Life ImproVed by Exercise (LIVE Trial)
LIVE
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.
1 other identifier
interventional
206
1 country
1
Brief Summary
This is a prospective randomized controlled trial in which patients with previous breast cancer will be randomized into two treatment arms:
- 1.Control Group of Usual Physical Activity
- 2.Intervention Group of Increased Physical Activity
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Jul 2014
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 19, 2015
CompletedFirst Posted
Study publicly available on registry
December 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedSeptember 16, 2021
September 1, 2021
5.6 years
June 19, 2015
September 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
quality of life
questionnaire
8 weeks
Secondary Outcomes (10)
self-report questionaire of principal side effects of medical treatments
8 weeks
patients' self-reported perceptions of their cognitive abilities
8 weeks
subjective response to a specific traumatic event
8 weeks
body weight
8 weeks
sleep
8 weeks
- +5 more secondary outcomes
Study Arms (2)
Control Group
NO INTERVENTIONUsual Physical Activity
Intervention Group
EXPERIMENTAL8-week increased physical activity program
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
European Institute of Oncology
Milan, 20141, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oreste D Gentilini, MD
European Institute of Oncology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2015
First Posted
December 22, 2015
Study Start
July 1, 2014
Primary Completion
February 1, 2020
Study Completion
February 1, 2020
Last Updated
September 16, 2021
Record last verified: 2021-09