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Trial Title:
Exercise Program on Pain, Physical Function, and Quality of Life in Breast Cancer Survivors
NCT ID:
NCT06618690
Condition:
Female Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
breast cancer
exercise
quality of life
muscle strength
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
Exercise program
Description:
A supervised training plan will be carried out for 12 weeks with a frequency of 3
sessions per week with a duration of 60 minutes, an ideal estimate according to the
meta-analysis of Montaño-Rojas et al. The first two weeks the group exercises will be
performed to familiarize the participants with the exercises and then each participant
will perform them at home with a review every two weeks to assess the increase of the
load.
The exercises and loads included in this treatment plan have been designed and modified
based on previous clinical trials. The training plan will work upper limbs, lower limbs
and trunk. All sessions begin with a general warm-up, which will be previously instructed
to the participants, in which the heart rate will be increased (see Multimedia Appendix
1). After a two-minute break, the specific block of each session will begin (see Table 1
and Multimedia Appendix 1). All exercises will be performed with dumbbells, elastic bands
and a ball.
Arm group label:
Grupo experimental
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Universitario Torrecárdenas
Address:
City:
Àlmeria
Country:
Spain
Start date:
September 10, 2024
Completion date:
April 2, 2025
Lead sponsor:
Agency:
Universidad de Burgos
Agency class:
Other
Source:
Universidad de Burgos
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06618690
