Life ImproVed by Exercise (LIVE Trial)

Study Overview
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Brief Summary
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This is a prospective randomized controlled trial in which patients with previous breast cancer will be randomized into two treatment arms: Control Group of Usual Physical Activity Intervention Group of Increased Physical Activity No specific intervention will be performed In the patients randomized in the control group. Patients randomized in the Intervention group will receive a program of increased physical activity starting from 5000 steps/day up to 12000 steps/day after 8 weeks. At the same time patients of this group will receive an 8-week recreational program of brisk walking/running (3 times a week). All the patients enrolled in this trial will receive a pedometer device (Garmin Vìvofit) able to count the number of steps, determine a daily goal of steps, determine the covered distance (in Km), determine daily caloric consumption, and determine the movements during sleep.

Detailed Description
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In this prospective randomized controlled trial patients with previous breast cancer will be randomized into two treatment arms: Control Group of Usual Physical Activity Intervention Group of Increased Physical Activity No specific intervention will be performed In the patients randomized in the control group. Patients randomized in the Intervention Group will receive a program of increased physical activity starting from 5000 steps/day up to 12000 steps/day after 8 weeks. At the same time patients of this group will receive an 8-week recreational program of brisk walking/running (3 times a week). All the patients enrolled in this trial will receive a pedometer device (Garmin Vìvofit) able to count the number of steps, determine a daily goal of steps, determine the covered distance (in Km), determine daily caloric consumption, and determine the movements during sleep. Data will be downloaded in a specific application available online (Garmin Connect). All the patients will receive written information on the potential benefits of physical exercise and better lifestyle. At baseline, at the end of the study period (8 weeks) and after 1 year patients will be asked to fill out the following questionnaires: Funcional Assessment of Cancer Therapy- Breast (FACT-B, 37 items) Patient reported symptoms (PRS like International Breast Cancer Study Group form, 19 items) Funcional Assessment of Cancer Therapy- Fatigue (FACT-Fatigue, 13 items) Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog; 37 items) Impact of Event Scale (IES; 22 items) At baseline, at the end of the study period (8 weeks) patients will be asked to undergo blood draw for serum analysis of insulin, IGF-1, leptin, PCR, cholesterol, triglycerides leucocyte count, T lymphocyte subpopulations (T regulatory and TH17). The hypothesis of the study is that even a short course of increased physical activity may improve quality of life of non-regular exercisers women with a personal history of breast cancer who completed treatment (endocrine treatment excluded).

Official Title
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Effect of a Short Program (8 Week) of Increased Physical Activity on Quality of Life of Sedentary Women With Previous Breast Cancer. A Prospective Randomized Trial.

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Increased Physical Activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with personal history of breast cancer AND Written informed consent AND Willing to be randomized to either group AND Age 18-70 years Treatment (surgery, chemotherapy, radiotherapy, trastuzumab) completed since at least 6 months and up to 3 years (endocrine therapy allowed) Non regular exercisers (≤150 minutes per week of moderate-intense exercise). Exclusion Criteria: Diabetes or other insulin metabolic impairment General contraindications to regular physical activity participation Inability to ambulate Plan to relocate far from the study site Presence of any severe medical condition such that the patient is not expected to adhere at the planned study protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Usual Physical Activity | |
| Experimental: Intervention Group<br>8-week increased physical activity program | Behavioral: Increased Physical Activity<br>* Patients will receive a program of increased physical activity starting from 5000 steps/day up to 12000 steps/day after 8 weeks and an 8-week recreational program of brisk walking/running (3 times a week).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | questionnaire | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self-report questionaire of principal side effects of medical treatments |  | 8 weeks | 
| patients' self-reported perceptions of their cognitive abilities | 37 items consisting of 1) patients' perceived cognitive impair- ments, 2) perceived cognitive abilities, 3) noticeability or com- ments from others, and 4) impact of cognitive changes on quality of life | 8 weeks | 
| subjective response to a specific traumatic event | administration of self-report validated questionnaire | 8 weeks | 
| body weight | Registration of body weight at baseline and 8 weeks | 8 weeks | 
| sleep | Registration of movements during sleep (Data registered by the pedometer device) | 8 weeks | 
| insulin | serum analysis at baseline and 8 weeks | 8 weeks | 
| immune function (as determined by Th17 e T regulators) | serum analysis at baseline and 8 weeks | 8 weeks | 
| IGF-1 | serum analysis at baseline and 8 weeks | 8 weeks | 
| Leptin | serum analysis at baseline and 8 weeks | 8 weeks | 
| C Reactive Protein | serum analysis at baseline and 8 weeks | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Physical Activity, Quality of life