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

Virtual Reality Exercise Intradialysis: Tolerance and Dialysis Dose Effects During the Last vs. First Part of the Hemodialysis Session

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.

Study Overview

• Status: Recruiting
• Conditions: Hemodialysis Complication; End Stage Renal Disease on Dialysis
• Intervention / Treatment: Other: Conventional exercise; Other: Exercise during the last two hours of the hemodialysis session

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'.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alicia García-Testal, PhD; Phone Number: 00 34 637519626; Email: Agtestal@gmail.com
• Study Contact Backup: Name: Eva SEGURA-ORTÍ, PhD; Phone Number: 00 34 671580094; Email: eva.segura@gmail.com

Study Locations

• Spain
  • Valencia
    • Manises, Valencia, Spain, 46940
      • Recruiting
      • Hospital de Manises
      • Contact: Eva SEGURA-ORTÍ, PhD; Phone Number: 00 34 671580094; Email: eva.segura@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• At least 3 months in hemodialysis treatment
• Clinically stable

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional exercise time; During 12 months subjects will exercise during the first two hours of the hemodialysis session. A virtual reality exercise program will be implemented	Other: Conventional exercise; Virtual reality exercise performed during the first two hours of the hemodialysis session
Experimental: Experimental group; During 12 months subjects will exercise during the last two hours of the hemodialysis session. A virtual reality exercise program will be implemented	Other: Exercise during the last two hours of the hemodialysis session; Virtual reality exercise performed during the last two hours of the hemodialysis session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of hypotension episodes	Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias	3 Months
Number of hypotension episodes	Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias	6 Months
Number of hypotension episodes	Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline postdialysis rebound urea, creatinine, phosphorus and potassium at 3 months	Postdialysis rebound urea, creatinine, phosphorus and potassium. All measurements presented as a percentage.	Baseline and 3 months
Change from baseline dialysis dose at 3 months, 6 months, and 12 months	Dialysis dose, measured through Kt/V	Baseline, 3 Months, 6 months and 12 months
Adherence, as number of sessions performed /number of sessions offered	Sessions performed/sessions offered	Baseline, 3 Months, 6 months and 12 months
Change from baseline short physical performance battery at 3 months, 6 months, and 12 months	Score achieved at the battery that includes balance tests (4 points), sit to stand to sit 5 (4 points) and and gait speed (4 points). The total score is calculated , from 1 to 12, being 12 the highest functional score	Baseline, 3 Months, 6 months and 12 months
Change from baseline gait speed at 3 months, 6 months, and 12 months	Speed to cover 4 meters, in meters/second	Baseline, 3 Months, 6 months and 12 months
Change from baseline handgrip at 3 months, 6 months, and 12 months	Bilateral handgrip strength	Baseline, 3 Months, 6 months and 12 months
Change from baseline lower limb muscle strength at 3 months, 6 months, and 12 months	Muscle strength measured with a handheld dynamometer on the main muscle groups during hemodialysis	Baseline, 3 Months, 6 months and 12 months
Change from baseline one-leg standing test at 3 months, 6 months, and 12 months	Time achieved while standing on one leg	Baseline, 3 Months, 6 months and 12 months
Change from baseline sit to stand 10 test at 3 months, 6 months, and 12 months	Time to perform 10 repetitions sit to stand	Baseline, 3 Months, 6 months and 12 months
Change from baseline sit to stand 60 at 3 months, 6 months, and 12 months	Sit to stand repetitions performed in 60 seconds	Baseline, 3 Months, 6 months and 12 months
Change from baseline timed up and go at 3 months, 6 months, and 12 months	Time to stand up, walk 3 meters, come back and sit down again	Baseline, 3 Months, 6 months and 12 months
Change from baseline one-leg heel rise test at 3 months, 6 months, and 12 months	Number of heel rise repetitions achieved	Baseline, 3 Months, 6 months and 12 months
Change from baseline 6 minutes walk test at 3 months, 6 months, and 12 months	Number of meters walked in 6 minutes	Baseline, 3 Months, 6 months and 12 months
Change from baseline Physical activity level at 3 months, 6 months, and 12 months	Physical activity questionnaires	Baseline, 3 Months, 6 months and 12 months
Change from baseline Health related quality of life at 3 months, 6 months, and 12 months	Medical outcomes survey Short Form 36 questionnaire to measure health-related quality of life, rated from 0 to 100, being the highest score the better the quality of life	Baseline, 3 Months, 6 months and 12 months
Change from baseline Cognitive function at 3 months, 6 months, and 12 months	Mini-mental State Examination questionnaire, score ranges from 0 to 30, higher scores indicates higher cognitive function	Baseline, 3 Months, 6 months and 12 months
Change from baseline disability by Barthel Index at 3 months, 6 months, and 12 months	Functional evaluation by Barthel Index, to evaluate capacity to perform daily tasks without assistance. Score ranges from 0 to 100. Higher scores indicates higher capacity to perform activities.	Baseline, 3 Months, 6 months and 12 months
Change from baseline frailty (slowness; weakness; weight loss/malnutrition;low physical activity; exhaustion) at 3 months, 6 months, and 12 months	Frailty will be measured from 0 to 5, depending on how many of the 5 components are present in each subject, being 5 the highest frailty score	Baseline, 3 Months, 6 months and 12 months

Collaborators and Investigators

• Sponsor: Cardenal Herrera University
• Collaborators: Hospital de Manises; Universitat Politècnica de València
• Investigators: Principal Investigator: Eva Segura-Ortí, PhD, Universidad CEU Cardenal Herrera, UCH CEU

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2019
• Primary Completion (Estimated): February 29, 2024
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: August 2, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; physical function; Virtual reality; health-related quality of life; hemodynamic instability
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: ReVID

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No