Recruiting

Exercise

Sponsor:

VA Office of Research and Development

Code:

NCT06607913

Conditions

Chronic Kidney Disease (CKD)

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Exercise

Study Details

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)

Study ID

NCT06607913

Start date

Apr 11, 2025

Status verified date

Mar, 2026

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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 Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

no intervention: Usual Care

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

Interventions

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.

Primary outcome measure

  • Vastus Lateralis Muscle Thickness [ Time Frame: 4 month, 10 month ]
  • Function [ Time Frame: 4 month, 10 month ]
  • Lower Extremity Strength - Isometric Strength [ Time Frame: 4 month, 10 month ]
  • Upper Extremity Strength - Grip Strength [ Time Frame: 4 month, 10 month ]

Central Contacts and Locations

Central contacts

Michael Harris-Love, DSc MPT BS

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

Katie Boncella, MS

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

Locations

Rocky Mountain Regional VA Medical Center, Aurora, CO

Recruiting

Aurora, Colorado, United States, 80045-7211

Contacts

Katie Boncella, MS

303-724-0687katie.boncella@va.gov

Michael Harris-Love, DSc MPT BS

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

Principal Investigator:

Michael Harris-Love, DSc MPT BS

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

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Rhianna Patel, MS

410-605-7000rhianna.patel@va.gov

Odessa Addison, PhD

4106057000odessa.addison@va.gov

More Information

Sponsor

VA Office of Research and Development

Last update posted

Apr 7, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-04-07.