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Breast CancerNCT06766903

Onco-Vascular Exer-Study

A study testing Exercise training in people with Breast Cancer and Vascular Disease,Peripheral, run by Cristian Alvarez at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In Chile, in the year 2022, the main causes of death were diseases of the circulatory system (31,606) and cancer (with 28,453 deaths). Both causes of death came from diseases such as arterial hypertension, diabetes, and obesity, all highly associated to sedentary lifestyle (i.e., spending long hours sitting), physical… Read more about this study

Who is it for?
Ages 30 to 75 years, women only
What is being tested?
Exercise training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChile
Study dates
1 Apr 2024to 2 Nov 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 30 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Breast cancer diagnosed
  • With/without chemotherapy treatment
  • Normal weight body mass index [BMI] 18.6 to 24.9 or overweight/obesity condition by BMI 25.0 to 39.9 kg/m2
  • Age 30 to 75 years
  • With/without other associated co-morbidities (diagnosed of elevated fasting glucose, prediabetes or diabetes, hypertension or prehypertension, or metabolic syndrome, fatty liver or hypercholesterolemia or screened by our research team).
  • With/without hormonal therapy
  • With/without other pharmacotherapy for specific muscle-groups such as morphine patches, morphine droplets or other pharmacological therapy for SOS pain treatment

Who cannot join

  • History of abnormal ECG
  • Diagnosis of other cardio-vascular condition/history other than hypertension, vasculopathy
  • History of uncontrolled stage 3 of hypertension or hypertensive crisis
  • Diabetes complications such as varicose ulcers, nephropathies
  • Skeletal muscle abnormalities (e.g., knee, or hip arthrosis, muscle pain)
  • Using weight loss treatment/pharmacotherapy or being active in exercise training programs (or within the past three months)
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  • Use other pharmacotherapy that can influence body weight loss,
  • Respiratory disease type (chronic obstructive disease)
  • Kidney disease
  • Pregnancy
  • Smoking behaviour or dependence on other substances.

Trial locations and contacts

1 site in 1 country.

Chile1 site
  • ICER-Lab

    Talcahuano

Other trials in Chile

About this study

Official title: Effects of a Physical Exercise Program on Cardiovascular, Metabolic, Physical Fitness and Quality of Life in Cancer Survivors' Adult Women

In Chile, in the year 2022, the main causes of death were diseases of the circulatory system (31,606) and cancer (with 28,453 deaths). Both causes of death came from diseases such as arterial hypertension, diabetes, and obesity, all highly associated to sedentary lifestyle (i.e., spending long hours sitting), physical inactivity (i.e., not adhering to international recommendations of physical activity per week of 150 to 300 min of low to moderate intensity physical activity, or 75 to 150 min of vigorous physical activity per week) and others risk factors (i.e., healthy eating, and inflammation processes such as cancer). Worryingly, in the Bío-Bío, Chile region, women's deaths from cancer reported 1,380 deaths, one of the highest disease mortality in this country. On the other hand, exercise training (i.e., defined as a particular type of physical activity guided by a professional and regulated overtime) has demonstrated evidence to the prevention and treatment of cancer, as well as in diabetes and arterial hypertension (co-morbidities). This benefits of exercise training has been raised by the American College of Sports Medicine (ACSM), emphasizing the evidence in favor of the exercise training (i.e., particularly aerobic/moderate-intensity continuous and resistance-type exercise) from the strongest (anxiety, depression, fatigue, quality of life, lymphedema, physical function) to the least amount of evidence (cardio-vascular, pain, etc) benefits on cancer survivors. However, there is scarcity of knowledge about the effects of other exercise modalities such as concurrent training on cardiovascular, metabolic and physical fitness of adul woman breast cancer survivors.

