Effects of Exercise Training at Different Timeline on Shoulder Dysfunction After Breast Cancer Modified Radical Mastectomy
6 octobre 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Type d'étude
Interventionnel
Inscription (Réel)
200
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Hubei
-
Wuhan, Hubei, Chine, 430070
- Zhongnan Hospital of Wuhan University
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
25 ans à 75 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La description
Inclusion Criteria:
- Between the ages of 25 and 75 years;
- Diagnosed with breast cancer by pathological diagnosis, the time of diagnosis and the time of inclusion are less than 6 weeks;
- 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;
- Postoperative chemotherapy or radiation therapy according to the condition;
- No other malignant tumors within 5 years;
- No physical therapy related contraindications;
- Signing informed consent.
Exclusion Criteria:
- The result of SLNB is negative who did not receive ALND;
- Received breast reconstruction surgery (prosthesis, latissimus dorsi, etc.);
- Combined tumor metastasis with other tissues and organs (liver, kidney, lung, brain, etc.);
- Combined severe heart disease, cerebrovascular disease, and mental illness;
- Patients with shoulder joint dysfunction before surgery;
- Unable to understand the rehabilitation training program provided by doctors or physiotherapists.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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.
|
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. |
|
Expérimental: 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.
|
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. |
|
Expérimental: 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.
|
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. |
|
Expérimental: 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.
|
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Constant-Murley Shoulder Score
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Active and passive range of motion
Délai: 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
Délai: 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".
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3 days, 3, 6, 9 weeks after surgery
|
|
The power of gripping
Délai: 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
Délai: 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
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Visual Analogue Scale （VAS)
Délai: 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.
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1 day, 3 days, 1 week, 2 weeks after surgery
|
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Sum drainage from chest wall and axillary after operation.
Délai: 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.
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1 day, 3 days, 1 week, 2 weeks after surgery
|
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Upper limb circumference
Délai: Preoperative 3, 9, 12,18 weeks after surgery
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Preoperative 3, 9, 12,18 weeks after surgery
|
|
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body weight
Délai: Preoperative, 3, 9 weeks after surgery
|
Preoperative, 3, 9 weeks after surgery
|
Collaborateurs et enquêteurs
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
10 septembre 2018
Achèvement primaire (Réel)
31 mai 2020
Achèvement de l'étude (Réel)
31 mai 2020
Dates d'inscription aux études
Première soumission
29 août 2018
Première soumission répondant aux critères de contrôle qualité
31 août 2018
Première publication (Réel)
5 septembre 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
8 octobre 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 octobre 2020
Dernière vérification
1 octobre 2020
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CRE2018013
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime 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.
Délai de partage IPD
About six months after the trial complete
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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