Clinical trial NCT06766903: Onco-Vascular Exer-Study
Official title: Effects of a Physical Exercise Program on Cardiovascular, Metabolic, Physical Fitness and Quality of Life in Cancer Survivors' Adult Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Vascular Disease，Peripheral
Arterial Hypertension
Endothelial Dysfunction
Metabolic Disease
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
Lead sponsor: Universidad Nacional Andres Bello
Sponsor class: OTHER
Collaborators: name: Instituto Nacional de Deportes
First posted: 2025-01-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: PREVENTION

Brief 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 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* 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.

Primary outcomes:
measure: Flow-mediated dilation in (cm)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Pulse wave velocity in (m/s)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Carotid intima media thickness average in (cm)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Carotid intima media thickness maximum in (cm)
timeFrame: Baseline, 8 weeks after exercise training intervention
Secondary outcomes:
measure: Body mass in (kg)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Body mass index in (kg/m2)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Body fat in (%)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Skeletal muscle mass in (%)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Resting metbolic rate in (kcal)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Waist circumference in (cm)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Systolic blood pressure in (mmHg)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Diastolic blood pressure in (mmHg)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Mean arterial pressure in (mmHg)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Pulse pressure in (mmHg)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Heart rate at rest in (beats/min)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Systolic blood pressure of the ankle in (mmHg)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Diastolic blood pressure of the ankle in (mmHg)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Partial oxygen saturation in (%)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Total chlesterol in (mg/dL)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Fasting glucose in (mg/dL)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Triglycerides in (mg/dL)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Lactate
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Augmentation index in (%)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Ankle-Brachial Index in (%)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Aortic Systolic blood pressure in (mmHg)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Aortic pulse pressure in (mmHg)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Aortic augmentation index in (%)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Ejection duration in (m/s)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Diastolic reflection area
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Systolic area index
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Diastolic area index
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Return time of the aortic pulse wave
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Arterial age
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Heart rate during exercise in (beats/min)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Peak oxigen consumption (VO2peak)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Fat oxidation (FATox)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Carbohydrate oxidation (CHOox)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Maximum strength of leg extension (1RMleg)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Maximum strength of biceps curl (1RMbiceps)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Maximum strength of shoulder press (1RMsp)
timeFrame: Baseline, 8 weeks after exercise training intervention
measure: Maximum strength of back exercise (1RMb)
timeFrame: Baseline, 8 weeks after exercise training intervention
Other outcomes:
Locations:
city: Talcahuano
country: Chile
facility: ICER-Lab
Study officials:
affiliation: Universidad Andres Bello
name: Rodrigo Araneda, PhD
role: STUDY_CHAIR
References: