Virtual Reality Versus Conventional Exercise Intradialysis

NCT ID: NCT03120611

Last Updated: 2018-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2017-08-31

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.

Detailed Description

The first 16 weeks all participants followed an intradialysis exercise program. The exercise program consisted of strengthening exercises for lower limbs and for the upper limb free of fistula. The exercise program included isotonic exercises for quadriceps, triceps surae, psoas, glutei, and brachial biceps; and isometric exercises for hip adductors and hamstrings. Elastic bands were used to apply resistance. Progression was achieved from increasing from 1 set of 10 repetitions until 3 sets of 15 repetitions. This first part lasted no more than 30 minutes. The program also included aerobic exercise (cycling) for up to 30 minutes. Intensity was adapted through the duration of the study so that the participant felt the exercise from hard to somewhat hard (13 to 15 at the rate of perceived exertion 6 to 20). Time and resistance were adapted progressively.

The last four weeks of the program participants were randomized into virtual reality exercise or conventional exercise group. The virtual reality exercise group undertook 30 minutes of exercise. After warming up, participants had to play to an adapted 'treasure hunt' game. Their legs movements were the players projected into an individual tv that gave them feedback regarding their achievements. The aim of the game was to achieve the higher possible score.They moved to pick up coins and to avoid bombs. An adapted Kinect technology was used for the game development.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Virtural reality exercise

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

Group Type: EXPERIMENTAL

Virtual Reality Exercise

Intervention Type: OTHER

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

Conventional exercise intradialysis

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

Group Type: ACTIVE_COMPARATOR

Conventional exercise intradialysis

Intervention Type: OTHER

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

Interventions

Virtual Reality Exercise

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

Intervention Type: OTHER

Conventional exercise intradialysis

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients in HD therapy at least 3 months

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Manises, Valencia

UNKNOWN

Sponsor Role: collaborator

Cardenal Herrera University

OTHER

Sponsor Role: lead

Responsible Party

Eva Segura Ortí

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rafael García Maset, MD

Role: STUDY_CHAIR

Hospital de Manises

Locations

Hospital de Manises

Manises, Valencia, Spain

Countries

Spain

Other Identifiers

2015/0193

Identifier Type: -

Identifier Source: org_study_id