Clinical Research Directory

Early Exercise-Based Rehabilitation in Patients Hospitalized for Acute Pulmonary Embolism

Up to half of patients with pulmonary embolism (PE) suffer from impaired quality of life, reduced physical capacity, and symptoms like shortness of breath even three months after diagnosis, despite standard treatment with anticoagulation (blood thinners). The randomized RehabPE trial investigates whether an early, structured rehabilitation program with physical training and patient education can prevent such long-term effects. The study includes hospitalized patients with acute symptomatic PE who are at increased risk of impaired quality of life three months after diagnosis. After informed consent, patients are randomly assigned to one of two groups: one receives an early 6-8-week, center-based rehabilitation program; the other receives standard follow-up care without rehabilitation. The intervention group completes 16-18 outpatient sessions of endurance and strength training, along with two education sessions covering the condition, treatment, and symptom management. Over 180 days, changes in quality of life, physical exercise capacity, breathlessness, and psychological symptoms, and the time to return to work / usual daily activities will be monitored and compared between groups.

Olfactory Cell Transplantation and Intensive Rehabilitation to Repair Chronic Spinal Cord Injury

This is a randomised, blinded and controlled Phase I trial to measure the safety, feasibility and efficacy of a combined cell transplantation and intensive rehabilitation intervention to treat spinal cord injury. The trial aims to examine whether transplantation of olfactory cell nerve bridges combined with intensive rehabilitation is safe and feasible for people living with chronic spinal cord injury in Australia, and whether the intervention improves structural integrity of the spinal cord, functional recovery, overall health, and social wellbeing. For the olfactory cell nerve bridge transplant, cells from inside the patient's own nose will be purified and engrafted as 3D cellular nerve bridges. Participants will receive a dose that is dependent on the size of the accessible space within the injury site of the spinal cord with up to 60 million cells being engrafted. The surgery for the transplantation will be performed by a neurosurgeon in which the spinal cord will be exposed to enable the nerve bridges to be placed into the injury site. The duration of the procedure will be 3-4 hours. Surgical notes will be used to monitor adherence to the protocol. For intensive exercise rehabilitation, the intervention will be supervised and provided by physiotherapists and exercise physiologists at a for-purpose neurorehabilitation facility. The mode of administration will be one-on-one sessions. The 12- and 32-week rehabilitation programs will consist of up to 3 hours per day at the rehabilitation service providers, for 5 days per week. Participants will attend the provider that is within their geographical area. Over each week, sessions will involve a range and mix of activities which could include, but are not limited to, standing, gait training, upper limb strength, trunk stability/core strength, and aerobic training. Throughout the trial, logs of exercise activities will be completed by the participants and staff at the neurorehabilitation gyms. Rehabilitation will start from day 1 of the priming rehabilitation (PR) program and go for 12 weeks, then surgery and cell transplantation will occur at week 1 of the cell transplantation surgery and recover program which is 2 weeks post conclusion of Priming Rehabilitation (PR), followed by 5 weeks of recovery. Rehabilitation is for 32 weeks starting 6 weeks post transplant surgery. Regenerative rehabilitation program is from weeks 1-32 of the regenerative rehabilitation (RR) program. If nerve bridge production fails for whatever reason in the weeks prior to surgery, this will start an extension/contingency/alternative timeline, where a new nasal biopsy will need to be taken from the participant (along with accompanying tests). The cells will be grown up over the next 4 weeks with an additional week of nerve bridge production, while the participant engages in a further five weeks of priming rehabilitation.

Severe Chronic Neuropathic Pain: A Treatment Bundle, Using Spinal Cord Stimulation and Multidisciplinary Treatment, to Reduce Pain and Improve Physical Function.

