Exercise Based Prehabilitation in Valvular SurgeryCardiacEBPhbNCT05911191
Preoperative Strength-resistance Training in Valvular Heart Disease Patients
A study testing Exercise based prehabilitation in people with Exercise Based Prehabilitation in Valvular Surgery, run by Cardenal Herrera University at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exercise Based Prehabilitation in Valvular Surgery
- What is being tested?
- Exercise based prehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2023to 1 Jul 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario de La Ribera, Alzira
Alzira, Valencia, 46600
Jorge Montero, Phisical Therapist, 961369000 ext. 64539, jorge.camara@uchceu.es
About this study
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.
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.
- Being tested
- Exercise based prehabilitation
- Keywords
- Physiotherapy, Muscular strengthening, Quality of life, Hospital stay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise based prehabilitationOther
A peripheral muscle strengthening program
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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 |
| Experimental | Experimental | Addittionally, a preoperative musculoskeletal and cardiopulmonary rehabilitation program focused on peripheral resistance training, will be implemented in the experimental group Receives: Other: Exercise based prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of stay in hospital
length of hospital stay from admission to discharge
Measured: 1 year
Length of stay in ICU
length of ICU stay from admission until the transfer of the patient to his room
Measured: 1 year
EuroQoL-5D
Perception of quality of life
Measured: 1 year
Secondary outcomes (4)
Inspiratory capacity
the volume of air that can be inspired by the resting inspiratory position
Measured: 1 year
Peak expiratory flow
the maximum flow that a person can exhale during a brief maximal expiratory effort after full inspiration
Measured: 1 year
Respiratory pressures
the strength of the respiratory muscles, both at diaphragmatic (inspiratory) and abdominal and intercostal (expiratory) levels
Measured: 1 year
Exercise capacity
Patient's ability to perform physical exertion
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise Based Prehabilitation in Valvular SurgeryStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, parallel, non-randomised, single-centre, clinical trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de la Ribera, University of Valencia
- Responsible party
- Principal investigator, JORGE MONTERO CÁMARA, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911191
- Sponsor's protocol ID
- PI 04-05/23
- Acronym
- CardiacEBPhb
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 20 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05911191
- Acronym / sponsor ID
- CardiacEBPhb / PI 04-05/23
- Keywords
- Physiotherapy, Muscular strengthening, Quality of life, Hospital stay
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Collaborators
- Hospital de la Ribera, University of Valencia
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 20 Jun 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, parallel, non-randomised, single-centre, clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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 |
| Experimental | Experimental | Other: Exercise based prehabilitationAddittionally, a preoperative musculoskeletal and cardiopulmonary rehabilitation program focused on peripheral resistance training, will be implemented in the experimental group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Exercise based prehabilitationA peripheral muscle strengthening program | Other | Experimental |
Primary outcome
length of stay in hospital
Time frame: 1 year
length of hospital stay from admission to discharge
Length of stay in ICU
Time frame: 1 year
length of ICU stay from admission until the transfer of the patient to his room
EuroQoL-5D
Time frame: 1 year
Perception of quality of life
4 secondary outcomes
Inspiratory capacity
Time frame: 1 year
Peak expiratory flow
Time frame: 1 year
Respiratory pressures
Time frame: 1 year
Exercise capacity
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2023.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise based prehabilitation in people with Exercise Based Prehabilitation in Valvular Surgery, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of stay in hospital (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jun 2023.