NCT04246008

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
1 year until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

January 27, 2020

Last Update Submit

March 9, 2022

Conditions

Keywords

acute coronary syndromeneuromuscular trainingcardiac rehabilitationfunctional capacity

Outcome Measures

Primary Outcomes (1)

  • Incremental Shuttle Walking Test

    Maximum distance reached

    10 weeks

Secondary Outcomes (6)

  • Chester Step Test

    10 weeks

  • 30 seconds sit-to- stand test

    10 weeks

  • Changes in hip muscle strength

    10 weeks

  • Cardiopulmonary exercise testing

    10 weeks

  • Sexual Health Inventory for Men

    10 weeks

  • +1 more secondary outcomes

Study Arms (2)

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

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

Other: Conventional strength training

Interventions

The exercise training was developed based on assuring the correct performance of the exercise focusing in motor control.

Neuromuscular training group

The exercise training was developed based on standard strength training used in cardiac rehabiliation programmes

Conventional training group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute coronary syndrome patients
  • Physical activity must have been prescribed

You may not qualify if:

  • inflammatory cardiac disease
  • severe or moderate ventricular dysfunction
  • heart failure
  • severe arrhytmias
  • systemic hypertension \>95% percentile
  • pulmonary hypertension \>40 mmHg
  • aortic stenosis
  • baseline O2 \<90%
  • severe valve insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arguisuelas Martinez Maria Dolores

Valencia, Spain

Location

Related Publications (4)

  • 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.

    PMID: 11293642BACKGROUND
  • Skou 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.

    PMID: 28173795BACKGROUND
  • Thompson 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.

    PMID: 23851406BACKGROUND
  • Valtuena-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.

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Maria Dolores Arguisuelas

    Cardenal Herrera University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a mixed-design study. It includes a two-group parallel, randomized clinical trial with acute coronary syndrome patients.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Physiotherapy Department

Study Record Dates

First Submitted

January 27, 2020

First Posted

January 29, 2020

Study Start

February 1, 2021

Primary Completion

July 30, 2021

Study Completion

January 30, 2022

Last Updated

March 10, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations