Acute Coronary SyndromeNCT04246008
Effects of Neuromuscular Training on Functional Capacity in Acute Coronary Syndrome Patients
A study testing Neuromuscular training and Conventional strength training in people with Acute Coronary Syndrome, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
The purpose of this study is to analyse the effects of neuromuscular training on functional capacity in patients with acute coronary syndrome, compared to the classic strength training of the cardiac rehabilitation programs Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Neuromuscular training and Conventional strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2021to 30 Jan 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute coronary syndrome patients
- Physical activity must have been prescribed
Who cannot join
- inflammatory cardiac disease
- severe or moderate ventricular dysfunction
- heart failure
- severe arrhytmias
- systemic hypertension >95% percentile
- pulmonary hypertension >40 mmHg
Show all 9Show fewer
- aortic stenosis
- baseline O2 <90%
- severe valve insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to analyse the effects of neuromuscular training on functional capacity in patients with acute coronary syndrome, compared to the classic strength training of the cardiac rehabilitation programs
Read the detailed description
So far, there are no previous studies that analyze the effects of neuromuscular training on functional capacity in patients with acute coronary syndrome.
Aim: The main objective of this study is to assess the effects of a 10 weeks neuromuscular training vs traditional strength training programme in patients with acute coronary syndrome.
Design: Randomized clinical trial
- Conditions
- Acute Coronary Syndrome
- Being tested
- Neuromuscular training, Conventional strength training
- Keywords
- acute coronary syndrome, neuromuscular training, cardiac rehabilitation, functional capacity
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular trainingOther
The exercise training was developed based on assuring the correct performance of the exercise focusing in motor control.
Conventional strength trainingOther
The exercise training was developed based on standard strength training used in cardiac rehabiliation programmes
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular training group | Experimental | This group will receive a 60-min neuromuscular training sessions twice a week, for 10 weeks until the completion of twenty sessions Receives: Other: Neuromuscular training |
| Conventional training group | Active comparator | This group will receive a 60-min convencional cardiac rehabiliation session twice a week, for 10 weeks until the completion of twenty sessions Receives: Other: Conventional strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Shuttle Walking Test
Maximum distance reached
Measured: 10 weeks
Secondary outcomes (6)
Chester Step Test
Time performing the test
Measured: 10 weeks
30 seconds sit-to- stand test
Number of repetitions
Measured: 10 weeks
Changes in hip muscle strength
Measured with dynamometer
Measured: 10 weeks
Cardiopulmonary exercise testing
METS achieved in ergometry
Measured: 10 weeks
Sexual Health Inventory for Men
questionnaire score
Measured: 10 weeks
EQ-5D-5L
Health Related Quality of Life measure
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start1 Feb 2021
- Primary completion30 Jul 2021
- Study completion30 Jan 2022
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 Acute Coronary SyndromeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a mixed-design study. It includes a two-group parallel, randomized clinical trial with acute coronary syndrome patients.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ARGUISUELAS MARTINEZ MARÍA DOLORES, Cardenal Herrera University
- Investigators
- Maria Dolores Arguisuelas, Principal investigator, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246008
- Sponsor's protocol ID
- CEI18/111
- Status last verified
- Mar 2022
- First submitted
- 27 Jan 2020
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
EUROASPIRE I and II Group; European Action on Secondary Prevention by Intervention to Reduce Events. Clinical reality of coronary prevention guidelines: a comparison of EUROASPIRE I and II in nine countries. EUROASPIRE I and II Group. European Action on Secondary Prevention by Intervention to Reduce Events. Lancet. 2001 Mar 31;357(9261):995-1001. doi: 10.1016/s0140-6736(00)04235-5.
PubMed 11293642Skou ST, Roos EM. Good Life with osteoArthritis in Denmark (GLA:D): evidence-based education and supervised neuromuscular exercise delivered by certified physiotherapists nationwide. BMC Musculoskelet Disord. 2017 Feb 7;18(1):72. doi: 10.1186/s12891-017-1439-y.
PubMed 28173795Thompson PD, Arena R, Riebe D, Pescatello LS; American College of Sports Medicine. ACSM's new preparticipation health screening recommendations from ACSM's guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep. 2013 Jul-Aug;12(4):215-7. doi: 10.1249/JSR.0b013e31829a68cf. No abstract available.
PubMed 23851406Valtuena-Gimeno N, Fabregat-Andres O, Martinez-Hurtado I, Martinez-Olmos FJ, Lluesma-Vidal M, Arguisuelas MD, Ferrer-Sargues FJ. A cardiac rehabilitation programme based on neuromuscular training improves the functional capacity of patients with acute coronary syndrome: a preliminary randomised controlled trial. Physiotherapy. 2025 Mar;126:101428. doi: 10.1016/j.physio.2024.101428. Epub 2024 Sep 20.
