Virtual Reality Intradialysis: Last vs. First Part of the Session (VRI)

Cardenal Herrera University

Status: Enrolling

Conditions: Hemodialysis Complication; End Stage Renal Disease on Dialysis

Treatments: Other: Exercise during the last two hours of the hemodialysis session; Other: Conventional exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04046042

ReVID

Details and patient eligibility

About

The main objective of this investigation is to assess if an intradialysis virtual reality exercise program during the last two hours of the hemodialysis session results in greater hemodynamic stability than exercise performed during the first two hours of the hemodialysis session.

The secondary aims are to assess the impact of intradialysis virtual reality exercise during the last two hours of the hemodialysis session on dialysis efficacy, postdialysis molecules rebound, adherence to exercise, functional capacity, physical activity level, health-related quality of life, cognitive function, morbidity, frailty and dependency. We will also analyze the reliability of muscle strength assessment of lower limb muscles with a handheld dynamometer during hemodialysis.

Full description

Participants will be randomized into one of two groups. The first group will perform a virtual reality exercise during the first two hours of the hemodialysis session. The second group will perform a virtual reality exercise during the last two hours of the hemodialysis session. The exercise program will last for 9 months.

The virtual reality exercise will undertake up to 30 minutes of exercise. After warming up, participants will play to an adapted 'treasure hunt' game. Their legs movements will be the players projected into an individual tv that will give them feedback regarding their achievements. The aim of the game will be to achieve the higher possible score. They will move their legs to pick up coins and to avoid bombs. An adapted Kinect technology will be used for game development. The exercise session will end-up with a cool-down period that will include simple lower limb stretching exercises. Two more games will be introduced progressively for patients not to get bored, 'Air Hockey' and 'Simon'.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 3 months in hemodialysis treatment
• Clinically stable

Exclusion criteria

• Recent cardiac events (less than 3 months)
• Unable to exercise

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Conventional exercise time

Active Comparator group

Description:

During 12 months subjects will exercise during the first two hours of the hemodialysis session. A virtual reality exercise program will be implemented

Treatment:

Other: Conventional exercise

Experimental group

Experimental group

Description:

During 12 months subjects will exercise during the last two hours of the hemodialysis session. A virtual reality exercise program will be implemented

Treatment:

Other: Exercise during the last two hours of the hemodialysis session