Muscle Strength Quantitative Trait Locus 1NCT02982980
Upper Limb Muscular Strengthening in the Rehabilitation of Patients Submitted to the Breast Cancer Surgical Treatment
A study testing Physiotherapy Guidance and Physiotherapy Muscle strengthening in people with Muscle Strength Quantitative Trait Locus 1, run by Federal University of São Paulo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Muscle Strength Quantitative Trait Locus 1
- What is being tested?
- Physiotherapy Guidance and Physiotherapy Muscle strengthening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Muscle Strength Exercises After Breast Cancer Surgery: a Randomized Clinical Trial
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.
- Being tested
- Physiotherapy Guidance, Physiotherapy Muscle strengthening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy GuidanceProcedure or surgery
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 Muscle strengtheningProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy Guidance Mastectomy | Experimental | Patients who underwent radical breast surgery, received pre and postoperative assessment and orientation. Receives: 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. Receives: Procedure: Physiotherapy Muscle strengthening |
| Physiotherapy Guidance Quadrantectomy | Experimental | Patients who underwent partial breast surgery, received pre and postoperative assessment and orientation. Receives: 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. Receives: Procedure: Physiotherapy Muscle strengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
Muscle strength of shoulder movements with Hand Held Dynamometer model 01163, Lafayette Instrument Company.
Measured: two years
Secondary outcomes (5)
Range of motion
Shoulder range of motion measured by a goniometer
Measured: two years
Upper limb function
Upper limb function determined by the application of a specific questionnaire, the DASH (Disability of Arms, Shoulder and Hand Questionnaire)
Measured: two years
Pain
Pain: assessed by the application of the Verbal Numerical Pain Scale (VN)
Measured: two years
Perimeter
Perimeter: evaluated with a tape measure at eight distinct points in the upper limbs
Measured: two years
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 ).
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startAug 2011
- Primary completionAug 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Strength Quantitative Trait Locus 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gil Facina, Federal University of São Paulo
- Investigators
- Gil Facina, PhD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982980
- Sponsor's protocol ID
- FUSaoPauloPT5
- Status last verified
- Dec 2016
- First submitted
- 2 Dec 2016
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Strength Exercises After Breast Cancer Surgery: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02982980
- Acronym / sponsor ID
- FUSaoPauloPT5
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy Guidance Mastectomy | Experimental | Procedure: Physiotherapy GuidancePatients who underwent radical breast surgery, received pre and postoperative assessment and orientation. |
| Phys Muscle strengthening Mastectomy | Experimental | Procedure: Physiotherapy Muscle strengtheningPatients 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. |
| Physiotherapy Guidance Quadrantectomy | Experimental | Procedure: Physiotherapy GuidancePatients who underwent partial breast surgery, received pre and postoperative assessment and orientation. |
| Phys Muscle strengthening Quadrantectomy | Experimental | Procedure: Physiotherapy Muscle strengtheningPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapy GuidancePre 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. | Procedure or surgery | Physiotherapy Guidance Mastectomy, Physiotherapy Guidance Quadrantectomy |
| Physiotherapy Muscle strengtheningThe 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. | Procedure or surgery | Phys Muscle strengthening Mastectomy, Phys Muscle strengthening Quadrantectomy |
Primary outcome
Muscle strength
Time frame: two years
Muscle strength of shoulder movements with Hand Held Dynamometer model 01163, Lafayette Instrument Company.
5 secondary outcomes
Range of motion
Time frame: two years
Upper limb function
Time frame: two years
Pain
Time frame: two years
Perimeter
Time frame: two years
Quality of life
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gil Facina, PhD principal investigator
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy Guidance and Physiotherapy Muscle strengthening in people with Muscle Strength Quantitative Trait Locus 1, run by Federal University of São Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2016.