Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

patients managed with an electronic chest drainage system

patients managed with a traditional analogue chest drainage system

Patients in the intervention arm are connected to Thopaz, electronic drainage system immediately after closure of the chest, patients in the control group are connected to a traditional system. Chest tubes in both groups are then connected to suction of -20 cmH2O and maintained at that level until post-operative day #1.

On the morning of post-operative day #1, presence of air leak will be recorded on suction. Then, suction will be decreased to -8 cmH2O (so-called water seal). At that time, management of chest tube drainage and decision for chest tube removal will be dictated by clinical signs, symptoms, and surgeon preference following the standard clinical algorithm for post-operative care of general thoracic patients

electronic chest drainage system

Cecilia Pompili, MD

This study is designed to compare the Thopaz chest tube drainage system to the traditional collection chamber system. The Thopaz system is already in clinical use in the United States and throughout the world. As such, this study is not evaluating safety or efficacy of this system both of which have already been demonstrated. This study's primary aim is to determine whether the use of a digital chest drainage system compared with a traditional system affects duration of chest drainage and length of hospital stay.

Furthermore, we aim to determine whether the use of a digital chest drainage system compared with a traditional system increases the total distance of ambulation in the first 48 hours after thoracic surgery and affects overall patient satisfaction in the peri-operative period.

Finally, we want to determine whether the aforementioned outcomes relative to the chest tube drainage systems differ in different parts of the world.

Objective and Subjective Outcomes of an Electronic Chest Drainage System

Objective and Subjective Outcomes of an Electronic Chest Drainage System Versus Traditional Devices: a Randomized Comparison

The Leeds Teaching Hospitals NHS Trust

The University of Hong Kong

Yale University

Ospedali Riuniti Ancona

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Nervous System Diseases

Musculoskeletal Diseases

Heart and Blood Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Diabetes Mellitus

Kidney Failure, Chronic

Renal Insufficiency

Parkinson Disease

Arthritis

Frailty

Peripheral Arterial Disease

Peripheral Vascular Diseases

Mobility Limitation

Vascular Diseases

Parkinsonian Disorders

Ganglion Cysts

Synovial Cyst

Basal Ganglia Diseases

Brain Diseases

Central Nervous System Diseases

Movement Disorders

Synucleinopathies

Neurodegenerative Diseases

Kidney Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Atherosclerosis

Arteriosclerosis

Arterial Occlusive Diseases

Renal Insufficiency, Chronic

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

This group will be provided with a pair of New Balance 813 shoes plus a custom made MBB AFO for the duration of the study.

This group will be provided with a pair of New Balance 813 shoes for the duration of the study.

Subjects will be provided with a pair of New Balance 813 shoes plus a custom made MBB AFO

MBB AFO

Subjects will be provided with a pair of New Balance 813 shoes

Control

The investigators propose a randomized control trial to evaluate long term effects and effectiveness of Moore Balance Brace (MBB) ankle foot orthoses (AFO) in reducing risk of falling in older adults.

Primary Endpoints • Characterize the impact of MBB AFO on balance, gait, risk of falling, frailty status, and adverse events

Secondary Endpoints • Characterize the Impact of MBB AFO on spontaneous daily physical activities • Characterize the feasibility of the MBB AFO device on patient adherence, acceptability, user-friendliness, and perception of benefit for daily usage

OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO

Only de-identified data and associated results will be published in peer-reviewed papers or scientific abstracts

Hip sway (motion of hip joints in three dimensions) measured by wearable sensors while wearing their own shoes compared to the orthopedic shoes and compared to orthopedic shoes plus Ankle-Foot Orthosis (AFO)

Ankle sway (motion of ankle joint in three dimensions) measured by wearable inertial sensors while wearing their own shoes compared to the orthopedic shoes and compared to orthopedic shoes plus Ankle-Foot Orthosis (AFO)

Center of Mass (COM) sway measured by wearable inertial sensors while wearing their own shoes compared to the orthopedic shoes and compared to orthopedic shoes plus Ankle-Foot Orthosis (AFO)

The adherence of participants to the prescribed Ankle-Foot Orthosis (AFO) plus walking shoes was quantified using the response to a self-reported question ("How many hours per day did you wear the prescribed footwear?").

Concern for falling is quantified by Falls Efficacy Scale - International (FES-I) questionnaire. Scores range from minimum 16 (no concern about falling) to maximum 64 (severe concern about falling). Higher score indicate worse performance.

