Effects of Neuromuscular Training on Functional Capacity in Acute Coronary Syndrome Patients

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

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Other: Neuromuscular training; Other: Conventional strength training

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain
    • Arguisuelas Martinez Maria Dolores

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neuromuscular training group; 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; The exercise training was developed based on assuring the correct performance of the exercise focusing in motor control.
Active Comparator: Conventional training group; 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; The exercise training was developed based on standard strength training used in cardiac rehabiliation programmes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incremental Shuttle Walking Test	Maximum distance reached	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chester Step Test	Time performing the test	10 weeks
30 seconds sit-to- stand test	Number of repetitions	10 weeks
Changes in hip muscle strength	Measured with dynamometer	10 weeks
Cardiopulmonary exercise testing	METS achieved in ergometry	10 weeks
Sexual Health Inventory for Men	questionnaire score	10 weeks
EQ-5D-5L	Health Related Quality of Life measure	10 weeks

Collaborators and Investigators

• Sponsor: Cardenal Herrera University
• Investigators: Principal Investigator: Maria Dolores Arguisuelas, Cardenal Herrera University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): January 30, 2022

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (Actual): January 29, 2020

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: acute coronary syndrome; functional capacity; neuromuscular training; cardiac rehabilitation
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: CEI18/111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No