FRAILTYNCT03425227
FRED Exergame Including Biofeeback Supervision
A study testing FRED EXERGAME in people with FRAILTY, run by Begoña Garcia Zapirain at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- FRAILTY
- What is being tested?
- FRED EXERGAME
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSpain
- Study dates
- 30 May 2016to 5 Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- persons over 65 years of age with a Barthel score equal to or above 90 points who carry out no scheduled physical activity.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- FRAILTY
- Being tested
- FRED EXERGAME
- Keywords
- Frailty, Elderly People, Exergame, Physical Activity, Kinect, Biofeeback
- Medical subject headings
- Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FRED EXERGAMEOther
Also called blood pressure, heart rate and blood oxygen saturation were recorded.
biofeedback with physiological constants as follows: systolic blood pressure, diastolic blood pressure, heart rate and blood oxygen saturation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: FRED EXERGAME |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 min
Systolic blood pressure
Systolic blood pressure was recorded. Reference value: <150mmHg.
Measured: 5 min
Diastolic blood pressure
Diastolic blood pressure was recorded. Reference value: <90mmHg.
Measured: 5 min
Heart Rate
Heart rate was recorded. Reference value: <76% Maximum heart rate.
Measured: 2 min
Blood Oxygen Saturation
Blood oxygen saturation was recorded. Reference value: Variations <5%SpO2.
Measured: 2 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start30 May 2016
- Primary completion27 Jun 2016
- Study completion5 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for FRAILTYStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Begoña Garcia Zapirain
- Sponsor type
- University, hospital or other
- Collaborators
- Provincial Council of Bizkaia, Basque Government
- Responsible party
- Sponsor-investigator, Begoña Garcia Zapirain, University of Deusto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425227
- Sponsor's protocol ID
- FRED Exergame
- Status last verified
- Feb 2018
- First submitted
- 1 Feb 2018
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
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.
PubMed 23786540Cabanero-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.
PubMed 18990459EuroQol 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.
PubMed 10109801Cabrero-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.
PubMed 22608368Freiberger 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.
PubMed 22885845Wilson 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.
PubMed 2924519O'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.
PubMed 20110786
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty Level Monitoring and Analysis After a Pilot Six-week Randomized Controlled Clinical Trial Using FRED Exergame Including Biofeeback Supervision
- ClinicalTrials.gov ID
- NCT03425227
- Acronym / sponsor ID
- FRED Exergame
- Conditions
- FRAILTY
- Keywords
- Frailty, Elderly People, Exergame, Physical Activity, Kinect, Biofeeback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Begoña Garcia ZapirainUniversity, hospital or other
- Collaborators
- Provincial Council of Bizkaia, Basque Government
- Study start
- 30 May 2016 (actual)
- Primary completion
- 27 Jun 2016 (actual)
- Study completion
- 5 Aug 2016 (actual)
- First posted
- 7 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| study group / control group | Experimental | Other: FRED EXERGAMEThe 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. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- persons over 65 years of age with a Barthel score equal to or above 90 points who carry out no scheduled physical activity.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FRED EXERGAMEAlso: blood pressure, heart rate and blood oxygen saturation were recorded.biofeedback with physiological constants as follows: systolic blood pressure, diastolic blood pressure, heart rate and blood oxygen saturation | Other | study group / control group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Background: PubMed 23786540Bouillon 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.
- Results publication: PubMed 18990459Cabanero-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.
- Results publication: PubMed 10109801EuroQol 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.
- Results publication: PubMed 22608368Cabrero-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.
- Results publication: PubMed 22885845Freiberger 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.
- Results publication: PubMed 2924519Wilson 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.
- Results publication: PubMed 20110786O'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.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FRED EXERGAME in people with FRAILTY, run by Begoña Garcia Zapirain at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Short Physical Performance Battery (SPPB) (time frame: 10min). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03425227, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.