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

6 oktober 2020 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

200

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

25 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Ander: 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.
Experimenteel: 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.
Ander: 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.
Experimenteel: 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.
Ander: 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.
Experimenteel: 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.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Constant-Murley Shoulder Score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Active and passive range of motion
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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 uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Visual Analogue Scale （VAS)
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: Preoperative 3, 9, 12,18 weeks after surgery
Preoperative 3, 9, 12,18 weeks after surgery
body weight
Tijdsspanne: Preoperative, 3, 9 weeks after surgery
Preoperative, 3, 9 weeks after surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Wuhan University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

10 september 2018

Primaire voltooiing (Werkelijk)

31 mei 2020

Studie voltooiing (Werkelijk)

31 mei 2020

Studieregistratiedata

Eerst ingediend

29 augustus 2018

Eerst ingediend dat voldeed aan de QC-criteria

31 augustus 2018

Eerst geplaatst (Werkelijk)

5 september 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 oktober 2020

Laatste update ingediend die voldeed aan QC-criteria

6 oktober 2020

Laatst geverifieerd

1 oktober 2020

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CRE2018013

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

About six months after the trial complete

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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