FRED Exergame Including Biofeeback Supervision
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|ClinicalTrials.gov Identifier: NCT03425227|
Recruitment Status : Completed
First Posted : February 7, 2018
Last Update Posted : February 13, 2018
|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)|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- Systolic blood pressure [ Time Frame: 5 min ]Systolic blood pressure was recorded. Reference value: <150mmHg.
- Diastolic blood pressure [ Time Frame: 5 min ]Diastolic blood pressure was recorded. Reference value: <90mmHg.
- Heart Rate [ Time Frame: 2 min ]Heart rate was recorded. Reference value: <76% Maximum heart rate.
- Blood Oxygen Saturation [ Time Frame: 2 min ]Blood oxygen saturation was recorded. Reference value: Variations <5%SpO2.
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
|Bilbao, Vizcaya, Spain, 48004|