Improving physical function in older adults with advanced chronic kidney disease
Enhancing Physical Function in Older Adults With Chronic Kidney Disease (EPIC): A Pilot Randomized Controlled Trial
NA · Wake Forest University Health Sciences · NCT06738394
We will try a 12-week high-velocity resistance training program to see if it safely improves muscle power and physical function in mobility-limited older adults with advanced chronic kidney disease.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 65 Years to 100 Years |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences (other) |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT06738394 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial will enroll mobility-limited older adults with advanced CKD to compare a 12-week high-velocity resistance training (HVRT) program against an attention control of weekly healthy-lifestyle group sessions. The HVRT group will perform low-load, functional movements performed "as fast as possible" to target muscle power, while the control group receives education and social contact. The trial focuses on feasibility and safety and will collect preliminary outcome data on muscle power and physical function to inform a larger efficacy trial. Participants must be able to exercise safely, not be on dialysis, and attend in-person sessions at Wake Forest in Winston-Salem, NC.
Who should consider this trial
Good fit: Ideal candidates are mobility-limited older adults with stage 3–5 CKD who are not receiving dialysis, can safely perform exercise, are willing to be randomized, and live within about 20 miles of Wake Forest University in Winston-Salem, NC.
Not a fit: People on dialysis or expected to start dialysis soon, those who are wheelchair-dependent, currently enrolled in resistance training, or with recent/unstable cardiac or orthopedic issues are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, HVRT could increase muscle power and improve everyday mobility, helping older adults with CKD maintain independence and reduce disability.
How similar studies have performed: High-velocity resistance training has improved muscle power and function in general older adult populations, but exercise interventions focused on muscle power in CKD patients are scarce and not well tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Chronic kidney disease stages 3-5 * Capacity to complete physical exercise * Lives within 20 miles of Wake Forest Reynolda Campus * Fluent English speaker * Does not plan to travel outside of home area for an extended period of time during study * Willing to be randomized to either intervention group Exclusion Criteria: * Receiving renal replacement therapy (e.g. hemodialysis, peritoneal dialysis) or anticipated to start renal replacement therapy in the next 6 months * Dependent on a wheelchair * Current participation in a resistance training program * Joint replacement or orthopedic surgery in the previous 6 months or planning to have surgery in the next 6 months months * Absolute contraindications to exercise testing according to ACSM: Acute myocardial infarction within the past 6 months Ongoing unstable angina Uncontrolled cardiac arrhythmia with hemodynamic compromise Active endocarditis Symptomatic severe aortic stenosis Decompensated heart failure Acute pulmonary embolism, pulmonary infarction, or deep venous thrombosis Acute myocarditis or pericarditis Acute aortic dissection * Parkinson's disease * Respiratory disease requiring oxygen * Cancer requiring treatment * Currently receiving physical therapy or cardiopulmonary rehabilitation * Type I or insulin dependent Type II Diabetes * Scoring below 32 points on the Telephone Interview for Cognitive Status (TICS) * Site PI/Study Clinician discretion regarding medical status, appropriateness of participation or concern about intervention adherence
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Eliott Arroyo, PhD — Wake Forest University Health Sciences
- Study coordinator: Jenna Lauderback
- Email: epicstudy@wfu.edu
- Phone: 336-758-3784
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Kidney Diseases, kidney disease, resistance training, older adults