Physical activity level for 24 hours while wearing their own shoes compared to the walking shoes and compared to walking shoes plus Ankle-Foot Orthosis (AFO). To quantify physical activity, number of taken steps per day was monitored using a pendant wearable sensor called, PAMSys (Biosensics, MA, USA).

Number of participants with adverse events reported during the study. Adverse events was inquired at 1 months, 3 months, 6 months, 12 months after the baseline, and summed at 12 months. If the participant has at least one adverse event reported in any assessed time frame, the participant will be categorized as the participant with adverse event.

The participants perceived usefulness of ease of use of wearing Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) based on questionnaires of A technology acceptance model (TAM). Perceived usefulness was assessed using two questions (i.e., "I feel more stable when standing," and "I feel more stable when walking"). Perceived ease of use was assessed using two questions (i.e., "Was easy to take on and off," and "Was comfortable to wear"). The Likert scale (6-point scale from 0-5) was used to quantify how much they disagreed with each statement, including "strongly disagree," "disagree," "somewhat disagree," "somewhat agree," "agree," and "strongly agree," respectively. In this paper, responses were only categorized as positive (3-5 points) or negative (0-2 points) attitudes towards the use of AFO plus walking shoes.

stride velocity measured in single-task walking with normal speed

stride time measured in single task walking with normal speed

stride length measured in single-task walking with normal speed

Orthotic Holdings, Inc.

Bijan Najafi, PhD

Professor of Surgery

Incident of falls related to footwear/AFO, pain, and other relevant adverse events such as callus, foot ulcers, etc

This group will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) for the duration of the study.

Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO): Subjects will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO)

Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group

This group will be provided with a pair of New Balance 813 shoes for the duration of the study.

Control: Subjects will be provided with a pair of New Balance 813 shoes

No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Prof.Bijan Najafi

Repeated measures to compare changes in two groups from baseline to 6 months

Baseline

@6Month

Some participants in AFO and No AFO groups withdrew from study in 6 months. Mixed Model Analysis can handle such missing data

Hip Sway Change From Baseline to 6 Months

Repeated measures to compare the changes in both groups from baseline to 6 months

Ankle Sway Change From Baseline to 6 Months

Center of Mass (COM) Sway Change Baseline to 6 Months

Adherence (Hours Per Day to Wear Ankle-Foot Orthosis (AFO))

Repeated measures to compare the changes of both groups from pre-intervention to post-intervention year.

@12Month

Some participants in AFO and No AFO groups withdrew from study in 6 and 12 months. Generalized Estimating Equation Analysis can handle such missing data

Fall Incidents

Repeated measures to compare the changes between groups from baseline to 6 months

This group will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) for the duration of the study.

Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) : Subjects will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO)

Concern for Falling Change Form Baseline to 6 Months

Physical Activity Level

Number of Participants With Adverse Events

perceived usefulness

perceived ease of use

Percentage of Participants Who Found the Device Useful and Easy to Use

6 months

Stride Velocity

Stride Time

Stride Length

Overall Study

Pre-operative: Participants will receive weekly sessions of higher level, task-specific transfer training. All MAT participants will learn the GCS set of exercises chosen to activate core muscles and lessen decline in core strength. These sessions will be supplemented by a home-based walking and physical activity enhancement program of the participants' choosing, focusing on attaining a safe community-based rate of perceived exertion. A pedometer and home exercise log will be used to encourage compliance and advance activities.

Post-operative: Participants will be screened by physical therapy for standard physical therapy with focus on early mobilization. The GCS exercises taught pre-operatively will be reinstituted.

Post-discharge/home: Participants will continue the GCS program and begin to return to elements of their pre-operative home-based MAT program. The program physical therapist will call weekly to review progress.

Pre-operative: Participants will be given the National Institute on Aging guide to home-based exercise but no further instruction or incentive for walking or physical activity enhancement.

Post-operative: Participants will be screened by in-hospital physical therapy for standard physical therapy with focus on early mobilization. Those who do not receive physical therapy will not be given any additional training, as is standard for reimbursed hospital services.

Post-discharge: Program nurse will call weekly to provide health education but no instruction or incentives for mobility or physical activity enhancement.

