Clinical trial NCT03988270: Prefistula Forearm Exercise in Pts Requiring Chronic HD Therapy
Official title: Presurgical Arm Exercises Prior to Creation of a Forearm AV Fistula in Hemodialysis (HD) Patients With End-stage Kidney Disease: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arterio-venous Fistula
Kidney Failure
Hemodialysis Access Failure
Keywords: Hemodialysis
Fistula
Access Failure
Hemodialysis Fistula Creation
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized study with two arms: Intervention arm with a pre-fistula placement exercise program versus a control arm with no prefistula placement exercise
Primary purpose: PREVENTION

Brief summary: For chronic hemodialysis patients, the creation of a well-functioning arteriovenous (AV) fistula is critical for ensuring that patient receive adequate hemodialysis. Unfortunately, the primary failure rate for AV fistulas after surgery is about 40%, and this percentage has not changed despite a number of trials of pharmaceutical agents and biologic agents. A key to success in the development of a useable AV fistula is an adequate arterial and venous diameter in the access forearm. Although exercise is commonly used to increase vessel diameter after AV fistula placement, Investigators are unaware of published studies that report on the effect of exercise prior to AV fistula placement to assist with the maturation of a newly created AV fistula. In this pilot trial, the Principal Investigator will evaluate the feasibility and possible benefits of pre-surgical exercise on forearm AV fistulas.

Detailed 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 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.

Eligibility criteria: Inclusion Criteria:

* Scheduled for placement of an elective forearm AV fistula for chronic hemodialysis access.

Exclusion Criteria:

* The presence of joint or musculoskeletal impairments that prevent the patient from using a handgrip device on a daily basis

Primary outcomes:
measure: Number of participants with fistula usable without intervention
timeFrame: Up to 12 weeks after surgical creation of the AV fistula
measure: Number of participants with fistula usable with intervention
timeFrame: Up to 12 weeks after surgical creation of the AV fistula
measure: Number of participants with fistula not usable
timeFrame: Up to 12 weeks after surgical creation of the AV fistula
Secondary outcomes:
measure: Mean Number of hand grips per day
timeFrame: Up to 8 weeks after start of the intervention
measure: Mean Number of days hand grips performed
timeFrame: Up to 8 weeks after start of the intervention
measure: Total mean number of hand grip repetitions performed
timeFrame: Up to 8 weeks after start of the intervention
measure: Cephalic Vein Doppler measurement
timeFrame: Up to 8 weeks after start of the intervention
measure: Basilic Vein Doppler measurement
timeFrame: Up to 8 weeks after start of the intervention
measure: Median Cubital Doppler measurement
timeFrame: Up to 8 weeks after start of the intervention
measure: Radial Artery Doppler measurement
timeFrame: Up to 8 weeks after start of the intervention
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Michael Rocco, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: