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

6 ottobre 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

200

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 25 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Altro: 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.
Sperimentale: 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.
Altro: 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.
Sperimentale: 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.
Altro: 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.
Sperimentale: 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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Constant-Murley Shoulder Score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Active and passive range of motion
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Visual Analogue Scale （VAS)
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: Preoperative 3, 9, 12,18 weeks after surgery
Preoperative 3, 9, 12,18 weeks after surgery
body weight
Lasso di tempo: Preoperative, 3, 9 weeks after surgery
Preoperative, 3, 9 weeks after surgery

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Wuhan University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

10 settembre 2018

Completamento primario (Effettivo)

31 maggio 2020

Completamento dello studio (Effettivo)

31 maggio 2020

Date di iscrizione allo studio

Primo inviato

29 agosto 2018

Primo inviato che soddisfa i criteri di controllo qualità

31 agosto 2018

Primo Inserito (Effettivo)

5 settembre 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 ottobre 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 ottobre 2020

Ultimo verificato

1 ottobre 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CRE2018013

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Periodo di condivisione IPD

About six months after the trial complete

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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