Upper Limb Muscular Strengthening in the Rehabilitation of Patients Submitted to the Breast Cancer Surgical Treatment

Sponsor
Federal University of São Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT02982980
Collaborator
(none)
121
4
26

Study Details

Study Description

Brief Summary

The presence of pain, reduced range of motion and decrease of muscle strength of the upper limb in the early postoperative period are some of the major deficiencies of the breast cancer patients.

The objectives of this study were to evaluate muscle strength, range of motion (ROM), pain, perimetry of the upper limbs and applied questionnaires of the upper lim function and quality of life, in patients after surgical treatment of breast cancer in different postoperative periods and different groups following rehabilitation: traditional postoperatively exercise to perform at home versus traditional exercises associated with weekly physiotherapy sessions to strength training for shoulder movements.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Physiotherapy Guidance
  • Procedure: Physiotherapy Muscle strengthening
N/A

Detailed Description

A clinical trial, randomized, blinded study. The groups were divided according to the type of rehabilitation (weekly sessions of Physiotherapy-F and Orientation -O). The surgical type (M-Mastectomy and Q-Quadrantectomy) was also taken into account.

Were not included in the study those patients who underwent previous surgeries of breast cancer, breast reconstruction, those with some neurological deficit or acute orthopedic shoulder injury, such as tendonitis or bursitis, patients with previous histories of shoulder fracture with limited range of motion and tumor stage T4b or N3 or patients with bone or brain metastases.

All patients underwent preoperative evaluation and guidance of general care; then returned after one, two, three and six months postoperatively for reassessment and reorientation. The physiotherapy group, in addition to receiving guidance, had, weekly, physical therapy sessions with the goal to increase muscle strength in the upper limbs, between one and three months after surgery.The exercises performed were active-free, with the aid of a stick or resistance by elastic bands and dumbbells for flexion, extension, adduction, abduction, external and internal rotation of the shoulder, and elbow flexion and extension, besides activities to enable movements functional. The mode of execution of the exercises was isotonic, done slowly and within the joint amplitude reached by the patient, using resistance according to the muscular capacity of each patient.

All evaluations were performed by the physiotherapy team; the professionals were not aware of whether the patient belonged to the physiotherapy group or to the guidance group, constituted by a single evaluator (blinded study).

The evaluations were: muscular strength of the shoulder, evaluated by means of a manual isokinetic dynamometer, which records the peak of force, in kilograms, during five seconds of muscle contraction duration; range of motion of the shoulder: measured by a goniometer; function of the upper limb: ascertained by the application of a specific questionnaire, the Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) assesses functional capacity in upper limb diseases and measures the abilities to perform certain activities; pain: evaluated by the application of the Verbal Numerical Pain Scale (NVA); perimetry: evaluated with a tape measure in eight distinct points in the upper limbs and quality of life, analyzed by a European Organization for Research and Treatment of Cancer (EORTC) Quality of Life C30 (QLQ-C30) questionnaire with a Specific module for breast cancer (BR) 23 - Breast Specific Module.

Study Design

Study Type:
Interventional
Actual Enrollment :
121 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Muscle Strength Exercises After Breast Cancer Surgery: a Randomized Clinical Trial
Study Start Date :
Aug 1, 2011
Actual Primary Completion Date :
Aug 1, 2012
Actual Study Completion Date :
Oct 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Physiotherapy Guidance Mastectomy

Patients who underwent radical breast surgery, received pre and postoperative assessment and orientation.

Procedure: Physiotherapy Guidance
Pre and postoperative assessment and orientation, guidelines for lymphedema prevention and self drainage, follow-up for rehabilitation or maintenance of joint amplitude of shoulder movements and functional return.

Experimental: Phys Muscle strengthening Mastectomy

Patients who underwent radical breast surgery, in addition to receiving guidance, had, weekly, physical therapy sessions with the goal to increase muscle strength in the upper limbs, between one and three months after surgery.

Procedure: Physiotherapy Muscle strengthening
The exercises performed were active-free, with the aid of a stick or resistance by elastic bands and dumbbells for flexion, extension, adduction, abduction, external and internal rotation of the shoulder, and elbow flexion and extension, besides activities to enable movements Functional. The mode of execution of the exercises was isotonic, done slowly and within the joint amplitude reached by the patient, using resistance according to the muscular capacity of each patient.

Experimental: Physiotherapy Guidance Quadrantectomy

Patients who underwent partial breast surgery, received pre and postoperative assessment and orientation.

Procedure: Physiotherapy Guidance
Pre and postoperative assessment and orientation, guidelines for lymphedema prevention and self drainage, follow-up for rehabilitation or maintenance of joint amplitude of shoulder movements and functional return.

Experimental: Phys Muscle strengthening Quadrantectomy

Patients who underwent partial breast surgery, in addition to receiving guidance, had, weekly, physical therapy sessions with the goal to increase muscle strength in the upper limbs, between one and three months after surgery.

Procedure: Physiotherapy Muscle strengthening
The exercises performed were active-free, with the aid of a stick or resistance by elastic bands and dumbbells for flexion, extension, adduction, abduction, external and internal rotation of the shoulder, and elbow flexion and extension, besides activities to enable movements Functional. The mode of execution of the exercises was isotonic, done slowly and within the joint amplitude reached by the patient, using resistance according to the muscular capacity of each patient.

Outcome Measures

Primary Outcome Measures

  1. Muscle strength [two years]

    Muscle strength of shoulder movements with Hand Held Dynamometer model 01163, Lafayette Instrument Company.

Secondary Outcome Measures

  1. Range of motion [two years]

    Shoulder range of motion measured by a goniometer

  2. Upper limb function [two years]

    Upper limb function determined by the application of a specific questionnaire, the DASH (Disability of Arms, Shoulder and Hand Questionnaire)

  3. Pain [two years]

    Pain: assessed by the application of the Verbal Numerical Pain Scale (VN)

  4. Perimeter [two years]

    Perimeter: evaluated with a tape measure at eight distinct points in the upper limbs

  5. Quality of life [two years]

    Quality of life, analyzed by a questionnaire C30 (QLQ-C30) from the European Organization for Research and Treatment of Cancer (EORTC) Cancer, BR-23 (Breast Specific Module ).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients undergoing radical or conservative surgical treatment of breast cancer

  • Patients who did some type of investigation of axillary lymph node involvement, sentinel lymph node biopsy (BLS) or lymph node dissection (LND)

  • Patients who have performed the final and final evaluation

  • Patients in the Muscular Strength group, who have not missed more than 3 treatment sessions

Exclusion Criteria:
  • patients submitted to a new breast surgical intervention during the total time of follow-up of the research.

  • previous surgeries of breast cancer;

  • bilateral surgeries

  • immediate breast reconstruction

  • neurological deficit or acute orthopedic affection in the shoulder,

  • advanced tumor stage T4b or N3 or patients with bone or brain metastases

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Federal University of São Paulo

Investigators

  • Principal Investigator: Gil Facina, PhD, Federal University of São Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gil Facina, Doctor, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT02982980
Other Study ID Numbers:
  • FUSaoPauloPT5
First Posted:
Dec 6, 2016
Last Update Posted:
Dec 14, 2016
Last Verified:
Dec 1, 2016

Study Results

No Results Posted as of Dec 14, 2016