Adapted Physical Activity (APA) in a Breast Cancer Population.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-12-31

Brief Summary

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The aim of this study is to investigate the effect of a 6-months program of Adapted Physical Activity (APA) on lifestyle, physical activity levels, insulin resistance and adipokines, oxidative stress, microcirculatory haemodynamics and serum levels of specific circulating miRNA in post-menopausal, physically inactive breast cancer patients in oncologic follow-up with or without hormone therapy that had completed adjuvant treatment (radiotherapy and/or chemotherapy) .

Furthermore, the study will determine the impact of APA on functional capabilities, on self-reported physical activity, quality of life and psychic health.

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Detailed Description

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This is a randomized controlled double-group assignment study with intermedial switch-over including post-menopausal, physically inactive breast cancer patients in oncological follow-up with or without hormone therapy, that had completed adjuvant post-surgical treatment (radiotherapy and/or chemotherapy) from at least 3 months and from not more than 3 years.

Patients in hormonal therapy and patient not in hormonal therapy will be assigned in two different groups, each one of 50 patients. In each groups, patients will be randomized divided in a control group (25 pt) and in a 6 months-physical training group (25 pt). After 6-months patient in control group will be switched in the physical training group.

The duration of the study is 2 year. Clinical evaluation of the patients will be made: at the enrollment, after 6, 12, and 24 months.

Physical activity will be adapted according to arm and shoulder morbidity, after fracture risk assessment. Exercise will be concentrated solely on leg muscles (pedalling on a cycle or bed ergometer) in individuals with limitations in the range of motion of the arms (eg, due to breast, axillary, or thoracic surgery). In patients experiencing ataxia, dizziness, or peripheral neuropathy, walking outdoors and mostly cycle-ergometry training will be preferred to other activities that also involve large muscle groups but require additional balance and coordination (eg, treadmill walking, outdoor cycling).

Exercises will be performed at the Unipolar Spinal Unit of "S. Maria della Misericordia" Hospital, Perugia.

The aim of the study is to confirm the positive effect of APA on metabolic stress, body mass composition, functional capacity, serum levels of specific circulating miRNA and quality of life in breast cancer patients in oncological follow-up.

Currently, only few data are available about the relationship between physical activity and microcirculatory hemodynamics that, together with oxidative stress, could be involved in genesis and progression of breast cancer.

Conditions

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Breast Neoplasms Exercise Exercise Therapy Insulin Resistance Oxidative Stress Microcirculation Quality of Life Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized, controlled, double-group assignment, open label study with intermediate crossover

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise

Patients involved in the 6 months-physical training group.

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

The exercise intervention consists of 60 minutes sessions, divided into 40 minutes of aerobic exercise and 20 minutes of circuit training for muscular strength and flexibility exercises.

Aerobic exercise is performed using treadmill, exercise bikes, syncro and arm-ergometers, gradually increasing the exercise intensity, after a 10 minutes period of warming-up, to 60-80 % of Maximum Heart Rate.

Resistance training consists of resistance exercises for large muscle groups, performed with body weight-exercises and isotonic machines.

Control

Patients in control group carry on their usual follow-up programme.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

The exercise intervention consists of 60 minutes sessions, divided into 40 minutes of aerobic exercise and 20 minutes of circuit training for muscular strength and flexibility exercises.

Aerobic exercise is performed using treadmill, exercise bikes, syncro and arm-ergometers, gradually increasing the exercise intensity, after a 10 minutes period of warming-up, to 60-80 % of Maximum Heart Rate.

Resistance training consists of resistance exercises for large muscle groups, performed with body weight-exercises and isotonic machines.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* breast cancer patients in oncological follow-up
* post-menopausal age
* physically inactivity (light to moderate or vigorous leisure-time physical activity less than 10 minutes a day, US National Health Interview Survey)
* assuming or not hormone therapy
* after 3 months - 3 years from adjuvant post-surgical treatment (radiotherapy and/or chemotherapy)

Exclusion Criteria

Permanent

* Patients older than 80 years
* Inability to carry on physical activity
* Metastatic neoplasia or unknown stage and/or histology
* Concomitant neoplasia
* Patients on corticosteroid treatment
* Known heart disease (heart failure NYHA II (New York Heart Association II) or superior, angina pectoris or positive exercise stress test, treatment-related cardiotoxicity)
* Currently on a weight loss plan or on moderate physical activity before the start of the project (no more than three sessions a week)
* Severe cachexia (loss of more than of 35% premorbid weight or weight loss more than 10% in the last 6 months).
* Morbidly obesity (BMI \>40 kg/m2),
* Immunodepression (absolute neutrophils count \< 500/mmc)

Temporary

* Uncontrolled pain or new onset bone pain until further diagnostic study
* Severe anemia (haemoglobin below 8 g/dL) or platelet count lower than \<50000/μL
* Fever (temperature above 38ºC) or acute infections
* Severe nausea and vomiting within previous 24-36 h
* Uncontrolled blood pressure (systolic blood pressure \> 160 mm Hg and/or diastolic blood pressure \>99 mm Hg)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No