FRED Exergame Including Biofeeback Supervision

February 10, 2018 updated by: Begoña Garcia Zapirain

Frailty Level Monitoring and Analysis After a Pilot Six-week Randomized Controlled Clinical Trial Using FRED Exergame Including Biofeeback Supervision

A pilot six-week randomised controlled trial was carried out introducing biofeedback with physiological constants as follows: systolic blood pressure, diastolic blood pressure, heart rate and blood oxygen saturation in the intervention group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objectives:

The main objectives are as follows:

  • Verify that the risk of frailty has decreased upon completion of the ExerGame protocol.
  • Assess the safety and cardiac healthiness of the exercises done using FRED.

Subject Recruitment Methods:

Contact was established with two residential homes for elderly people, and the necessary permits were requested and obtained from the management at the residential homes.

Approval was requested and obtained from the Ethics Committee in Research of the University of Deusto.

Recruitment at both residential homes was undertaken via informative talks that were given. These talks were open to all interested residents and were advertised via informative posters and pamphlets.

Informed Consent Process:

Interested subjects signed the duly-informed consent form.

Research Procedures:

Screening was arranged for 65 subjects in total in accordance with the following criteria:

Inclusion criteria: persons over 65 years of age with a Barthel score equal to or above 90 points who carry out no scheduled physical activity.

Exclusion criteria: persons over 65 years of age with a Barthel score less than 90 points or with a Barthel score equal to or above 90 points who carry out scheduled physical activity.

Of the 65 individuals who showed interest in taking part in the study, 46 met the inclusion criteria, and these subjects were again asked to carry out some specific tests in order to evidence their degree of frailty.

Frailty screening was undertaken using the short physical performance battery (SPPB), validated and normalised within our milieu, which combines balance testing, gait speed and chair stand. This prioritization was based on its successful validation in detecting frailty and great reliability in predicting disability.

Of the 46 subjects, 40 obtained scores below 10, i.e. 40 subjects may be considered frail.

In addition to the Barthel scale, the 40 subjects filled in the following questionnaire: EuroQol 5D-5L™. Medical records related to risk of heart failure were also gathered.

To undertake randomisation, these 40 subjects were classified according to range of age, gender and Barthel score, obtaining a study group and a control group of subjects respectively.

The subjects belonging to the study group carried out three sessions per week over a 6-week period. Each session involved 20 minutes of activity divided into three parts. The first targeted both the upper and lower extremities, while the second and third targeted specifically the upper and lower extremities respectively. On completion of each part, the subject has the chance to rate the exertion made using the simplified Borg scale [21]. Depending on their rating, they will either be able to continue immediately, or after doing some abdominal-diaphragmatic breathing exercises that will be of a duration that depends on the rating of the exertion made. After completing these breathing exercises, they may choose to continue or otherwise abandon the activity.

The physiological constants - blood pressure, heart rate and blood oxygen saturation - were recorded prior to commencing the FRED game, immediately after completing it and after 5 minutes had elapsed, according to the publications reviewed.

After completing the FRED game session each day, each participant from the study group was asked 2 simple questions, with just a YES or NO answer.

The subjects belonging to the control group continued to lead their daily lives in the course of which they had no physical activity scheduled.

After 6 weeks and having taken part in 18 physical activity sessions with the FRED game, the short physical performance battery (SPPB) test was once again carried out to ascertain whether the degree of frailty had been reduced. The Barthel score and the EuroQol 5D-5L ™ questionnaire were in turn run passed again the subjects and lastly, the system usability scale (SUS) was applied exclusively to subjects from the intervention group.

Instrumentation and Statistical analysis:

FRED is a game developed with the Unity 3D engine. It needs a Kinect game controller connected to a computer and a screen or TV. The measurement of vital signs requires a pulsioxymeter and blood pressure monitor.

For the statistical tests and the creation of graphs, the open-source statistical program R, version 3.2.x for Windows is used.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48004
        • Asociación Emankor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 100 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • persons over 65 years of age with a Barthel score equal to or above 90 points who carry out no scheduled physical activity.

Exclusion Criteria:

  • persons over 65 years of age with a Barthel score less than 90 points or with a Barthel score equal to or above 90 points who carry out scheduled physical activity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group / control group

The subjects belonging to the study group carried out three sessions per week over a 6-week period. Each session involved 20 minutes of activity divided into three parts.

The subjects belonging to the control group continued to lead their daily lives in the course of which they had no physical activity scheduled.
Other: FRED EXERGAME
biofeedback with physiological constants as follows: systolic blood pressure, diastolic blood pressure, heart rate and blood oxygen saturation
Other Names:
  • blood pressure, heart rate and blood oxygen saturation were recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Short Physical Performance Battery (SPPB)
Time Frame: 10min

This Battery includes 3 tests: balance test, gait speed and standing up from/sitting down on a chair 5 times. These tests follow a hierarchical sequence.

A total score is obtained for the whole battery, which is the sum of that obtained from the 3 tests and ranges between 0 and 12, with scores below 10 evidencing frailty.
10min
Barthel Index
Time Frame: 10min

A scale with which a quantitative estimate is obtained of the degree of independence a subject has to pursue activities of daily living.

The score ranges 0-100.
10min
EuroQol 5D-5L
Time Frame: 10 min

A standardised measure for state of health developed by the EuroQol Group in order to provide a single, general measurement applicable to a wide range of health conditions and treatments, which in turn provides a single descriptive profile and a unique state of health rate that may be used in clinical assessment

. The individual themselves assesses their state of health - first in terms of seriousness via dimensions (descriptive system) and then via a visual analogue scale (VAS) for more general assessment purposes.
10 min
The System Usability Scale (SUS)
Time Frame: 10 min

A questionnaire based on the Likert scale to rate the capacity for using systems.

The score may be between 0 and 100, in which 100 represents the best usability and a score of ≥68 is considered positive.
10 min
Systolic blood pressure
Time Frame: 5 min
Systolic blood pressure was recorded. Reference value: <150mmHg.
5 min
Diastolic blood pressure
Time Frame: 5 min
Diastolic blood pressure was recorded. Reference value: <90mmHg.
5 min
Heart Rate
Time Frame: 2 min
Heart rate was recorded. Reference value: <76% Maximum heart rate.
2 min
Blood Oxygen Saturation
Time Frame: 2 min
Blood oxygen saturation was recorded. Reference value: Variations <5%SpO2.
2 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Begoña Garcia Zapirain

Collaborators

Provincial Council of Bizkaia
Basque Government

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2016

Primary Completion (Actual)

June 27, 2016

Study Completion (Actual)

August 5, 2016

Study Registration Dates

First Submitted

February 1, 2018

First Submitted That Met QC Criteria

February 1, 2018

First Posted (Actual)

February 7, 2018

Study Record Updates

Last Update Posted (Actual)

February 13, 2018

Last Update Submitted That Met QC Criteria

February 10, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRED Exergame

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The database will be available at Zenodo.

Iranzu Mugueta-Aguinaga, & Begonya Garcia-Zapirain. (2018). FRED_DATABASE [Data set]. Zenodo. http://doi.org/10.5281/zenodo.1163736

IPD Sharing Time Frame

Until the publication in the journal, the file will be embargoed. After that, the database will be available forever.

IPD Sharing Access Criteria

at Zenodo website

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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