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Набор скоро начнётся NCT06952270

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

Без фазы С лечением Breast Cancer Survivor Breast Cancer Breast Cancer Patients Breast Cancer - Female

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: plyometric exercise, Strength training exercise.
Кому может быть актуально
Состояния в реестре: Breast Cancer Survivor, Breast Cancer, Breast Cancer Patients, Breast Cancer - Female. Базовые параметры: 25 лет — 75 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Вмешательства

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

Первичные конечные точки

  • 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 [Срок оценки: From enrollment to the end of treatment at 6 weeks]
  • Change from Baseline in Disability Arm Shoulder and Hand at six weeks [Срок оценки: From enrollment to the end of treatment at 6 weeks]
  • Change from baseline in the maximum grip muscle strength at six weeks [Срок оценки: "From enrollment to the end of treatment at 6 weeks"]
  • Change from baseline in the proprioception at six weeks [Срок оценки: "From enrollment to the end of treatment at 6 weeks"]
  • Change from baseline in the maximum isometric upper limb strength at six weeks [Срок оценки: "From enrollment to the end of treatment at 6 weeks"]
  • Change from baseline in the circumference measurement: at six weeks [Срок оценки: "From enrollment to the end of treatment at 6 weeks"]
  • Change from baseline in the kinesiophobia at six weeks [Срок оценки: "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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From enrollment to the end of treatment at 6 weeks]
Вторичные конечные точки (4)
  • Sex [Срок оценки: At the baseline]
  • Age [Срок оценки: At the baseline]
  • Weight [Срок оценки: At the baseline]
  • Height [Срок оценки: At the baseline]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • Faculty of Physiotherapy of Pontevedra — Pontevedra

Публикации

  • 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
  • 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
  • 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
  • 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

Идентификаторы

NCT: NCT06952270 · 28022025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