Treatment Trials

22 Clinical Trials for Various Conditions

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COMPLETED
Feasibility of a Tele-game-based Exercise (Tele-exergame) Program to Prevent Deconditioning in Hospitalized COVID-19 Patients
Description

Background: Conventional face-to-face in-hospital mobility program (MP) is challenging for COVID-19 patients because of its associated risk of infection to hospital staff, staffing shortages as well as indirect risk of exposure to other hospitalized patients. Exergames are digital or web-based games that use body movement to promote physical activity and generally involve strength, balance, and flexibility exercises. The tele-exergame MP, developed by the team, uses a remotely supervised and game-based approach, which helps to increase patient motivation and engagement in a cognitively demanding exercise program. Objectives: To demonstrate the feasibility, acceptability, and effectiveness of the Tele-Exergame mobility program in COVID-19 or PUI (persons under investigation), during hospitalization and examine post-hospitalization outcomes. Research Design: Prospective randomized

COMPLETED
Exoskeleton Treatment of Deconditioning Due to Limited Ambulation Caused by Illness or Injury
Description

A safety and feasibility study of robotic exoskeleton training in deconditioned patients residing in a healthcare facility.

COMPLETED
Improving Function in Older Veterans With Hospital-Associated Deconditioning
Description

The investigators plan to test an innovative, home-based, short duration, high intensity exercise program designed for application in the immediate post-hospitalization period in older Veterans. Preliminary data suggest a more intensive approach to physical therapy in older adults after hospitalization is safe and maximizes mobility more than usual care. The Veterans participating in the high intensity exercise program will receive therapy utilizing higher resistance exercises. Outcomes from this group will be compared to data collected from the patients receiving standard, lower resistance therapies.

COMPLETED
Deconditioning in Transplant
Description

The purpose of this feasibility study is to test the potential for successful implementation of an intervention designed to study the effect of six hours out of bed time on the overall level of deconditioning in pediatric stem cell transplant (SCT) patients. Previous research has demonstrated that deconditioning occurs rapidly over the course of the hospitalization post-transplant and can negatively impact quality of life. By encouraging patients to be out of bed for six hours each day, it is anticipated that patients will experience less deconditioning than those patients who previously had no established minimum time out of the bed.

COMPLETED
A Trial of an Augmented Exercise Program in the Prevention of Deconditioning Among Survivors of Severe Burns
Description

Burn injuries can affect how well you are able to perform daily activities. The reason this study is being done is to find out if aerobic exercise helps burn patients recover function, strength and stamina. Participants will come to Johns Hopkins Bayview Medical Center, Burn Rehabilitation Gym for treadmill exercise sessions 3 days per week for 12 weeks. Participants will be tested for strength and stamina before the start of the 12 week program, at the end of the 12 week program, as well as 6 months, 1 year and 2 years after the end of the 12 week program. Patients who recently suffered a burn injury and who were discharged from the hospital in the past six months may be eligible to participate.

