Effect of ERAS and Upper Limb Exercise on LoS After Modif... | NCT07574372

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

NCT07574372

Sponsor

Prof. R. D. Kandou General Hospital

Status

Completed

Last Update Posted

May 7, 2026Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Modified Radical Mastectomy

Interventions

Enhanced Recovery After Surgery
Upper Limb Exercise

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2024Actual

Primary Completion Date

Mar 31, 2025Actual

Completion Date

Mar 31, 2025Actual

First Submitted Date

Apr 28, 2026

First Submission Date that Met QC Criteria

May 4, 2026

First Posted Date

May 7, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2026

Last Update Posted Date

May 7, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of Stay	Length of stay after Modified Radical Mastectomy	From the date of surgery until hospital discharge, assessed up to 10 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female with cancer mammae who will undergo MRM surgery

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prof. Dr. R. D. Kandou General Hospital		Manado	North Sulawesi		Indonesia

ID	Term
D009043	Motor Activity

ID	Term
D001519	Behavior

Intervention Browse Module

MeSH Terms

ID	Term
D000080482	Enhanced Recovery After Surgery

Ancestor Terms

ID	Term
D019990	Perioperative Care
D013514	Surgical Procedures, Operative

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