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Virtual Reality Versus Conventional Exercise Intradialysis

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Virtual Reality Exercise
Conventional exercise intradialysis
Sponsored by
Cardenal Herrera University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring Exercise, Hemodialysis, Virtual Reality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Patients in HD therapy at least 3 months

Exclusion Criteria:

  • recent myocardial infarction (within 6 weeks)
  • unstable angina
  • malignant arrhythmias
  • above the knee amputation without replacement
  • cerebral vascular disease (ictus, transient ischemia)
  • musculoskeletal and respiratory disorders that can get worse with exercise
  • impossibility to achieve functional testing

Sites / Locations

  • Hospital de Manises

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtural reality exercise

Conventional exercise intradialysis

Arm Description

Virtual reality exercise performed during the hemodialysis session, using the Kinect, specially adapted for patients undertaking hemodialysis

Exercise combining both aerobic (cycling) and strengthening exercise of lower limbs for patients during the hemodialysis session

Outcomes

Primary Outcome Measures

Sit to Stand to Sit test 10
Time required to stand up from a chair and sit down 10 consecutive times

Secondary Outcome Measures

Short Physical Performance Battery
Balance, gait speed and sit to stand to sit 5 times
Timed Up and Go
Time to stand up, walk a short distance, turn, walk back and sit down to the chair again
One leg stand test
Time to keep balance on one leg
Sit to Stand to Sit test 60 seconds
Number of repetitions achieved of standing up from a chair during 60 seconds
Handgrip
Handgrip strength right and left hands
One leg heel rise test
Number of repetitions of standing on toes in both legs
6 minutes walk test
Number of meters covered during 6 minutes of walking
Adherence
Sessions performed/offered
Physical Activity
Human activity profile, adjusted and maximal activity score
Physical Activity
Physical activity score for the elderly
Inflammatory markers
Interleukin 6 (IL6)
Inflammatory markers
Monocyte chemoattractant protein-1 (MCP-1)
Inflammatory markers
C-Reactive Protein (CRP)
Inflammatory markers
Human Tumor Necrosis Factor α (TNF-α)
Health-related quality of life
SF-36 subscales and components
Oxidative stress markers
Malondialdehyde (MDA)
Oxidative stress markers
Carbonylated proteins

Full Information

First Posted
April 10, 2017
Last Updated
May 22, 2018
Sponsor
Cardenal Herrera University
Collaborators
Hospital de Manises, Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT03120611
Brief Title
Virtual Reality Versus Conventional Exercise Intradialysis
Official Title
Comparison of Two Exercise Programs Intradialysis: Virtual Reality Exercise Versus Conventional Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
July 30, 2017 (Actual)
Study Completion Date
August 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardenal Herrera University
Collaborators
Hospital de Manises, Valencia

4. Oversight

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

5. Study Description

Brief Summary
All participants exercised during 16 weeks following a conventional intradialysis exercise program. The last 4 weeks of the study participants were randomized into two different exercise programs intradialysis. One group exercised through a virtual reality exercise adapted specially for patients while receiving hemodialysis treatment. The other group exercised with a conventional exercise program, combining aerobic cycling and strengthening exercises.
Detailed Description
The first 16 weeks all participants followed an intradialysis exercise program. The exercise program consisted of strengthening exercises for lower limbs and for the upper limb free of fistula. The exercise program included isotonic exercises for quadriceps, triceps surae, psoas, glutei, and brachial biceps; and isometric exercises for hip adductors and hamstrings. Elastic bands were used to apply resistance. Progression was achieved from increasing from 1 set of 10 repetitions until 3 sets of 15 repetitions. This first part lasted no more than 30 minutes. The program also included aerobic exercise (cycling) for up to 30 minutes. Intensity was adapted through the duration of the study so that the participant felt the exercise from hard to somewhat hard (13 to 15 at the rate of perceived exertion 6 to 20). Time and resistance were adapted progressively. The last four weeks of the program participants were randomized into virtual reality exercise or conventional exercise group. The virtual reality exercise group undertook 30 minutes of exercise. After warming up, participants had to play to an adapted 'treasure hunt' game. Their legs movements were the players projected into an individual tv that gave them feedback regarding their achievements. The aim of the game was to achieve the higher possible score.They moved to pick up coins and to avoid bombs. An adapted Kinect technology was used for the game development.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
Exercise, Hemodialysis, Virtual Reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtural reality exercise
Arm Type
Experimental
Arm Description
Virtual reality exercise performed during the hemodialysis session, using the Kinect, specially adapted for patients undertaking hemodialysis
Arm Title
Conventional exercise intradialysis
Arm Type
Active Comparator
Arm Description
Exercise combining both aerobic (cycling) and strengthening exercise of lower limbs for patients during the hemodialysis session
Intervention Type
Other
Intervention Name(s)
Virtual Reality Exercise
Intervention Description
Game developed by the Kinect, adapted to the lying position of participants.
Intervention Type
Other
Intervention Name(s)
Conventional exercise intradialysis
Intervention Description
Aerobic exercise (cycling) and strengthening exercise for lower limbs using elastic bands and gravity
Primary Outcome Measure Information:
Title
Sit to Stand to Sit test 10
Description
Time required to stand up from a chair and sit down 10 consecutive times
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Short Physical Performance Battery
Description
Balance, gait speed and sit to stand to sit 5 times
Time Frame
20 weeks
Title
Timed Up and Go
Description
Time to stand up, walk a short distance, turn, walk back and sit down to the chair again
Time Frame
20 weeks
Title
One leg stand test
Description
Time to keep balance on one leg
Time Frame
20 weeks
Title
Sit to Stand to Sit test 60 seconds
Description
Number of repetitions achieved of standing up from a chair during 60 seconds
Time Frame
20 weeks
Title
Handgrip
Description
Handgrip strength right and left hands
Time Frame
20 weeks
Title
One leg heel rise test
Description
Number of repetitions of standing on toes in both legs
Time Frame
20 weeks
Title
6 minutes walk test
Description
Number of meters covered during 6 minutes of walking
Time Frame
20 weeks
Title
Adherence
Description
Sessions performed/offered
Time Frame
20 weeks
Title
Physical Activity
Description
Human activity profile, adjusted and maximal activity score
Time Frame
16 weeks
Title
Physical Activity
Description
Physical activity score for the elderly
Time Frame
16 weeks
Title
Inflammatory markers
Description
Interleukin 6 (IL6)
Time Frame
16 weeks
Title
Inflammatory markers
Description
Monocyte chemoattractant protein-1 (MCP-1)
Time Frame
16 weeks
Title
Inflammatory markers
Description
C-Reactive Protein (CRP)
Time Frame
16 weeks
Title
Inflammatory markers
Description
Human Tumor Necrosis Factor α (TNF-α)
Time Frame
16 weeks
Title
Health-related quality of life
Description
SF-36 subscales and components
Time Frame
16 weeks
Title
Oxidative stress markers
Description
Malondialdehyde (MDA)
Time Frame
16 weeks
Title
Oxidative stress markers
Description
Carbonylated proteins
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Patients in HD therapy at least 3 months Exclusion Criteria: recent myocardial infarction (within 6 weeks) unstable angina malignant arrhythmias above the knee amputation without replacement cerebral vascular disease (ictus, transient ischemia) musculoskeletal and respiratory disorders that can get worse with exercise impossibility to achieve functional testing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafael García Maset, MD
Organizational Affiliation
Hospital de Manises
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital de Manises
City
Manises
State/Province
Valencia
ZIP/Postal Code
46940
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Virtual Reality Versus Conventional Exercise Intradialysis

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