People with nerve damage can develop nerve pain. The pain can sometimes be severe and unpredictable, causing odd or alarming sensations - for example, lightning-like or electric shock feelings in the area served by the damaged nerve. The investigators will examine a treatment for nerve pain in the legs caused by nerve damage, which can occur after a herniated disc or a bone fracture, with or without surgery. Previous research suggests that spinal cord stimulation can relieve nerve pain in the legs after surgery or injury, but its effectiveness is still debated. Other studies show that multidisciplinary treatment helps people with long-term pain to improve their quality of life and to better cope in life. National and international guidelines recommend this kind of multidisciplinary care for long-term pain. There has yet been published research on spinal cord stimulation combined with multidisciplinary treatment as a bundle intervention. The investigators therefore want to find out whether this combined approach can reduce nerve pain in the legs and improve physical functioning.

Immersive Virtual Reality and Exercise Programs in Multiple Sclerosis

TITLE: Immersive Virtual Reality and Exercise Programs in Multiple Sclerosis INTRODUCTION: Multiple sclerosis (MS) is a chronic neuroimmunological and degenerative disease characterized by demyelination within the central nervous system. Its clinical course involves motor impairment, sensory disturbances, cognitive dysfunction, and a progressive decline in functional independence. MS is one of the leading causes of non-traumatic disability in young adults. This highlights the considerable impact of the disease, both in terms of healthcare burden and healthcare expenditure. Within this context, therapeutic exercise has evolved from being considered potentially harmful to being recognized as a safe and effective intervention capable of improving gait, balance, cardiorespiratory fitness, fatigue, and quality of life in people with MS. A model has been proposed for prescribing and progressing exercise at different stages of MS: passive range-of-motion exercises designed for patients with the most severe symptoms, a second stage incorporating active muscle-strengthening exercises, and finally, integrated exercise programs that incorporate strength, endurance, balance, and coordination training. Evidence from systematic reviews and meta-analyses shows that structured exercise (including high-intensity protocols when performed under supervision) is safe and can improve functional outcomes. Our ExeRVIEM II project (High-Intensity Exercise Program with Immersive Virtual Reality in Multiple Sclerosis) represents a novel strategy to facilitate rehabilitation exercise programs using head-mounted virtual reality displays. HYPOTHESIS: The ExeRVIEM II project, based on training physical function in people with MS, is feasible and safe, and could have a potential clinical impact in the motor and cognitive domains, as well as applicability in community settings, such as patient associations. GENERAL OBJECTIVES: 1.1 To design and implement an ExeRVIEM II exercise program/protocol for people with MS. 1.2 To evaluate the feasibility and safety of the high-intensity virtual reality exercise program. SPECIFIC OBJECTIVES: 2.1 To analyze the possible changes in disability, functional variables, cognitive domains and biomarkers in the short and medium term in people who attend a patient association and carry out the ExeRVIEM II exercise program/protocol for people with MS. METHODOLOGY: An exploratory, pre-feasibility, single-arm, single-cohort study will be conducted at the AVEMPO patient association (Vigo, Spain). The intervention will consist of an 8-week supervised virtual rehabilitation program, with two weekly sessions on alternate days, in addition to the standard rehabilitation prescribed by the AVEMPO clinical team (physiotherapy, occupational therapy, and cognitive training sessions). An inmersive virtual reality (IVR) boxing exercise videogame will be used, administered via a virtual reality headset. In accordance with clinical guidelines for IVR, and given the exploratory nature of the study, sessions will be intentionally brief (10 minutes) to minimize cybersickness and excessive fatigue. Assessments will be conducted at baseline (week 0) and immediately after the intervention (week 8). Demographic and clinical data will also be collected, including sex, age, comorbidities, disease duration, MS subtype, and pharmacological treatment. Assessments will be conducted at the patient association and in the Neurology Department of the referral hospital. Feasibility and safety assessments will be performed at the patient association by the supervising physiotherapist, while the remaining assessments will be completed at the hospital by a neurologist specializing in MS (without blinding due to the single-group design and small setting). The content of the assessments will be: Patient characteristics: an ad hoc registration form that will include data on age, sex, years since diagnosis, MS subtype, and pharmacological treatment. Feasibility: Number of virtual sessions attended by each participant (adherence rate via registration sheet). Rate Perceived Effort using the modified Borg scale, which measures the level of perceived exertion on a scale of 0 to 10 from no effort to maximum effort. Usability of the virtual tool using the Sistem Usability Scale (SUS) range 0-100. Safety: adverse events (side effects related to virtual reality exposure) using the Simulator Sickness Questionnaire (SSQ). Level o disability: using the Expanded Disability Status Scale (EDSS). Gait will be evaluated using the 25Foot Walk Test (25FWT). Manual dexterity will be assessed using by 9-Hole Peg Test (9HPT). Cognitive domains evaluated by the Symbol Digit Modalities Test (SDMT) Axonal injury biomarker evaluated by Neurofilament light chain (sNfL) concentrations

