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

NCT02982980 | Completed DMC

• 1 other identifier: FUSaoPauloPT5
• Study Type: interventional
• Target: 121
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Muscle Strength Quantitative Trait Locus 1

Outcome Measures

Primary Outcomes (1)

• Muscle strength

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

  two years

Secondary Outcomes (5)

• Range of motion

  two years

• Upper limb function

  two years

• Pain

  two years

• Perimeter

  two years

• Quality of life

  two years

Study Arms (4)

Physiotherapy Guidance Mastectomy

EXPERIMENTAL

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

Procedure: Physiotherapy Guidance

Phys Muscle strengthening Mastectomy

EXPERIMENTAL

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

Physiotherapy Guidance Quadrantectomy

EXPERIMENTAL

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

Procedure: Physiotherapy Guidance

Phys Muscle strengthening Quadrantectomy

EXPERIMENTAL

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

Interventions

Physiotherapy Guidance PROCEDURE

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.

Physiotherapy Guidance Mastectomy; Physiotherapy Guidance Quadrantectomy

Physiotherapy Muscle strengthening PROCEDURE

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.

Phys Muscle strengthening Mastectomy; Phys Muscle strengthening Quadrantectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Officials

• Gil Facina, PhD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 6, 2016
• Study Start: August 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: October 1, 2013
• Last Updated: December 14, 2016

Record last verified: 2016-12