Heart FailureNCT03909919
Functional Parameters Indicative of Heart Failure.
A study of Heart Failure, run by University of Malaga at 1 site in Spain.
Trial summary
The present study aims to validate the kinematic analysis obtained by two motion capture instruments for the functional objective assessment of elderly patients with Heart Failire (HF) and to develop a new functional index formed by kinematic parameters and other functional objective parameters and scales which may be… Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 18 Jan 2020to 18 May 2024
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Subjects older than 70 years.
- Healthy subjects and subjects diagnosed with Heart failure.
- Subjects able of filling out questionnaires and performing functional tests.
- subjects who are in a clinical stability and optimal treatment phase.
Who cannot join
- Participants with cardiac pathologies other than heart failure.
- Score in the NYHA scale equal to 4.
- Hospitalization in a period of time equal to or less than 3 months.
- Score on the Mini-Mental scale below 24.
- Inability to get up from the chair at least 5 times or 30 seconds.
- Inability to walk for 6 minutes.
Show all 9Show fewer
- Inability to walk independently without a walking assistance device (cane, crutch or walker).
- Subjects participating in an experimental study where they receive a treatment.
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The present study aims to validate the kinematic analysis obtained by two motion capture instruments for the functional objective assessment of elderly patients with Heart Failire (HF) and to develop a new functional index formed by kinematic parameters and other functional objective parameters and scales which may be impaired in patients with HF and they could allow the stratification of these patients based on different levels of functional impairment.
Read the detailed description
Cardiovascular diseases carried on being the leading cause of disability due to noncommunicable diseases from 1990 to 2016. Within cardiovascular diseases, it has been estimated that heart failure (HF) has a prevalence in the population of approximately 2% to 3%. However, it is the only cardiovascular disease that is increasing in incidence and prevalence due to the aging of the world population, since the prevalence of this disease increases with age. Furthermore, heart failure represents the most important hospital diagnosis in older adults, being the main cause of hospital admissions for people older than 65 years and contributing to the increase of medical care costs.
Subjects with HF use to show a reduced aerobic capacity, a decreased muscle strength in the lower limbs, low weekly physical activity, intolerance to exercise and a lower walking speed than healthy subjects of the same age. In general, patients with heart failure have altered functional capacities and experience a decline in the ability to carry out activities of daily living and suffer a reduced quality of life. When it is assessed functional parameters in patients with heart failure, the maximum oxygen consumption (V0₂ max) obtained from a cardiopulmonary exercise test is considered the gold standard measure of cardiovascular functional capacity. Moreover, some functional tests have been used, such as the 6-Minute Walking Test, which provides an indirect measure of cardiovascular functional capacity, and the Short Physical Performance Battery (SPPB), which also provides a useful and indirect indication of muscle functional capacity. However, at the time of diagnosing or classifying patients with heart failure, the functional assessment does not use to be considered. The implementation of diagnostic guidelines or a functional assessment based on evidence can be important to improve prognosis and quality of life in patients with HF.
Therefore, there is a need to identify functional markers related to functionality that are indicative of heart failure. For this, it is necessary to use instruments to measure functional variables that must be valid and reliable, as established by the COSMIN taxonomy. Kinematic measurements allow quantifying normal and pathological movements, quantifying the degree of deterioration, planning rehabilitation strategies and evaluating the effect of various interventions. Inertial sensors and depth cameras are accurate and reliable methods for the kinematic analysis of human movement, in addition to presenting a good correlation of kinematic data between them.
Currently, it can be used the Simmer3 Inertial Sensor and 3D motion capture systems with a camera to analyse kinematics and these instruments are being integrated as a rehabilitation tool in patients. The use of Shimmer3 Inertial Sensor and 3D motion capture cameras would help to find fast and cheap assessment methods for professionals.
- Conditions
- Heart Failure
- Being tested
- Standard Care or Usual Clinical Practice
- Keywords
- Heart Failure, Kinematics, Validation, Functional task
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Care or Usual Clinical PracticeProcedure or surgery
The guidelines for the management according to the heart failure in primary care will be the treatment guidelines for the Standard Care.
