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Preoperative Strength-resistance Training in Valvular Heart Disease Patients (CardiacEBPhb)

Primary Purpose

Exercise Based Prehabilitation in Valvular Surgery

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise based prehabilitation
Sponsored by
Cardenal Herrera University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exercise Based Prehabilitation in Valvular Surgery focused on measuring Physiotherapy, Muscular strengthening, Quality of life, Hospital stay

Eligibility Criteria

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

Inclusion Criteria: adult patients diagnosed with valvular pathology who have been admitted as candidates for cardiac surgery for the first time, and who have been scheduled for surgery Exclusion Criteria: stage 4 or 5 renal failure, low ejection fraction, Euroscore greater than 15 (Nashef et al., 2012) , non-ST-segment elevation acute coronary syndrome (NSTEACS), coronary artery disease, or need for urgent intervention

Sites / Locations

  • Hospital Universitario de La Ribera, Alzira

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Experimental

Arm Description

Both groups will receive a first session in which they will be instructed to carry out the unsupervised home EBPrehab program, consisting of respiratory training, ventilatory training, strengthening of the respiratory muscles, aerobic endurance exercise through continuous walking, and a series of recommendationss on post-surgical care

Addittionally, a preoperative musculoskeletal and cardiopulmonary rehabilitation program focused on peripheral resistance training, will be implemented in the experimental group

Outcomes

Primary Outcome Measures

length of stay in hospital
length of hospital stay from admission to discharge
Length of stay in ICU
length of ICU stay from admission until the transfer of the patient to his room
EuroQoL-5D
Perception of quality of life

Secondary Outcome Measures

Inspiratory capacity
the volume of air that can be inspired by the resting inspiratory position
Peak expiratory flow
the maximum flow that a person can exhale during a brief maximal expiratory effort after full inspiration
Respiratory pressures
the strength of the respiratory muscles, both at diaphragmatic (inspiratory) and abdominal and intercostal (expiratory) levels
Exercise capacity
Patient's ability to perform physical exertion

Full Information

First Posted
June 12, 2023
Last Updated
June 12, 2023
Sponsor
Cardenal Herrera University
Collaborators
Hospital de la Ribera, University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT05911191
Brief Title
Preoperative Strength-resistance Training in Valvular Heart Disease Patients
Acronym
CardiacEBPhb
Official Title
Can Resistance Training Bring Additional Benefits to a Cardiac Surgery Exercises Based Prehabilitation Program? Protocol for a Non-randomized Controlled Clinical Study of Valvular Heart Disease Patients. Cardiac EBPrehab.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardenal Herrera University
Collaborators
Hospital de la Ribera, University of Valencia

4. Oversight

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

5. Study Description

Brief Summary
Cardiovascular diseases (CVD) are a group of illnesses that include coronary heart disease, cerebrovascular disease, congenital heart disease, and deep vein thrombosis. CVD is the leading cause of mortality worldwide, representing 31% of deaths. In Spain, CVD caused 24% of all deaths in 2020. Major surgery is often chosen as the treatment of choice for CVD. The concept of fast-track rehabilitation after surgery appeared in the 1970s. Participation in these exercise-based prehabilitation programs may decrease postoperative complications and length of hospital stay. The purpose of the present study is to evaluate whether the implementation of an additional resistance training (RT) prehabilitation protocol within a cardiac exercise-based prehabilitation can reduce ICU length of stay, postoperative complications, and hospital length of stay (LOS). Additionally, the secondary objective is to determine whether a program that includes RT in addition to respiratory and aerobic training can have better effects on ventilatory variables. This study follows the protocol of a prospective, parallel, non-randomized clinical trial. Ninety-six adult patients diagnosed with valvular pathology and who have been scheduled for surgery will be included. The control group will be treated with ventilatory and strengthening of respiratory muscles, as well as aerobic exercise. The experimental group, in addition, will receive RT targeting peripheral muscles. Variables such as hospital stay, quality of life, respiratory values, and exercise capacity will be evaluated. Quantitative variables will be analyzed using a t-test or ANOVA, or Mann-Whitney test if the distribution is non-parametric.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Based Prehabilitation in Valvular Surgery
Keywords
Physiotherapy, Muscular strengthening, Quality of life, Hospital stay

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, parallel, non-randomised, single-centre, clinical trial
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
None of the evaluators or caregivers will know the group assignment of each participant. The person responsible for analyzing the data will only see on the data sheet whether they belong to group 1 or group 0, but they will not know which group each of the values is assigned to.
Allocation
Non-Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Both groups will receive a first session in which they will be instructed to carry out the unsupervised home EBPrehab program, consisting of respiratory training, ventilatory training, strengthening of the respiratory muscles, aerobic endurance exercise through continuous walking, and a series of recommendationss on post-surgical care
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Addittionally, a preoperative musculoskeletal and cardiopulmonary rehabilitation program focused on peripheral resistance training, will be implemented in the experimental group
Intervention Type
Other
Intervention Name(s)
Exercise based prehabilitation
Intervention Description
A peripheral muscle strengthening program
Primary Outcome Measure Information:
Title
length of stay in hospital
Description
length of hospital stay from admission to discharge
Time Frame
1 year
Title
Length of stay in ICU
Description
length of ICU stay from admission until the transfer of the patient to his room
Time Frame
1 year
Title
EuroQoL-5D
Description
Perception of quality of life
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Inspiratory capacity
Description
the volume of air that can be inspired by the resting inspiratory position
Time Frame
1 year
Title
Peak expiratory flow
Description
the maximum flow that a person can exhale during a brief maximal expiratory effort after full inspiration
Time Frame
1 year
Title
Respiratory pressures
Description
the strength of the respiratory muscles, both at diaphragmatic (inspiratory) and abdominal and intercostal (expiratory) levels
Time Frame
1 year
Title
Exercise capacity
Description
Patient's ability to perform physical exertion
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients diagnosed with valvular pathology who have been admitted as candidates for cardiac surgery for the first time, and who have been scheduled for surgery Exclusion Criteria: stage 4 or 5 renal failure, low ejection fraction, Euroscore greater than 15 (Nashef et al., 2012) , non-ST-segment elevation acute coronary syndrome (NSTEACS), coronary artery disease, or need for urgent intervention
Facility Information:
Facility Name
Hospital Universitario de La Ribera, Alzira
City
Alzira
State/Province
Valencia
ZIP/Postal Code
46600
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Montero, Phisical Therapist
Phone
961369000
Ext
64539
Email
jorge.camara@uchceu.es

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Preoperative Strength-resistance Training in Valvular Heart Disease Patients

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