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

Sponsor
Assuta Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03389204
Collaborator
(none)
160
1
4
14
11.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: PHYSICAL THERAPY
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
RCT intervention and not interventionRCT intervention and not intervention
Masking:
Single (Participant)
Masking Description:
Participants were blinded to physical support or not
Primary Purpose:
Supportive Care
Official Title:
Upper Limb Function After Breast Cancer Surgery: the Role of Post-operative Physical Therapy Intervention- Randomized Control Trial
Actual Study Start Date :
Jul 1, 2018
Actual Primary Completion Date :
Jul 1, 2019
Actual Study Completion Date :
Sep 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Breast surgery and exercise

Patient that underwent breast surgery only without other intervention with exercise of the upper limb and instruction to continue after discharge.

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

Active Comparator: Breast surgery and no exercise

Patient after breast surgery alone are discharged without exercise and instructions.

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

Active Comparator: Breast, axilar surgery with exercise

Patients that underwent surgery of the breast and axilar lymph node surgery with exercise of the upper limb and instruction to continue after discharge.

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

Active Comparator: Breast, axillar surgery without exercise

The patients that underwent surgery of the breast and axilar nodes samples or dissection are discharged without exercise and instructions.

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

Outcome Measures

Primary Outcome Measures

  1. Shoulder pain [6 mnth]

    The intensity of pain and chronological modification will be monitored

Other Outcome Measures

  1. Function of upper limb [six month]

    The mobility of the shoulder will be evaluates in all movements

  2. Complications [six month]

    Possible complications after surgery will be recorded

  3. Lymph edema [6 mnth]

    Radius of upper limb will be measured

  4. physical activities influence in recovery after breast cancer surgery [6 mnth]

    patient will be agruped by intensity and frequency of PA

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assuta Medican Center Tel Aviv Israel 69710

Sponsors and Collaborators

  • Assuta Medical Center

Investigators

  • Study Director: Sergio G Susmallian, MD, Assuta Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sergio Gabriel Susmallian, Head of the Department of General Surgery, Assuta Medical Center
ClinicalTrials.gov Identifier:
NCT03389204
Other Study ID Numbers:
  • AMC2020-17
First Posted:
Jan 3, 2018
Last Update Posted:
Jan 26, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sergio Gabriel Susmallian, Head of the Department of General Surgery, Assuta Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 26, 2021