- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07574372
Effect of ERAS and Upper Limb Exercise on LoS After Modified Radical Mastectomy
The Effect of Enhanced Recovery After Surgery and Upper Limb Exercise on Length of Stay After Modified Radical Mastectomy
The goal of this clinical trial is to learn if Enhanced Recovery After Surgery (ERAS) protocol and upper limb exercise shorten the length of stay (LoS) in adults after modified radical mastectomy (MRM) surgery. The main questions it aims to answer are:
• Do ERAS protocol and upper limb exercise shorten the LoS after modified radical mastectomy (MRM)? Researchers will compare the ERAS protocol and upper limb exercise intervention to standard care to determine whether these interventions reduce LoS.
Four weeks before surgery, participants in intervention group will do:
- Aerobic exercise by walking for 30 minutes at moderate intensity (Borg scale 12-14) with frequency twice a week and by cycling for 30 minutes at moderate intensity (40-60% HRR / 64-76% HRmax/RPE 12-14) with frequency three times a week.
- Strengthening exercise of lower limbs three times a week, intensity 60-80% 1RM, 3 set, 10 repetition, rest 60 seconds between sets by machine pulley.
- Strengthening exercise of upper limbs at intensity 60-80% 1RM, frequency three times a week, 10 repetition, rest 60 seconds by bench press and cable front raise.
- Stretching exercise of upper limbs and range of motion exercise frequency three times a week, hold 10 seconds, by static stretching.
After surgery, both groups will do:
• Mobilization, ambulation, and shoulder range of motion exercise in first 24 hours after surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Sulawesi
-
Manado, North Sulawesi, Indonesia
- Prof. Dr. R. D. Kandou General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women aged 30-65 years
- Diagnosed with breast cancer by histopathological examination and will undergo the first MRM surgery
- Planned to undergo neoadjuvant chemotherapy
- Hemodynamically stable (assessed by vital signs)
- Mini Mental State Examination (MMSE) score > 25
- Comorbid diseases are controlled
- Corrected nutritional status
- No balance or coordination disorders
- Normal or corrected vision function
- Normal hearing function as tested by whisper test
- Willing and agree to participate in the study until completion and sign informed consent
Exclusion Criteria:
- Presence of distant metastasis
- Presence of lymphedema
- Limited joint range of motion
- Other cardiovascular conditions that contraindicate physical exercise according to the American College of Sports Medicine (ACSM) guidelines
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard Care
|
|
|
Experimental: ERAS protocol and upper limb exercises
|
Four weeks before surgery, participants in intervention group will do:
Four weeks before surgery, participants in intervention group will do:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of Stay
Time Frame: From the date of surgery until hospital discharge, assessed up to 10 days
|
Length of stay after Modified Radical Mastectomy
|
From the date of surgery until hospital discharge, assessed up to 10 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200/EC/KEPK-KANDOU/X/2024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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