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure | Experimental | Heart Failure patients Subjects diagnosed with heart faikure, who will receive the best treatment of clinical practice, will be recruited. They must be more than 70 years old. Receives: Procedure: Standard Care or Usual Clinical Practice |
| Healthy Subjects | Active comparator | Healthy Subjects/ Match control Healthy subjects of the same age as people with heart failure. Receives: Procedure: Standard Care or Usual Clinical Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motion parameters
Kinematic parameters will be analysed using an inertial sensor included in the Shimmer3 instrument during the performance of different functional task.
Measured: 1 hour
Kinematic analysis by 3D motion capture
A camera will perform a motion capture of the functional task. This system will calculate the displacement and the time of the functional task.
Measured: 1 hour
Responsiveness
The Responsiveness Box of COSMIN checklist will be used to determinate the response to change of the Shimmer 3 Inertial Sensor and the 3D cameras. All possible items will be followed.
Measured: 1 hour
Reliability
The Reliability Box of COSMIN checklist will be used to determinate the Test-Retest reliability of the Shimmer3 Inertial Sensor and the 3D cameras. All possible items will be followed.
Measured: 1 hour
Secondary outcomes (6)
abbreviated comprehensive geriatric assessment (aCGA): a questionnaire formed by items originating from four different scales.
Questionnaire used to assess functional, emotional and cognitive components. It is composed of 15 items from the 4 instruments such as the geriatric depression scale (GDS), the Mini-Mental State Examination (MMSE), activities of daily living (ADL) using the Katz index and instrumental activities of daily living (IADL) using the Lawnton \& Brody scale. The score varies from 0 to 30 points, giving 1 point to each of the items of the GDS (4 points in total), 12 to the 3 items from the scale of Lawton \& Brody, 8 points to the 4 items from the MMSE and 6 points to the 3 items from the Katz index.
Measured: 15 minutes
SARC-F
It is a simple questionnaire to rapidly diagnose Sarcopenia. It is composed by 5 components: Strength, Assistance to walk, Get up from a chair, Climb stairs and Falls. Scores range from 0 to 10, with 0 to 2 points for each component. A score equal to or greater than 4 could predict sarcopenia and poor results.
Measured: 10 minutes
Cardiopulmonary function
The heart rate will be assessed using the ECG Unit of Shimmer3.
Measured: 1 hour
Quadriceps thickness
Muscular thickness will be analysed using the B-mode ultrasonography device (SonoSite 180 Plus, SonoSite Japan, Tokyo, Japan).
Measured: 15 minutes
Quadriceps muscle echo-intensity
Muscle echo-intensity will be analysed using the B-mode ultrasonography device (SonoSite 180 Plus, SonoSite Japan, Tokyo, Japan).
Measured: 15 minutes
Mortality
examining death rates and risk measures like standardized mortality ratios (SMRs)
Measured: until the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start18 Jan 2020
- Primary completion18 May 2024
- Study completion18 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Principal investigator, Dr. Antonio I Cuesta-Vargas, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909919
- Sponsor's protocol ID
- Funnel study
- Status last verified
- Oct 2023
- First submitted
- 4 Apr 2019
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fuentes-Abolafio IJ, Ricci M, Bernal-Lopez MR, Gomez-Huelgas R, Cuesta-Vargas AI, Perez-Belmonte LM. Relationship between quadriceps femoris echotexture biomarkers and muscle strength and physical function in older adults with heart failure with preserved ejection fraction. Exp Gerontol. 2024 Jun 1;190:112412. doi: 10.1016/j.exger.2024.112412. Epub 2024 Apr 6.
PubMed 38570057Fuentes-Abolafio IJ, Trinidad-Fernandez M, Ricci M, Roldan-Jimenez C, Gomez-Huelgas R, Arjona-Caballero JM, Escriche-Escuder A, Bernal-Lopez MR, Perez-Belmonte LM, Cuesta-Vargas AI. Kinematic parameters related to functional capacity, fatigue, and breathlessness during the 6-min walk test in older adults with heart failure with preserved ejection fraction. Eur J Cardiovasc Nurs. 2024 Jan 12;23(1):69-80. doi: 10.1093/eurjcn/zvad027.
PubMed 36808232Fuentes-Abolafio IJ, Bernal-Lopez MR, Gomez-Huelgas R, Ricci M, Cuesta-Vargas AI, Perez-Belmonte LM. Relationship between quadriceps femoris muscle architecture and muscle strength and physical function in older adults with heart failure with preserved ejection fraction. Sci Rep. 2022 Dec 15;12(1):21660. doi: 10.1038/s41598-022-26064-7.
