Hemodialysis Complication Clinical Trial
— VRIOfficial title:
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | August 30, 2024 |
Est. primary completion date | August 29, 2024 |
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital de Manises | Manises | Valencia |
Lead Sponsor | Collaborator |
---|---|
Cardenal Herrera University | Hospital de Manises, Universitat Politècnica de Valéncia |
Spain,
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. — View 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. — View 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. — 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of hypotension episodes | Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias | 3 Months | |
Primary | Number of hypotension episodes | Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias | 6 Months | |
Primary | Number of hypotension episodes | Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias | 12 Months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Adherence, as number of sessions performed /number of sessions offered | Sessions performed/sessions offered | Baseline, 3 Months, 6 months and 12 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Change from baseline handgrip at 3 months, 6 months, and 12 months | Bilateral handgrip strength | Baseline, 3 Months, 6 months and 12 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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