Read the detailed description

Despite the "solid" evidence in favor of the effects of exercise training in cancer survivors (CS) to improve variables such as anxiety, depressive symptoms, fatigue, quality of life, lymphedema, and physical function, unfortunately they are still unknown and there is minimal evidence about the effects of exercise training on cardio-vascular and metabolic variables in cancer survivors' persons. The phenomenon of the exercise training in CS persons is of relevance, because as it is pointed out, cancer is the second cause of death in Chile, and in particular breast cancer is the first cause among all types of cancer, and where exercise training has a relevant value as a treatment and post-treatment. Thus, it is required to fill the scientific gap in terms of the need to increase the evidence of exercise training in cardio-vascular physiologyof CS population, such as parameters related to blood pressure, and endothelial dysfunction such as carotid intima-media thickness (cIMT), dilation-mediated flow (FMD) and pulse wave velocity (PWV), as well as metabolic factors related to the resting metabolism and metablism during exercise such as the oxidative and glycolytic capacity, which determine the oxidation of fat and glucose during resting and exercise. There is consolidated or "solid" evidence, about the effects of physical exercise, according to the American College of Sports Medicine (ACSM) exercise recommendations guide for CS.

Different types of exercise training modalities have been reported in breast CS individuals during and following the completion of their treatment (Radiotherapy, Chemotherapy, Hormonal therapy), where the benefits of aerobic nature exercise training predominantly (i.e., exercises that promote an increase in aerobic enzymatic activity, mitochondrial biogenesis and in general oxidative metabolism [that promote the elaboration of ATP via fatty acids]) in combination with muscle strength as resistance training with the use of external overloads (i.e., controlled exercises with a certain level of muscle load based on prior assessment of maximal strength, usually measured by means of 1-repetition maximal test on different muscle groups), which are exercises that promote an increase in protein synthesis, muscle mass formation, and therefore both types of exercise training (Moderate-intensity continuous [MICT] + resistance training [RT]) are usually referred to in the literature as combined exercise or concurrent exercise (MICT+RT). Among the main effects or benefits of exercise training in breast CS individuals, particularly in terms of reducing anxiety, depressive symptoms, fatigue, quality of life, lymphedema, and physical function. It has also been reported that there is only "moderate" evidence on the effects of exercise in CS at the level of bone health, and sleep, but worryingly, there is insufficient evidence in favor of physical exercise at the level of vascular function, falls, cognitive function, and pain, among other health parameters (sexual function, nausea, peripheral neuropathies). The potential results of the project will ultimately translate into greater technical, scientific and management knowledge to be able to analyze the increase in the offer of physical exercise programs or workshops for breast CS persons in Chile. The latter should translate into an improvement not only in the physical condition and health of CS people, but also in a lower risk of relapsing into cancer, mental illnesses (depression) and, of course, a reduction in mortality. From here, high-intensity interval training, a particular exercise modality of brief intense exercise intervals have been poorly studied in breast CS. Similarly, RT using lower exercise intensities (i.e., one repetition maximum test [1RM] load of ≤60% of 1 RM) have been also little tested for cardio-vascular (i.e., PWV, FMD, and cIMT) and metabolic health in breast CS women. Preliminary evidence show that concurrent exercise training decrease blood pressure, and that high-intensity interval training (HIIT) also decrease arterial stiffness in adult women. Eight-weeks of HIIT was superior to MICT for increasing FMD in HIIT vs MICT (Δ+8.9 vs. 5.1%). Twelve-weeks of HIIT (four sets [4 min] intervals at 80-90% HRmax with resting periods of 60-70% HRmax cycling) reduced minimally PWV (-0.1 m·s-1) in hypertensive older adults. One-year of HIIT (60 s interval, 60 s of resting at 90% of the reserve oxygen consumption) decreased both systolic [SBP] (Δ-6.5)/diastolic [DBP] blood pressure (Δ-4.2 mmHg), and decreased cIMTav (Δ-0.95 mm). Thus, concurrent training of both HIIT plus RT in lower 1RM intensities could promote potential benefits for both cardiovascular health and metabolic and physical condition parameters of breast CS women, however, there is scarcity of studies about this exercise modalities in patients who are CS and that have been exposure to higher and lower chemotherapy doses.