Adherence to Home-Based Exercises in Musculoskeletal Disorders

Home exercise program is recommended by physicians to patients and their relatives to do at home and It is a treatment option in which the physician describes how to do it. Home workout program to be completed at home to complement and reinforce their program in the clinic It is a personalized set of therapeutic exercises that are taught. There are factors that can change exercise compliance; There are some reasons why some patients adhere to the prescribed home exercise program and others do not. Adherence to home exercises is a major issue in rehabilitation and the reasons for this are multifactorial; It includes both psychological and specific conditions factors that vary between each individual and these conditions should be taken into account by clinicians in designing personalized exercise programs. Home exercise programs constitute a fundamental component of rehabilitation and are widely prescribed by physicians support therapeutic gains beyond the clinical environment. These individualized programs aim to maintain functional improvements, reduce symptoms, and promote self-management among individuals with musculoskeletal disorders. Although adherence to home-based exercises is recognized as a key determinant of rehabilitation outcomes, non-adherence remains a persistent challenge. Despite growing emphasis on the importance of exercise compliance, the existing literature provides relatively limited and insufficient evidence regarding the factors that influence adherence across different musculoskeletal conditions, including degenerative, orthopedic, and neurological disorders. Addressing this gap, the present prospective longitudinal cohort study aims to evaluate adherence to individualized home-based exercise programs among patients with diverse musculoskeletal conditions and to determine whether adherence behaviors differ across diagnostic groups. In addition, the study seeks to identify demographic, clinical, psychosocial, and functional factors associated with exercise compliance. By integrating structured clinical evaluations with validated outcome measures, this study aims not only to clarify the determinants of exercise adherence but also to contribute to the development of more effective, condition-specific strategies to enhance sustained engagement in home-based rehabilitation.

Home-Based Physiotherapy in Oncology

The goal of this clinical trial is to assess the feasibility, acceptability, and safety of a supervised home-based physiotherapy programme for adult oncology patients. The programme combines aerobic cycling exercise, resistance training, and mental preparation strategies, delivered at home with regular professional supervision. The main questions this study aims to answer are: Is a 6-month supervised home-based physiotherapy programme feasible in terms of recruitment, adherence, and retention? Is the programme safe for oncology patients undergoing or having recently completed cancer treatment? Is the programme acceptable and satisfactory from the patient's perspective? How do physical function and health-related quality of life change over the course of the programme? This is a single-arm feasibility study with no comparison group. Participants will: Receive a stationary exercise bike delivered and installed at their home Follow a 6-month individualized physiotherapy programme including: Three weekly sessions combining moderate-intensity cycling and resistance exercises Wear a connected activity watch during exercise sessions to monitor heart rate and exercise duration Receive weekly supervision from oncology-trained physiotherapists through alternating in-person hospital visits and structured phone calls Complete physical function assessments and questionnaires on quality of life, fatigue, and programme satisfaction at baseline, mid-program, and study completion The results of this study will inform the design of a future larger controlled trial and contribute to the development of accessible home-based rehabilitation programmes for oncology patients.

