An interventional study of FRED EXERGAME in FRAILTY, sponsored by Begoña Garcia Zapirain. Completed at 1 site in Spain. Open to participants aged 65 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-13.
Sponsored by Begoña Garcia Zapirain · Not applicable, Interventional, and Treatment
Among 132 studies in Frailty with a site in Spain — 46 open to participants now, 54 under way, none of them phase 3. Frailty · Spain.
Among the 132 studies in Frailty with a site in Spain, this one is the 58th largest by enrollment of the 96 interventional ones that give a count, is one of 3 that started in 2016, is one of 93 with no phase, and was the 13th registered.
1,284 studies on the registry are indexed under Frailty; 452 are open to participants now.
Browse Frailty studies →46 of the 132 studies in Frailty with a site in Spain are open now. Recruiting first, the newest first:
Universidad de Granada · Sites in Spain
University of Vigo · Sites in Spain
Fundacion Miguel Servet · Sites in Spain
Alberto Bermejo Franco · Sites in Spain
Fundación para la Investigación del Hospital Clínico de Valencia · Sites in Spain
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 300 Frailty studies recruiting now, 236 (79%) set no upper age limit and 9 (3%) stop at 75 or younger; 7 take children under 18; 66 take healthy volunteers.
This study: 65 Years to 100 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
132 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 3 started in 2016.
This study's enrollment of 65 is below the median of 81 across 767 interventional studies indexed under Frailty.
Median enrollment 90 across the 96 interventional studies, 432 across the 36 observational. Of the 60 that completed or were terminated, 2 (3%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 132 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Begoña Garcia Zapirain as lead sponsor.
Begoña Garcia Zapirain has 1 study filed under Frailty — fewer than ten, so there is no comparison to draw.
11 of the studies in Frailty with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04926597Philipp SchuetzEffect of Continued Nutritional Support at Hospital Discharge on Mortality, Frailty, Functional Outcomes and Recovery | 2026-12 |
| NCT06556537Universidad de ZaragozaEffects of Physical Exercise on Frailty, Mental and Physical Health of Older Adults in Rural Areas. | 2026-12-20 |
| NCT07275996Universidad de BurgosNeuromuscular and Multi-Omics Synergy of Combined Creatine × HMB Supplementation Plus Exercise to Improve Muscle Function in Sarcopenic Frailty | 2026-12-30 |
| NCT07643064Alberto Bermejo FrancoMulticomponent Exercise and Comprehensive Geriatric Assessment Program (FRAIL+AP) for Frail Older Adults in Primary Care | 2026-12-31 |
| NCT07848802University of VigoPhysical Function and Fall Risk in Older Adults in the Lalín Frailty Prevention Program | 2027-01-15 |
Among the 132 studies in Frailty with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Objectives:
The main objectives are as follows:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Also known as: blood pressure, heart rate and blood oxygen saturation were recorded.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 10 min
Systolic blood pressure
Systolic blood pressure was recorded. Reference value: \<150mmHg.
Time frame: 5 min
Diastolic blood pressure
Diastolic blood pressure was recorded. Reference value: \<90mmHg.
Time frame: 5 min
Heart Rate
Heart rate was recorded. Reference value: \<76% Maximum heart rate.
Time frame: 2 min
Blood Oxygen Saturation
Blood oxygen saturation was recorded. Reference value: Variations \<5%SpO2.
Time frame: 2 min
Plan to share: Yes — 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
Data sharing details ↗ · doi.org
Ran from May 2016 to primary completion in Jun 2016, 0 months.
Of 513 non-industry interventional studies with no phase under Frailty, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 39. This study's 0 months is below that.
Counting every sponsor, half of 517 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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