Clinical trial NCT04046042: Virtual Reality Intradialysis: Last vs. First Part of the Session
Official title: Virtual Reality Exercise Intradialysis: Tolerance and Dialysis Dose Effects During the Last vs. First Part of the Hemodialysis Session
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End Stage Renal Disease on Dialysis
Hemodialysis Complication
Keywords: Exercise
Virtual reality
physical function
health-related quality of life
hemodynamic instability
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
Collaborators: name: Hospital de Manises
name: Universitat Politècnica de Valéncia
First posted: 2019-08-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into one of two exercise groups, during the first two hours of hemodialysis or during the last two hours of hemodialysis
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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'.

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: Number of hypotension episodes
timeFrame: 3 Months
measure: Number of hypotension episodes
timeFrame: 6 Months
measure: Number of hypotension episodes
timeFrame: 12 Months
Secondary outcomes:
measure: Change from baseline postdialysis rebound urea, creatinine, phosphorus and potassium at 3 months
timeFrame: Baseline and 3 months
measure: Change from baseline dialysis dose at 3 months, 6 months, and 12 months
timeFrame: Baseline, 3 Months, 6 months and 12 months
measure: Adherence, as number of sessions performed /number of sessions offered
timeFrame: Baseline, 3 Months, 6 months and 12 months
measure: Change from baseline short physical performance battery at 3 months, 6 months, and 12 months
timeFrame: Baseline, 3 Months, 6 months and 12 months
measure: Change from baseline gait speed at 3 months, 6 months, and 12 months
timeFrame: Baseline, 3 Months, 6 months and 12 months
measure: Change from baseline handgrip at 3 months, 6 months, and 12 months
timeFrame: Baseline, 3 Months, 6 months and 12 months
measure: Change from baseline lower limb muscle strength at 3 months, 6 months, and 12 months
timeFrame: Baseline, 3 Months, 6 months and 12 months
measure: Change from baseline one-leg standing test at 3 months, 6 months, and 12 months
timeFrame: Baseline, 3 Months, 6 months and 12 months
measure: Change from baseline sit to stand 10 test at 3 months, 6 months, and 12 months
timeFrame: Baseline, 3 Months, 6 months and 12 months
measure: Change from baseline sit to stand 60 at 3 months, 6 months, and 12 months
timeFrame: Baseline, 3 Months, 6 months and 12 months
measure: Change from baseline timed up and go at 3 months, 6 months, and 12 months
timeFrame: Baseline, 3 Months, 6 months and 12 months
measure: Change from baseline one-leg heel rise test at 3 months, 6 months, and 12 months
timeFrame: Baseline, 3 Months, 6 months and 12 months
measure: Change from baseline 6 minutes walk test at 3 months, 6 months, and 12 months
timeFrame: Baseline, 3 Months, 6 months and 12 months
measure: Change from baseline Physical activity level at 3 months, 6 months, and 12 months
timeFrame: Baseline, 3 Months, 6 months and 12 months
measure: Change from baseline Health related quality of life at 3 months, 6 months, and 12 months
timeFrame: Baseline, 3 Months, 6 months and 12 months
measure: Change from baseline Cognitive function at 3 months, 6 months, and 12 months
timeFrame: Baseline, 3 Months, 6 months and 12 months
measure: Change from baseline disability by Barthel Index at 3 months, 6 months, and 12 months
timeFrame: Baseline, 3 Months, 6 months and 12 months
measure: Change from baseline frailty (slowness; weakness; weight loss/malnutrition;low physical activity; exhaustion) at 3 months, 6 months, and 12 months
timeFrame: Baseline, 3 Months, 6 months and 12 months
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, Perez-Dominguez B, Ortega-Perez de Villar L, Melendez-Oliva E, Martinez-Gramage J, Garcia-Maset R, Gil-Gomez JA. Virtual reality exercise intradialysis to improve physical function: A feasibility randomized trial. Scand J Med Sci Sports. 2019 Jan;29(1):89-94. doi: 10.1111/sms.13304. Epub 2018 Oct 7.
citation: Segura-Orti E, Garcia-Testal A. Intradialytic virtual reality exercise: Increasing physical activity through technology. Semin Dial. 2019 Jul;32(4):331-335. doi: 10.1111/sdi.12788. Epub 2019 Mar 27.
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: Garcia Testal A, Garcia Maset R, Hervas Marin D, Perez-Dominguez B, Royo Maicas P, Rico Salvador IS, Melendez-Oliva E, Molina Aracil J, Murgui Chiva M, Del Pozo Blanco O, Olague Diaz P, Fernandez Najera JE, Torregrosa De Juan E, Benedito Carrera C, Segura-Orti E. Influence of Physical Exercise on the Dialytic Adequacy Parameters of Patients on Hemodialysis. Ther Apher Dial. 2019 Apr;23(2):160-166. doi: 10.1111/1744-9987.12762. Epub 2018 Oct 19.
citation: Ortega-Perez de Villar L, Martinez-Olmos FJ, Junque-Jimenez A, Amer-Cuenca JJ, Martinez-Gramage J, Mercer T, Segura-Orti E. Test-retest reliability and minimal detectable change scores for the short physical performance battery, one-legged standing test and timed up and go test in patients undergoing hemodialysis. PLoS One. 2018 Aug 22;13(8):e0201035. doi: 10.1371/journal.pone.0201035. eCollection 2018.
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.