Study of Functional Magnetic Resonance Signal Variations in Patients Undergoing Anterior Cruciate Ligament Reconstruction With the Application of a Dedicated Neuromotor Training

Lower limb injuries represent the majority of sports-related injuries, with knee injuries being among the most common. In particular, anterior cruciate ligament (ACL) injuries are considered highly devastating and career-threatening for both professional and amateur athletes. Current surgical and rehabilitation treatments often fail to provide fully satisfactory short- and long-term outcomes. A very high risk of re-injury exists, especially in younger patients, with up to 35% experiencing a second ACL injury, alongside a significant long-term risk of early knee osteoarthritis. Most ACL injuries are non-contact or indirect contact injuries, implicating biomechanical factors and neuromuscular control as key determinants of injury mechanisms. Recent literature shows that patients suffering a non-contact ACL injury have a higher risk of re-injury compared to those with contact injuries, suggesting a significant cognitive component in injury processing, surgery, rehabilitation, and return to sport. Recent rehabilitation studies have introduced targeted neuromotor training designed to "rebuild" biomechanical and neuromuscular patterns to avoid mechanisms leading to re-injury. Movement quality tests are used post-training to confirm the reduction of risky biomechanical patterns, often resulting in a score indicating movement quality. Given the brain's involvement in such injuries, pioneering studies have used functional magnetic resonance imaging (fMRI) to investigate changes in cortical brain areas following ACL injury and reconstruction. Evidence shows adaptations in both central and peripheral nervous systems, with altered sensorimotor cortex activation in patients during simple motor tasks, differing from healthy subjects. Prefrontal cortex alterations correlate with severe quadriceps muscle activation asymmetries, linking these brain patterns to post-injury return-to-sport outcomes. However, no studies have yet evaluated the interaction between cortical activation (neural compensations) measured by fMRI and outcomes from targeted neuromotor training during ACL rehabilitation. Understanding brain activation implications is crucial for developing large-scale rehabilitation protocols to reduce the risk of a second, potentially more devastating, knee injury. This study aims to reveal whether a neuromotor training protocol can positively influence cognitive brain areas related to human movement, particularly by reducing risky injury patterns. It will be the first to test whether dedicated neuromuscular training effectively reduces neural compensations and cortical activation related to non-automated movement, favoring automation areas important for a safe return to sport. Patients will directly benefit from participating in the innovative neuromotor training program, with functional MRI scans conducted before training begins (post-surgery) and after training completion. Indirectly, the study will assess whether neuromotor training can adapt patient neuromotor patterns to reduce re-injury risk, ultimately benefiting future patients undergoing ACL reconstruction.

Effect of Meditation as an Adjunct to Cardiac Rehabilitation

Cardiovascular rehabilitation is a well-established standard of care that significantly reduces morbidity and mortality while improving quality of life. However, integrating behavioral interventions into physical training may offer additional benefits for autonomic regulation and emotional well-being. This randomized clinical trial aims to investigate the efficacy of adding a brief, guided mindfulness meditation session to a standard cardiovascular rehabilitation program. The study seeks to determine whether this combined intervention enhances blood pressure control, improves perceived quality of life, and increases patient adherence compared to standard rehabilitation alone. Participants newly enrolled in the Cardiac Rehabilitation Service will be randomized into two groups. Both groups will undergo a standard 12-week regimen of aerobic and resistance training combined with optimized medical therapy. The intervention group will additionally receive 15 minutes of voice-guided mindfulness meditation at the end of each exercise session. Key outcome measures include blood pressure variability, quality of life scores (assessed via EQ-5D), and attendance rates.

