Effects of Two Strength Exercise Programs on Upper Limb Functionality in Breast Cancer

NCT06952270 | Not Yet Recruiting

• 1 other identifier: 28022025
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (10)

• 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.

  From enrollment to the end of treatment at 6 weeks

• 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.

  From enrollment to the end of treatment at 6 weeks

• 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.

  "From enrollment to the end of treatment at 6 weeks"

• 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.

  "From enrollment to the end of treatment at 6 weeks"

• Change from baseline in the maximum isometric upper limb strength at six 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.

  "From enrollment to the end of treatment at 6 weeks"

• Change from baseline in the circumference measurement: at six 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.

  "From enrollment to the end of treatment at 6 weeks"

• Change from baseline in the kinesiophobia at six 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.

  "From enrollment to the end of treatment at 6 weeks"

• Change from baseline in the Sensation of heaviness of the upper limb at six 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.

  From enrollment to the end of treatment at 6 weeks

• Change from baseline in the Sensation of pain of the upper limb at six 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.

  From enrollment to the end of treatment at 6 weeks

• Change from baseline in the Sensation of tension of the upper limb at six 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.

  From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (4)

• Sex

  At the baseline

• Age

  At the baseline

• Weight

  At the baseline

• Height

  At the baseline

Study Arms (2)

plyometric exercise group

EXPERIMENTAL

this group will perform a program of different exercises focused on the upper limb and shoulder girdle based on plyometric exercises.

Other: plyometric exercise

Strength training exercise group

EXPERIMENTAL

This group will perform a strength training program by performing different exercises focused on the upper limb, lower limb and trunk muscle strengthening.

Other: Strength training exercise

Interventions

plyometric exercise OTHER

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).

plyometric exercise group

Strength training exercise OTHER

Strength training exercises (Squats, Stair climbing and jumps, Bench Press, Push-ups, Core Exercises (Plank, Bridge)).

Strength training exercise group

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Vigo: lead

Study Sites (1)

Faculty of Physiotherapy of Pontevedra

Pontevedra, Spain

Location

Related Publications (4)

• 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.

  PMID: 36512157 BACKGROUND

• 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.

  PMID: 33407753 BACKGROUND

• 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.

  PMID: 32415386 BACKGROUND

• 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.

  PMID: 27632848 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Plyometric Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Yoana Gonzalez-Gonzalez, PhD

CONTACT

(+34) 986801767; yoana@uvigo.gal

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2025
• First Posted: April 30, 2025
• Study Start: May 2, 2025
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)