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Cardiac RehabilitationCARDresflujNCT07361393

Application of Blood Flow Restriction Training in Cardiac Patients: CARDresfluj Study

A study testing Blood Flow Restriction Exercise and Traditional Cardiac Rehabilitation, phase III in people with Cardiac Rehabilitation, run by University of Valencia at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

1. Research Objective To describe and compare the effects on cardiovascular health, physical fitness, quality of life, oxidative stress, and sleep quality resulting from a conventional resistance training program versus a conventional resistance training program partially implemented with Blood Flow Restriction (BFR)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Rehabilitation
What is being tested?
Blood Flow Restriction Exercise and Traditional Cardiac Rehabilitation, phase III
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSpain
Study dates
1 Feb 2026to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • All participants must be of legal age (≥18 years) and provide signed informed consent prior to any study procedures
  • Participants must have a confirmed medical diagnosis of stable cardiac disease (e.g., post-myocardial infarction, stable angina, or post-revascularization) as documented by a specialist.
  • All subjects must be currently enrolled in or actively participating in a Phase III Cardiac Rehabilitation program (the maintenance phase).
  • Evidence of clinical stability is required, ensuring that participants can safely perform resistance training without immediate cardiovascular contraindications.

Who cannot join

  • Unstable Cardiovascular Status: Presence of unstable angina, uncontrolled cardiac arrhythmias, or severe symptomatic aortic stenosis.
  • Recent Acute Events: Myocardial infarction, coronary artery bypass graft (CABG), or other major cardiac surgeries within the last 3 months (or outside the timeframe defined for Phase III eligibility).
  • Uncontrolled Hypertension: Resting systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg despite pharmacological treatment.
  • Specific Contraindications to BFR: History of deep vein thrombosis (DVT), peripheral vascular disease, or severe lymphedema in the limbs designated for cuff application.
  • Musculoskeletal Limitations: Any orthopedic or neuromuscular condition that prevents the safe performance of biceps curls or leg press exercises.
  • Concurrent High-Intensity Training: Participation in any other structured vigorous-intensity exercise program that could confound the results of the intervention.
  • Medical Instability: Significant comorbid conditions, such as uncontrolled metabolic disease (e.g., Type 2 Diabetes with severe complications), advanced renal failure, or respiratory diseases that limit functional capacity below the study requirements.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Poliesportiu Municipal

    Ontinyent, Valencia, 46870

Other trials in Spain

About this study

  1. Research Objective To describe and compare the effects on cardiovascular health, physical fitness, quality of life, oxidative stress, and sleep quality resulting from a conventional resistance training program versus a conventional resistance training program partially implemented with Blood Flow Restriction (BFR) in patients with Phase III cardiac disease.
  2. Methodology, Expected Collaboration, and Duration

Participants will be invited to undergo assessments for physical fitness, functional capacity, cardiological, hemodynamic, and biochemical control, as well as perceived quality of life and sleep quality, both prior to and following the intervention.

Read more

Your collaboration in this study will consist of participating in a Phase III Cardiac Rehabilitation program, monitored by specialized personnel and supervised by a cardiologist.

The intervention is based on a resistance training program supplemented with leg press and biceps curl exercises. These specific exercises will be performed using a blood flow restriction cuff.

The intervention will be conducted twice weekly over a 10-week period, followed by a 2-months washout (rest) period. Subsequently, the 10-week intervention will be repeated; however, if the first phase was completed with the use of cuffs, the second phase will be conducted without them, and vice-versa (cross-over design).

Being tested
Blood Flow Restriction Exercise, Traditional Cardiac Rehabilitation, phase III
Keywords
blood flow restriction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood Flow Restriction ExerciseOther

    Also called Occlusive training

    A pneumatic compression cuff, calibrated to 40% of the total arterial occlusion pressure-preliminarily determined via Doppler ultrasound-will be positioned at the axillary region for the performance of biceps curls and at the inguinal region for the leg press. The training protocol will follow the established consensus of one set of 30 repetitions followed by three sets of 15 repetitions, with 60-second inter-set rest intervals during which the cuff will be deflated to allow for reperfusion

  • Traditional Cardiac Rehabilitation, phase IIIOther

    Also called Cardiovascular Rehabilitation

    The control group will undergo the identical intervention protocol, but without the application of blood flow restriction

