Enhancing Physical Function in Older Adults With Chronic Kidney Disease (EPIC): A Pilot Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chronic Kidney Diseases
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Number of Participants Enrolled
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
The goal of this pilot randomized controlled trial is to examine the feasibility and safety of a 12-week high-velocity resistance training (HVRT) intervention in older adults with chronic kidney disease (CKD) stages 4-5 and to generate preliminary data to inform a future study investigating the efficacy of HVRT for improving muscle power and physical function. Researchers will compare HVRT to an attention control condition consisting of weekly group sessions covering topics on healthy lifestyle. This study seeks to:
- Determine whether implementing an HVRT intervention is feasible and safe for mobility-limited older adults with advanced CKD.
- Collect preliminary data on the efficacy of HVRT for improving muscle power and physical function in mobility-limited older adults with advanced CKD.
Detailed Description
Older adults with advanced chronic kidney disease (CKD) commonly exhibit severe impairments in physical function (i.e., inability to perform activities of daily living). Muscle power-the product of muscle force and velocity of contraction- is now widely considered to be a critical determinant of physical function in older adults. Despite this, muscle power has been largely overlooked in the aims and outcomes of exercise interventions for patients with CKD. Several clinical trials have shown that high-velocity resistance training (HVRT) programs consisting of functional movements performed "as fast as possible" with low external loads are safe and effective for improving muscle power and physical function in older adults. However, the available evidence on the effects of exercise interventions designed to improve muscle power in patients with CKD is scarce. This study seeks to determine whether an HVRT intervention in mobility-limited older adults with advanced CKD is feasible, safe, and potentially effective for improving muscle power and physical function.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Number of Participants Enrolled
Time Frame: Month 6
Number of participants enrolled with a goal of 30.
Percent of Participant Adherence
Time Frame: Week 13
Percentage of exercise sessions attended for the HVRT group (out of 36 total exercise sessions)
Percent of Participant Retention
Time Frame: Week 13
Percentage of participants retained at the final follow visit.
Secondary Outcomes
- Change in Short Physical Performance Battery (SPPB) Score(From baseline to Follow-up (Week 13))
- Change in Timed Up and Go Test duration(From baseline to Follow-up (Week 13))
- Change in lower body peak power(From baseline to Follow-up (Week 13))