COMPLETED
The Bed Rest Avoidance Study
Description

Hospitalized patients spend the majority of their time lying in bed, even when they are capable of being out of bed. Up to 50% of inpatients suffer functional decline at least in part due to lying in bed after admission, and even those who are not placed on bed rest by their physicians spend an average of 20 out of 24 hours lying in bed. The loss of functional ability and exercise tolerance happens remarkably fast, as early as hospital day 2 (24-48 hours). Functional decline often results in a prolonged hospital stay and the need for additional rehabilitation resources both during and after the hospitalization to return a patient to their baseline functional status. Functional decline has also been associated with excess mortality. The investigators sought to flip the culture of hospital-based care such that the bed was viewed as a place for patients to sleep, and patients would be encouraged to get out of bed when they were not trying to sleep. The investigators hypothesized that patients were unaware of the risks of prolonged immobilization and that the lack of an alternative comfortable place for patients to sit other than their bed contributed to their immobility. Previous studies have demonstrated that mobility protocols improve patient-centered outcomes in narrow patient populations such as post-surgical patients or the elderly, but such interventions have not been studied in a heterogeneous patient population. Additionally, previously studied protocols have been labor-intensive from a nursing standpoint, requiring, for example, that staff provide one-on-one supervised ambulation 3-4 times per day. The investigators aimed to determine whether establishing a relatively low-intensity, pragmatic protocol to discourage patients from lying in bed would result in shorter length of stay by improving mobility. The investigators further aimed to assess the additional impact of providing a recliner chair, a safe and comfortable alternative to their bed on these outcomes. This a prospective, controlled investigation of a novel intervention intended to reduce time subjects spent lying in bed. The intervention will be conducted at Los Angeles County + University of Southern California (LAC+USC) Medical Center from March 20, 2017 through September 19, 2017. The intervention and control wards are symmetrically laid out. All wards consist of medical/surgical beds without cardiac telemetry monitoring. Subjects will be admitted per clinical routine, with bed assignments made by the bed control department, which was not aware of the study. Handouts developed at a 3rd grade level will inform subjects and their families about the risks of bed rest and encouraged the subjects to only lie in bed when they were attempting to sleep. Handouts are translated into 5 languages (Spanish, Korean, Tagalog, Mandarin, Vietnamese). Nursing staff on the intervention wards will provide these handouts to subjects and their families as part of the standard admission process. In addition, laminated reminder signs identical to the handouts will be posted on the wall opposite the head of the bed. Posters were placed in the main entrance of the study units. Half of the intervention rooms will also be provided with recliner chairs (Winco Vero Care Cliner) that were bariatrics rated to 500 pounds, vinyl-covered for facile disinfection, and had 180-degree swing arms and locking casters. The other intervention rooms and the control rooms had standard hospital chairs in addition to the hospital bed. The primary outcome measure is the difference in the length of hospital stay for admissions to intervention rooms compared to control rooms. Subjects' age and gender will be collected in order to control for these factors in the primary analysis. The Medicare Severity Diagnosis Related Group (MS DRG) relative weight for each patient will be collected to control for illness severity. As a secondary endpoint, functional status will be assessed using the "6-Clicks" objective functional scoring system. Scores will be measured at several points during the each hospitalization As a process measure, nurses will maintain a log of hours per shift that subjects spend in bed. Finally, as a safety measure, the rates of falls per 1000 patient-days will be collected. Data will be abstracted using an automated query of the electronic health record's bed management database (Cerner, Kansas City, MO). All patients who are placed on one of the study wards during the intervention period-including those admitted from the emergency department, elective medical and surgical admissions, inter-hospital transfers and intra-hospital transfers-will be included.

COMPLETED
Shifting Rehabilitation Paradigms in Skilled Nursing Facilities
Description

This study seeks to improve rehabilitation methods for restoring physical function with skilled nursing facility care. More specifically, this study is designed to evaluate the effectiveness of an intensive therapeutic rehabilitation program for older adult skilled nursing home residents compared to usual care.

TERMINATED
Improving Physical Function in Skilled Nursing Facility Residents
Description