RESEARCH PROBLEM: Despite the "solid" evidence in favor of the effects of exercise training in breast CS to improve variables such as anxiety, depressive symptoms, fatigue, quality of life, lymphedema and physical function, however, unfortunately, the effects of exercise training on cardio-vascular and metabolic variables, there is still unknown the effects of concurrent exercise training including HIIT plus RT in lower 1RM doses in CS women at level of their cardio-vascular and metabolic health. This is due to the fact that year after year there is an increase in the number of early diagnoses, as well as an increase in the number of CS with a successful completion of their breast cancer treatment (Radiotherapy, Chemotherapy, Hormonal Therapy), which also leads as an effect to an inherent increase in the number of CS persons, requiring the insertion of this population back into active life. Another effect of the scientific rationale lies in the scarce offer of physical activity and/or exercise training programs for this population of women between 40 and 70 years of age, which would be significantly overcome with the application of the present intervention project that would report cardiovascular, metabolic, physical condition, quality of life and eating patterns variables.

Being tested
Exercise training
Keywords
Exercise training, Concurrent training, High-intensity interval training, Resistance training, Arterial stiffness, Pulse wave velocity, Carotid intima-media thickness, Flow mediated dilation, Cancer survivors, Cardiorrespiratory fitness, Physical fitness
Medical subject headings
Breast Neoplasms, Peripheral Vascular Diseases, Hypertension, Metabolic Diseases

What participants receive

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

  • Exercise trainingBehavioural

    Also called Physical therapy intervention

    All subjects will participate of 8-weeks of exercise training intervention of concurrent training of high-intensity interval training (HIIT) using stationnaire bikes plus resistance training (RT) using free weight under lab conditions.

    The exercise program will be monitored by 8-weeks, adapted individually to each participants in terms of exercise intensity an volume.

Study groups in NCT06766903
Study groupRoleWhat they receive
EG-HCTExperimental(EG-HCT) Exercise group high chemotherapy dose: All participants of this groups will be breast cancer survivors and received no more than 7 chemotherapy sessions during cancer treatment.
Receives: Behavioral: Exercise training
EG-LCTActive comparator(EG-LCT) Exercise group low chemotherapy dose: All participants of this groups will be breast cancer survivors and received more than 8 chemotherapy sessions during cancer treatment.
Receives: Behavioral: Exercise training

What is being measured

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

  1. Flow-mediated dilation in (cm)

    Change in flow-mediated dilation in the brachial artery registered by a linear transducer using images from a Doppler ultrasound

    Measured: Baseline, 8 weeks after exercise training intervention

  2. Pulse wave velocity in (m/s)

    Change in pulse wave velocity in the brachial artery registered by an oscillometric cuff in the brachial artery

    Measured: Baseline, 8 weeks after exercise training intervention

  3. Carotid intima media thickness average in (cm)

    Change in Carotid intima media thickness in the common carotid artery registered by a linear transducer using images from a Doppler ultrasound

    Measured: Baseline, 8 weeks after exercise training intervention

  4. Carotid intima media thickness maximum in (cm)

    Change in Carotid intima media thickness maximum in the common carotid artery registered by a linear transducer using images from a Doppler ultrasound

    Measured: Baseline, 8 weeks after exercise training intervention

Secondary outcomes (37)
  1. Body mass in (kg)

    Change in body mass registered by a digital scale in kilograms

    Measured: Baseline, 8 weeks after exercise training intervention

  2. Body mass index in (kg/m2)

    Change in body mass index registered by from the calculation of the weight plus the height dividev by the suare of the height

    Measured: Baseline, 8 weeks after exercise training intervention

  3. Body fat in (%)

    Change in body fat percentage registered by from a digital bio-impedanciometer equipment

    Measured: Baseline, 8 weeks after exercise training intervention

  4. Skeletal muscle mass in (%)

    Change in skeletal muscle mass in percentage registered by from a digital bio-impedanciometer equipment

    Measured: Baseline, 8 weeks after exercise training intervention

  5. Resting metbolic rate in (kcal)

    Change in resting metabolic rate obtained in kcalories from a digital bio-impedanciometer equipment

    Measured: Baseline, 8 weeks after exercise training intervention

  6. Waist circumference in (cm)

    Change in waist circumference obtained from a measuring tape in centimeters

    Measured: Baseline, 8 weeks after exercise training intervention

  7. Systolic blood pressure in (mmHg)

    Change in systolic blood pressure obtained from a digital cuff sphingomanometer in mmHg from the brachial artery in seated position

