Clinical trial NCT06607913: Exercise and Monitoring With Post-Hospitalization Muscle Atrophy to Sustain Intrinsic Capacity and Strength
Official title: BCCMA: Recovery of Aged Muscle After Disuse Atrophy (REMEDY): Exercise and Monitoring With Post-Hospitalization Muscle Atrophy to Sustain Intrinsic Capacity and Strength (EMPHASIS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease (CKD)
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2024-09-23
Enrollment: 250
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel study design features a Cohort Arm who will undergo regular assessments and observations for a minimum of 2 years. Participants who are hospitalized during the course of the study will undergo random assignment to an Exercise Group or a Usual Care group for 16-weeks.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

Aim 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.

Aim 3: Evaluate a supervised flywheel exercise program against usual care. Both groups are expected to improve, with the supervised group have better results.

Eligibility criteria: Inclusion Criteria:

* Age \> 55 years
* Diagnosis of stage 3-4 CKD or an eGFR of \<45 mL/min/1.73m2

Exclusion Criteria:

* Cardiovascular risk: Poorly controlled hypertension (\>160/100)

  * 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)

Primary outcomes:
measure: Vastus Lateralis Muscle Thickness
timeFrame: 4 month, 10 month
measure: Function
timeFrame: 4 month, 10 month
measure: Lower Extremity Strength - Isometric Strength
timeFrame: 4 month, 10 month
measure: Upper Extremity Strength - Grip Strength
timeFrame: 4 month, 10 month
Secondary outcomes:
measure: Rectus Femoris Muscle Thickness
timeFrame: 4 month, 10 month
measure: Bicep Brachii Muscle Thickness
timeFrame: 4 month, 10 month
measure: Middle Deltoid Muscle Thickness
timeFrame: 4 month, 10 month
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
state: Colorado
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
Study officials:
affiliation: Rocky Mountain Regional VA Medical Center, Aurora, CO
name: Michael Harris-Love, DSc MPT BS
role: PRINCIPAL_INVESTIGATOR
References: