and sleep), health markers (like blood sugar and cholesterol), and blood vessel health (like how well blood flows and how stiff the blood vessels are) affect brain function in older breast cancer survivors. The investigators will include 152 females aged 60-85 years, who finished chemotherapy for early-stage breast cancer at least 1 year ago. The investigators will use special tests to check different parts of brain function, like language, memory, and attention, as well as brain blood vessel health. This will help to understand which factors might speed up or slow down memory and thinking problems. Since many Canadian breast cancer survivors experience faster decline in brain function after chemotherapy, this study aims to find out what might make it worse. The results could help to create better and more personalized treatment plans for older breast cancer survivors that protect brain health and reduce problems with brain function in the future.

The Impact of Whey Protein on Frailty in Older Adults Classified as Pre-frail

This pilot study aims to determine the impact of whey protein supplementation on brain antioxidant levels and to assess the effects of whey protein supplementation on physical function, body composition, and cognition in pre-frail older adults.

Novel Respiratory Training as Part of Palliative Care for Older Adults With Heart Failure

In a randomized controlled trial, to study the utility of inspiratory muscle training (IMT) to improve functional outcomes in adults aged ≥70 years with heart failure (HF) who have been referred to palliative care for end-stage HF management. * The study team hypothesize that older HF patients will be able to use IMT safely, reliably, and effectively in a 12-week home-based training regimen. * The study team hypothesize that physical function (sit to stand, gait speed, grip strength), respiratory/pulmonary function, self-efficacy, fatigue and quality of life will increase among older HF patients randomized IMT versus those randomized to usual care.

Building Resilience for Surgical Recovery

The goal of this clinical trial is to test problem solving therapy (PST) in older adults who are undergoing major surgery. The main question it aims to answer is: What is the feasibility and acceptability of delivering PST to older surgical patients with depressive symptoms or report lacking social support in the pre-operative and post-operative setting?

Church-based Intervention to Improve Physical Function

This is a 12-month multi-level behavioral cluster randomized trial testing a church-based intervention to improve physical function (PF) in Americans with PF limitations.

Intradialysis Exercise Functional Capacity, Body Composition and Survival in Hemodialysis Patients

Chronic kidney disease and renal replacement treatments (hemodialysis, peritoneal dialysis, kidney transplant) produce various alterations at the level of muscle, bones, fat content and the heart; can alter physical capabilities such as muscle strength, resistance to climb a step repeatedly intensely, and the ability to move the joints freely, in addition to producing an increase or decrease in weight and alterations in its distribution (for example, decreasing muscle and increase fat). The above, added to the particular factors of hemodialysis such as the reduction in daily time to exercise due to the sessions, or the fatigue after it, can together generate greater repercussions on functional capacity and thus increase the risk of suffering from cardiovascular problems. and accelerate the evolution of the disease. Therefore, this study aims to determine the effect of a 12-week supervised physical exercise program during hemodialysis on strength and ability to move, the amount of fat and muscle in the body, as well as bone wear. ; and compare these results with a group of patients who do not perform supervised exercise. In addition, it will be determined how exercise can act in the long term, preventing the risk of hospitalization and death due to cardiovascular causes. The above is useful in order to establish recommendations and protocols that help us increase the quality of life and survival of the person.

Movement and Behaviours Measurement Study

There are few studies that already have validated specific raw accelerometer cut-points for people over 65 years old. The purpose of the present study is to validate raw accelerometer cut points for general people over 65 years old and specific raw accelerometer cut points based on the functional status of older adults over 65 years old. The study will be carried out with an observational approach. Participants will be divided into 4 groups. First of them will be made grouping all subjects and the rest divided according to their functional status. They will perform different-intensity physical activities while wearing accelerometers attached to their body and wearing a portable gas analyser too. Their intensity will be assessed based on their own Rest Metabolic Rate (RMR). Energy expenditure and accelerations will be matched and, based on that, sedentary behaviour, light physical activity and moderate-to-vigorous physical activity cut-points will be derived.

Face-to-face vs Online Physical Exercise in Seniors Living in Nursing Homes (ExerMOT-NH)

The benefits of multicomponent physical exercise (MPE) in the mental and physical health of older adults are widely accepted. However, during Covid19 pandemic, some face-to-face programs for physical exercise were canceled. The situation was particularly complex in nursing homes (NHs) because residents were often confined to their floors and many leisure activities were canceled. Online physical exercise sessions increased their popularity during the pandemic. However, there is no evidence that online physical exercise sessions are an effective alternative to face-to-face sessions for older people living in NHs. The current project aims to assess a synchronous online MPE program's feasibility, acceptability, and effects. With this aim, first a synchronous online MPE intervention was designed and then a multicenter randomized controlled trial with 3 branches was developed: face-to-face MPE, online MPE and control. Participants in the control group will receive advice to maintain physical activity and reduce sedentary behavior. Additionally, those in the intervention groups will also participate in 24-week individualized and progressive MPE programs performed at moderate intensity that will be focused on strength, balance, and endurance. MPE will be performed through supervised sessions (2 per week). One of the intervention groups will be supervised face-to-face whereas the other will be supervised synchronously online. Study assessments will be conducted at baseline, at the end of the 24-week intervention, and after 24-week follow-up. The primary outcomes of the study will be changes in mental and physical health. Secondary outcomes will include other parameters of mental and physical health, together with physical activity, frailty, quality of life, and biological markers. The dropout rate, the adherence, the injuries and other adverse events suffered by the participants, and technical incidences produced in the online modality will be recorded. A mixed-model ANCOVA will be performed to compare the data between intervention and control groups, considering as co-variables baseline measurements. The statistical analysis will be performed on the whole sample and separated for sex/gender. The study received ethical approval (M10\_2022\_405\_IRAZUSTA ASTIAZARAN). The results of this project will be transferred to institutions and entities involved in managing NHs to increase the opportunities for the residents to remain physically active.