Virtual Reality Versus Conventional Exercise Intradialysis

Not Applicable

Completed

• Conditions: End Stage Renal Disease
• Interventions: Other: Virtual Reality Exercise; Other: Conventional exercise intradialysis

• Registration Number: NCT03120611
• Lead Sponsor: Cardenal Herrera University

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.

Study Timeline

• Study First Submitted: 2017-04-10
• Study First Submitted QC: 2017-04-15
• Study First Posted: 2017-04-19
• Study Start: 2017-06-01
• Primary Completion: 2017-07-30
• Study Completion: 2017-08-31
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-22
• Last Update Posted: 2018-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Virtural reality exercise	Virtual Reality Exercise	Virtual reality exercise performed during the hemodialysis session, using the Kinect, specially adapted for patients undertaking hemodialysis
Conventional exercise intradialysis	Conventional exercise intradialysis	Exercise combining both aerobic (cycling) and strengthening exercise of lower limbs for patients during the hemodialysis session

Primary Outcome Measures

Name	Time	Method
Sit to Stand to Sit test 10	20 weeks	Time required to stand up from a chair and sit down 10 consecutive times

Secondary Outcome Measures

Name	Time	Method
One leg heel rise test	20 weeks	Number of repetitions of standing on toes in both legs
Adherence	20 weeks	Sessions performed/offered
Inflammatory markers	16 weeks	Human Tumor Necrosis Factor α (TNF-α)
Timed Up and Go	20 weeks	Time to stand up, walk a short distance, turn, walk back and sit down to the chair again
Handgrip	20 weeks	Handgrip strength right and left hands
6 minutes walk test	20 weeks	Number of meters covered during 6 minutes of walking
Physical Activity	16 weeks	Physical activity score for the elderly
Oxidative stress markers	16 weeks	Carbonylated proteins
One leg stand test	20 weeks	Time to keep balance on one leg
Short Physical Performance Battery	20 weeks	Balance, gait speed and sit to stand to sit 5 times
Sit to Stand to Sit test 60 seconds	20 weeks	Number of repetitions achieved of standing up from a chair during 60 seconds
Health-related quality of life	16 weeks	SF-36 subscales and components

Trial Locations

Locations (1)

Hospital de Manises; 🇪🇸 Manises, Valencia, Spain