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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03389204
• Other study ID #: AMC2020-17
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: January 2021
• Source: Assuta Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: September 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Other:
• PHYSICAL THERAPY
EXERCISES AND EDUCATION TO FOLLOWING AFTER DISCHARGE PHYSICAL TREATMENT

Locations

Country	Name	City	State
Israel	Assuta Medican Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Assuta Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Function of upper limb	The mobility of the shoulder will be evaluates in all movements	six month
Other	Complications	Possible complications after surgery will be recorded	six month
Other	Lymph edema	Radius of upper limb will be measured	6 mnth
Other	physical activities influence in recovery after breast cancer surgery	patient will be agruped by intensity and frequency of PA	6 mnth
Primary	Shoulder pain	The intensity of pain and chronological modification will be monitored	6 mnth