Clinical Research Directory

Lifestyle Intervention to Improve Muscle Function in Older Adults

The goal of this randomized controlled two-arm trial is to determine the effect of a diet and exercise intervention for 12 weeks on body composition, muscle function, and energy balance in 80 adults aged 50 years and over with obesity and insulin resistance. The main questions the trial aims to answer are: Will 12 weeks of a structured nutrition plan + exercise reduce fat mass, improve muscle function, and increase energy deficit compared to the usual diet + exercise. The hypothesis is that 12 weeks of a structured nutrition plan + exercise will reduce fat mass, improve muscle function, and produce greater energy deficit than the usual diet + exercise. Participants will be provided with all meals for 12 weeks and will exercise at the Center under supervision three times each week. Pre and post-intervention, body composition, physical function, and energy deficit will be measured.

Resistance Training and Creatine Supplementation for Head and Neck Cancer

The study will examine a 10-week resistance training program, with or without creatine monohydrate supplementation, in adult survivors of head and neck cancer. Participants will undergo screening and complete study assessments before and after the training period and at a follow-up evaluation. The study will evaluate feasibility, safety, body composition, physical function, cancer-related fatigue, quality of life, and symptom burden in this population.

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.

Symptoms, Physical Function, and Recovery in Patients Receiving Lung Cancer Treatment Before Surgery

This study will examine how symptoms and physical abilities change during lung cancer treatment given before planned surgery, and how these changes relate to recovery after surgery. Treatment given before surgery is called neoadjuvant therapy. The main questions are: * How do symptoms and the ability to perform everyday activities change during treatment and before surgery? * Are symptoms and reduced physical function before surgery associated with lung complications or slower recovery afterward? * Can patient-reported information add useful information to routine preoperative assessment? Participants will complete questionnaires before starting neoadjuvant therapy, during treatment, before surgery, and during recovery after surgery. The questionnaires will assess symptoms such as fatigue, breathlessness, and pain, along with physical abilities and well-being. Researchers will also collect information from medical records about cancer treatment, lung function, anesthesia, surgery, pain management, and postoperative complications. Changes to the planned treatment pathway, including delays or cancellation of surgery, will be recorded. This is an observational study. Cancer treatment, surgery, and anesthesia will be determined by the treating clinical teams, not assigned by the research team. The findings may help identify patients who need additional assessment and support before and after lung surgery.

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.

Flywheel Resistance Training and Traditional Resistance Training in Older Women With Sedentary Behaviors

There are easily accessible and safe strategies, such as resistance training, that can contribute to reducing depressive symptoms and preserving physical and executive function in older women. Resistance training is defined as exercises performed either in water or on land, involving the use of a constant load or uniform weight, regardless of the training program. Various types of resistance training equipment are available, including free weights, pneumatic resistance machines, elastic bands, or even body weight. Specifically, eccentric muscle action occurs when the force applied to the muscle exceeds the momentary force produced by the muscle itself, resulting in the forced elongation of the muscle-tendon system during contraction. To date, evidence from randomized clinical trials has compared the effectiveness of aerobic, resistance, and Pilates exercises in reducing depressive symptoms and improving physical and executive function in older women. While experimental studies have demonstrated the efficacy of physical exercise, the effect of long-term eccentrically reinforced resistance training on depressive symptoms, physical function, and executive function in sedentary older women remains unclear. Therefore, this study aims to evaluate the safety and effect of eccentrically reinforced resistance exercise versus traditional resistance training on depressive symptoms, physical and executive function, quality of life, different manifestations of muscle strength, body composition, vital signs, abdominal circumference, fall risk, and fatigue symptoms in sedentary older women over a 9-month period.

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.

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

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.

Metformin in Elderly Patients With Type 2 Diabetes and Muscle Strength, Muscle Mass, and Physical Function: Positive or Negative Correlation?

