Cardiovascular DiseasesNCT06211361
Cardiac Rehabilitation Program in Patients with Cardiovascular Disease
A study testing Cardiac rehabilitation in people with Cardiovascular Diseases, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
This protocol study aims to evaluate the effectiveness of a cardiac rehabilitation intervention program in patients with cardiovascular diseases to improve both anthropometric and biochemical data, as well as other variables related to cardiovascular disorders (cardiorespiratory fitness, muscle strength, …), and… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Cardiac rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jul 2024to 30 Oct 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 20 and 80 years
- Having suffered an acute event or presenting chronic cardiovascular pathology with a decrease/limitation of their functional capacity
- Residing in the provinces of Cuenca, Toledo, or Albacete
- Desire to participate voluntarily and acceptance of the conditions
Who cannot join
- Have some physical or mental pathology that prevents their participation
- Inability to adhere to the full program as reported in the initial consultation
- Being outside the age criteria defined above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Cardiac Rehabilitation Program in Patients with Cardiovascular Disease
This protocol study aims to evaluate the effectiveness of a cardiac rehabilitation intervention program in patients with cardiovascular diseases to improve both anthropometric and biochemical data, as well as other variables related to cardiovascular disorders (cardiorespiratory fitness, muscle strength, …), and emotional aspects (anxiety, depression).
Additionally, this study aims to evaluate the effectiveness of the cardiac rehabilitation program in improving body composition (waist circumference and body fat percentage), blood pressure and health-related quality of life.
Objectives: i) To assess the functional capacity of patients with a recent cardiovascular event (acute coronary syndrome, onset heart failure, valve or bypass surgery) or with chronic decompensated cardiovascular disease (valvulopathy, pulmonary hypertension, congenital heart disease, heart failure) chronic), ii) to determine the different cardiorespiratory parameters obtained from cardiopulmonary exercise testing (CPET), iii) to determine the lifestyle habits and cardiovascular risk factors, iv) to develop a cardiac rehabilitation program according to and adapted to the need of each of these patients, v) to estimate the effect of the intervention, both in the muscle strength and in post-intervention CPET, biochemical and anthropometric parameters, v) to estimate the effect of the intervention in the quality of life, anxiety, depression, and adherence to the Mediterranean diet.
Read the detailed description
Methodology: our project is a quantitative study. Patients belonging to the integrated health area of the provinces Cuenca, Toledo, and Albacete will be included. The quantitative study will be a pre-post clinical trial in which at least 80 patients of both genders will be analyzed; who have suffered a coronary event in recent months.
Patients will receive a physical exercise intervention within a cardiac rehabilitation program, lasting 2 months, 3 days per week. The intervention consists of a first part of warm up the large muscle groups, accompanied by breathing exercises (10-15 minutes), followed by a part of strength and muscular resistance training exercises (upper and lower limbs and abdominal muscles), through an exercise table with weights of different weights, depending on the patient's 1RM (maximum repetition), elastic bands of different resistances and weights (15 minutes). Depending on the pathology, a series of special considerations will be taken into account regarding progressive loading (with weights) and resistance, degrees of joint mobility of the upper limbs.
The design of the strength and muscular resistance exercises will be planned taking into account heart rate (HR), cardiovascular pathology, physical capacity of the patient, hemodynamic response at rest, during exercise and after recovery from it, as well as the perception effort and pharmacological action.
Following the recommendations made by the existing literature, we will work the upper limb muscles with a load of 30-40% of the 1RM, with 50-60% of the 1RM being the workload prescribed for lower limb training. Next, we would move on to the aerobic exercise part (continuous and interval), using a treadmill or cycle ergometer, depending on the pathology and the individual characteristics of each patient. The objective we set for ourselves is to increase the duration and intensity progressively until we reach after 45 minutes, after a few weeks. The program would end with a cool-down phase or return to calm.
Study design: This project will have a quantitative design, specifically a pre-post clinical trial.
Patients aged between 20-80 with cardiovascular pathology meeting the inclusion criteria who will be referred from outpatient clinics, hospitalization or primary care and belonging to the provinces of Cuenca, Toledo, and Albacete will be included.
The participants under study will be recruited through their primary care doctor, or cardiologists from the provinces assigned to this project.
