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

NCT04046042 | Recruiting

• 1 other identifier: ReVID
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease on Dialysis; Hemodialysis Complication

Keywords

Exercise; Virtual reality; physical function; health-related quality of life; hemodynamic instability

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (18)

• Change from baseline postdialysis rebound urea, creatinine, phosphorus and potassium at 3 months

  Baseline and 3 months

• Change from baseline dialysis dose at 3 months, 6 months, and 12 months

  Baseline, 3 Months, 6 months and 12 months

• Adherence, as number of sessions performed /number of 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

  Baseline, 3 Months, 6 months and 12 months

• Change from baseline gait speed at 3 months, 6 months, and 12 months

  Baseline, 3 Months, 6 months and 12 months

Study Arms (2)

Conventional exercise time

ACTIVE COMPARATOR

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

Experimental group

EXPERIMENTAL

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

Interventions

Conventional exercise OTHER

Virtual reality exercise performed during the first two hours of the hemodialysis session

Conventional exercise time

Exercise during the last two hours of the hemodialysis session OTHER

Virtual reality exercise performed during the last two hours of the hemodialysis session

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 3 months in hemodialysis treatment
• Clinically stable

You may not qualify if:

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

Sponsors & Collaborators

• Cardenal Herrera University: lead
• Hospital de Manises: collaborator
• Universitat Politècnica de Valéncia: collaborator

Study Sites (1)

Hospital de Manises

Manises, Valencia, 46940, Spain

RECRUITING

Related Publications (9)

• 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.

  PMID: 30230041 BACKGROUND

• 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.

  PMID: 30916415 BACKGROUND

• 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.

  PMID: 21719637 BACKGROUND

• 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.

  PMID: 20701722 BACKGROUND

• 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.

  PMID: 20098466 BACKGROUND

• 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.

  PMID: 30226299 BACKGROUND

• 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.

  PMID: 30133445 BACKGROUND

• 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.

  PMID: 19473613 BACKGROUND

• 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.

  PMID: 18336134 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Eva Segura-Ortí, PhD

  Universidad CEU Cardenal Herrera, UCH CEU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Segura-Ortí, PhD

CONTACT

00 34 671580094; eva.segura@gmail.com

Alicia García-Testal, PhD

CONTACT

00 34 637519626; Agtestal@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A team of assessors, different from the researchers implementing the exercise, will record all dependent variables. A blind researcher will randomize participants
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 6, 2019
• Study Start: September 2, 2019
• Primary Completion: August 29, 2024
• Study Completion: August 30, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

ES (1)