ClinicalTrials.gov
ClinicalTrials.gov Menu

FRED Exergame Including Biofeeback Supervision

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03425227
Recruitment Status : Completed
First Posted : February 7, 2018
Last Update Posted : February 13, 2018
Sponsor:
Collaborators:
Provincial Council of Bizkaia
Basque Government
Information provided by (Responsible Party):
Begoña Garcia Zapirain, University of Deusto

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
FRAILTY Other: FRED EXERGAME Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Intervention Model: Single Group Assignment
Intervention Model Description:

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

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).

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.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Frailty Level Monitoring and Analysis After a Pilot Six-week Randomized Controlled Clinical Trial Using FRED Exergame Including Biofeeback Supervision
Actual Study Start Date : May 30, 2016
Actual Primary Completion Date : June 27, 2016
Actual Study Completion Date : August 5, 2016

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 Name: blood pressure, heart rate and blood oxygen saturation were recorded.




Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.


  5. Systolic blood pressure [ Time Frame: 5 min ]
    Systolic blood pressure was recorded. Reference value: <150mmHg.

  6. Diastolic blood pressure [ Time Frame: 5 min ]
    Diastolic blood pressure was recorded. Reference value: <90mmHg.

  7. Heart Rate [ Time Frame: 2 min ]
    Heart rate was recorded. Reference value: <76% Maximum heart rate.

  8. Blood Oxygen Saturation [ Time Frame: 2 min ]
    Blood oxygen saturation was recorded. Reference value: Variations <5%SpO2.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03425227


Locations
Spain
Asociación Emankor
Bilbao, Vizcaya, Spain, 48004
Sponsors and Collaborators
Begoña Garcia Zapirain
Provincial Council of Bizkaia
Basque Government

Publications of Results:

Other Publications:
Responsible Party: Begoña Garcia Zapirain, PI of eVIDA Research Group, University of Deusto
ClinicalTrials.gov Identifier: NCT03425227     History of Changes
Other Study ID Numbers: FRED Exergame
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

Time Frame: Until the publication in the journal, the file will be embargoed. After that, the database will be available forever.
Access Criteria: at Zenodo website
URL: http://doi.org/10.5281/zenodo.1163736

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Begoña Garcia Zapirain, University of Deusto:
Frailty
Elderly People
Exergame
Physical Activity
Kinect
Biofeeback