PubMed 36522418Fuentes-Abolafio IJ, Ricci M, Bernal-Lopez MR, Gomez-Huelgas R, Cuesta-Vargas AI, Perez-Belmonte LM. Biomarkers and the quadriceps femoris muscle architecture assessed by ultrasound in older adults with heart failure with preserved ejection fraction: a cross-sectional study. Aging Clin Exp Res. 2022 Oct;34(10):2493-2504. doi: 10.1007/s40520-022-02189-7. Epub 2022 Aug 8.
PubMed 35939260
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Parameters Indicative of Heart Failure.
- ClinicalTrials.gov ID
- NCT03909919
- Acronym / sponsor ID
- Funnel study
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Kinematics, Validation, Functional task
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 18 Jan 2020 (actual)
- Primary completion
- 18 May 2024 (actual)
- Study completion
- 18 May 2024 (actual)
- First posted
- 10 Apr 2019 (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.
The present study aims to validate the kinematic analysis obtained by two motion capture instruments for the functional objective assessment of elderly patients with Heart Failire (HF) and to develop a new functional index formed by kinematic parameters and other functional objective parameters and scales which may be impaired in patients with HF and they could allow the stratification of these patients based on different levels of functional impairment.
Detailed description
Cardiovascular diseases carried on being the leading cause of disability due to noncommunicable diseases from 1990 to 2016. Within cardiovascular diseases, it has been estimated that heart failure (HF) has a prevalence in the population of approximately 2% to 3%. However, it is the only cardiovascular disease that is increasing in incidence and prevalence due to the aging of the world population, since the prevalence of this disease increases with age. Furthermore, heart failure represents the most important hospital diagnosis in older adults, being the main cause of hospital admissions for people older than 65 years and contributing to the increase of medical care costs.
Subjects with HF use to show a reduced aerobic capacity, a decreased muscle strength in the lower limbs, low weekly physical activity, intolerance to exercise and a lower walking speed than healthy subjects of the same age. In general, patients with heart failure have altered functional capacities and experience a decline in the ability to carry out activities of daily living and suffer a reduced quality of life. When it is assessed functional parameters in patients with heart failure, the maximum oxygen consumption (V0₂ max) obtained from a cardiopulmonary exercise test is considered the gold standard measure of cardiovascular functional capacity. Moreover, some functional tests have been used, such as the 6-Minute Walking Test, which provides an indirect measure of cardiovascular functional capacity, and the Short Physical Performance Battery (SPPB), which also provides a useful and indirect indication of muscle functional capacity. However, at the time of diagnosing or classifying patients with heart failure, the functional assessment does not use to be considered. The implementation of diagnostic guidelines or a functional assessment based on evidence can be important to improve prognosis and quality of life in patients with HF.
Therefore, there is a need to identify functional markers related to functionality that are indicative of heart failure. For this, it is necessary to use instruments to measure functional variables that must be valid and reliable, as established by the COSMIN taxonomy. Kinematic measurements allow quantifying normal and pathological movements, quantifying the degree of deterioration, planning rehabilitation strategies and evaluating the effect of various interventions. Inertial sensors and depth cameras are accurate and reliable methods for the kinematic analysis of human movement, in addition to presenting a good correlation of kinematic data between them.
Currently, it can be used the Simmer3 Inertial Sensor and 3D motion capture systems with a camera to analyse kinematics and these instruments are being integrated as a rehabilitation tool in patients. The use of Shimmer3 Inertial Sensor and 3D motion capture cameras would help to find fast and cheap assessment methods for professionals.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart Failure | Experimental | Procedure: Standard Care or Usual Clinical PracticeHeart Failure patients Subjects diagnosed with heart faikure, who will receive the best treatment of clinical practice, will be recruited. They must be more than 70 years old. |
| Healthy Subjects | Active comparator | Procedure: Standard Care or Usual Clinical PracticeHealthy Subjects/ Match control Healthy subjects of the same age as people with heart failure. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Subjects older than 70 years.
- Healthy subjects and subjects diagnosed with Heart failure.