The study will be carried out at the "Virgen de la Luz Hospital", in Cuenca, among patients with cardiac pathology described in the inclusion criteria, who will be included in a cardiac rehabilitation program. The variables collected before and after the intervention will be analyzed and studied to assess the adherence of the program and the medium-long term objectives.
The recruitment of participants will be carried out throughout the entire project.
- Conditions
- Cardiovascular Diseases
- Being tested
- Cardiac rehabilitation
- Keywords
- cardiovascular diseases, heart failure, ischemic heart disease, cardiac rehabilitation, exercise training, cardiopulmonary exercise test, oxygen uptake
- Medical subject headings
- Cardiovascular Diseases, Heart Failure, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac rehabilitationOther
Also called Exercise training program
Physical exercise intervention within a cardiac rehabilitation program, lasting 2 months, 3 days per week. The intervention consists of a first part of warm up the large muscle groups, accompanied by breathing exercises, followed by a part of strength and muscular resistance training exercises (upper and lower limbs and abdominal muscles), another part of aerobic exercise part (continuous and interval), using a treadmill or cycle ergometer, and finally a part of stretching exercises and a cool-down phase.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will be included in a cardiac rehabilitation program. Receives: Other: Cardiac rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak oxygen uptake
Cardiopulmonary exercise test (CPET)
Measured: Baseline and at the end of the 8weeks intervention
Change in cardiorespiratory fitness
6 minutes walking test (6MWT)
Measured: Baseline and at the end of the 8weeks intervention
Secondary outcomes (39)
Change in blood pressure
Measured before and after the intervention with the Omron M7 Intelli blood pressure monitor
Measured: Baseline and at the end of the 8weeks intervention
Change in basal heart rate
Measured before and after the intervention after CPET with the Omron M7 Intelli blood pressure monitor.
Measured: Baseline and at the end of the 8weeks intervention
Change in Maximum heart rate:
Measured before and after the intervention after CPET with the Omron M7 Intelli blood pressure monitor
Measured: Baseline and at the end of the 8weeks intervention
Change in oxygen consumption efficiency slope (OUES)
Cardiopulmonary exercise test (CPET)
Measured: Baseline and at the end of the 8weeks intervention
Change in Respiratory gas exchange ratio (RER)
Cardiopulmonary exercise test (CPET)
Measured: Baseline and at the end of the 8weeks intervention
Change in Ventilatory thresholds (VT1 -VT2)
Cardiopulmonary exercise test (CPET)
Measured: Baseline and at the end of the 8weeks intervention
Change in Heart rate at ventilatory thresholds
Cardiopulmonary exercise test (CPET)
Measured: Baseline and at the end of the 8weeks intervention
Change in ventilatory equivalents
Cardiopulmonary exercise test (CPET)
Measured: Baseline and at the end of the 8weeks intervention
Change in partial pressures
Cardiopulmonary exercise test (CPET)
Measured: Baseline and at the end of the 8weeks intervention
Change in oxygen pulse
Cardiopulmonary exercise test (CPET)
Measured: Baseline and at the end of the 8weeks intervention
Change in ventilation (VE)
Cardiopulmonary exercise test (CPET)
Measured: Baseline and at the end of the 8weeks intervention
Change in respiratory reserve (BR)
Cardiopulmonary exercise test (CPET)
Measured: Baseline and at the end of the 8weeks intervention
Change in muscle efficiency
Cardiopulmonary exercise test (CPET)
Measured: Baseline and at the end of the 8weeks intervention
Change in forced vital capacity (FVC)
Using spirometry
Measured: Baseline and at the end of the 8weeks intervention
Change in forced expired volume in 1 second (FEV1)
Using spirometry
Measured: Baseline and at the end of the 8weeks intervention
Changes in FEV1/FVC
Using spirometry
Measured: Baseline and at the end of the 8weeks intervention
Changes in Maximum Flow 75 (MEF75)(Maximum Flow at 75% of Forced Vital Capacity)
Using spirometry
Measured: Baseline and at the end of the 8weeks intervention
Changes in Maximum Flow 50 (MEF50) (Maximum Flow at 50% of Forced Vital Capacity)
Using spirometry
Measured: Baseline and at the end of the 8weeks intervention
Changes in Maximum Flow 25 (MEF25) (Maximum Flow at 25% of Forced Vital Capacity)
Using spirometry
Measured: Baseline and at the end of the 8weeks intervention
Changes in Peak expiratory flow (PEF)
Using spirometry
Measured: Baseline and at the end of the 8weeks intervention
Changes in tidal volume (VC)
Using spirometry
Measured: Baseline and at the end of the 8weeks intervention
Change in Weight
the mean of two measurements (using a OmronBF511 bioimpedance scale) with the participant barefoot and lightly clothed.