Study groups in NCT07361393
Study groupRoleWhat they receive
Blood Flow RestrictionExperimentalA pneumatic compression cuff, calibrated to 40% of the total arterial occlusion pressure-preliminarily determined via Doppler ultrasound-will be positioned at the axillary region for the performance of biceps curls and at the inguinal region for the leg press. The training protocol will follow the established consensus of one set of 30 repetitions followed by three sets of 15 repetitions, with 60-second inter-set rest intervals during which the cuff will be deflated to allow for reperfusion
Receives: Other: Blood Flow Restriction Exercise
Traditional Cardiac Rehabilitation, phase IIIActive comparatorThe control group will undergo the identical intervention protocol, but without the application of blood flow restriction
Receives: Other: Traditional Cardiac Rehabilitation, phase III

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Indirect 1 repetition maximum

    The Brzycki formula is a widely recognized equation used to predict a participant's maximum strength based on submaximal performance. Similar to the Epley method, it is highly valued in clinical settings-such as Phase III Cardiac Rehabilitation-because it avoids the excessive cardiovascular strain and the Valsalva maneuver associated with maximal (1RM) testing.

    Procedure and ProtocolSubmaximal Loading: A load is selected that the participant can lift for a range of 2 to 10 repetitions. Research suggests that the Brzycki formula maintains higher accuracy when the number of repetitions is kept below 10.

    1Execution to Volitional Fatigue: The participant performs the exercise (e.g., leg press or biceps curl) with controlled technique until they reach a point where no further complete repetitions can be performed.

    Calculation: The achieved repetitions and the weight used are integrated into the formula to determine the theoretical 1RM.

    Measured: Pre intervention (week 0) and post intervention (week 11) in experimental and control phases

  2. Heart Rate Variability

    Heart Rate Variability (HRV) will be monitored to evaluate the balance between sympathetic and parasympathetic nervous system activity. The Polar H10 heart rate monitor-a chest-strap based sensor-will be utilized to capture R-R intervals (the time between successive heartbeats) with high temporal resolution.

    Data Acquisition Protocol Preparation: To ensure optimal conductivity and signal quality, the electrode areas of the Polar H10 strap will be moistened with water or conductive gel before being secured firmly around the participant's chest, just below the pectoral muscles.

    Stabilization Period: Participants will remain in a seated position for a 15-minute stabilization period to achieve a resting physiological state and minimize external artifacts.

    Recording: R-R interval data will be recorded for a duration of whole session and 15 minutes post-session

    Signal Processing: The raw data will be filtered using a compatible software interface (e.g., Kubios HRV).

    Measured: Pre intervention (week 0) and post intervention (week 11) in experimental and control phases

  3. Tendon Thickness

    To evaluate structural adaptations following the intervention, the tendon thickness of the biceps brachii and the quadriceps femoris (specifically the patellar tendon) was measured using high-resolution B-mode ultrasonography. This non-invasive imaging technique allows for the precise quantification of connective tissue morphology.

    Measurement ProtocolBiceps Brachii Tendon: Measurements were taken with the participant in a supine position, with the arm fully extended and supinated. The transducer was placed longitudinally over the bicipital groove of the humerus to identify the long head of the biceps tendon.

    Quadriceps Femoris (Patellar Tendon): The participant was placed in a supine position with the knee flexed at 30% to maintain tendon tension and eliminate slack. The measurement was localized at proximal region of the patella.

    Data Acquisition: Images were captured in the longitudinal and transversal plane.

    Measured: Pre intervention (week 0) and post intervention (week 11) in experimental and control phases

Secondary outcomes (7)
  1. CSA grossor

    Muscle Thickness and Cross-Sectional Area (CSA) were measured using high-resolution B-mode ultrasonography. Specifically, the biceps brachii and the rectus femoris were assessed at standardized anatomical landmarks.

    Measurement Sites and Protocol for Biceps Brachii: Measurements were taken at two-thirds of the distance from the acromion process to the cubital fossa (lateral epicondyle). This site ensures the measurement captures the muscle at its maximum morphological development.

    Rectus Femoris: The assessment was conducted at two-thirds of the distance between the anterior superior iliac spine (ASIS) and the superior border of the patella. This distal measurement site is highly sensitive to changes in muscle architecture during resistance training.

    Technique: The ultrasound transducer was placed perpendicular to the longitudinal axis of the muscle. Minimal pressure was applied to the skin to avoid tissue compression, which could lead to an underestimation of thickness.