    Measured: Baseline, 8 weeks after exercise training intervention

  8. Diastolic blood pressure in (mmHg)

    Change in diastolic blood pressure obtained from a digital cuff sphingomanometer in mmHg from the brachial artery in seated position

    Measured: Baseline, 8 weeks after exercise training intervention

  9. Mean arterial pressure in (mmHg)

    Change in mean arterial pressure obtained from a digital cuff sphingomanometer in mmHg from the brachial artery in seated position, particularly from the data systolic and diastolic blood pressure obtained from this equipment

    Measured: Baseline, 8 weeks after exercise training intervention

  10. Pulse pressure in (mmHg)

    Change in pulse pressure obtained from a digital cuff sphingomanometer in mmHg from the brachial artery in seated position, particularly from the data systolic and diastolic blood pressure obtained from this equipment

    Measured: Baseline, 8 weeks after exercise training intervention

  11. Heart rate at rest in (beats/min)

    Change in heart rate at rest obtained from a digital watch cardiometer in beats/min

    Measured: Baseline, 8 weeks after exercise training intervention

  12. Systolic blood pressure of the ankle in (mmHg)

    Change in systolic blood pressure obtained from a digital cuff sphingomanometer in mmHg by the Arteriograpgh equipment from the brachial artery in supine position.

    Measured: Baseline, 8 weeks after exercise training intervention

  13. Diastolic blood pressure of the ankle in (mmHg)

    Change in systolic blood pressure obtained from a digital cuff sphingomanometer in mmHg by the Arteriograpgh equipment from the brachial artery in supine position.

    Measured: Baseline, 8 weeks after exercise training intervention

  14. Partial oxygen saturation in (%)

    Change in Partial oxygen saturation in (%) obtained from a digital saturometer from the index finger in seated position

    Measured: Baseline, 8 weeks after exercise training intervention

  15. Total chlesterol in (mg/dL)

    Change in total cholesterol in (mg/dL) obtained from a capillary droplet sample from the index finger from a digital portatile equipment

    Measured: Baseline, 8 weeks after exercise training intervention

  16. Fasting glucose in (mg/dL)

    Change in fasting glucose in (mg/dL) obtained from a capillary droplet sample from the index finger from a digital portatile equipment

    Measured: Baseline, 8 weeks after exercise training intervention

  17. Triglycerides in (mg/dL)

    Change in triglycerides in (mg/dL) obtained from a capillary droplet sample from the index finger from a digital portatile equipment

    Measured: Baseline, 8 weeks after exercise training intervention

  18. Lactate

    Change in Lactate in (mmol/L) obtained from a capillary droplet sample from the index finger from a digital portatile equipment

    Measured: Baseline, 8 weeks after exercise training intervention

  19. Augmentation index in (%)

    Change in Augmentation index in (%) obtained from a digital cuff sphingomanometer in mmHg by the Arteriograpgh equipment from the brachial artery in supine position.

    Measured: Baseline, 8 weeks after exercise training intervention

  20. Ankle-Brachial Index in (%)

    Change in Ankle-Brachial Index in (%) obtained from a digital cuff sphingomanometer in mmHg by the Arteriograpgh equipment from the brachial artery in supine position.

    Measured: Baseline, 8 weeks after exercise training intervention

  21. Aortic Systolic blood pressure in (mmHg)

    Change in Aortic Systolic blood pressure in (mmHg) obtained from a digital cuff sphingomanometer in mmHg by the Arteriograpgh equipment from the brachial artery in supine position.

    Measured: Baseline, 8 weeks after exercise training intervention

  22. Aortic pulse pressure in (mmHg)

    Change in Aortic pulse pressure in (mmHg) obtained from a digital cuff sphingomanometer in mmHg by the Arteriograpgh equipment from the brachial artery in supine position.

    Measured: Baseline, 8 weeks after exercise training intervention

  23. Aortic augmentation index in (%)

    Change in Aortic augmentation index in (%) obtained from a digital cuff sphingomanometer in % by the Arteriograpgh equipment from the brachial artery in supine position.

    Measured: Baseline, 8 weeks after exercise training intervention

  24. Ejection duration in (m/s)

    Change in Ejection duration in (m/s) obtained from a digital cuff sphingomanometer in % by the Arteriograpgh equipment from the brachial artery in supine position.

