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

NCT06607913 | Recruiting DMC

• 1 other identifier: CAMM-005-23F
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Kidney Disease (CKD)

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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 Outcomes (3)

• Rectus Femoris Muscle Thickness

  4 month, 10 month

• Bicep Brachii Muscle Thickness

  4 month, 10 month

• Middle Deltoid Muscle Thickness

  4 month, 10 month

Study Arms (2)

Exercise

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

Participants will not have any study intervention visits for usual care.

Interventions

Exercise OTHER

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.

Exercise

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

NOT YET RECRUITING

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Michael Harris-Love, DSc MPT BS

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Harris-Love, DSc MPT BS

CONTACT

(720) 857-2802; MICHAEL.HARRIS-LOVE@CUANSCHUTZ.EDU

Katie Boncella, MS

CONTACT

(303) 724-0687; katie.boncella@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: April 11, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2029
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)