- Subjects able of filling out questionnaires and performing functional tests.
- subjects who are in a clinical stability and optimal treatment phase.
Key exclusion criteria (9 listed)
- Participants with cardiac pathologies other than heart failure.
- Score in the NYHA scale equal to 4.
- Hospitalization in a period of time equal to or less than 3 months.
- Score on the Mini-Mental scale below 24.
- Inability to get up from the chair at least 5 times or 30 seconds.
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 |
|---|---|---|
| Standard Care or Usual Clinical PracticeThe guidelines for the management according to the heart failure in primary care will be the treatment guidelines for the Standard Care. | Procedure or surgery | Healthy Subjects, Heart Failure |
Primary outcome
Motion parameters
Time frame: 1 hour
Kinematic parameters will be analysed using an inertial sensor included in the Shimmer3 instrument during the performance of different functional task.
Kinematic analysis by 3D motion capture
Time frame: 1 hour
A camera will perform a motion capture of the functional task. This system will calculate the displacement and the time of the functional task.
Responsiveness
Time frame: 1 hour
The Responsiveness Box of COSMIN checklist will be used to determinate the response to change of the Shimmer 3 Inertial Sensor and the 3D cameras. All possible items will be followed.
Reliability
Time frame: 1 hour
The Reliability Box of COSMIN checklist will be used to determinate the Test-Retest reliability of the Shimmer3 Inertial Sensor and the 3D cameras. All possible items will be followed.
6 secondary outcomes
abbreviated comprehensive geriatric assessment (aCGA): a questionnaire formed by items originating from four different scales.
Time frame: 15 minutes
SARC-F
Time frame: 10 minutes
Cardiopulmonary function
Time frame: 1 hour
Quadriceps thickness
Time frame: 15 minutes
Quadriceps muscle echo-intensity
Time frame: 15 minutes
Mortality
Time frame: until the end of the study
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 22 Sep 2025.
- Derived from this study: PubMed 38570057Fuentes-Abolafio IJ, Ricci M, Bernal-Lopez MR, Gomez-Huelgas R, Cuesta-Vargas AI, Perez-Belmonte LM. Relationship between quadriceps femoris echotexture biomarkers and muscle strength and physical function in older adults with heart failure with preserved ejection fraction. Exp Gerontol. 2024 Jun 1;190:112412. doi: 10.1016/j.exger.2024.112412. Epub 2024 Apr 6.
- Derived from this study: PubMed 36808232Fuentes-Abolafio IJ, Trinidad-Fernandez M, Ricci M, Roldan-Jimenez C, Gomez-Huelgas R, Arjona-Caballero JM, Escriche-Escuder A, Bernal-Lopez MR, Perez-Belmonte LM, Cuesta-Vargas AI. Kinematic parameters related to functional capacity, fatigue, and breathlessness during the 6-min walk test in older adults with heart failure with preserved ejection fraction. Eur J Cardiovasc Nurs. 2024 Jan 12;23(1):69-80. doi: 10.1093/eurjcn/zvad027.
- Derived from this study: PubMed 36522418Fuentes-Abolafio IJ, Bernal-Lopez MR, Gomez-Huelgas R, Ricci M, Cuesta-Vargas AI, Perez-Belmonte LM. Relationship between quadriceps femoris muscle architecture and muscle strength and physical function in older adults with heart failure with preserved ejection fraction. Sci Rep. 2022 Dec 15;12(1):21660. doi: 10.1038/s41598-022-26064-7.
- Derived from this study: PubMed 35939260Fuentes-Abolafio IJ, Ricci M, Bernal-Lopez MR, Gomez-Huelgas R, Cuesta-Vargas AI, Perez-Belmonte LM. Biomarkers and the quadriceps femoris muscle architecture assessed by ultrasound in older adults with heart failure with preserved ejection fraction: a cross-sectional study. Aging Clin Exp Res. 2022 Oct;34(10):2493-2504. doi: 10.1007/s40520-022-02189-7. Epub 2022 Aug 8.
- Individual participant dataSharing planned: No
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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 of Heart Failure, run by University of Malaga 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 4 inclusion and 9 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 22 Sep 2025. 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?
Motion parameters (time frame: 1 hour). The study lists 4 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 NCT03909919, which also lists 4 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 22 Sep 2025.