Virtual Reality Versus Conventional Exercise Intradialysis

NCT03120611 | Completed

• 1 other identifier: 2015/0193
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

All participants exercised during 16 weeks following a conventional intradialysis exercise program. The last 4 weeks of the study participants were randomized into two different exercise programs intradialysis. One group exercised through a virtual reality exercise adapted specially for patients while receiving hemodialysis treatment. The other group exercised with a conventional exercise program, combining aerobic cycling and strengthening exercises.

Conditions

End Stage Renal Disease

Keywords

Exercise; Hemodialysis; Virtual Reality

Outcome Measures

Primary Outcomes (1)

• Sit to Stand to Sit test 10

  Time required to stand up from a chair and sit down 10 consecutive times

  20 weeks

Secondary Outcomes (17)

• Short Physical Performance Battery

  20 weeks

• Timed Up and Go

  20 weeks

• One leg stand test

  20 weeks

• Sit to Stand to Sit test 60 seconds

  20 weeks

• Handgrip

  20 weeks

Study Arms (2)

Virtural reality exercise

EXPERIMENTAL

Virtual reality exercise performed during the hemodialysis session, using the Kinect, specially adapted for patients undertaking hemodialysis

Other: Virtual Reality Exercise

Conventional exercise intradialysis

ACTIVE COMPARATOR

Exercise combining both aerobic (cycling) and strengthening exercise of lower limbs for patients during the hemodialysis session

Other: Conventional exercise intradialysis

Interventions

Virtual Reality Exercise OTHER

Game developed by the Kinect, adapted to the lying position of participants.

Virtural reality exercise

Conventional exercise intradialysis OTHER

Aerobic exercise (cycling) and strengthening exercise for lower limbs using elastic bands and gravity

Conventional exercise intradialysis

Eligibility Criteria

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

You may qualify if:

• \- Patients in HD therapy at least 3 months

You may not qualify if:

• recent myocardial infarction (within 6 weeks)
• unstable angina
• malignant arrhythmias
• above the knee amputation without replacement
• cerebral vascular disease (ictus, transient ischemia)
• musculoskeletal and respiratory disorders that can get worse with exercise
• impossibility to achieve functional testing

Sponsors & Collaborators

• Cardenal Herrera University: lead
• Hospital de Manises, Valencia: collaborator

Study Sites (1)

Hospital de Manises

Manises, Valencia, 46940, Spain

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Motor Activity

Interventions

Exergaming

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Rafael García Maset, MD

  Hospital de Manises

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 19, 2017
• Study Start: June 1, 2017
• Primary Completion: July 30, 2017
• Study Completion: August 31, 2017
• Last Updated: May 23, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)