NCT06618690Active, not recruitingNot Applicable
Efficacy of a Supervised Exercise Program on Pain, Physical Function, and Quality of Life in Breast Cancer Survivors: Protocol for a Randomized Clinical Trial
Universidad de Burgos1 site in 1 country325 target enrollmentStarted: September 10, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Universidad de Burgos
- Enrollment
- 325
- Locations
- 1
- Primary Endpoint
- repeated measures ANOVA
Study Overview
Brief Summary
The purpose of this project is to develop a randomized clinical trial to determine the efficacy of a supervised exercise program on pain, physical function and quality of life in female breast cancer survivors
Detailed Description
A randomized, double-blind, clinical trial will be conducted with 325 participants. The intervention group will receive a supervised exercise program for 12 weeks, while the control group will receive no intervention. Participants' pain, physical function and quality of life will be assessed at baseline, post-intervention and 12 weeks post-intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •women between 18 and 65 years of age,
- •women with oncologic treatment completed less than 3 months ago,
- •women without metastasis,
- •women without pathologies that contraindicate exercise,
- •women who have agreed to sign the informed consent form
Exclusion Criteria
- •not attending scheduled sessions to instruct on the exercises to be performed, - being part of other studies,
- •undergoing another type of therapy
- •pregnancy patients.
Outcomes
Primary Outcomes
repeated measures ANOVA
Time Frame: 12 weeks
the range of motion, tone and muscle strength of the group will be measured in 3 measures over the 12 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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