Onco-Vascular Exer-Study

NCT06766903 | Completed DMC

• 1 other identifier: UNAB-FCR-KINE2024A
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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

  Baseline, 8 weeks after exercise training intervention

• Pulse wave velocity in (m/s)

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

  Baseline, 8 weeks after exercise training intervention

• 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

  Baseline, 8 weeks after exercise training intervention

• 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

  Baseline, 8 weeks after exercise training intervention

Secondary Outcomes (37)

• Body mass in (kg)

  Baseline, 8 weeks after exercise training intervention

• Body mass index in (kg/m2)

  Baseline, 8 weeks after exercise training intervention

• Body fat in (%)

  Baseline, 8 weeks after exercise training intervention

• Skeletal muscle mass in (%)

  Baseline, 8 weeks after exercise training intervention

• Resting metbolic rate in (kcal)

  Baseline, 8 weeks after exercise training intervention

Study Arms (2)

EG-HCT

EXPERIMENTAL

(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.

Behavioral: Exercise training

EG-LCT

ACTIVE 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.

Behavioral: Exercise training

Interventions

Exercise training BEHAVIORAL

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.

Also known as: Physical therapy intervention

EG-HCT; EG-LCT

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cristian Alvarez: lead
• Instituto Nacional de Deportes: collaborator

Study Sites (1)

ICER-Lab

Talcahuano, Chile

Location

MeSH Terms

Conditions

Breast Neoplasms; Peripheral Vascular Diseases; Hypertension; Metabolic Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Vascular Diseases; Cardiovascular Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rodrigo Araneda, PhD

  Universidad Andres Bello

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: All participants will be randomly allocated to blinded to "participants" and "investigators" to an exercise group of high chemotherapy (EG-HCT) or a control condition that will be an exercise group of low chemotherapy (EG-LCT).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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).

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 9, 2025
• Study Start: April 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 2, 2024
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)