Recruiting

Combination Exercise

Sponsor:

VA Office of Research and Development

Code:

NCT04397159

Conditions

Chronic Kidney Disease Predialysis

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

Combination Exercise

Study Details

Brief summary:

The VA health care system uses a health promotion-focused model which aims to provide longitudinal care through a patient-aligned care team for Veterans with chronic kidney disease. Since the largest subpopulation of Veterans with chronic kidney disease is comprised of those not requiring dialysis, neuromuscular screening assessments may provide valuable information regarding an individual overall health status and potential for future complications. Furthermore, identifying at risk individuals early in the disease process will allow for the prescription of timely interventions. Exercise strategies such as combination exercise, which uses flywheel resistance plus aerobic exercise, may provide a valuable treatment option for combating neuromuscular dysfunction and functional decline in patients with chronic kidney disease.

Conditions

Chronic Kidney Disease Predialysis

Study ID

NCT04397159

Start date

Jun 1, 2022

Status verified date

Mar, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Ambulatory (with or without a gait aid), 50 years of age or older diagnosed with chronic kidney disease (CKD) stages 3 \& 4 predialysis (as defined by eGFR 59-15 ml/min per 1.73m2)
  • Control group will include ambulatory individuals without clinical evidence of kidney disease (defined by eGRF >60 ml/min per 1.73m2) within the last 12-months
  • All participants must be able to speak and read English, and demonstrate orientation to person, place, and time

Exclusion Criteria:

  • adults diagnosed with acute renal failure/injury within the last 12-months
  • non-ambulatory individuals
  • adults who do not use the DC VAMC as their main site for renal care
  • those who have any uncontrolled cardiovascular
  • musculoskeletal disease
  • or other conditions that, in the opinion of the principal investigator, could make participation in the study unsafe
  • any orthopedic or joint pain which would prevent the participant from safely engaging in the study protocol
  • additionally, individuals with plans to relocate from the DC metro area within one year will not be eligible for the intervention portion of the study

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Combination Exercise

Flywheel resistance exercise plus aerobic exercise

no intervention: Standard-of-care

Participants will maintain standard-of-care and current activity levels during the course of the study.

Interventions

Combination Exercise

Flywheel Resistance Plus Aerobic Exercise

Primary outcome measure

  • change in knee extensor fatigability [ Time Frame: week 6 and 12 ]
  • change in perceived fatigability [ Time Frame: week 6 and 12 ]
  • change in muscle blood flow [ Time Frame: week 6 and 12 ]

Central Contacts and Locations

Central contacts

Jared M Gollie, PhD

(202) 745-8000Jared.Gollie@va.gov

Locations

Washington DC VA Medical Center, Washington, DC

Recruiting

Washington D.C., District of Columbia, United States, 20422-0001

Contacts

Jared M Gollie, PhD

202-745-8000Jared.Gollie@va.gov

Principal Investigator:

Jared M. Gollie, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Keywords

  • fatigability
  • strength
  • rehabilitation
  • eccentric exercise
  • combination exercise

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 2026-03-12.