Virtual Reality Versus Conventional Exercise Intradialysis

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03120611
• Other study ID #: 2015/0193
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: August 31, 2017

Study information

• Verified date: May 2018
• Source: Cardenal Herrera University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 31, 2017
• Est. primary completion date: July 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Other:
• Virtual Reality Exercise
Game developed by the Kinect, adapted to the lying position of participants.
• Conventional exercise intradialysis
Aerobic exercise (cycling) and strengthening exercise for lower limbs using elastic bands and gravity

Locations

Country	Name	City	State
Spain	Hospital de Manises	Manises	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Cardenal Herrera University	Hospital de Manises, Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sit to Stand to Sit test 10	Time required to stand up from a chair and sit down 10 consecutive times	20 weeks
Secondary	Short Physical Performance Battery	Balance, gait speed and sit to stand to sit 5 times	20 weeks
Secondary	Timed Up and Go	Time to stand up, walk a short distance, turn, walk back and sit down to the chair again	20 weeks
Secondary	One leg stand test	Time to keep balance on one leg	20 weeks
Secondary	Sit to Stand to Sit test 60 seconds	Number of repetitions achieved of standing up from a chair during 60 seconds	20 weeks
Secondary	Handgrip	Handgrip strength right and left hands	20 weeks
Secondary	One leg heel rise test	Number of repetitions of standing on toes in both legs	20 weeks
Secondary	6 minutes walk test	Number of meters covered during 6 minutes of walking	20 weeks
Secondary	Adherence	Sessions performed/offered	20 weeks
Secondary	Physical Activity	Human activity profile, adjusted and maximal activity score	16 weeks
Secondary	Physical Activity	Physical activity score for the elderly	16 weeks
Secondary	Inflammatory markers	Interleukin 6 (IL6)	16 weeks
Secondary	Inflammatory markers	Monocyte chemoattractant protein-1 (MCP-1)	16 weeks
Secondary	Inflammatory markers	C-Reactive Protein (CRP)	16 weeks
Secondary	Inflammatory markers	Human Tumor Necrosis Factor a (TNF-a)	16 weeks
Secondary	Health-related quality of life	SF-36 subscales and components	16 weeks
Secondary	Oxidative stress markers	Malondialdehyde (MDA)	16 weeks
Secondary	Oxidative stress markers	Carbonylated proteins	16 weeks