Virtual Reality Versus Conventional Exercise Intradialysis

Comparison of Two Exercise Programs Intradialysis: Virtual Reality Exercise Versus Conventional Exercise

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Other: Virtual Reality Exercise; Other: Conventional exercise intradialysis

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia
    • Manises, Valencia, Spain, 46940
      • Hospital de Manises

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtural reality exercise; Virtual reality exercise performed during the hemodialysis session, using the Kinect, specially adapted for patients undertaking hemodialysis	Other: Virtual Reality Exercise; Game developed by the Kinect, adapted to the lying position of participants.
Active Comparator: Conventional exercise intradialysis; Exercise combining both aerobic (cycling) and strengthening exercise of lower limbs for patients during the hemodialysis session	Other: Conventional exercise intradialysis; Aerobic exercise (cycling) and strengthening exercise for lower limbs using elastic bands and gravity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	20 weeks
One leg stand test	Time to keep balance on one leg	20 weeks
Sit to Stand to Sit test 60 seconds	Number of repetitions achieved of standing up from a chair during 60 seconds	20 weeks
Handgrip	Handgrip strength right and left hands	20 weeks
One leg heel rise test	Number of repetitions of standing on toes in both legs	20 weeks
6 minutes walk test	Number of meters covered during 6 minutes of walking	20 weeks
Adherence	Sessions performed/offered	20 weeks
Physical Activity	Human activity profile, adjusted and maximal activity score	16 weeks
Physical Activity	Physical activity score for the elderly	16 weeks
Inflammatory markers	Interleukin 6 (IL6)	16 weeks
Inflammatory markers	Monocyte chemoattractant protein-1 (MCP-1)	16 weeks
Inflammatory markers	C-Reactive Protein (CRP)	16 weeks
Inflammatory markers	Human Tumor Necrosis Factor α (TNF-α)	16 weeks
Health-related quality of life	SF-36 subscales and components	16 weeks
Oxidative stress markers	Malondialdehyde (MDA)	16 weeks
Oxidative stress markers	Carbonylated proteins	16 weeks

Collaborators and Investigators

• Sponsor: Cardenal Herrera University
• Collaborators: Hospital de Manises, Valencia
• Investigators: Study Chair: Rafael García Maset, MD, Hospital de Manises

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): July 30, 2017
• Study Completion (Actual): August 31, 2017

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 15, 2017
• First Posted (Actual): April 19, 2017

Study Record Updates

• Last Update Posted (Actual): May 23, 2018
• Last Update Submitted That Met QC Criteria: May 22, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Exercise; Virtual Reality; Hemodialysis
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: 2015/0193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No