PubMed 39549308
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neuromuscular Training on Functional Capacity in Acute Coronary Syndrome Patients
- ClinicalTrials.gov ID
- NCT04246008
- Acronym / sponsor ID
- CEI18/111
- Conditions
- Acute Coronary Syndrome
- Keywords
- acute coronary syndrome, neuromuscular training, cardiac rehabilitation, functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 29 Jan 2020 (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 purpose of this study is to analyse the effects of neuromuscular training on functional capacity in patients with acute coronary syndrome, compared to the classic strength training of the cardiac rehabilitation programs
Detailed description
So far, there are no previous studies that analyze the effects of neuromuscular training on functional capacity in patients with acute coronary syndrome.
Aim: The main objective of this study is to assess the effects of a 10 weeks neuromuscular training vs traditional strength training programme in patients with acute coronary syndrome.
Design: Randomized clinical trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a mixed-design study. It includes a two-group parallel, randomized clinical trial with acute coronary syndrome patients.
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular training group | Experimental | Other: Neuromuscular trainingThis group will receive a 60-min neuromuscular training sessions twice a week, for 10 weeks until the completion of twenty sessions |
| Conventional training group | Active comparator | Other: Conventional strength trainingThis group will receive a 60-min convencional cardiac rehabiliation session twice a week, for 10 weeks until the completion of twenty sessions |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute coronary syndrome patients
- Physical activity must have been prescribed
Key exclusion criteria (9 listed)
- inflammatory cardiac disease
- severe or moderate ventricular dysfunction
- heart failure
- severe arrhytmias
- systemic hypertension >95% percentile
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 |
|---|---|---|
| Neuromuscular trainingThe exercise training was developed based on assuring the correct performance of the exercise focusing in motor control. | Other | Neuromuscular training group |
| Conventional strength trainingThe exercise training was developed based on standard strength training used in cardiac rehabiliation programmes | Other | Conventional training group |
Primary outcome
Incremental Shuttle Walking Test
Time frame: 10 weeks
Maximum distance reached
6 secondary outcomes
Chester Step Test
Time frame: 10 weeks
30 seconds sit-to- stand test
Time frame: 10 weeks
Changes in hip muscle strength
Time frame: 10 weeks
Cardiopulmonary exercise testing
Time frame: 10 weeks
Sexual Health Inventory for Men
Time frame: 10 weeks
EQ-5D-5L
Time frame: 10 weeks
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 10 Mar 2022.
- Background: PubMed 11293642EUROASPIRE I and II Group; European Action on Secondary Prevention by Intervention to Reduce Events. Clinical reality of coronary prevention guidelines: a comparison of EUROASPIRE I and II in nine countries. EUROASPIRE I and II Group. European Action on Secondary Prevention by Intervention to Reduce Events. Lancet. 2001 Mar 31;357(9261):995-1001. doi: 10.1016/s0140-6736(00)04235-5.
- Background: PubMed 28173795Skou ST, Roos EM. Good Life with osteoArthritis in Denmark (GLA:D): evidence-based education and supervised neuromuscular exercise delivered by certified physiotherapists nationwide. BMC Musculoskelet Disord. 2017 Feb 7;18(1):72. doi: 10.1186/s12891-017-1439-y.
- Background: PubMed 23851406Thompson PD, Arena R, Riebe D, Pescatello LS; American College of Sports Medicine. ACSM's new preparticipation health screening recommendations from ACSM's guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep. 2013 Jul-Aug;12(4):215-7. doi: 10.1249/JSR.0b013e31829a68cf. No abstract available.
- Derived from this study: PubMed 39549308Valtuena-Gimeno N, Fabregat-Andres O, Martinez-Hurtado I, Martinez-Olmos FJ, Lluesma-Vidal M, Arguisuelas MD, Ferrer-Sargues FJ. A cardiac rehabilitation programme based on neuromuscular training improves the functional capacity of patients with acute coronary syndrome: a preliminary randomised controlled trial. Physiotherapy. 2025 Mar;126:101428. doi: 10.1016/j.physio.2024.101428. Epub 2024 Sep 20.
- 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.
Maria Dolores Arguisuelas principal investigator
Cardenal Herrera University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular training and Conventional strength training in people with Acute Coronary Syndrome, run by Cardenal Herrera University 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 2 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 10 Mar 2022. 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?
Incremental Shuttle Walking Test (time frame: 10 weeks). 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 NCT04246008, 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 10 Mar 2022.