[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06607913":3,"trial-entities:NCT06607913":128,"trial-summary:NCT06607913":132},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":34,"secondary_outcomes":48,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":77,"locations":80,"central_contacts":120,"overall_officials":124,"references":126,"see_also_links":127},"NCT06607913","CAMM-005-23F","Exercise and Monitoring With Post-Hospitalization Muscle Atrophy to Sustain Intrinsic Capacity and Strength","BCCMA: Recovery of Aged Muscle After Disuse Atrophy (REMEDY): Exercise and Monitoring With Post-Hospitalization Muscle Atrophy to Sustain Intrinsic Capacity and Strength (EMPHASIS)","RECRUITING","2029-09-30","2026-03","2026-04-07","2025-04-11","VA Office of Research and Development","FED",true,"The aging Veteran population has more frequent inpatient hospitalization than non-Veterans. In addition, older Veterans have an inability to fully recover muscle mass and function after hospital-acquired weakness. The problem of hospital-acquired weakness is greatly increased in at-risk Veteran populations such as those with chronic kidney disease (CKD). The purpose of this collaborative study involving Denver and Baltimore VAMC sites is to improve health through the detection and rehabilitation management of hospital-acquired weakness in those with CKD. The study goals include identifying and monitoring the optimal muscle assessment sites in clinical settings, examining how muscle health impacts length of hospital stay and physical resilience, and determining how home-based and supervised exercise comparatively addresses post-hospitalization physical resilience using performance tests and Veteran feedback.","This condition, known as disuse muscle atrophy, poses a substantial challenge to the health and well-being of individuals, particular those hospitalized. To tackle this problem , the project focuses on a specific group of individuals particularly vulnerable to this issues: Veterans with chronic kidney disease (CKD). This disease affects a substantial population of over 500,000 Veterans, leading to a progressive decline in mobility, unfavorable changes in lean body mass, and heightened hospitalization rates. To comprehensively address this concern, the project indents to develop and implement assessment and intervention strategies tailored to the target cohort's needs. By concentrating on Veterans with CKD, the project seeks to generate approaches that can be widely applied to address muscle atrophy among individuals with similar conditions. To achieve this, the project twill commence by establishing a baseline cohort of Veterans with Stage 3 and 4 CKD at two distinct Veterans Affairs sites located in Denver and Baltimore. Upon enrollment, the Veterans muscles health will be assessed, encompassing various dimensions such as strength, lean muscle mass, muscle composition, mobility, and intrinsic capacity. This comprehensive evaluation will provide a snapshot of their pre-hospitalization muscle health. Subsequently, the enrolled Veterans will be closely monitored for at least two years. The project's approach involves conducting regular assessments of their muscle health every six months. Additionally, the participating Veterans will provide information about their strength and functional status every quarter, facilitated through a smartphone application. A particular noteworthy aspect of the project is its inclusion of a pragmatic rehabilitation intervention trail. Veterans who experience hospitalization during the study will have the opportunity to participate in this trial. They will be assigned to either a supervised flywheel strengthening exercise group or receive usual care over 16 weeks. This intervention trial aims to assess the effective ness of targeted exercise in mitigating the effects of disuse muscle atrophy post-hospitalization. The overarching design of the project encompasses three main objectives:\n\nAim 1: Identify effective muscle assessment sites for disuse muscle atrophy. Aim 2: Assess if standardized intrinsic capacity and physical resilience assessments predict hospital outcomes. The investigators anticipate that physical resilience scores will improve hospitalization and strength outcomes predictions.\n\nAim 3: Evaluate a supervised flywheel exercise program against usual care. Both groups are expected to improve, with the supervised group have better results.",[19],"Chronic Kidney Disease (CKD)",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},250,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"OTHER","Exercise","The participants will exercise 2 days a week for 16 weeks. The exercises will include 4 movements: squats, shoulder press, seated row, and bicep curl focusing on internal load and contraction velocity.",[31],[35,39,42,45],{"measure":36,"description":37,"timeFrame":38},"Vastus Lateralis Muscle Thickness","A measure of the Vastus Lateralis muscle will be examined using ultrasound technology to determine the muscle size, quality, and composition. Post-intervention levels will be compared to 6 months after the cessation of the intervention.","4 month, 10 month",{"measure":40,"description":41,"timeFrame":38},"Function","The short physical performance battery test is a function measure that utilizes 3 tasks scores 0-4 (total possible score of 12) to determine functional status and lower extremity function. Pre-test scores will be compared to post intervention test scores.",{"measure":43,"description":44,"timeFrame":38},"Lower Extremity Strength - Isometric Strength","A measures of maximal isometric muscle strength