Virtual Reality Versus Conventional Exercise Intradialysis | NCT03120611

Studies
Virtual Reality Versus Conventional Exercise Intradialysis

NCT03120611

Sponsor

Cardenal Herrera University

Status

Completed

Last Update Posted

May 23, 2018Actual

Enrollment

18Actual

Phase

Not Applicable

Conditions

End Stage Renal Disease

Interventions

Virtual Reality Exercise
Conventional exercise intradialysis

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Actual

Primary Completion Date

Jul 30, 2017Actual

Completion Date

Aug 31, 2017Actual

First Submitted Date

Apr 10, 2017

First Submission Date that Met QC Criteria

Apr 15, 2017

First Posted Date

Apr 19, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2018

Last Update Posted Date

May 23, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eva Segura Ortí, Principal investigator, Cardenal Herrera UniversityPrincipal Investigator

Lead Sponsor

Cardenal Herrera UniversityOTHER

Collaborators

Name	Class
Hospital de Manises, Valencia	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Virtural reality exercise	Experimental	Virtual reality exercise performed during the hemodialysis session, using the Kinect, specially adapted for patients undertaking hemodialysis	Other: Virtual Reality Exercise
Conventional exercise intradialysis	Active Comparator	Exercise combining both aerobic (cycling) and strengthening exercise of lower limbs for patients during the hemodialysis session	Other: Conventional exercise intradialysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Virtual Reality Exercise	Other	Game developed by the Kinect, adapted to the lying position of participants.	Virtural reality exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sit to Stand to Sit test 10	Time required to stand up from a chair and sit down 10 consecutive times	20 weeks

Secondary Outcomes

Measure	Description	Time Frame
Short Physical Performance Battery	Balance, gait speed and sit to stand to sit 5 times	20 weeks
Timed Up and Go	Time to stand up, walk a short distance, turn, walk back and sit down to the chair again

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rafael García Maset, MD	Hospital de Manises	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Manises		Manises	Valencia	46940	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic
D009043	Motor Activity

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000088544	Exergaming

Ancestor Terms

ID	Term
D015444	Exercise
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided