Exercise and Monitoring With Post-Hospitalization Muscle Atrophy to Sustain Intrinsic Capacity and Strength (EMPHASIS)

BCCMA: Recovery of Aged Muscle After Disuse Atrophy (REMEDY): Exercise and Monitoring With Post-Hospitalization Muscle Atrophy to Sustain Intrinsic Capacity and Strength (EMPHASIS)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease (CKD)
• Intervention / Treatment: Other: Exercise

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.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Harris-Love, DSc MPT BS; Phone Number: (720) 857-2802; Email: MICHAEL.HARRIS-LOVE@CUANSCHUTZ.EDU
• Study Contact Backup: Name: Katie Boncella, MS; Phone Number: (303) 724-0687; Email: katie.boncella@va.gov

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045-7211
      • Recruiting
      • Rocky Mountain Regional VA Medical Center, Aurora, CO
      • Contact: Michael Harris-Love, DSc MPT BS; Phone Number: (720) 857-2802; Email: MICHAEL.HARRIS-LOVE@CUANSCHUTZ.EDU
      • Principal Investigator: Michael Harris-Love, DSc MPT BS
      • Contact: Katie Boncella, MS; Phone Number: 303-724-0687; Email: katie.boncella@va.gov
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
      • Contact: Rhianna Patel, MS; Phone Number: 55393 410-605-7000; Email: rhianna.patel@va.gov
      • Contact: Odessa Addison, PhD; Phone Number: 55393 4106057000; Email: odessa.addison@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: Usual Care; Participants will not have any study intervention visits for usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 month, 10 month
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
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.	4 month, 10 month
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.	4 month, 10 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 month, 10 month
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.	4 month, 10 month
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.	4 month, 10 month

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Michael Harris-Love, DSc MPT BS, Rocky Mountain Regional VA Medical Center, Aurora, CO

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: CAMM-005-23F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No