Measured: Baseline and at the end of the 8weeks intervention
Change in Body mass index (BMI)
as weight (kg)/height2 (m2)
Measured: Baseline and at the end of the 8weeks intervention
Change in Waist circumference
the mean of three measurements using a flexible tape measure at the midpoint between the last rib and the iliac crest at the end of a normal exhalation.
Measured: Baseline and at the end of the 8weeks intervention
Change in Hip circumference
the mean of three measurements using a flexible tape measure between one and another greater trochanter.
Measured: Baseline and at the end of the 8weeks intervention
Change in waist hip index
as waist circumference (cm)/ hip circumference (cm).
Measured: Baseline and at the end of the 8weeks intervention
Change in Body fat percentage
the mean of two measurements using a OnromBF511 bioimpedance scale.
Measured: Baseline and at the end of the 8weeks intervention
Change in HbA1c
Measured by blood test.
Measured: Baseline and at the end of the 8weeks intervention
Change in total cholesterol
Measured by blood test.
Measured: Baseline and at the end of the 8weeks intervention
Change in LDL-c cholesterol
Measured by blood test.
Measured: Baseline and at the end of the 8weeks intervention
Change in HDL-c cholesterol
Measured by blood test.
Measured: Baseline and at the end of the 8weeks intervention
Change in triglycerides
Measured by blood test.
Measured: Baseline and at the end of the 8weeks intervention
Change in one repetition maximum (1RM)
Measured indirectly by Brzycki´s formula.
Measured: Baseline and at the end of the 8weeks intervention
Change in handgrip in right arm
Measured by CAMRY digital dynamometer.
Measured: Baseline and at the end of the 8weeks intervention
Change in handgrip in left arm
Measured by Camry digital dynamometer.
Measured: Baseline and at the end of the 8weeks intervention
Change in maximum respiratory pressures
Measured by MicroMedical-Carefusion MicroRPM model.
Measured: Baseline and at the end of the 8weeks intervention
Change in Health-related quality of life
36-Item Short Form Survey (SF-36)
Measured: Baseline and at the end of the 8weeks intervention
Change in Depression and anxiety.
Hospital Anxiety and Depression Scale (HADS)
Measured: Baseline and at the end of the 8weeks intervention
Change in adherence to the Mediterranean diet
Predimed questionnaire.
Measured: Baseline and at the end of the 8weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start10 Jul 2024
- Primary completion30 Jul 2024
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Our project is a quantitative study
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Virgen de la Luz
- Responsible party
- Sponsor
- Investigators
- Susana Priego-Jiménez, MsC, Principal investigator, Hospital Virgen de la LuzLaura Núñez-Martínez, MsC, Principal investigator, Hospital Virgen de la Luz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211361
- Sponsor's protocol ID
- REG: 2023/PI0523
- Status last verified
- Sep 2024
- First submitted
- 8 Jan 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Cardiac Rehabilitation Program in Patients with Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT06211361
- Acronym / sponsor ID
- REG: 2023/PI0523
- Conditions
- Cardiovascular Diseases
- Keywords
- cardiovascular diseases, heart failure, ischemic heart disease, cardiac rehabilitation, exercise training, cardiopulmonary exercise test, oxygen uptake
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Hospital Virgen de la Luz
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 18 Jan 2024 (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.
This protocol study aims to evaluate the effectiveness of a cardiac rehabilitation intervention program in patients with cardiovascular diseases to improve both anthropometric and biochemical data, as well as other variables related to cardiovascular disorders (cardiorespiratory fitness, muscle strength, …), and emotional aspects (anxiety, depression).
Additionally, this study aims to evaluate the effectiveness of the cardiac rehabilitation program in improving body composition (waist circumference and body fat percentage), blood pressure and health-related quality of life.