Each year Medicare spends approximately $31.3 billion on 2.4 million skilled nursing facility (SNF) episodes of care. SNFs rely on interdisciplinary approaches to patient care to maximize rehabilitation potential for return to prior level of function and reduce the risk of adverse events in older adults. However despite a substantial increase in spending on SNF services and minimal change in complexity of the caseload, 68% of patients are below their pre-hospitalization level of function at discharge, 25% return to the community, and 18% are hospitalized. This may be partially explained by current SNF approaches to patient care which foster inactivity and participation in low intensity rehabilitation interventions (preliminary data). Both inactivity and low-intensity interventions may perpetuate further functional decline or impede maximal recovery. The serious implication of risk with functional decline is exemplified by studies which have shown declines in physical function can increase the risk of being re-hospitalized six-fold and may infer other long term effects such as increased risk for mortality, morbidity, and institutionalization. Muscle weakness, reduced cardiorespiratory reserve, and neuromuscular deficits have been attributed to this acute decline in function. However current rehabilitation strategies in SNFs do not promote adequate dose and mode of interventions to induce beneficial systemic adaptations, perhaps due to the lack of evidence on effective rehabilitation protocols for this medically-complex population. Therefore, the investigators have designed an rehabilitation program, which uniquely integrates principles of physiologic tissue overload with strengthening and functional interventions for greater gains in physical function. Data will be collected on the first cohort of patients who cycle through a SNF during Stage 1, in which usual care occurs (5 months). Then, staff training on progressive rehabilitation interventions will occur over 2 months. Finally, data will be collected on a second cohort of patients who cycle through a SNF during Stage 2, in which progressive rehabilitation is implemented by SNF staff (5 months). Given the high turnover of patients in SNFs (average length of stay \~21 days), 2 different cohorts of patients will be studied and the analysis will consist of independent 2-sample t-tests. During Stage 1 and 2, measures of physical function will be assessed on all eligible patients at admission and discharge from SNF. Therapists will be assessed on adherence to the protocol through documentation audits and use of on-site observational checklist. Acceptability of the intervention by the patients will be assessed by a patient satisfaction survey. Any adverse events will be obtained from the medical record and documented. The discharge location of all patients will be documented.

COMPLETED
Benefits of Intrahospital Exercise Program in Pediatric HSCT
Description

This randomized control study examines the effect of an intrahospital exercise regimen on the physical deconditioning that occurs due to hematopoietic stem cell transplant in the pediatric population.

RECRUITING
Advancing Rehabilitation Paradigms for Older Adults in Skilled Nursing Facilities
Description

This cluster randomized clinical trial seeks to provide large-scale, foundational evidence that high-intensity rehabilitation is effective and can be systematically implemented to improve functional outcomes for patients admitted to skilled nursing facilities following hospitalization. Additionally, this study will generate a descriptive overview of factors that predict implementation success while informing effective implementation strategies for future skilled nursing facilities innovation.

COMPLETED
Predictors of Recovery and the App-Facilitated Tele-Rehabilitation (AFTER) Program for COVID-19 Survivors
Description

The aim of this study is to investigate the feasibility (safety, adherence) and initial efficacy (physical function and patient reported outcomes) of a multicomponent tele-rehabilitation program during COVID-19 recovery of patients who have been hospitalized due to COVID-19.

RECRUITING
Multicomponent Telerehabilitation to Engage Veterans in Effective Self-Management of Complex Health Conditions
Description

Medically complex older Veterans are at greater risk for progressive declines in physical function, lower quality of life, and increasing care needs. Additionally, older Veterans experience social isolation and loneliness, and have low levels of physical activity. While the Veterans Health Administration has established programs to address rehabilitation needs, these programs tend to be diagnosis-focused, lack self-management approaches, include low-intensity rehabilitation, and typically require in-person attendance. A MultiComponent TeleRehabilitation (MCTR) program that includes high-intensity rehabilitation and self-management interventions, social support, and telehealth and technology supports may be more effective in improving and sustaining physical function for older Veterans with complex health conditions. Therefore, this project is designed to determine whether the MCTR program improves strength and physical function more effectively than traditional interventions.

COMPLETED
Engaging Medically Complex Veterans in Tele-Rehabilitation Using a Biobehavioral Approach
Description

The aims of this study are to determine the feasibility and acceptability of a multicomponent telerehabilitation program for medically complex older Veterans and to preliminarily assess participant outcomes (physical activity, physical function, quality of life, loneliness) to the program.

COMPLETED
Progressing Home Health Rehabilitation for Older Adults
Description

This research study explores the effects of a progressive, multi-component intervention following a stay in the hospital or rehabilitation facility. The purpose of this research study is to compare a multi-component intervention (higher intensity exercise, nutritional supplementation, and greater emphasis on functionally enhanced care transitions) with usual care physical therapy.