The MUSICare Project: Effects of Differentiated Music Exposure on Exercise-Related Affect Among Cardiac Rehabilitation Inpatients

Affective phenomena, such as core affect, remembered pleasure, or forecasted pleasure, play a key role in promoting physical activity (PA) behaviour, especially among inpatients. The use of music has been shown to be a particularly cost-effective and low-friction approach to promoting positive affective valence during PA. However, interventions using music to improve exercise-related affective phenomena among inpatients are lacking. This study will aim to investigate an intervention that combines the effects of music with the "peak-end rule" on core affective responses (valence and arousal), remembered pleasure, and forecasted pleasure associated with exercise sessions among cardiac rehabilitation inpatients. The primary objective of the present study will be to examine the effect of differentiated music exposure on core affective responses, ratings of perceived exertion and psychophysiological responses to moderate-intensity continuous training (MICT), as well as on associated remembered pleasure, exercise enjoyment, and forecasted pleasure. A secondary objective will be to assess the potential mediating effect of affective valence at the end of the MICT on remembered pleasure and exercise enjoyment. A third objective will be to assess the effect of MICT with or without music on an emotional rating task, together with pupillometric measures. Finally, the study will examine the influence of remembered pleasure on subsequent forecasted pleasure.

Comprehensive Therapeutic Program For People With Multiple Sclerosis

This study investigates the effectiveness of an intensive multidisciplinary rehabilitation program for people with multiple sclerosis (PwMS). The program integrates intensive outpatient physiotherapy, psychotherapeutic consultations, and nutritional counseling to enhance motor and cognitive functions, promote neuroplasticity, and improve overall well-being as well as physical performance in PwMS. Through clinical assessments and standardized questionnaires, the study aims to provide scientific evidence on the benefits of comprehensive, non-pharmacological therapy as a core element in MS treatment.

Online Physical Activity and Health Counseling for Survivors of Childhood Acute Lymphoblastic Leukemia

Advances in the medical treatment of childhood acute lymphoblastic leukemia (ALL) have resulted in 5-year survival rates above 90%- however, the success is not without consequences. Childhood ALL survivors experience markedly impaired physical capacity - reducing their opportunity to engage in everyday activities including leisure activities, sports, and school - affecting their quality of life. Furthermore, Childhood ALL survivors have markedly increased risk of chronic medical conditions including cardiometabolic diseases - that can be prevented through an active lifestyle. Thus, it is imperative to develop novel interventions that can mitigate these treatment-related late-effects. In this RCT, including 82 childhood ALL survivors (10-21 years-old), we will investigate a 26-week online exercise intervention combined with access to a lifestyle physical activity webpage, and health consultations on cardiorespiratory fitness (primary outcome) markers of metabolic syndrome, and physical activity habits. While other pilot studies have investigated the effects of exercise for childhood ALL survivors, this study is the first RCT internationally to investigate the effects of online exercise combined with education through an app and health counselling for childhood ALL survivor. Using this approach, we are geographically able to reach every survivor in our targeted population, thereby, minimizing logistic challenges like travel distances. This study has the potential to radically change the way physical rehabilitation is approached in childhood ALL survivors - Potentially changing the workflow of health professionals from referring only survivors with specific deficits to local physiotherapy to referring all survivors to an exercise program tailored to their needs. By improving the children's general physical capacity, we can give the children the required tools to re-enter everyday life activities, including school physical education, leisure activities, and sports earlier after treatment has ended - ultimately minimizing the social complications of treatment. This study will also answer the government´s call to digitalize 30% of rehabilitation by the 2030.

State of Play of Physiotherapy in the Postoperative Management of Prostate Cancer : Prospective, Monocentric, National Survey, Aiming to Explore the Technics of Physiotherapy (PREduKiné)

In France, a considerable number of radical prostactectomy for cancer is carried out every year.This number was estimated at 20.000 in 2016.This surgery may have negative impact on the continence's subjects and their quality of life. The rehabilitation, preoperative or postoperative, practiced by a physiotherapist, can reduced those side effects. The rehabilitation techniques are many and their efficacy may differ. No study where found about the clasification and evaluation of those rehabilitation techniques.

Programmable Smart Watch for Remote Pre-habilitation/Rehabilitation Monitoring

The purpose of this research study is to validate the M5Stick Programmable watch as a prototype to monitor specific prehabilitation exercises and to monitor the frequency of exercises and the number of repetitions the subject makes in a home setting.