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Interactive Hand Exercise Game on Grip Strength and Vascular Maturation

Primary Purpose

Muscle Weakness, Angiogenesis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Interactive Hand Exercise Game
Soft ball exercise ( routine care)
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Weakness focused on measuring Hand-grip Strength, Hemodialysis

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of chronic renal failure stage 4 to 5 (before dialysis) and stage 5 (patients who have started hemodialysis).
  • Newly established surgical patients with autologous arteriovenous fistula.
  • Aged between 20 and 70 years old.
  • Having clear consciousness and being able to communicate in Chinese.

Exclusion Criteria:

  • Previous dysfunction of an autologous arteriovenous fistula in the same arm.
  • Injury to the fistula extremity.
  • Neuromusculoskeletal abnormalities.
  • Upper extremity arthritis.
  • Peripheral neuropathy.
  • Peripheral arterial dysfunction.
  • Venous disease.
  • Rheumatic disease.

Sites / Locations

  • Hsiao-Yean Chiu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interactive Hand Exercise Game

Soft ball exercise ( routine care)

Arm Description

Participants will receive an Interactive Hand Exercise Game for 30 minutes every day for consecutive two months.

Participants will receive a soft ball exercise for 30 minutes every day for consecutive two months.

Outcomes

Primary Outcome Measures

Changes in vein diameter
This will be measured by using duplex ultrasound. The maturation of autologous arteriovenous fistula is defined as a cross-sectional luminal diameter of the draining vein >6 mm.
Changes in the depth of the fistula from the epidermis
The depth of the fistula from the epidermis is measured using duplex ultrasound. The maturation of autologous arteriovenous fistula should be <0.6 cm from the epidermis.
Changes in brachial artery blood flow rate
The flow rate is measured using duplex ultrasound. The maturation of autologous arteriovenous fistula is defined as a flow velocity in the artery >600 ml/min.

Secondary Outcome Measures

Changes in grip strength
The grip strength is measured using the Jamar Grip. The size is set to 2 for women, 1 for those with smaller hands, and 3 for men.

Full Information

First Posted
August 4, 2022
Last Updated
August 8, 2022
Sponsor
Taipei Medical University
Collaborators
Mackay Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05493046
Brief Title
Interactive Hand Exercise Game on Grip Strength and Vascular Maturation
Official Title
Effects of Interactive Hand Exercise Game on Grip Strength and Vascular Maturation in Patients Undergoing Arteriovenous Fistula Surgery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2022 (Anticipated)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University
Collaborators
Mackay Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Hemodialysis is currently the most commonly used renal replacement therapy. Compared with arteriovenous graft, central venous catheter, and autologous arteriovenous fistula, the possibility of postoperative re-dredging is low and there are few complications, so isometric hand exercise training is the first choice for hemodialysis strategy. The intervention of smart technology has greatly improved the treatment effect and quality of life of patients, and it has unique advantages when applied to health care or behavior change intervention programs. This study expects to enhance hand grip strength through interactive hand exercise games combined with grip strength equipment, thereby increasing the vascular maturity of patients with postoperative autologous arteriovenous fistula, and enhancing the motivation of patients to participate.
Detailed Description
Hemodialysis is currently the most commonly used renal replacement therapy. Compared with arteriovenous graft, central venous catheter, and autologous arteriovenous fistula, the possibility of postoperative re-dredging is low and there are few complications, so isometric hand exercise training is the first choice for hemodialysis strategy. The intervention of smart technology has greatly improved the treatment effect and quality of life of patients, and it has unique advantages when applied to health care or behavior change intervention programs. This study expects to enhance hand grip strength through interactive hand exercise games combined with grip strength equipment, thereby increasing the vascular maturity of patients with a postoperative autologous arteriovenous fistula, and enhancing the motivation of patients to participate. The patients will be assigned to the experimental group and the control group by a simple random method, with 15 patients in each group. The experimental group was guided by the interactive hand exercise game program, while the control group received conventional softball exercise. Two groups of patients will start to perform hand exercises on the first day after returning home. The two groups need to perform 30 minutes each time, twice a day (once in the morning and once in the afternoon), for a total of two months. To assess the study outcomes (i.e., hand grip strength and maturation) will use self-structured questionnaires, Noblus ultrasonic machine and Jamar hydraulic grip. The measurement time points are the one week before, the first week, the fourth weeks and the eighth weeks after the autologous arteriovenous fistula operation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness, Angiogenesis
Keywords
Hand-grip Strength, Hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcomes assessor will be unaware of the treatment assignment before the completion of the study
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interactive Hand Exercise Game
Arm Type
Experimental
Arm Description
Participants will receive an Interactive Hand Exercise Game for 30 minutes every day for consecutive two months.
Arm Title
Soft ball exercise ( routine care)
Arm Type
Active Comparator
Arm Description
Participants will receive a soft ball exercise for 30 minutes every day for consecutive two months.
Intervention Type
Behavioral
Intervention Name(s)
Interactive Hand Exercise Game
Intervention Description
Interactive Hand Exercise Game to Improve Vascular Maturity and Grip Strength in Patients undergoing Arteriovenous Fistula Surgery
Intervention Type
Behavioral
Intervention Name(s)
Soft ball exercise ( routine care)
Intervention Description
Soft ball exercise ( routine care)
Primary Outcome Measure Information:
Title
Changes in vein diameter
Description
This will be measured by using duplex ultrasound. The maturation of autologous arteriovenous fistula is defined as a cross-sectional luminal diameter of the draining vein >6 mm.
Time Frame
The 1th week, the 4th weeks and the 8th weeks after the autologous arteriovenous fistula surgery
Title
Changes in the depth of the fistula from the epidermis
Description
The depth of the fistula from the epidermis is measured using duplex ultrasound. The maturation of autologous arteriovenous fistula should be <0.6 cm from the epidermis.
Time Frame
The 1th week, the 4th weeks and the 8th weeks after the autologous arteriovenous fistula operation.
Title
Changes in brachial artery blood flow rate
Description
The flow rate is measured using duplex ultrasound. The maturation of autologous arteriovenous fistula is defined as a flow velocity in the artery >600 ml/min.
Time Frame
The 1th week, the 4th weeks and the 8th weeks after the autologous arteriovenous fistula operation.
Secondary Outcome Measure Information:
Title
Changes in grip strength
Description
The grip strength is measured using the Jamar Grip. The size is set to 2 for women, 1 for those with smaller hands, and 3 for men.
Time Frame
The 1th week, the 4th weeks and the 8th weeks after the autologous arteriovenous fistula operation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of chronic renal failure stage 4 to 5 (before dialysis) and stage 5 (patients who have started hemodialysis). Newly established surgical patients with autologous arteriovenous fistula. Aged between 20 and 70 years old. Having clear consciousness and being able to communicate in Chinese. Exclusion Criteria: Previous dysfunction of an autologous arteriovenous fistula in the same arm. Injury to the fistula extremity. Neuromusculoskeletal abnormalities. Upper extremity arthritis. Peripheral neuropathy. Peripheral arterial dysfunction. Venous disease. Rheumatic disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chiu Hsiao-Yean, PhD
Phone
+886-2-27361661
Ext
6329
Email
hychiu0315@tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiu Hsiao-Yean, PhD
Organizational Affiliation
Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hsiao-Yean Chiu
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsiao-Yean Chiu, PhD
Phone
02273616616329
Ext
6329
Email
hychiu0315@tmu.edu.tw

12. IPD Sharing Statement

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Interactive Hand Exercise Game on Grip Strength and Vascular Maturation

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