Clinical trial NCT06952270: Effects of Two Strength Exercise Programs on Upper Limb Functionality in Breast Cancer
Official title: Effects of Two Strength Exercise Programs on Upper Limb Functionality in Breast Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer Survivor
Breast Cancer
Breast Cancer Patients
Breast Cancer - Female
Keywords: breast cancer
plyometric exercise
upper limb
strength training
exercise
Recovery of Function
clinical trial
Lead sponsor: University of Vigo
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 24
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this experimental study is to evaluate the effect of a therapeutic exercise program based on upper limb plyometric exercises in breast cancer patients and breast cancer survivors to determine changes in upper limb functionality.

The main question it aims to answer is: Does upper limb plyometric strength exercise improve upper limb dysfunctions in breast cancer patients and survivors? The researchers will compare the effects of plyometric exercise with the effects of strength training exercise to determine whether plyometric exercise improves shoulder dysfunctions in breast cancer patients and survivors.

Participants from the Pontevedra group will undergo the intervention using plyometric exercise (Experimental Group), while those from the Vigo group will perform strength training exercise (Control Group). They will complete two sessions per week for six weeks. Outcome variables related to upper limb functionality will be assessed at baseline and after the intervention.


Eligibility criteria: Inclusion Criteria:

* Pathological diagnosis of breast cancer.
* Patients who have undergone a mastectomy, including unilateral, total breast, or breast-conserving surgery.
* Postoperative chemotherapy or radiotherapy as required.
* No other malignant tumors in the last 5 years.
* Absence of contraindications related to physiotherapy or physical exercise.
* Willingness to participate in the study and sign the informed consent form.

Exclusion Criteria:

* Metastasis to other organs and tissues (liver, kidney, lung, brain, etc.) that prevent participation in the exercise program.
* Underlying heart disease, cerebrovascular disease, or mental illness that impairs proper execution of the exercise program.
* Pre-existing shoulder pathology before surgery.
* Inability to understand the plyometric exercise program.

Primary outcomes:
measure: Change from Baseline in pain and activities of daily living, range of motion in flexion, abduction, external rotation, and internal rotation and sustained submaximal strength at six weeks
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Change from Baseline in Disability Arm Shoulder and Hand at six weeks
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Change from baseline in the maximum grip muscle strength at six weeks
timeFrame: "From enrollment to the end of treatment at 6 weeks"
measure: Change from baseline in the proprioception at six weeks
timeFrame: "From enrollment to the end of treatment at 6 weeks"
measure: Change from baseline in the maximum isometric upper limb strength at six weeks
timeFrame: "From enrollment to the end of treatment at 6 weeks"
measure: Change from baseline in the circumference measurement: at six weeks
timeFrame: "From enrollment to the end of treatment at 6 weeks"
measure: Change from baseline in the kinesiophobia at six weeks
timeFrame: "From enrollment to the end of treatment at 6 weeks"
measure: Change from baseline in the Sensation of heaviness of the upper limb at six weeks
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Change from baseline in the Sensation of pain of the upper limb at six weeks
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Change from baseline in the Sensation of tension of the upper limb at six weeks
timeFrame: From enrollment to the end of treatment at 6 weeks
Secondary outcomes:
measure: Sex
timeFrame: At the baseline
measure: Age
timeFrame: At the baseline
measure: Weight
timeFrame: At the baseline
measure: Height
timeFrame: At the baseline
Other outcomes:
Locations:
city: Pontevedra
country: Spain
facility: Faculty of Physiotherapy of Pontevedra
Study officials:
References:
citation: Lin Y, Wu C, He C, Yan J, Chen Y, Gao L, Liu R, Cao B. Effectiveness of three exercise programs and intensive follow-up in improving quality of life, pain, and lymphedema among breast cancer survivors: a randomized, controlled 6-month trial. Support Care Cancer. 2022 Dec 13;31(1):9. doi: 10.1007/s00520-022-07494-5.
citation: Shao YW, Shu Q, Xu D, Teng H, Wu GS, Hou JX, Tian J. Effect of different rehabilitation training timelines to prevent shoulder dysfunction among postoperative breast cancer patients: study protocol for a randomized controlled trial. Trials. 2021 Jan 6;22(1):16. doi: 10.1186/s13063-020-04954-3.
citation: Hasenoehrl T, Palma S, Ramazanova D, Kolbl H, Dorner TE, Keilani M, Crevenna R. Resistance exercise and breast cancer-related lymphedema-a systematic review update and meta-analysis. Support Care Cancer. 2020 Aug;28(8):3593-3603. doi: 10.1007/s00520-020-05521-x. Epub 2020 May 15.
citation: Swanik KA, Thomas SJ, Struminger AH, Bliven KC, Kelly JD, Swanik CB. The Effect of Shoulder Plyometric Training on Amortization Time and Upper-Extremity Kinematics. J Sport Rehabil. 2016 Dec;25(4):315-323. doi: 10.1123/jsr.2015-0005. Epub 2016 Aug 24.