Efficacy of a Supervised Exercise Program on Pain, Physical Function, and Quality of Life in Breast Cancer Survivors: Protocol for a Randomized Clinical Trial
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.
Arms & Interventions
Grupo experimental
The participants will be recruited through the oncologists of the Hospital Universitario Torrecárdenas (Almería). The proposal will be carried out in the intervention group (group 1), while the control group (group 2) will undergo the conventional recommendations indicated for this type of patients.
Intervention: Exercise program (Other)
group control
The participants will be recruited through the oncologists of the Hospital Universitario Torrecárdenas (Almería). The proposal will be carried out in the intervention group (group 1), while the control group (group 2) will undergo the conventional recommendations indicated for this type of 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