Effect of Exercise With Virtual Reality in Hemodialysis Patients

NCT05606484 | Unknown DMC

• 1 other identifier: TFM.MMC.EJPP.EMO.220221
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background. An increase in inflammatory biomarkers is associated with impaired kidney function and increased cardiovascular risk and mortality. Physical exercise has been shown to improve the functional capacity and inflammatory status of patients undergoing hemodialysis (HD) treatment, increasing their health-related quality of life. Virtual reality (VR) is an effective and safe tool to increase patient adherence to the exercise program, however, there are very few studies that analyze its effect on the functional capacity of patients with chronic kidney disease (CKD) in HD and none analyze its effect on the inflammatory state of these patients, which justifies the performance of this study. Methods. Eighty patients with CKD on HD treatment will be randomly assigned into two groups, one of them will perform an intradialysis exercise program with non-immersive VR (intervention group; n=40), and the other will exercise with a static pedal (control group; n). =40). The functional capacity of the patients and their inflammatory and psychological status, as well as their exercise adherende, will be analyzed before and after exercise programs.

Conditions

Kidney Failure, Chronic

Keywords

Kidney Failure, Chronic; Inflammation; Functional capacity; Psychological state; Renal Dialysis

Outcome Measures

Primary Outcomes (5)

• Change of Interleuquine 6 (IL-6) (pg/ml)

  Inflammatoy marker

  Change from Baseline IL-6 at 12 weeks

• Change of Tumoral Necrosis Factor-alpha (TNF-alpha) (pg/ml)

  Inflammatoy marker

  Change from Baseline TNF-a at 12 weeks

• Change of C Reactive Protein (CRP) (mg/L)

  Inflammatoy marker

  Change from Baseline CRP at 12 weeks

• Change of Intercellular Adhesion Molecule 1 (ICAM 1) (ng/ml)

  Inflammatoy marker

  Change from Baseline ICAM 1 at 12 weeks

• Change of Vascular cell adhesion protein 1 (VCAM 1) (ng/ml)

  Inflammatoy marker

  Change from Baseline VCAM 1 at 12 weeks

Secondary Outcomes (5)

• Assessment of the functional capacity of patients: Short Physical Performance Battery (SPPB)

  baseline and up to 12 weeks

• Assessment of the functional capacity of patients: 10 Sit To Stand Test (10 STS).

  baseline and up to 12 weeks

• Assessment of the functional capacity of patients: 60 Sit To Stand Test (60 STS).

  baseline and up to 12 weeks

• Assessment of the functional capacity of patients: 6 minute walk test (6MWT)

  baseline and up to 12 weeks

• Psychological assessment of patients: Multidimensional Questionnaire of Adaptation to the Disease for Renal Patients on Dialysis

  baseline and up to 12 weeks

Study Arms (2)

Intervention Group (IG)

EXPERIMENTAL

They will perform an intradialysis physical exercise program with non-immersive virtual reality during the first two hours of hemodialysis treatment (n = 40).

Other: Exercise with non-immersive virtual reality; Other: Exercise with a static pedal

Control Group (CG)

ACTIVE COMPARATOR

They will exercise with a static pedal during the first two hour of hemodialysis treatment (n = 40).

Other: Exercise with non-immersive virtual reality; Other: Exercise with a static pedal

Interventions

Exercise with non-immersive virtual reality OTHER

Patients will exercise for 30 minutes with non-immersive virtual reality (VR) with a perceived exertion between 12-15 (somewhat hard-hard) on the Borg scale. Patients will perform 3 weekly sessions during the second hour of hemodialysis, on simultaneous days.

Control Group (CG); Intervention Group (IG)

Exercise with a static pedal OTHER

Patients will exercise with a stationary pedal for 30 minutes at an intensity of 12-15 (somewhat hard-hard) on the Borg scale of perceived exertion. The patients will carry out an exercise session 3 times a week on alternate days, coinciding with the patients of the exercise with VR.

Control Group (CG); Intervention Group (IG)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients with CKF in a stable clinical situation who have been on HD treatment for at least 3 months.

You may not qualify if:

• Had a myocardial infarction in the 6 months before the start of the study
• Suffered unstable angina at rest or during exercise
• Have cerebrovascular diseases (such as transient ischemia or stroke)
• Present amputation of lower limbs above the knee without prothesis
• Present a musculoskeletal or respiratory pathology likely to worsen with exercise
• Present an inability to carry out functional assessment tests
• Present visual or cognitive impairments that affect the ability to use the VR equipment or understand the VR exercise

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead
• European University of Madrid: collaborator

MeSH Terms

Conditions

Kidney Failure, Chronic; Inflammation

Interventions

Exercise

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patients and the evaluator will be blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Experimental, controlled and randomized study, whose methodology complies with the CONSORT standards for clinical trials

Study Record Dates

• First Submitted: September 25, 2022
• First Posted: November 4, 2022
• Study Start: June 9, 2023
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share