COMPLETED
Reducing Falls With RENEW in Older Adults Who Have Fallen
Description

This clinical trial will compare the effects of a high intensity Resistance Exercise via Negative Work (RENEW) vs. Traditional resistance exercise (TRAD) as part of a mult-component exercise and fall-reduction program on muscle conditioning; falling risks; as well as the fall incidence in older adults who have fallen. We anticipate that muscle conditioning will mediate the effect of RENEW on falling risks and fall incidence.

COMPLETED
Physical Therapy Using Virtual Reality/Augmented Reality
Description

The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality (VR) headset, Augmented Reality (AR) Headset) are more effective than the standard of care (i.e., no technology-based distraction) for improving clinical outcomes in patients requiring acute rehabilitation due to deconditioning and surgery. Measures will include include range of motion, gait progression, strength progression, time to first out of bed, time to first step.

ACTIVE_NOT_RECRUITING
Progressive Rehabilitation Therapy in Patients With Advanced Lung Disease
Description

The International Society of Heart and Lung Transplantation Registry data shows that there is a growing population of critically ill patients with advanced lung disease undergoing lung transplantation. The goal of our study is to evaluate the role of intensive physical therapy for patients with advanced lung disease requiring transplant or ECMO(extracorporeal membrane oxygenation)- bridge to transplant with emphasis on the restoration of functional independence and prevention of functional declines after lung transplantation. The project is a designed as a randomized prospective research study investigating the impact of a multi-modal rehabilitation program(MRP), which incorporates neuromuscular electric stimulation(NMES), strength and mobility training, and nutritional supplementation(NS) in ameliorating the loss of muscle mass and strength, and lower extremity balance, strength and coordination that will decrease time on the ventilator or ECMO, stay in the ICU and hospital.

COMPLETED
Early Progressive Mobility in the CVICU: Assessing Current Status
Description

The current study is proposed to assess the frequency and type of progressive mobility procedures currently performed in the CVICU The study will evaluate the type and frequency of progressive mobility orders, whether or not progressive mobility steps are being taken by the nursing teams, define what steps patients are receiving, and record time to first weight bearing. Other outcome measures will be the days of required mechanical ventilation, and current ICU length of stay and cost to treat.

COMPLETED
Home Telerehabilitation for Deconditioned Older Adults
Description

The purpose of this study is to develop a home exercise program for patients 60 years of age and over who are deconditioned following their discharge from the hospital, or recruited from GLA outpatient clinics. The program will be designed to monitor and improve patients' exercise behavior through the use of home technology, such as text messaging monitors.

Conditions
COMPLETED
Evaluating Muscle Function After Ankle Surgery
Description

Patients who are forced to rest or reduce activity as a result of illness, injury, or surgery often experience resulting muscle weakness. This study will evaluate muscle features and muscle strength in patients who are recovering from surgery for broken ankles. The goal of this study is to improve the recovery of muscle function and overall ability after prolonged periods of ankle inactivity due to surgery.

COMPLETED
Safety and Feasibility of a Novel In--Bed Resistance Training Device in Elderly Inpatients
Description

The purpose of this study is to decrease deconditioning of elderly inpatients in acute care institutions and to assess the safety and feasibility of a newly developed resistance training device. Investigators believe this device will help hospitalized seniors maintain their independence by preventing the loss of functionality from deconditioning and improve value of care through decreased length of stay and utilization of care. Current therapy will be complemented with a new in--bed resistance training device to target weak elderly patients and standardize progressive resistance training in facilities.

COMPLETED
Treadmill Exercise Prescriptions to Improve Fitness Versus Ambulatory Function After Stroke.
Description

Individuals disabled by stroke are at risk of losing cardiovascular fitness and muscle due to disease. This worsens disability and can increase the risk of having another stroke or a heart attack. We would like to find out if and how different types of regular exercise (intense walking, long walking) can increase fitness, balance and improve walking function and activities of daily living in individuals who have suffered a stroke.

Conditions