Pre-operative: Transfer training: bed and chair transferring exercises rising with and without use of hand assistance including supine to sit in or to the side in bed, and sit to stand from a normal and low height chair. GCS exercises: 1) supine pelvic bracing with transverse abdominal recruitment 2) hip bridges with abductor squeeze 3) supine bent leg abduction with light theraband and 4) supine isometric core and pelvic stabilization with legs flexed and shoulder flexion to raise arms over head with advancement to using theraband. For patients able to stand safely 5) standing mini squats against the wall.

Post-operative: Early mobilization to include standard physical therapy techniques to enhance bed mobility, facilitated sit to stand and walking with therapist assist as needed. All GCS exercises begin 24 hr post op with goal of 5-10 reps and progressing to 3 sets of 10 reps. Participants will be encouraged to move from a roll to the side first supine to sit strategy by week 2.

Mobility and Activity Training

Michael J Englesbe, MD

Neil Alexander, MD

Angela E Thelen, BS

In this pilot study a group of older adults undergoing midline laparotomy for gastrointestinal malignancy will participate in a mobility and activity training (MAT) program. MAT is designed to advance functional mobility and physical activity and spans the pre-operative, inpatient, and post-operative period. Patients undergoing abdominal surgery will be randomized to MAT versus control usual care and evaluated at their first appointment 4 weeks preoperatively (baseline), immediately prior to surgery, on hospital discharge, and 6 weeks post operatively. We hope to prove that abdominal surgery patients undergoing MAT will show less decline and earlier recovery in functional activity, and trunk and thigh muscle strength mass. This study is uniquely innovative in that it links functional activity assessment and training and analysis of trunk morphomics (muscle mass) in exploring mechanisms of post-operative recovery. Results from this pilot will be used to determine an effect size for the recruitment of a larger cohort and to study key surgical outcomes, including surgical complications, operative symptoms, hospital length of stay, and cost of care.

Older and sicker patients are at increased risk of poor surgical outcomes, with more complications, longer lengths of stay, more utilization of skilled nursing facilities, increased mortality, and high costs when compared with younger and healthier patients undergoing similar procedures. In addition, more high-risk patients are having surgery, as overall surgical volumes are predicted to increase up to 47% (from 2000 to 2020). Within this context, efforts to improve surgical quality among high-risk patients have become of paramount importance and new proven strategies to improve surgical outcomes are needed.

Work by the PI Englesbe suggests that trunk muscle lean mass is strongly associated with poor surgical outcomes, suggesting an independent link between muscle loss (sarcopenia) and surgical outcome, even when controlling for comorbidity and functional impairment. Furthermore, their work notes that trunk muscle mass declines rapidly in the peri-operative period. Whether exercise interventions can remediate this risk is unknown. Few randomized control trials exist that address whether pre-operative exercise interventions can alter eventual post-operative outcomes, and none focus on training the trunk musculature in abdominal surgery patients. Further, trunk musculature is critical for mobilization and several published trials (such as in an intensive care unit) suggest that early mobilization is associated with improved outcomes. Thus, the link between reduction in muscle loss via exercise and improved mobility in post-surgical patients remains to be proven but seems promising. Co-PI Alexander has extensive experience in studies of mobility task assessment and enhancement in able and disabled adults. Of particular relevance to the present proposal are studies of rising from a bed (supine to sit) and from a chair (sit to stand) and the improvement that can be noted, using a task-specific approach in older adults at risk for mobility impairment. His most recent funded investigations focus on home-based mobility and physical activity enhancement.

We propose to pilot study a group of older adults undergoing midline laparotomy for gastrointestinal malignancy and who participate in a mobility and activity training (MAT) program. MAT is designed to advance functional mobility and physical activity and spans the pre-operative, inpatient, and post-operative period. Patients undergoing abdominal surgery will be randomized to MAT versus control usual care and evaluated at their first appointment 4 weeks preoperatively (baseline), immediately prior to surgery, on hospital discharge, and 6 weeks post operatively. We hope to prove that abdominal surgery patients undergoing MAT will show less decline and earlier recovery in functional activity, and trunk and thigh muscle strength mass. This study is uniquely innovative in that it links functional activity assessment and training and analysis of trunk morphomics (muscle mass) in exploring mechanisms of post-operative recovery. Results from this pilot will be used to determine an effect size for the recruitment of a larger cohort and to study key surgical outcomes, including surgical complications, operative symptoms, hospital length of stay, and cost of care.

