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出境医 / 临床实验 / Prefistula Forearm Exercise in Pts Requiring Chronic HD Therapy

Prefistula Forearm Exercise in Pts Requiring Chronic HD Therapy

Study Description
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.

Condition or disease Intervention/treatment Phase
Arterio-venous Fistula Kidney Failure Hemodialysis Access Failure Other: Exercise Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Exercise
Participant randomized to an exercise protocol using a hand grip device that is used on a daily basis. Participant will be encouraged to increase the number of repetitions used by the hand grip device during the course of the trial
 Other: Exercise
Participant randomized to an exercise protocol using a hand grip device that is used on a daily basis. Participant will be encouraged to increase the number of repetitions used by the hand grip device during the course of the trial
No Intervention: Control
Participants in the control group will not receive any pre-surgical instructions for exercise in the access arm
Outcome Measures
Primary Outcome Measures :
  1. Number of participants with fistula usable without intervention [ Time Frame: Up to 12 weeks after surgical creation of the AV fistula ]
    Fistula usability will be measured by the use of the AV fistula for two needle cannulation for chronic dialysis sessions within 12 weeks after surgical creation.

  2. Number of participants with fistula usable with intervention [ Time Frame: Up to 12 weeks after surgical creation of the AV fistula ]
    Fistula usability will be measured by the use of the AV fistula for two needle cannulation for chronic dialysis sessions within 12 weeks after surgical creation.

  3. Number of participants with fistula not usable [ Time Frame: Up to 12 weeks after surgical creation of the AV fistula ]
    Fistula usability will be measured by the use of the AV fistula for two needle cannulation for chronic dialysis sessions within 12 weeks after surgical creation.


Secondary Outcome Measures :
  1. Mean Number of hand grips per day [ Time Frame: Up to 8 weeks after start of the intervention ]
  2. Mean Number of days hand grips performed [ Time Frame: Up to 8 weeks after start of the intervention ]
  3. Total mean number of hand grip repetitions performed [ Time Frame: Up to 8 weeks after start of the intervention ]
  4. Cephalic Vein Doppler measurement [ Time Frame: Up to 8 weeks after start of the intervention ]
    The diameter of the vessel in centimeters will be measured using a Duplex Doppler.

  5. Basilic Vein Doppler measurement [ Time Frame: Up to 8 weeks after start of the intervention ]
    The diameter of the vessel in centimeters will be measured using a Duplex Doppler.

  6. Median Cubital Doppler measurement [ Time Frame: Up to 8 weeks after start of the intervention ]
    The diameter of the vessel in centimeters will be measured using a Duplex Doppler.

  7. Radial Artery Doppler measurement [ Time Frame: Up to 8 weeks after start of the intervention ]
    The diameter of the vessel in centimeters will be measured using a Duplex Doppler.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
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Contact: Michael Rocco, MD, MSCE 336-716-4650 mrocco@wakehealth.edu
Contact: Audrey Tuttle, PA 336-716-4650 atuttle@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Principal Investigator: Michael Rocco, MD         
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Layout table for investigator information
Principal Investigator: Michael Rocco, MD, MSCE Wake Forest University Health Sciences
Tracking Information
First Submitted Date  ICMJE June 12, 2019
First Posted Date  ICMJE June 17, 2019
Last Update Posted Date August 28, 2020
Actual Study Start Date  ICMJE June 17, 2019
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
  • Number of participants with fistula usable without intervention [ Time Frame: Up to 12 weeks after surgical creation of the AV fistula ]
    Fistula usability will be measured by the use of the AV fistula for two needle cannulation for chronic dialysis sessions within 12 weeks after surgical creation.
  • Number of participants with fistula usable with intervention [ Time Frame: Up to 12 weeks after surgical creation of the AV fistula ]
    Fistula usability will be measured by the use of the AV fistula for two needle cannulation for chronic dialysis sessions within 12 weeks after surgical creation.
  • Number of participants with fistula not usable [ Time Frame: Up to 12 weeks after surgical creation of the AV fistula ]
    Fistula usability will be measured by the use of the AV fistula for two needle cannulation for chronic dialysis sessions within 12 weeks after surgical creation.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
  • Mean Number of hand grips per day [ Time Frame: Up to 8 weeks after start of the intervention ]
  • Mean Number of days hand grips performed [ Time Frame: Up to 8 weeks after start of the intervention ]
  • Total mean number of hand grip repetitions performed [ Time Frame: Up to 8 weeks after start of the intervention ]
  • Cephalic Vein Doppler measurement [ Time Frame: Up to 8 weeks after start of the intervention ]
    The diameter of the vessel in centimeters will be measured using a Duplex Doppler.
  • Basilic Vein Doppler measurement [ Time Frame: Up to 8 weeks after start of the intervention ]
    The diameter of the vessel in centimeters will be measured using a Duplex Doppler.
  • Median Cubital Doppler measurement [ Time Frame: Up to 8 weeks after start of the intervention ]
    The diameter of the vessel in centimeters will be measured using a Duplex Doppler.
  • Radial Artery Doppler measurement [ Time Frame: Up to 8 weeks after start of the intervention ]
    The diameter of the vessel in centimeters will be measured using a Duplex Doppler.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prefistula Forearm Exercise in Pts Requiring Chronic HD Therapy
Official Title  ICMJE Presurgical Arm Exercises Prior to Creation of a Forearm AV Fistula in Hemodialysis (HD) Patients With End-stage Kidney Disease: A Pilot Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Arterio-venous Fistula
  • Kidney Failure
  • Hemodialysis Access Failure
Intervention  ICMJE Other: Exercise
Participant randomized to an exercise protocol using a hand grip device that is used on a daily basis. Participant will be encouraged to increase the number of repetitions used by the hand grip device during the course of the trial
Study Arms  ICMJE
  • Experimental: Exercise
    Participant randomized to an exercise protocol using a hand grip device that is used on a daily basis. Participant will be encouraged to increase the number of repetitions used by the hand grip device during the course of the trial
    Intervention: Other: Exercise
  • No Intervention: Control
    Participants in the control group will not receive any pre-surgical instructions for exercise in the access arm
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 14, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael Rocco, MD, MSCE 336-716-4650 mrocco@wakehealth.edu
Contact: Audrey Tuttle, PA 336-716-4650 atuttle@wakehealth.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03988270
Other Study ID Numbers  ICMJE IRB00058671
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Rocco, MD, MSCE Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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