Virtual Reality During Hemodialysis

End Stage Renal Disease Clinical Trial

— VRHD  

Official title:

Virtual Reality Exercise During Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03456414
• Other study ID #: 2017/0638
• Status: Completed
• Phase: N/A
• Start date: April 11, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: July 2020
• Source: Cardenal Herrera University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 30, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 3 months in hemodialysis treatment

• Clinically stable

Exclusion Criteria:

• Recent cardiac events (less than 3 months)

• Unable to exercise

Related Conditions & MeSH terms

• End Stage Renal Disease
• Hemodialysis-Induced Symptom
• Kidney Failure, Chronic

Intervention

Other:
• Virtual reality exercise during hemodialysis
Subjects will play a virtual reality game specially adapted for subjects undertaking hemodialysis treatment

Locations

Country	Name	City	State
Spain	Hospital de Manises	Manises	Valencia

Sponsors (3)

Lead Sponsor	Collaborator
Cardenal Herrera University	Hospital de Manises, Universitat Politècnica de València

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Segura-Ortí 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. — View 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. Review. — View Citation

Segura-Ortí E, Kouidi E, Lisón 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. — View Citation

Segura-Ortí E, Martínez-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. — View Citation

Segura-Ortí E, Rodilla-Alama V, Lisón JF. [Physiotherapy during hemodialysis: results of a progressive resistance-training programme]. Nefrologia. 2008;28(1):67-72. Spanish. — View Citation

Segura-Ortí 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. Review. Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline gait speed at 12 weeks	Speed to cover 4 meters at normal speed	Baseline, 12 weeks
Secondary	Change from baseline sit to stand 10 at 12 weeks	Time to perform 10 sit to stand repetitions,	Baseline, 12 weeks
Secondary	Change from baseline sit to stand 60 at 12 weeks	Sit to stand repetitions performed in 60 seconds	Baseline, 12 weeks
Secondary	Change from baseline timed up and go at 12 weeks	Time to stand up, walk 3 meters, come back and sit down again	Baseline, 12 weeks
Secondary	Change from baseline short physical performance battery at 12 weeks	Score achieved at the battery that includes balance tests, sit to stand to sit 5 and and gait speed	Baseline, 12 weeks
Secondary	Change from baseline handgrip at 12 weeks	Bilateral handgrip strength	Baseline, 12 weeks
Secondary	Change from baseline one-leg standing test at 12 weeks	Time achieved while standing on one leg	Baseline, 12 weeks
Secondary	Change from baseline one-leg heel rise test at 12 weeks	Number of heel rise repetitions achieved	Baseline, 12 weeks
Secondary	Change from baseline 6 minutes walk test at 12 weeks	Number of meters walked in 6 minutes	Baseline, 12 weeks
Secondary	Change from baseline Physical activity level at 12 weeks	Physical activity questionnaires	Baseline, 12 weeks
Secondary	Change from baseline Health related quality of life at 12 weeks	Short Form 36 questionnaire to measure health-related quality of life	Baseline, 12 weeks
Secondary	Change from baseline Cognitive function at 12 weeks	Mini-mental State Examination questionnaire	Baseline, 12 weeks
Secondary	Adherence	Sessions performed/sessions offered	12 weeks
Secondary	Healthcare resources expenditure and costs	Total amount in euros spent on external consultations, laboratory tests, radiology tests, hospital pharmacy, emergency department healthcare provision, and hospitalisation.	12 months before starting the exercise program- 12 months after the starting date