Effects of Two Strength Exercise Programs on Upper Limb Functionality in Breast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-75
SponsorUniversity of Vigo
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
plyometric exercise
Other interventionUpper limb plyometric exercise (proprioceptive neuromuscular facilitation of extensor and flexor pattern, external rotation exercise at 90º-90º, chest throw, external rotation and overhead and wall flexion).
Strength training exercise
Other interventionStrength training exercises (Squats, Stair climbing and jumps, Bench Press, Push-ups, Core Exercises (Plank, Bridge)).
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: plyometric exercise groupExperimental treatment 1 intervention
Group B: Strength training exercise groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Constant-Murley Score (Spanish version): Minimum and maximum values: 0 to 100. The scoring system includes 35 points for subjective measurement and 65 points for objective measurement. Interpretation: Higher scores indicate less disability.
Time frame
From enrollment to the end of treatment at 6 weeks2
Change from Baseline in Disability Arm Shoulder and Hand at six weeks
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire: Minimum and maximum values: The Spanish version of the DASH is a 30-item questionnaire where each question offers response options ranging from "no difficulty" or "none," scored as 1, to "unable" or "very severe," scored as 5. The total score ranges from 0 (no disability) to 100 (severe disability). At least 27 out of 30 questions must be completed to calculate a score. The values assigned to each response are summed and divided by the number of responses to obtain an average score from 1 to 5. This value is then transformed to a 0-100 score by subtracting 1 and multiplying by 25. This transformation facilitates comparison with other tools that report results on a 0-100 scale. Interpretation: Higher scores indicate greater disability.
Time frame
From enrollment to the end of treatment at 6 weeks3
Change from baseline in the maximum grip muscle strength at six weeks
Minimum and maximum values: Maximum grip strength is measured using dynamometry and determined by the average of three measurements at each time point. Interpretation: Higher scores indicate less disability.
Time frame
"From enrollment to the end of treatment at 6 weeks"4
Change from baseline in the proprioception at six weeks
Assessed by determining force sense: First, maximum grip strength is measured, and the participant is then asked to reproduce half of that maximum force. Three measurements are taken, and the one closest to the target is recorded. Additionally, proprioception is assessed by determining joint position sense (statesthesia): The examiner moves the subject's wrist, and the subject is asked to memorize the position to reproduce it later with their eyes closed. In a second phase, with eyes covered, the subject is asked to reach the previously indicated position from a starting point. Any deviation from the neutral position is measured using a goniometer. One measurement is taken for each position, and the closest one is recorded.
Time frame
"From enrollment to the end of treatment at 6 weeks"Secondary outcomes
1
Sex
Female
Time frame
At the baseline2
Age
Years
Time frame
At the baseline3
Weight
Kilograms (measured using a Tanita electronic scale \[model 780 MA portable\]; with a measurement range of 0-200 kg and d=0.1 kg)
Time frame
At the baseline4
Height
Centimeters (measured using a stadiometer, d=0.1 mm and measurement range of 0 to 2000 mm).
Time frame
At the baselineSponsors and contacts
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Source ClinicalTrials.gov
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