Effect of ERAS and Upper Limb Exercise on LoS After Modified Radical Mastectomy

NCT07574372 | Completed

• 1 other identifier: 200/EC/KEPK-KANDOU/X/2024
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Modified Radical Mastectomy

Keywords

Enhanced Recovery After Surgery; Prehabilitation; Exercises

Outcome Measures

Primary Outcomes (1)

• Length of Stay

  Length of stay after Modified Radical Mastectomy

  From the date of surgery until hospital discharge, assessed up to 10 days

Study Arms (2)

ERAS protocol and upper limb exercises

EXPERIMENTAL

ERAS protocol and upper limb exercises

Behavioral: Enhanced Recovery After Surgery; Behavioral: Upper Limb Exercise

Standard Care

NO INTERVENTION

Standard Care

Interventions

Enhanced Recovery After Surgery BEHAVIORAL

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.

ERAS protocol and upper limb exercises

Upper Limb Exercise BEHAVIORAL

Four weeks before surgery, participants in intervention group will do: * 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.

ERAS protocol and upper limb exercises

Eligibility Criteria

• Age: 30 Years - 65 Years
• Gender Eligibility Details: Female with cancer mammae who will undergo MRM surgery
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. R. D. Kandou General Hospital: lead

Study Sites (1)

Prof. Dr. R. D. Kandou General Hospital

Manado, North Sulawesi, Indonesia

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Enhanced Recovery After Surgery

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Perioperative Care; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 7, 2026
• Study Start: October 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

ID (1)