FRED Exergame Including Biofeeback Supervision

NCT03425227 | Completed DMC

• 1 other identifier: FRED Exergame
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

FRAILTY

Keywords

Frailty; Elderly People; Exergame; Physical Activity; Kinect; Biofeeback

Outcome Measures

Primary Outcomes (8)

• The Short Physical Performance Battery (SPPB)

  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

  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

  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)

  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

  Systolic blood pressure was recorded. Reference value: \<150mmHg.

  5 min

• Diastolic blood pressure

  Diastolic blood pressure was recorded. Reference value: \<90mmHg.

  5 min

• Heart Rate

  Heart rate was recorded. Reference value: \<76% Maximum heart rate.

  2 min

• Blood Oxygen Saturation

  Blood oxygen saturation was recorded. Reference value: Variations \<5%SpO2.

  2 min

Study Arms (1)

study group / control group

EXPERIMENTAL

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

Interventions

FRED EXERGAME OTHER

biofeedback with physiological constants as follows: systolic blood pressure, diastolic blood pressure, heart rate and blood oxygen saturation

Also known as: blood pressure, heart rate and blood oxygen saturation were recorded.

study group / control group

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Begoña Garcia Zapirain: lead
• Provincial Council of Bizkaia: collaborator
• Basque Government: collaborator

Study Sites (1)

Asociación Emankor

Bilbao, Vizcaya, 48004, Spain

Location

Related Publications (7)

• Bouillon K, Kivimaki M, Hamer M, Sabia S, Fransson EI, Singh-Manoux A, Gale CR, Batty GD. Measures of frailty in population-based studies: an overview. BMC Geriatr. 2013 Jun 21;13:64. doi: 10.1186/1471-2318-13-64.

  PMID: 23786540 BACKGROUND

• Cabanero-Martinez MJ, Cabrero-Garcia J, Richart-Martinez M, Munoz-Mendoza CL. The Spanish versions of the Barthel index (BI) and the Katz index (KI) of activities of daily living (ADL): a structured review. Arch Gerontol Geriatr. 2009 Jul-Aug;49(1):e77-84. doi: 10.1016/j.archger.2008.09.006. Epub 2008 Nov 5.

  PMID: 18990459 RESULT

• EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.

  PMID: 10109801 RESULT

• Cabrero-Garcia J, Munoz-Mendoza CL, Cabanero-Martinez MJ, Gonzalez-Llopis L, Ramos-Pichardo JD, Reig-Ferrer A. [Short physical performance battery reference values for patients 70 years-old and over in primary health care]. Aten Primaria. 2012 Sep;44(9):540-8. doi: 10.1016/j.aprim.2012.02.007. Epub 2012 May 16. Spanish.

  PMID: 22608368 RESULT

• Freiberger E, de Vreede P, Schoene D, Rydwik E, Mueller V, Frandin K, Hopman-Rock M. Performance-based physical function in older community-dwelling persons: a systematic review of instruments. Age Ageing. 2012 Nov;41(6):712-21. doi: 10.1093/ageing/afs099. Epub 2012 Aug 10.

  PMID: 22885845 RESULT

• Wilson RC, Jones PW. A comparison of the visual analogue scale and modified Borg scale for the measurement of dyspnoea during exercise. Clin Sci (Lond). 1989 Mar;76(3):277-82. doi: 10.1042/cs0760277.

  PMID: 2924519 RESULT

• O'Brien E, Atkins N, Stergiou G, Karpettas N, Parati G, Asmar R, Imai Y, Wang J, Mengden T, Shennan A; Working Group on Blood Pressure Monitoring of the European Society of Hypertension. European Society of Hypertension International Protocol revision 2010 for the validation of blood pressure measuring devices in adults. Blood Press Monit. 2010 Feb;15(1):23-38. doi: 10.1097/MBP.0b013e3283360e98. No abstract available.

  PMID: 20110786 RESULT

MeSH Terms

Conditions

Frailty; Motor Activity

Interventions

Blood Pressure; Heart Rate

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI of eVIDA Research Group

Model Details: 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.

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 7, 2018
• Study Start: May 30, 2016
• Primary Completion: June 27, 2016
• Study Completion: August 5, 2016
• Last Updated: February 13, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share
• 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

Locations

ES (1)