Clinical trial NCT03456414: Virtual Reality During Hemodialysis
Official title: Virtual Reality Exercise During Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Hemodialysis-Induced Symptom
Keywords: exercise
physical function
health related quality of life
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
Collaborators: name: Hospital de Manises
name: Universitat Politècnica de València
First posted: 2018-03-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants will receive during hemodialysis the conditions 'virtual reality exercise' for 12 weeks and 'control period-no exercise' for 12 more weeks
Primary purpose: TREATMENT

Brief summary: The main objective of this investigation is to assess if an intradialysis virtual reality exercise-based program results in an improvement in physical function and if it results in high adherence rates to exercise. The secondary aim is to assess the effect of intradialysis VR in physical activity level, health related quality of life and in cognitive function.

Detailed description: Participants will be randomized into one of two groups. The first group will start with 12 weeks of virtual reality exercise during hemodialysis and will carry on with a control period of 12 weeks. The second group will start with a control period of 12 weeks (no exercise) and will carry on with a virtual reality exercise period of 12 weeks.

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 the game development. The exercise session will end-up with a cool-down period that will include simple lower limb stretching exercises.

Eligibility criteria: Inclusion Criteria:

* At least 3 months in hemodialysis treatment
* Clinically stable

Exclusion Criteria:

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

Primary outcomes:
measure: Change from baseline gait speed at 12 weeks
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change from baseline sit to stand 10 at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Change from baseline sit to stand 60 at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Change from baseline timed up and go at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Change from baseline short physical performance battery at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Change from baseline handgrip at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Change from baseline one-leg standing test at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Change from baseline one-leg heel rise test at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Change from baseline 6 minutes walk test at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Change from baseline Physical activity level at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Change from baseline Health related quality of life at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Change from baseline Cognitive function at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Adherence
timeFrame: 12 weeks
measure: Healthcare resources expenditure and costs
timeFrame: 12 months before starting the exercise program- 12 months after the starting date
Other outcomes:
Locations:
city: Manises
country: Spain
facility: Hospital de Manises
state: Valencia
Study officials:
affiliation: Universidad CEU Cardenal Herrera, UCH CEU
name: Eva SEGURA-ORTÍ, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Segura-Orti E, Gordon PL, Doyle JW, Johansen KL. Correlates of Physical Functioning and Performance Across the Spectrum of Kidney Function. Clin Nurs Res. 2018 Jun;27(5):579-596. doi: 10.1177/1054773816689282. Epub 2017 Jan 23.
citation: Segura-Orti E, Martinez-Olmos FJ. Test-retest reliability and minimal detectable change scores for sit-to-stand-to-sit tests, the six-minute walk test, the one-leg heel-rise test, and handgrip strength in people undergoing hemodialysis. Phys Ther. 2011 Aug;91(8):1244-52. doi: 10.2522/ptj.20100141. Epub 2011 Jun 30.
citation: Segura-Orti E, Johansen KL. Exercise in end-stage renal disease. Semin Dial. 2010 Jul-Aug;23(4):422-30. doi: 10.1111/j.1525-139X.2010.00766.x.
citation: Segura-Orti E. [Exercise in haemodyalisis patients: a literature systematic review]. Nefrologia. 2010;30(2):236-46. doi: 10.3265/Nefrologia.pre2010.Jan.10229. Epub 2010 Jan 21. Spanish.
citation: Segura-Orti E, Kouidi E, Lison JF. Effect of resistance exercise during hemodialysis on physical function and quality of life: randomized controlled trial. Clin Nephrol. 2009 May;71(5):527-37. doi: 10.5414/cnp71527.
citation: Segura-Orti E, Rodilla-Alama V, Lison JF. [Physiotherapy during hemodialysis: results of a progressive resistance-training programme]. Nefrologia. 2008;28(1):67-72. Spanish.