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Exercise Program on Pain, Physical Function, and Quality of Life in Breast Cancer Survivors

Efficacy of a Supervised Exercise Program on Pain, Physical Function, and Quality of Life in Breast Cancer Survivors: Protocol for a Randomized Clinical Trial

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06618690
Acronym
IO/2024
Enrollment
325
Registered
2024-10-01
Start date
2024-09-10
Completion date
2025-04-02
Last updated
2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Breast Cancer

Keywords

breast cancer, exercise, quality of life, muscle strength

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.

Interventions

OTHERExercise program

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.

Sponsors

Universidad de Burgos
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
repeated measures ANOVA12 weeksthe range of motion, tone and muscle strength of the group will be measured in 3 measures over the 12 weeks

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026