Health TrialsbyHealthPanel

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

ConditionsEnd Stage Renal Disease on DialysisHemodialysis Complication
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCardenal Herrera University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At least 3 months in hemodialysis treatment

Clinically stable

Disqualifiers

Recent cardiac events (less than 3 months)

Unable to exercise

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conventional exercise

    Other intervention

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

  • Exercise during the last two hours of the hemodialysis session

    Other intervention

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Conventional exercise timeActive comparator 1 intervention
Group B: Experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of hypotension episodes

Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias

Time frame
3 Months
2

Number of hypotension episodes

Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias

Time frame
6 Months
3

Number of hypotension episodes

Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias

Time frame
12 Months

Secondary outcomes

1

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.

Time frame
Baseline and 3 months
2

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

Dialysis dose, measured through Kt/V

Time frame
Baseline, 3 Months, 6 months and 12 months
3

Adherence, as number of sessions performed /number of sessions offered

Sessions performed/sessions offered

Time frame
Baseline, 3 Months, 6 months and 12 months
4

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

Time frame
Baseline, 3 Months, 6 months and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cardenal Herrera University

Lead sponsor

Hospital de Manises

Collaborator

Universitat Politècnica de Valéncia

Collaborator

Source ClinicalTrials.gov
Apply now