    Measured: Pre intervention (week 0) and post intervention (week 11) in experimental and control phases

  2. Blood Pressure

    Resting arterial blood pressure (BP)-specifically Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-was measured using a digital oscillometric sphygmomanometer (Omron Healthcare, Inc.). This non-invasive method was utilized to monitor hemodynamic stability throughout the study duration. The blood pressure assessment followed the standardized clinical procedures detailed in the American Heart Association (AHA) guidelines for blood pressure measurement in humans. This rigorous adherence ensured the minimization of observer bias and controlled for external factors that could influence hemodynamic readings.

    Measured: Pre intervention (week 0) and post intervention (week 11) in experimental and control phases

  3. Handgrip test

    Handgrip strength (HGS) was measured using a calibrated hydraulic dynamometer (e.g., Jamar or similar) to evaluate maximal isometric upper-body strength. This test serves as a reliable proxy for total muscle strength and is a critical functional marker in Phase III Cardiac Rehabilitation. Participants were instructed to exert their maximum grip force for 3 to 5 seconds. Strong verbal encouragement was provided to ensure peak effort ("Squeeze, squeeze, squeeze!").

    Measured: Pre intervention (week 0) and post intervention (week 11) in experimental and control phases

  4. Timed-uo and Go

    Functional mobility and dynamic balance will be assessed using the Timed Up and Go (TUG) test. Following standardized clinical protocols, participants start seated in a standard armchair (approx. 46 cm high). On the "go" command, they rise, walk at a comfortable and safe pace to a line marked 3 meters away, turn, return to the chair, and sit down.

    Timing starts at the signal and stops when the participant's back touches the backrest. To ensure reliability, a practice trial will be performed, followed by two recorded trials, using the average time for analysis. This test is a validated predictor of fall risk and functional independence in Phase III cardiac patients. All procedures will be supervised to ensure participant safety, particularly during the turn and sitting phases.

    Measured: Pre intervention (week 0) and post intervention (week 11) in experimental and control phases

  5. 30 seconds sit to stand

    The 30-second Sit-to-Stand test will be used to assess proximal lower-limb functional strength and endurance. Following the established protocol, the participant sits in the middle of a chair (approx. 43-45 cm high) with a flat backrest, feet shoulder-width apart, and arms crossed over the chest.

    On the "start" command, the participant rises to a full standing position and returns to a full sit as many times as possible within 30 seconds. The score is the total number of completed stands; if the participant is over halfway to a standing position when time expires, it counts as a full stand. This test is a validated clinical tool for cardiac populations, reflecting the ability to perform activities of daily living. A demonstration and a brief practice of two repetitions will precede the final assessment to ensure proper technique and safety.

    Measured: Pre intervention (week 0) and post intervention (week 11) in experimental and control phases

  6. 6 min walking

    Submaximal exercise capacity will be assessed using the 6-Minute Walk Test (6MWT) in accordance with the American Thoracic Society (ATS) guidelines. The test will be performed on a flat, 30-meter indoor corridor. Participants are instructed to walk as far as possible for six minutes at their own pace, being permitted to slow down or rest if necessary. The total distance covered (6MWD) in meters will be recorded as the primary outcome. This test is highly sensitive to changes in functional status and is a gold-standard prognostic marker in Phase III cardiac rehabilitation. A technician will supervise the test with emergency equipment available to ensure patient safety.

    Measured: Pre intervention (week 0) and post intervention (week 11) in experimental and control phases

  7. SF-36

    Health-related quality of life (HRQoL) will be assessed using the Short Form-36 (SF-36) Health Survey, a widely validated multidimensional instrument. This questionnaire consists of 36 items that evaluate eight health domains: physical functioning, physical role limitations, bodily pain, general health perceptions, vitality, social functioning, emotional role limitations, and mental health.

    Results are aggregated into two primary summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Scores for each domain range from 0 to 100, where higher scores represent superior perceived health status. The SF-36 is highly sensitive to the effects of exercise interventions in cardiac populations. Participants will complete the survey in a quiet environment to minimize external influence, ensuring the capture of reliable subjective data regarding their well-being.

    Measured: Pre intervention (week 0) and post intervention (week 11) in experimental and control phases

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2026
  2. Study start1 Feb 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07361393
Sponsor's protocol ID
2024-FIS-3751550
Acronym
CARDresfluj
Status last verified
Apr 2026
First submitted
13 Jan 2026
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Blood Flow Restriction Exercise and Traditional Cardiac Rehabilitation, phase III in people with Cardiac Rehabilitation, run by University of Valencia 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 7 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: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2026. 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?

This study is still under way. Results are not available in the source record yet.

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?

Indirect 1 repetition maximum (time frame: Pre intervention (week 0) and post intervention (week 11) in experimental and control phases). 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 27 Apr 2026.

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