With the accelerating aging process in China, sarcopenia has drawn increasing attention. Sarcopenia is an age-related geriatric syndrome characterized by reductions in muscle mass, muscle strength, and/or physical function. Sarcopenia has a high prevalence, often insidious onset, and broad impacts on physiological functions. According to the 2019 report from the Asian Working Group for Sarcopenia (AWGS), sarcopenia prevalence among elderly Asians ranged from 5.5% to 25.7%, with males exhibiting higher rates (5.1% to 21.0%) than females (4.1% to 16.3%). Particularly among patients with diabetes, sarcopenia incidence was significantly elevated, with a prevalence of 14.8% reported in Chinese diabetic populations. Sarcopenia exerts numerous adverse effects. Sarcopenia is strongly associated with adverse cardiovascular events and increased mortality. Sarcopenia is linked to cancer and significantly elevates the risk of various postoperative complications in patients with gastrointestinal malignancies, including dysphagia, cognitive impairment, fractures, falls, hospitalization, and all-cause mortality. Sarcopenia and diabetes frequently coexist within the same individual, leading to multiple adverse outcomes. Sarcopenia results in declining in function flexibility and responsiveness in diabetic patients, causing gait alterations and impaired balance, limiting daily activities, and is closely linked to risks of falls, fractures, depression, frailty, and mortality. Thus, it is critically important to treat sarcopenia alongside diabetes and avoid detrimental effects of hypoglycemic drugs on muscle. Metformin lowers blood glucose by increasing muscle glucose uptake, inhibiting hepatic glucose output and gluconeogenesis, and promoting glucose excretion into the intestinal lumen; it also reduces the risk of diabetic cardiovascular disease, diabetic retinopathy, nephropathy, and neuropathy. There remains controversy in current studies regarding metformin's impact on sarcopenia. Some studies indicate that metformin may have potential beneficial effects on grip strength, skeletal muscle mass, and gait speed. Nordklint AK reported that after 18 months of metformin intervention in patients with type 2 diabetes, bone mineral content and density were improved. Qaisar R conducted a 16-week metformin trial on older men, finding improvements in grip strength and gait speed with statistical significance (P \< 0.05). Klimova AV found that a 6-month metformin intervention improved physical function in patients. Lyu Q's murine study demonstrated that 5 months of metformin treatment conferred benefits and recovery effects on the gastrocnemius muscle in sarcopenia models. Conversely, some studies indicate no impact of metformin on muscle mass, grip strength, or gait speed. Qaisar R reported no improvement in body composition or gait speed after 4 months of metformin use. Laksmi PW found no significant difference in grip strength between groups after a 16-week metformin intervention. Koshizaka M reported that after 24 weeks of intervention with ipragliflozin or metformin in patients with type 2 diabetes, metformin had no significant effect on muscle mass. Previous studies have also elucidated mechanisms underlying metformin's effects on muscle. According to Kang MJ, metformin induced myostatin expression in skeletal muscle cells via the Adenosine5'-monophosphate-activated protein kinase (AMPK)-FoxO3a-HDAC6 pathway, thereby impairing muscle function. Other studies found that metformin reduced expression of mTORC1-related genes in muscles of elderly individuals with impaired glucose tolerance, potentially leading to decreased muscle protein synthesis or increased autophagy. Therefore, this study enrolled elderly patients with type 2 diabetes and employed a cross-sectional design with propensity score matching to elucidate the association between metformin and muscle strength, muscle mass, and physical function, providing evidence for rational clinical use of hypoglycemic drugs.

Effects of a Powered Lower-Limb Exoskeleton on Walking Performance in Older Adults

The goal of this clinical trial is to learn whether a powered wearable lower-limb exoskeleton can improve walking performance in independently ambulatory older adults aged 65 to 75 years. The main questions it aims to answer are: * Does use of a powered lower-limb exoskeleton increase comfortable walking speed over 10 meters? * Does use of a powered lower-limb exoskeleton increase average walking speed during a 400-meter walk? Researchers will compare walking performance in older adults during walking with the powered exoskeleton and walking without the device to determine whether the exoskeleton improves mobility. Young-adult reference participants will also complete walking assessments to provide reference values for walking performance. Participants will: * Attend a screening and familiarization visit. * Complete walking assessments with and without the powered exoskeleton in randomized order (older adults only). * Perform a 10-meter walk test, a 400-meter walk test, and other physical performance assessments. * Complete questionnaires about balance confidence, fear of falling, and device usability. * Be monitored for safety events during testing.

