Clinical trial NCT03120611: Virtual Reality Versus Conventional Exercise Intradialysis
Official title: Comparison of Two Exercise Programs Intradialysis: Virtual Reality Exercise Versus Conventional Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Keywords: Exercise
Hemodialysis
Virtual Reality
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
Collaborators: name: Hospital de Manises, Valencia
First posted: 2017-04-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Sit to Stand to Sit test 10
timeFrame: 20 weeks
Secondary outcomes:
measure: Short Physical Performance Battery
timeFrame: 20 weeks
measure: Timed Up and Go
timeFrame: 20 weeks
measure: One leg stand test
timeFrame: 20 weeks
measure: Sit to Stand to Sit test 60 seconds
timeFrame: 20 weeks
measure: Handgrip
timeFrame: 20 weeks
measure: One leg heel rise test
timeFrame: 20 weeks
measure: 6 minutes walk test
timeFrame: 20 weeks
measure: Adherence
timeFrame: 20 weeks
measure: Physical Activity
timeFrame: 16 weeks
measure: Physical Activity
timeFrame: 16 weeks
measure: Inflammatory markers
timeFrame: 16 weeks
measure: Inflammatory markers
timeFrame: 16 weeks
measure: Inflammatory markers
timeFrame: 16 weeks
measure: Inflammatory markers
timeFrame: 16 weeks
measure: Health-related quality of life
timeFrame: 16 weeks
measure: Oxidative stress markers
timeFrame: 16 weeks
measure: Oxidative stress markers
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Manises
country: Spain
facility: Hospital de Manises
state: Valencia
Study officials:
affiliation: Hospital de Manises
name: Rafael García Maset, MD
role: STUDY_CHAIR
References: