Prefistula Forearm Exercise in Pts Requiring Chronic HD Therapy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Arterio-venous Fistula
- Hemodialysis Access Failure
- Kidney Failure
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized study with two arms: Intervention arm with a pre-fistula placement exercise program versus a control arm with no prefistula placement exerciseMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The trial is designed to determine if a pre-surgical exercise program will improve the likelihood of a useable forearm AV fistula. In this pilot study, the feasibility of the proposed intervention will be assessed in terms of both patient acceptability and patient outcomes. In addition, results from...
The trial is designed to determine if a pre-surgical exercise program will improve the likelihood of a useable forearm AV fistula. In this pilot study, the feasibility of the proposed intervention will be assessed in terms of both patient acceptability and patient outcomes. In addition, results from this feasibility study will be used to help determine power calculations for a full-scale trial. Patients will be eligible for this pilot clinical trial if scheduled for placement of an elective forearm AV fistula for chronic hemodialysis access. Patients will be randomized using a random number generator to either the intervention or the control group. The intervention group will be instructed in the use of hand grip with built in digital counter. These instructions will include the use of the hand grip on a daily basis with an increasing number of hand grip squeezes to be performed each week up until the time of fistula placement. Patients in the control group will not receive any pre-surgical instructions for exercise in the access arm. In both groups, patients will be provided with post-surgical instructions on the use of a squeeze ball on a daily basis once the steri-strips from the surgical site have fallen off.
Tracking Information
- NCT #
- NCT03988270
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Michael Rocco, MD, MSCE Wake Forest University Health Sciences