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Effects of Exercise Training at Different Timeline on Shoulder Dysfunction After Breast Cancer Modified Radical Mastectomy

6. Oktober 2020 aktualisiert von: Qing Shu, Wuhan University

Effect of Exercise Training at Different Timeline on Shoulder Dysfunction in Patients After Breast Cancer Modified Radical Mastectomy: A Randomized Controlled Trial

Patients who underwent modified radical mastectomy were enrolled in the study. 200 subjects were randomly divided into 4 groups: 7 days postoperative shoulder isotonic training + 4 weeks postoperative progressive resistance training group, postoperative 7 Isometric training for the shoulder joint + progressive resistance training for 3 weeks after surgery group, 3 days postoperative isotope training + 4 weeks postoperative progressive resistance training group, 3 days postoperative shoulder isotonic training + postoperative 3 Weekly progressive resistance training group. The effects of interventional rehabilitation at different time points on the recovery of shoulder function after breast cancer operation were observed. The results of the study will provide evidence-based evidence for the time point of intervention in early functional exercise after modified radical mastectomy for breast cancer.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

200

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • China
    • Hubei
      • Wuhan, Hubei, China, 430070
        • Zhongnan Hospital of Wuhan University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

25 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

Inclusion Criteria:

  1. Between the ages of 25 and 75 years;
  2. Diagnosed with breast cancer by pathological diagnosis, the time of diagnosis and the time of inclusion are less than 6 weeks;
  3. Patients undergoing modified radical mastectomy: mastectomy includes unilateral total breast or breast-conserving surgery, as well as dissection of the affected axillary lymph nodes, but does not include sentinel lymph node biopsy;
  4. Postoperative chemotherapy or radiation therapy according to the condition;
  5. No other malignant tumors within 5 years;
  6. No physical therapy related contraindications;
  7. Signing informed consent.

Exclusion Criteria:

  1. The result of SLNB is negative who did not receive ALND;
  2. Received breast reconstruction surgery (prosthesis, latissimus dorsi, etc.);
  3. Combined tumor metastasis with other tissues and organs (liver, kidney, lung, brain, etc.);
  4. Combined severe heart disease, cerebrovascular disease, and mental illness;
  5. Patients with shoulder joint dysfunction before surgery;
  6. Unable to understand the rehabilitation training program provided by doctors or physiotherapists.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 7 days SIE plus 4 weeks PRE
Participants in this group will start shoulder isotonic exercise 7 days after surgery and begin progressive resistance exercise 4 weeks after surgery.
Sonstiges: 7 days SIE plus 4 weeks PRE

Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint.

Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity.
Experimental: 7 days SIE plus 3 weeks PRE
Participants in this group will start shoulder isotonic exercise 7 days after surgery and begin progressive resistance exercise 3 weeks after surgery.
Sonstiges: 7 days SIE plus 3 weeks PRE

Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint.

Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity.
Experimental: 3 days SIE plus 4 weeks PRE
Participants in this group will start shoulder isotonic exercise 3 days after surgery and begin progressive resistance exercise 4 weeks after surgery.
Sonstiges: 3 days SIE plus 4 weeks PRE

Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint.

Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity.
Experimental: 3 days SIE plus 3 weeks PRE
Participants in this group will start shoulder isotonic exercise 3 days after surgery and begin progressive resistance exercise 3 weeks after surgery.
Sonstiges: 3 days SIE plus 3 weeks PRE

Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint.

Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Constant-Murley Shoulder Score
Zeitfenster: 1 weeks after surgery
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function.
1 weeks after surgery
Constant-Murley Shoulder Score
Zeitfenster: 3 weeks after surgery
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function.
3 weeks after surgery
Constant-Murley Shoulder Score
Zeitfenster: 6 weeks after surgery
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function.
6 weeks after surgery
Constant-Murley Shoulder Score
Zeitfenster: 9 weeks after surgery
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function.
9 weeks after surgery
Constant-Murley Shoulder Score
Zeitfenster: 12 weeks after surgery
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function.
12 weeks after surgery
Constant-Murley Shoulder Score
Zeitfenster: 18 weeks after surgery
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function.
18 weeks after surgery

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Active and passive range of motion
Zeitfenster: 3 days，1, 2, 3, 6, and 9 weeks after surgery
In the standard position, the mobility of the shoulder flexion, extension, external rotation and internal rotation was measured by using protractor. The range of flexion is 0-180°, the range of extension is 0-180°, the range of external rotation is 0-90°, and the range of internal rotation is measured. 0-70°. The assessments will be performed in the active and passive state separately.
3 days，1, 2, 3, 6, and 9 weeks after surgery
Shoulder joint muscle strength
Zeitfenster: 3 days, 3, 6, 9 weeks after surgery
In the standard position, the muscle strength of the flexion, extension, external rotation and internal rotation of the shoulder joint were assessed according to the "manual muscle test standard".
3 days, 3, 6, 9 weeks after surgery
The power of gripping
Zeitfenster: 1, 3 days and 1, 2, 3, 6, and 9 weeks after surgery
In the standard position, the grip of the patient's palm is measured using a dynamometer.
1, 3 days and 1, 2, 3, 6, and 9 weeks after surgery
EORTC QLQ BR23 Breast Cancer Quality of Life Questionnaire
Zeitfenster: 1, 3, 9, 12, 18 weeks after surgery
The quality of life assessment of breast cancer patients was evaluated by the total score of the EORTC QLQ BR23 Breast Cancer Quality of Life Questionnaire, which ranged from 0 to 92. Higher scores indicate better quality of life.
1, 3, 9, 12, 18 weeks after surgery
SF-36 Health status questionnaire
Zeitfenster: 1, 3, 9, 12, 18 weeks after surgery
The quality of life assessment of breast cancer patients was evaluated by the total score of the SF-36 Health status questionnaire, which ranged from 0 to 92. Higher scores indicate better quality of life.
1, 3, 9, 12, 18 weeks after surgery

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Visual Analogue Scale （VAS)
Zeitfenster: 1 day, 3 days, 1 week, 2 weeks after surgery
Visual Analogue Scale（VAS): Used to assess the degree of pain. Draw a 10 cm horizontal line on the paper. One end of the horizontal line is 0, indicating no pain; the other end is 10, indicating severe pain; the middle part indicates different degrees of pain.
1 day, 3 days, 1 week, 2 weeks after surgery
Sum drainage from chest wall and axillary after operation.
Zeitfenster: 1 day, 3 days, 1 week, 2 weeks after surgery
The postoperative drainage was the total volume of the chest wall drainage tube and the underarm drainage tube. The volume measurement and recording in the drainage bag were observed daily by the nurse.
1 day, 3 days, 1 week, 2 weeks after surgery
Upper limb circumference
Zeitfenster: Preoperative 3, 9, 12,18 weeks after surgery
Preoperative 3, 9, 12,18 weeks after surgery
body weight
Zeitfenster: Preoperative, 3, 9 weeks after surgery
Preoperative, 3, 9 weeks after surgery

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Wuhan University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

10. September 2018

Primärer Abschluss (Tatsächlich)

31. Mai 2020

Studienabschluss (Tatsächlich)

31. Mai 2020

Studienanmeldedaten

Zuerst eingereicht

29. August 2018

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

31. August 2018

Zuerst gepostet (Tatsächlich)

5. September 2018

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

8. Oktober 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. Oktober 2020

Zuletzt verifiziert

1. Oktober 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CRE2018013

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

The study protocol, statistical analysis plan, informed consent form and clinical study report will be shared online about six months after the trial complete.

IPD-Sharing-Zeitrahmen

About six months after the trial complete

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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