Objectives: i) To assess the functional capacity of patients with a recent cardiovascular event (acute coronary syndrome, onset heart failure, valve or bypass surgery) or with chronic decompensated cardiovascular disease (valvulopathy, pulmonary hypertension, congenital heart disease, heart failure) chronic), ii) to determine the different cardiorespiratory parameters obtained from cardiopulmonary exercise testing (CPET), iii) to determine the lifestyle habits and cardiovascular risk factors, iv) to develop a cardiac rehabilitation program according to and adapted to the need of each of these patients, v) to estimate the effect of the intervention, both in the muscle strength and in post-intervention CPET, biochemical and anthropometric parameters, v) to estimate the effect of the intervention in the quality of life, anxiety, depression, and adherence to the Mediterranean diet.
Detailed description
Methodology: our project is a quantitative study. Patients belonging to the integrated health area of the provinces Cuenca, Toledo, and Albacete will be included. The quantitative study will be a pre-post clinical trial in which at least 80 patients of both genders will be analyzed; who have suffered a coronary event in recent months.
Patients will receive a physical exercise intervention within a cardiac rehabilitation program, lasting 2 months, 3 days per week. The intervention consists of a first part of warm up the large muscle groups, accompanied by breathing exercises (10-15 minutes), followed by a part of strength and muscular resistance training exercises (upper and lower limbs and abdominal muscles), through an exercise table with weights of different weights, depending on the patient's 1RM (maximum repetition), elastic bands of different resistances and weights (15 minutes). Depending on the pathology, a series of special considerations will be taken into account regarding progressive loading (with weights) and resistance, degrees of joint mobility of the upper limbs.
The design of the strength and muscular resistance exercises will be planned taking into account heart rate (HR), cardiovascular pathology, physical capacity of the patient, hemodynamic response at rest, during exercise and after recovery from it, as well as the perception effort and pharmacological action.
Following the recommendations made by the existing literature, we will work the upper limb muscles with a load of 30-40% of the 1RM, with 50-60% of the 1RM being the workload prescribed for lower limb training. Next, we would move on to the aerobic exercise part (continuous and interval), using a treadmill or cycle ergometer, depending on the pathology and the individual characteristics of each patient. The objective we set for ourselves is to increase the duration and intensity progressively until we reach after 45 minutes, after a few weeks. The program would end with a cool-down phase or return to calm.
Study design: This project will have a quantitative design, specifically a pre-post clinical trial.
Patients aged between 20-80 with cardiovascular pathology meeting the inclusion criteria who will be referred from outpatient clinics, hospitalization or primary care and belonging to the provinces of Cuenca, Toledo, and Albacete will be included.
The participants under study will be recruited through their primary care doctor, or cardiologists from the provinces assigned to this project.
The study will be carried out at the "Virgen de la Luz Hospital", in Cuenca, among patients with cardiac pathology described in the inclusion criteria, who will be included in a cardiac rehabilitation program. The variables collected before and after the intervention will be analyzed and studied to assess the adherence of the program and the medium-long term objectives.
The recruitment of participants will be carried out throughout the entire project.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Our project is a quantitative study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Cardiac rehabilitationParticipants will be included in a cardiac rehabilitation program. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged between 20 and 80 years
- Having suffered an acute event or presenting chronic cardiovascular pathology with a decrease/limitation of their functional capacity
- Residing in the provinces of Cuenca, Toledo, or Albacete
- Desire to participate voluntarily and acceptance of the conditions
Key exclusion criteria (3 listed)
- Have some physical or mental pathology that prevents their participation
- Inability to adhere to the full program as reported in the initial consultation
- Being outside the age criteria defined above
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 |
|---|---|---|
| Cardiac rehabilitationAlso: Exercise training programPhysical exercise intervention within a cardiac rehabilitation program, lasting 2 months, 3 days per week. The intervention consists of a first part of warm up the large muscle groups, accompanied by breathing exercises, followed by a part of strength and muscular resistance training exercises (upper and lower limbs and abdominal muscles), another part of aerobic exercise part (continuous and interval), using a treadmill or cycle ergometer, and finally a part of stretching exercises and a cool-down phase. | Other | Intervention |