produced in knee extensor muscles will be assessed with a Biodex device. Post-intervention levels will be compared to 6 months after the cessation of exercise.",{"measure":46,"description":47,"timeFrame":38},"Upper Extremity Strength - Grip Strength","A measures of maximal isometric muscle strength produced in upper extremity muscles will be assessed by grip strength. Post-intervention levels will be compared to 6 months after the cessation of exercise.",[49,52,55],{"measure":50,"description":51,"timeFrame":38},"Rectus Femoris Muscle Thickness","A measure of the Rectus Femoris muscle will be examined using ultrasound technology to determine the muscle size, quality, and composition. Post-intervention levels will be compared to 6 months after the cessation of the intervention.",{"measure":53,"description":54,"timeFrame":38},"Bicep Brachii Muscle Thickness","A measure of the Bicep Brachii muscle will be examined using ultrasound technology to determine the muscle size, quality, and composition. Post-intervention levels will be compared to 6 months after the cessation of the intervention.",{"measure":56,"description":57,"timeFrame":38},"Middle Deltoid Muscle Thickness","A measure of the Middle Deltoid muscle will be examined using ultrasound technology to determine the muscle size, quality, and composition. Post-intervention levels will be compared to 6 months after the cessation of the intervention.","ALL","55 Years",null,false,{"inclusion":63,"exclusion":66,"raw_text":76},[64,65],"Age \\> 55 years","Diagnosis of stage 3-4 CKD or an eGFR of \\\u003C45 mL\u002Fmin\u002F1.73m2",[67,68,69,70,71,72,73,74,75],"Cardiovascular risk: Poorly controlled hypertension (\\>160\u002F100)","Coronary event in past 6 months","Class III or IV CHF","symptomatic angina at rest or during exercise","Syncope in past year, without known resolution of cause","COPD requiring home oxygen","Contraindications to resistance training, including history of intracranial or retinal bleeding; Diabetes with active proliferative retinopathy","History of significant spinal osteoarthritis or spinal stenosis","Dementia (on medical record review or mini-mental status exam score)","Inclusion Criteria:\n\n* Age \\> 55 years\n* Diagnosis of stage 3-4 CKD or an eGFR of \\\u003C45 mL\u002Fmin\u002F1.73m2\n\nExclusion Criteria:\n\n* Cardiovascular risk: Poorly controlled hypertension (\\>160\u002F100)\n\n  * Coronary event in past 6 months\n  * Class III or IV CHF\n  * symptomatic angina at rest or during exercise\n  * Syncope in past year, without known resolution of cause\n* COPD requiring home oxygen\n* Contraindications to resistance training, including history of intracranial or retinal bleeding; Diabetes with active proliferative retinopathy\n* History of significant spinal osteoarthritis or spinal stenosis\n* Dementia (on medical record review or mini-mental status exam score)",[78,79],"ADULT","OLDER_ADULT",[81,102],{"facility":82,"status":8,"city":83,"state":84,"zip":85,"country":86,"contacts":87,"geoPoint":99},"Rocky Mountain Regional VA Medical Center, Aurora, CO","Aurora","Colorado","80045-7211","United States",[88,93,97],{"name":89,"role":90,"phone":91,"email":92},"Katie Boncella, MS","CONTACT","303-724-0687","katie.boncella@va.gov",{"name":94,"role":90,"phone":95,"email":96},"Michael Harris-Love, DSc MPT BS","(720) 857-2802","MICHAEL.HARRIS-LOVE@CUANSCHUTZ.EDU",{"name":94,"role":98},"PRINCIPAL_INVESTIGATOR",{"lat":100,"lon":101},39.72943,-104.83192,{"facility":103,"status":8,"city":104,"state":105,"zip":106,"country":86,"contacts":107,"geoPoint":117},"Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD","Baltimore","Maryland","21201",[108,113],{"name":109,"role":90,"phone":110,"phoneExt":111,"email":112},"Rhianna Patel, MS","410-605-7000","55393","rhianna.patel@va.gov",{"name":114,"role":90,"phone":115,"phoneExt":111,"email":116},"Odessa Addison, PhD","4106057000","odessa.addison@va.gov",{"lat":118,"lon":119},39.29038,-76.61219,[121,122],{"name":94,"role":90,"phone":95,"email":96},{"name":89,"role":90,"phone":123,"email":92},"(303) 724-0687",[125],{"name":94,"affiliation":82,"role":98},[],[],{"nct_id":4,"conditions":129,"biomarkers":131},[130],"Chronic Kidney Disease",[],{"nct_id":4,"found":15,"summary":133,"prompt_version":143},{"design":134,"status":135,"heading":136,"summary":137,"follow_up":138,"word_count":139,"commitments":140,"compensation":141,"drugs_mentioned":142},"This interventional study plans to enroll 250 participants. It is not specified if it is randomized or blinded.","completed","Exercise and Monitoring for Muscle Weakness in CKD","This study is for Veterans aged 55 and older with stage 3 or 4 chronic kidney disease (CKD), which means their kidneys aren't working as well as they should. It aims to help people who experience muscle weakness after being in the hospital. Participants will do exercises two days a week for 16 weeks, focusing on squats, shoulder presses, seated rows, and bicep curls. Researchers will measure muscle thickness, function, and strength at 4 and 10 months to see if the exercise program helps. You cannot join if you have uncontrolled high blood pressure, a recent heart event, severe heart failure, or certain other health issues. The study is currently recruiting 250 participants at VA sites in Denver and Baltimore.","Participants will be followed for at least 10 months after starting the study, with measurements taken at 4 and 10 months.",120,"Participants will exercise two days a week for 16 weeks. Muscle health, strength, and mobility will be assessed at the start, and then at 4 and 10 months.","Not stated in the trial record.",[31],"v2"]