Primary Aim 1: To determine the changes in extent of decline and in recovery of functional activity, strength, and muscle mass resulting from activity training (MAT) Primary hypothesis: Abdominal surgery patients randomized to MAT, as opposed to usual care controls (UC) and compared to their baseline evaluation 4 weeks pre-operatively, will have reduced loss of functional activity and reduced loss of muscle strength and mass in the trunk and thigh 6 weeks post-operatively.

Secondary Aim 1: To determine the effects of individual MAT program segments provided pre-operatively, in-hospital, and post-hospital discharge Secondary hypothesis: Abdominal surgery patients randomized to MAT, as opposed to UC, will have reduced loss of functional activity and reduced loss of muscle strength and mass in the trunk and thigh when comparing 1) baseline versus surgical admission; 2) surgical admission versus hospital discharge; and 3) hospital discharge versus post-operative follow-up at 6 weeks.

Exploratory Aim: To determine the effect of MAT on surgical complications, operative symptoms, hospital length of stay and peri-operative cost.

Exploratory hypothesis: Abdominal surgery patients randomized to peri-operative MAT, as opposed to UC, will have reduced surgical complications, fewer operative symptoms, shorter hospital length of stay, and lower cost of care.

Mobility and Activity Training (MAT) to Optimize Outcomes for Older Adult Abdominal Surgery Patients

An additional exploratory aim of this study is to determine the effect of MAT on surgical complications. We predict that abdominal surgery patients randomized to peri-operative MAT, as opposed to UC, will have reduced surgical complications.

An additional exploratory aim of this study is to determine the effect of MAT on peri-operative cost. We predict that abdominal surgery patients randomized to peri-operative MAT, as opposed to UC, will have lower cost of care

An additional exploratory aim of this study is to determine the effect of MAT on operative symptoms. We predict that abdominal surgery patients randomized to peri-operative MAT, as opposed to UC, will have fewer operative symptoms.

An additional exploratory aim of this study is to determine the effect of MAT on hospital length of stay. We predict that abdominal surgery patients randomized to peri-operative MAT, as opposed to UC, will have shorter hospital length of stay.

Participants randomized to MAT, as opposed to usual care controls (UC), will undergo physical therapy training as described in the intervention arm. The physical therapy will be used to assess functional activity and strength. Patients randomized into the MAT group will be compared to their baseline evaluation 4 weeks pre-operatively and the patients randomized into the UC group. We predict MAT study participants will have reduced loss of functional activity and reduced loss of muscle strength 6 weeks post-operatively.

Abdominal surgery patients will undergo 3-4 CT scans at baseline, pre-operatively, at hospital discharge, and at 6 weeks post-operatively. The CT scans will be used to measure changes in muscle mass. We predict MAT study participants will have reduced loss of muscle strength and mass in the trunk and thigh 6 weeks post-operatively.

We hope to determine the effects of the individual MAT program segments provided pre-operatively, in-hospital, and at post-hospital discharge. Using the CT scans and physical therapy training and assessments, we will compare muscle mass and strength between each individual segment of the program. We predict that abdominal surgery patients randomized to MAT, as opposed to UC, will have reduced loss of functional activity and reduced loss of muscle strength and mass in the trunk and thigh when comparing 1) baseline versus surgical admission; 2) surgical admission versus hospital discharge; and 3) hospital discharge versus post-operative follow-up at 6 weeks.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Objective and Subjective Outcomes of an Electronic Chest Drainage System	NCT01747889	Lung Cancer	electronic ches...	18 Years - 90 Years	Ospedali Riuniti Ancona
Objective and Subjective Outcomes of an Electronic Chest Drainage System	NCT01747889	Lung Cancer	electronic ches...	18 Years - 90 Years	Ospedali Riuniti Ancona
OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO	NCT02819011	Accidental Fall... Fall Due to Los... High Risk of Fa... Diabetes Arthritis Cancer Peripheral Arte... Parkinson's Dis... End Stage Renal...	MBB AFO Control	65 Years -	Baylor College of Medicine
Mobility and Activity Training (MAT) to Optimize Outcomes for Older Adult Abdominal Surgery Patients	NCT02007876	Gastrointestina...	Mobility and Ac...	60 Years -	University of Michigan

Spots Global Cancer Trial Database for mobility

Every month we try and update this database with for mobility cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mobility

Every month we try and update this database with for mobility cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mobility cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.