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Upper Limb Function After Breast Cancer Surgery: the Role of Post-operative Physical Therapy Intervention

Upper Limb Function After Breast Cancer Surgery: the Role of Post-operative Physical Therapy Intervention- Randomized Control Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03389204
Enrollment
160
Registered
2018-01-03
Start date
2018-07-01
Completion date
2019-09-01
Last updated
2021-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

Breast surgery, Physiotherapy, Breast Cancer, Shoulder pain, Shoulder motion

Brief summary

Surgical treatments can cause late effects influencing activity of daily living, physical activity, and overall health. Late effects include persistent pain reported by 30 - 50% of women that underwent breast operations, restrictions of arm and shoulder movement were reported in 35% of patients, lymphedema in 15 - 25% of women who undergo axillary lymph node dissection and in about 6% of women who undergo sentinel lymph node biopsy. Lymphedema results in physical impairments including compromised function, diminished strength, fatigue, and pain in the affected arm . The axillary web syndrome is a self-limiting and frequently overlooked cause of significant morbidity in the early postoperative period after breast cancer, which is characterized by axillary pain that runs down the medial arm, limited shoulder range of motion (ROM) . Physiotherapy and exercise in the postoperative period can result in a significant improvement in shoulder ROM in women treated for breast cancer, Additionally, exercises are an effective intervention to improve quality of life, cardiorespiratory fitness, physical functioning and fatigue in breast cancer patients. However, in the postoperative period consideration should be given to the early implementation of exercises because of the potential for seroma and increases in wound drainage volume and duration. There is limited evidence on the influence of postoperative physiotherapy intervention, and instruction program on upper limb range of motion and return to physical activity divided by the type of surgery and regarding complications.

Detailed description

Aim The aim of this study is to evaluate the influence of early postoperative physical therapy program on upper-limb function and returning to physical activity in the first 6 months following surgery. Hypotheses * Early physical activity performed post-operative will improve ROM and therefore, will help women after breast surgeries to return faster to their routine physical activity and by that promote physical health. * Early postoperative physical therapy is safe when the program for is tailored to the type of surgery. Methods Study design Parallel group prospective randomized controlled clinical trial. Two surgical department's including general surgery department and genecology department in Assuta hospital, Tel Aviv, Israel Sample All women undergoing breast cancer surgeries in Assuta hospital between 02.01.2018 and till 07.01.2019 will be randomized into two groups: Group A (intervention group) will be instructed first day post-operative to exercise program; Group B (control group) without intervention.

Interventions

OTHERPHYSICAL THERAPY

EXERCISES AND EDUCATION TO FOLLOWING AFTER DISCHARGE PHYSICAL TREATMENT

Sponsors

Assuta Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Masking description

Participants were blinded to physical support or not

Intervention model description

RCT intervention and not intervention

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Women * Age 18-65. * Diagnosed with breast cancer, undergoing breast surgery, * Functional independence prior to the operation. * Ability to communicate in Hebrew.

Exclusion criteria

* Cognitive disorders, patients unable to sign the consent form. * Back and spinal morbidity. * Fibromyalgia or chronic pain disorders. * Neurological disorders. * Renal failure with the need for dialysis. * Lymphedema prior to surgery. * History of breast surgery. * Shoulder surgery or shoulder injuries with limited ROM. * Ischemic heart disease, heart failure and radical heart insufficiency. * Radical mastectomy, LD and DEIP reconstruction, exchange breast prosthesis.

Design outcomes

Primary

MeasureTime frameDescription
Shoulder pain6 mnthThe intensity of pain and chronological modification will be monitored

Other

MeasureTime frameDescription
Function of upper limbsix monthThe mobility of the shoulder will be evaluates in all movements
Complicationssix monthPossible complications after surgery will be recorded
Lymph edema6 mnthRadius of upper limb will be measured
physical activities influence in recovery after breast cancer surgery6 mnthpatient will be agruped by intensity and frequency of PA

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026