    Measured: Baseline, 8 weeks after exercise training intervention

  25. Diastolic reflection area

    Change in Diastolic reflection area obtained from a digital cuff sphingomanometer in % by the Arteriograpgh equipment from the brachial artery in supine position.

    Measured: Baseline, 8 weeks after exercise training intervention

  26. Systolic area index

    Change in Diastolic area index obtained from a digital cuff sphingomanometer in % by the Arteriograpgh equipment from the brachial artery in supine position.

    Measured: Baseline, 8 weeks after exercise training intervention

  27. Diastolic area index

    Change in Diastolic area index obtained from a digital cuff sphingomanometer in % by the Arteriograpgh equipment from the brachial artery in supine position.

    Measured: Baseline, 8 weeks after exercise training intervention

  28. Return time of the aortic pulse wave

    Change in Return time of the aortic pulse wave measured in the brachial artery obtained from a digital cuff sphingomanometer in % by the Arteriograpgh equipment from the brachial artery in supine position.

    Measured: Baseline, 8 weeks after exercise training intervention

  29. Arterial age

    Change in arterial age estimated from a digital cuff Arteriograph equipment measured from the brachial artery

    Measured: Baseline, 8 weeks after exercise training intervention

  30. Heart rate during exercise in (beats/min)

    Heart rate measured using a cardiometer watch equipment at different power output intensities using an cycle ergometer equipment

    Measured: Baseline, 8 weeks after exercise training intervention

  31. Peak oxigen consumption (VO2peak)

    Change in VO2peak estimated from an equipment of indirect calorimetry and gas calibration of O2/VCO2, measured from breathing by breathing on a stationnaire bike ergometer

    Measured: Baseline, 8 weeks after exercise training intervention

  32. Fat oxidation (FATox)

    Change in FATox estimated from an equipment of indirect calorimetry and gas calibration of O2/VCO2, measured from breathing by breathing during 10 minutes on a stretcher

    Measured: Baseline, 8 weeks after exercise training intervention

  33. Carbohydrate oxidation (CHOox)

    Change in CHOox estimated from an equipment of indirect calorimetry and gas calibration of O2/VCO2, measured from breathing by breathing during 10 minutes on a stretcher

    Measured: Baseline, 8 weeks after exercise training intervention

  34. Maximum strength of leg extension (1RMleg)

    Change in the 1RMleg strength estimated from a leg-extension exercise machine using kilograms

    Measured: Baseline, 8 weeks after exercise training intervention

  35. Maximum strength of biceps curl (1RMbiceps)

    Change in the 1RMbiceps strength estimated using free weight in kilograms, bilateral and in stand position

    Measured: Baseline, 8 weeks after exercise training intervention

  36. Maximum strength of shoulder press (1RMsp)

    Change in the 1RMsp strength estimated using free weight in kilograms, bilateral and in stand position

    Measured: Baseline, 8 weeks after exercise training intervention

  37. Maximum strength of back exercise (1RMb)

    Change in the 1RMb strength estimated using free weight in kilograms, bilateral and in stand position

    Measured: Baseline, 8 weeks after exercise training intervention

Timeline

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

  1. First posted9 Jan 2025
  2. Study start1 Apr 2024
  3. Primary completion1 Nov 2024
  4. Study completion2 Nov 2024

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
It will be compared two different breast cancer survivors groups under exercise training condition, such as; exercise group of high chemotherapy (EG-HCT) or a control condition that will be an exercise group of low chemotherapy (EG-LCT).
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06766903
Sponsor's protocol ID
UNAB-FCR-KINE2024A
Status last verified
Jan 2025
First submitted
26 Dec 2024
Last updated
22 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise training in people with Breast Cancer and Vascular Disease,Peripheral, run by Cristian Alvarez at 1 site in Chile.

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 7 inclusion and 11 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: finished, as of the sponsor's last update on 22 Jan 2025. 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 Chile. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Flow-mediated dilation in (cm) (time frame: Baseline, 8 weeks after exercise training intervention). The study lists 4 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 22 Jan 2025.

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Onco-Vascular Exer-Study (NCT06766903) | AzTrials