Structured Self-Talk and Wearable-Assisted Walking for Physical Activity and Function in Older Adults

The goal of this randomized clinical trial was to examine whether adding structured self-talk to wearable-assisted walking could support physical activity and physical function in community-dwelling older adults. The study also examined whether wearable-assisted walking provided benefits compared with a walking program without wearable feedback. Participants were randomly assigned to one of three groups for 12 weeks: (1) wearable-assisted walking combined with structured self-talk, (2) wearable-assisted walking without structured self-talk, or (3) a walking-only active control condition. All groups followed the same moderate-intensity walking schedule. The main questions were whether wearable-assisted walking was associated with better physical activity and functional performance than walking alone, and whether adding structured self-talk provided additional benefits beyond wearable-assisted walking. Physical activity, functional performance, and other protocol-specified health-related measures were assessed before and after the intervention.

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?

Women's Health Initiative Strong and Healthy Study

The WHISH trial applies state-of-the science behavioral principles and currently available technologies to deliver a physical activity intervention without face-to-face contact to \~25,000 older U.S. women expected to consent. It includes the National Institute of Aging (NIA) Go4Life® Exercise \& Physical Activity materials 3 and WHISH developed targeted materials based on Go4Life® to provide inspirational tips and recommendations about how to achieve nationally recommended levels of PA and overcome barriers to exercise, with a means for self-monitoring and setting personal goals. The intervention builds upon evidence-based behavioral science principles and intervention components that have proven to be effective in increasing PA in older women, with innovative adaptive approaches to tailoring the delivery to meet individual (personal) needs.

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.

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.

The Role of Resilience for Physical Functioning of Patients With Fibromyalgia Syndrome Using the 6-Min Walk Test

Fibromyalgia (FM) is a prevalent chronic pain disorder, characterized by widespread musculoskeletal pain and fatigue that is associated with significant functional limitations. Its mechanisms are only partially understood. The investigators hypothesize that physical functioning (as measured by the 6-Min Walk Test) of FM patients and healthy controls is negatively influenced by resilience and pain sensitivity. The investigators will perform a case control study to test our hypothesis within and between groups.

Effects of Exercise Board Games on Cognitive Function in Older Adults

This study aims to evaluate the effects of an exercise-based board game intervention on cognitive function, physical function, and health promotion among community-dwelling older adults. Participants will take part in a structured program that combines physical activity with board game activities. The intervention is designed to promote cognitive engagement, social interaction, and physical movement in older adults. Outcome measures will be collected before and after the intervention to examine changes in cognitive and physical function.

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.

Frame Running for Exercise and Participation for Children and Young People With Physical Disabilities

The goal of this quasi-experimental single-arm trial is to evaluate whether a structured Frame Running training program can improve functional ability, participation, and quality of life in children and young people with physical disabilities. The study includes participants aged 8-18 years with cerebral palsy or other conditions causing physical disabilities. The aim of the study is to investigate changes in the primary outcome measure; functional ability using the Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT), and a series of secondary outcome measures on mobility capacity, physical endurance, performance of everyday activities, and health-related quality of life in children and young people with physical disabilities. Participants will complete a 24-week training program carried out in community athletics clubs: 12-week low-intensity control period with one supervised weekly Frame Running session focused on familiarization. 12-week moderate-to-high intensity intervention period with two weekly training sessions, including warm-up, technique training, endurance and speed intervals, and participation-focused activities. Data collection comprises four standardized questionnaires, four physical performance tests conducted at multiple time points, an electronic training diary, and Rating of Perceived Exertion-Pediatric Scale (RPE-P) obtained before and after selected endurance tests.

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.

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, 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