Primary outcome
Change in peak oxygen uptake
Time frame: Baseline and at the end of the 8weeks intervention
Cardiopulmonary exercise test (CPET)
Change in cardiorespiratory fitness
Time frame: Baseline and at the end of the 8weeks intervention
6 minutes walking test (6MWT)
39 secondary outcomes
Change in blood pressure
Time frame: Baseline and at the end of the 8weeks intervention
Change in basal heart rate
Time frame: Baseline and at the end of the 8weeks intervention
Change in Maximum heart rate:
Time frame: Baseline and at the end of the 8weeks intervention
Change in oxygen consumption efficiency slope (OUES)
Time frame: Baseline and at the end of the 8weeks intervention
Change in Respiratory gas exchange ratio (RER)
Time frame: Baseline and at the end of the 8weeks intervention
Change in Ventilatory thresholds (VT1 -VT2)
Time frame: Baseline and at the end of the 8weeks intervention
Change in Heart rate at ventilatory thresholds
Time frame: Baseline and at the end of the 8weeks intervention
Change in ventilatory equivalents
Time frame: Baseline and at the end of the 8weeks intervention
Change in partial pressures
Time frame: Baseline and at the end of the 8weeks intervention
Change in oxygen pulse
Time frame: Baseline and at the end of the 8weeks intervention
Change in ventilation (VE)
Time frame: Baseline and at the end of the 8weeks intervention
Change in respiratory reserve (BR)
Time frame: Baseline and at the end of the 8weeks intervention
Change in muscle efficiency
Time frame: Baseline and at the end of the 8weeks intervention
Change in forced vital capacity (FVC)
Time frame: Baseline and at the end of the 8weeks intervention
Change in forced expired volume in 1 second (FEV1)
Time frame: Baseline and at the end of the 8weeks intervention
Changes in FEV1/FVC
Time frame: Baseline and at the end of the 8weeks intervention
Changes in Maximum Flow 75 (MEF75)(Maximum Flow at 75% of Forced Vital Capacity)
Time frame: Baseline and at the end of the 8weeks intervention
Changes in Maximum Flow 50 (MEF50) (Maximum Flow at 50% of Forced Vital Capacity)
Time frame: Baseline and at the end of the 8weeks intervention
Changes in Maximum Flow 25 (MEF25) (Maximum Flow at 25% of Forced Vital Capacity)
Time frame: Baseline and at the end of the 8weeks intervention
Changes in Peak expiratory flow (PEF)
Time frame: Baseline and at the end of the 8weeks intervention
Changes in tidal volume (VC)
Time frame: Baseline and at the end of the 8weeks intervention
Change in Weight
Time frame: Baseline and at the end of the 8weeks intervention
Change in Body mass index (BMI)
Time frame: Baseline and at the end of the 8weeks intervention
Change in Waist circumference
Time frame: Baseline and at the end of the 8weeks intervention
Change in Hip circumference
Time frame: Baseline and at the end of the 8weeks intervention
Change in waist hip index
Time frame: Baseline and at the end of the 8weeks intervention
Change in Body fat percentage
Time frame: Baseline and at the end of the 8weeks intervention
Change in HbA1c
Time frame: Baseline and at the end of the 8weeks intervention
Change in total cholesterol
Time frame: Baseline and at the end of the 8weeks intervention
Change in LDL-c cholesterol
Time frame: Baseline and at the end of the 8weeks intervention
Change in HDL-c cholesterol
Time frame: Baseline and at the end of the 8weeks intervention
Change in triglycerides
Time frame: Baseline and at the end of the 8weeks intervention
Change in one repetition maximum (1RM)
Time frame: Baseline and at the end of the 8weeks intervention
Change in handgrip in right arm
Time frame: Baseline and at the end of the 8weeks intervention
Change in handgrip in left arm
Time frame: Baseline and at the end of the 8weeks intervention
Change in maximum respiratory pressures
Time frame: Baseline and at the end of the 8weeks intervention
Change in Health-related quality of life
Time frame: Baseline and at the end of the 8weeks intervention
Change in Depression and anxiety.
Time frame: Baseline and at the end of the 8weeks intervention
Change in adherence to the Mediterranean diet
Time frame: Baseline and at the end of the 8weeks intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
Susana Priego-Jiménez, MsC principal investigator
Hospital Virgen de la Luz
Laura Núñez-Martínez, MsC principal investigator
Hospital Virgen de la Luz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac rehabilitation in people with Cardiovascular Diseases, run by University of Castilla-La Mancha 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 4 inclusion and 3 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 19 Sep 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peak oxygen uptake (time frame: Baseline and at the end of the 8weeks intervention). The study lists 2 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 19 Sep 2024.