Virtual Reality During Hemodialysis

NCT03456414 | Completed

• 1 other identifier: 2017/0638
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease; Hemodialysis-Induced Symptom

Keywords

exercise; physical function; health related quality of life

Outcome Measures

Primary Outcomes (1)

• Change from baseline gait speed at 12 weeks

  Speed to cover 4 meters at normal speed

  Baseline, 12 weeks

Secondary Outcomes (13)

• Change from baseline sit to stand 10 at 12 weeks

  Baseline, 12 weeks

• Change from baseline sit to stand 60 at 12 weeks

  Baseline, 12 weeks

• Change from baseline timed up and go at 12 weeks

  Baseline, 12 weeks

• Change from baseline short physical performance battery at 12 weeks

  Baseline, 12 weeks

• Change from baseline handgrip at 12 weeks

  Baseline, 12 weeks

Study Arms (2)

Virtual reality during hemodialysis

EXPERIMENTAL

During 12 weeks subjects will exercise during hemodialysis. The intervention will be virtual reality exercise during hemodialysis.

Other: Virtual reality exercise during hemodialysis

Control period - no exercise

NO INTERVENTION

During 12 weeks subjects will not exercise during hemodialysis

Interventions

Virtual reality exercise during hemodialysis OTHER

Subjects will play a virtual reality game specially adapted for subjects undertaking hemodialysis treatment

Virtual reality during hemodialysis

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 València: collaborator

Study Sites (1)

Hospital de Manises

Manises, Valencia, 46940, Spain

Location

Related Publications (6)

• 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.

  PMID: 28114792 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

• 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

Kidney Failure, Chronic; Motor Activity

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Eva SEGURA-ORTÍ, PhD

  Universidad CEU Cardenal Herrera, UCH CEU

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: All participants will receive during hemodialysis the conditions 'virtual reality exercise' for 12 weeks and 'control period-no exercise' for 12 more weeks

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 7, 2018
• Study Start: April 11, 2018
• Primary Completion: September 1, 2018
• Study Completion: September 30, 2018
• Last Updated: July 17, 2020

Record last verified: 2020-07

Locations

ES (1)