Faculty of Physiotherapy of Pontevedra
Pontevedra, Spain
NCT Number: NCT06952270
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.
Trial opening soon.
Get Notified25 year–75 year
Female
Interventional
Not applicable
Pontevedra, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Upper 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 exercises (Squats, Stair climbing and jumps, Bench Press, Push-ups, Core Exercises (Plank, Bridge)).
Time frame: From enrollment to the end of treatment at 6 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 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 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"
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"
The variable of maximum isometric upper limb strength will be measured using the MicroFET2 in internal rotation, external rotation, and flexion, all performed in the scapular plane. Two measurements of maximum strength will be taken, with 30 seconds of rest between attempts. Each contraction will be held for 3 seconds.
The researcher will passively position the upper limb at 0º of shoulder flexion and 90º of elbow flexion, with the force applied to the palmar side of the distal third of the forearm for internal rotation, and to the dorsal side for external rotation. For flexion, the arm will be positioned at 90º of shoulder flexion in the scapular plane and 90º of elbow flexion, with force applied at the distal part of the humerus.
Minimum and maximum values: The test is performed twice, and the highest value is recorded.
Interpretation: Higher scores indicate better results.
Time frame: "From enrollment to the end of treatment at 6 weeks"
The diameter of the upper limb with lymphedema will be measured using a thin, flexible plastic measuring tape at four anatomical points: the metacarpophalangeal joint, the wrist, 10 cm below, and 10 cm above the lateral epicondyles. The subject will be positioned in a supine position with the arm in the anatomical position, in supination. Three measurements will be taken at each point, and the average of the three measurements will be calculated.
Time frame: "From enrollment to the end of treatment at 6 weeks"
Tampa Scale of Kinesiophobia-11 (TSK-11): The score ranges from 11 to 44. Interpretation: The lowest score (11) indicates no or insignificant kinesiophobia, and higher scores indicate increasing levels of kinesiophobia.
Time frame: From enrollment to the end of treatment at 6 weeks
Minimum and maximum values: The reported value is recorded using a visual analog scale from 0 to 10, where 0 means no heaviness and 10 means maximum heaviness.
Interpretation: Higher scores indicate greater disability.
Time frame: From enrollment to the end of treatment at 6 weeks
Minimum and maximum values: The reported value is recorded using a visual analog scale from 0 to 10, where 0 means no pain and 10 means maximum pain.
Interpretation: Higher scores indicate greater disability.
Time frame: From enrollment to the end of treatment at 6 weeks
Minimum and maximum values: The reported value is recorded using a visual analog scale from 0 to 10, where 0 means no tension and 10 means maximum tension.
Interpretation: Higher scores indicate greater disability.
Time frame: At the baseline
Female
Time frame: At the baseline
Years
Time frame: At the baseline
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 baseline
Centimeters (measured using a stadiometer, d=0.1 mm and measurement range of 0 to 2000 mm).
Contact information is provided by the study sponsor or research team.
University of Vigo
Other
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