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Breast Cancer SurvivorNCT06952270

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

A study testing plyometric exercise and Strength training exercise in people with Breast Cancer Survivor and Breast Cancer, run by University of Vigo at 1 site in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 75 years, women only
What is being tested?
plyometric exercise and Strength training exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteSpain
Study dates
2 May 2025to Jul 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yoana Gonzalez-Gonzalez, PhD contact

(+34) 986801767

yoana@uvigo.gal

Spain1 site
  • Faculty of Physiotherapy of Pontevedra

    Pontevedra

Other trials in Spain

About this study

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.

Being tested
plyometric exercise, Strength training exercise
Keywords
breast cancer, plyometric exercise, upper limb, strength training, exercise, Recovery of Function, clinical trial
Medical subject headings
Breast Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • plyometric exerciseOther

    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 exerciseOther

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

Study groups in NCT06952270
Study groupRoleWhat they receive
plyometric exercise groupExperimentalthis group will perform a program of different exercises focused on the upper limb and shoulder girdle based on plyometric exercises.
Receives: Other: plyometric exercise
Strength training exercise groupExperimentalThis group will perform a strength training program by performing different exercises focused on the upper limb, lower limb and trunk muscle strengthening.
Receives: Other: Strength training exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollment to the end of treatment at 6 weeks

  2. 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.

    Measured: From enrollment to the end of treatment at 6 weeks

  3. 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.

    Measured: "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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

    Measured: From enrollment to the end of treatment at 6 weeks

  9. 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.

    Measured: From enrollment to the end of treatment at 6 weeks

  10. 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.

    Measured: From enrollment to the end of treatment at 6 weeks

Secondary outcomes (4)
  1. Sex

    Female

    Measured: At the baseline

  2. Age

    Years

    Measured: At the baseline

  3. 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)

    Measured: At the baseline

  4. Height

    Centimeters (measured using a stadiometer, d=0.1 mm and measurement range of 0 to 2000 mm).

    Measured: At the baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2025
  2. Study start2 May 2025 (estimated)
  3. Primary completionJun 2025 (estimated)
  4. Study completionJul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06952270
Sponsor's protocol ID
28022025
Status last verified
Apr 2025
First submitted
29 Mar 2025
Last updated
30 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36512157
  • 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.

    PubMed 33407753
  • 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.

    PubMed 32415386
  • 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.

    PubMed 27632848

Questions about this trial

What is this clinical trial studying?

A study testing plyometric exercise and Strength training exercise in people with Breast Cancer Survivor and Breast Cancer, run by University of Vigo at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yoana Gonzalez-Gonzalez, PhD ((+34) 986801767, yoana@uvigo.gal), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: From enrollment to the end of treatment at 6 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06952270, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.

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