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CompletedNCT02982980Updated Dec 14, 2016

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

An interventional study of Physiotherapy Guidance and Physiotherapy Muscle strengthening in Muscle Strength Quantitative Trait Locus 1, sponsored by Federal University of São Paulo. Completed. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-14.

Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
121
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Muscle Strength Quantitative Trait Locus 1
03

In context

Lead sponsor

Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Investigator)
Enrollment
121 participants (actual)

Study arms

  • Experimental
    Physiotherapy Guidance Mastectomy

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

    Procedure: Physiotherapy Guidance

  • 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

  • Experimental
    Physiotherapy Guidance Quadrantectomy

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

    Procedure: Physiotherapy Guidance

  • 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

Interventions

  • ProcedurePhysiotherapy 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.

  • ProcedurePhysiotherapy 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.

06

What researchers measure

Primary outcomes

  1. Muscle strength

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

    Time frame: two years

Secondary outcomes

  1. Range of motion

    Shoulder range of motion measured by a goniometer

    Time frame: two years

  2. Upper limb function

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

    Time frame: two years

  3. Pain

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

    Time frame: two years

  4. Perimeter

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

    Time frame: two years

  5. Quality of life

    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 ).

    Time frame: two years

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Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02982980
Lead sponsor
Federal University of São Paulo
Responsible party
Gil Facina (Doctor, Federal University of São Paulo) — Principal investigator
First posted
Dec 6, 2016
Start date
Aug 2011
Primary completion
Aug 2012
Completion
Oct 2013
Last update
Dec 14, 2016

Study contacts

Gil Facina, PhD
principal investigator · Federal University of São Paulo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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