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

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Neuromuscular training
Conventional strength training
Sponsored by
Cardenal Herrera University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring acute coronary syndrome, neuromuscular training, cardiac rehabilitation, functional capacity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arguisuelas Martinez Maria Dolores

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neuromuscular training group

Conventional training group

Arm Description

This group will receive a 60-min neuromuscular training sessions twice a week, for 10 weeks until the completion of twenty sessions

This group will receive a 60-min convencional cardiac rehabiliation session twice a week, for 10 weeks until the completion of twenty sessions

Outcomes

Primary Outcome Measures

Incremental Shuttle Walking Test
Maximum distance reached

Secondary Outcome Measures

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

Full Information

First Posted
January 27, 2020
Last Updated
March 9, 2022
Sponsor
Cardenal Herrera University
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1. Study Identification

Unique Protocol Identification Number
NCT04246008
Brief Title
Effects of Neuromuscular Training on Functional Capacity in Acute Coronary Syndrome Patients
Official Title
Effects of Neuromuscular Training on Functional Capacity in Acute Coronary Syndrome Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
January 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardenal Herrera University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
acute coronary syndrome, neuromuscular training, cardiac rehabilitation, functional capacity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a mixed-design study. It includes a two-group parallel, randomized clinical trial with acute coronary syndrome patients.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neuromuscular training group
Arm Type
Experimental
Arm Description
This group will receive a 60-min neuromuscular training sessions twice a week, for 10 weeks until the completion of twenty sessions
Arm Title
Conventional training group
Arm Type
Active Comparator
Arm Description
This group will receive a 60-min convencional cardiac rehabiliation session twice a week, for 10 weeks until the completion of twenty sessions
Intervention Type
Other
Intervention Name(s)
Neuromuscular training
Intervention Description
The exercise training was developed based on assuring the correct performance of the exercise focusing in motor control.
Intervention Type
Other
Intervention Name(s)
Conventional strength training
Intervention Description
The exercise training was developed based on standard strength training used in cardiac rehabiliation programmes
Primary Outcome Measure Information:
Title
Incremental Shuttle Walking Test
Description
Maximum distance reached
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Chester Step Test
Description
Time performing the test
Time Frame
10 weeks
Title
30 seconds sit-to- stand test
Description
Number of repetitions
Time Frame
10 weeks
Title
Changes in hip muscle strength
Description
Measured with dynamometer
Time Frame
10 weeks
Title
Cardiopulmonary exercise testing
Description
METS achieved in ergometry
Time Frame
10 weeks
Title
Sexual Health Inventory for Men
Description
questionnaire score
Time Frame
10 weeks
Title
EQ-5D-5L
Description
Health Related Quality of Life measure
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Dolores Arguisuelas
Organizational Affiliation
Cardenal Herrera University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arguisuelas Martinez Maria Dolores
City
Valencia
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11293642
Citation
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.
Results Reference
background
PubMed Identifier
28173795
Citation
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.
Results Reference
background
PubMed Identifier
23851406
Citation
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.
Results Reference
background

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

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