Modified Radical MastectomyNCT07574372
Effect of ERAS and Upper Limb Exercise on LoS After Modified Radical Mastectomy
A study testing Enhanced Recovery After Surgery and Upper Limb Exercise in people with Modified Radical Mastectomy, run by Prof. R. D. Kandou General Hospital at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Modified Radical Mastectomy
- What is being tested?
- Enhanced Recovery After Surgery and Upper Limb Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Prof. Dr. R. D. Kandou General Hospital
Manado, North Sulawesi
About this study
Official title: 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.
Read more
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
- Being tested
- Enhanced Recovery After Surgery, Upper Limb Exercise
- Keywords
- Enhanced Recovery After Surgery, Prehabilitation, Exercises
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery After SurgeryBehavioural
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.
Upper Limb ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ERAS protocol and upper limb exercises | Experimental | ERAS protocol and upper limb exercises Receives: Behavioral: Enhanced Recovery After Surgery; Behavioral: Upper Limb Exercise |
| Standard Care | No intervention | Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay
Length of stay after Modified Radical Mastectomy
Measured: From the date of surgery until hospital discharge, assessed up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start1 Oct 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Modified Radical MastectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. R. D. Kandou General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574372
- Sponsor's protocol ID
- 200/EC/KEPK-KANDOU/X/2024
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Enhanced Recovery After Surgery and Upper Limb Exercise on Length of Stay After Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT07574372
- Acronym / sponsor ID
- 200/EC/KEPK-KANDOU/X/2024
- Conditions
- Modified Radical Mastectomy
- Keywords
- Enhanced Recovery After Surgery, Prehabilitation, Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Prof. R. D. Kandou General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS protocol and upper limb exercises | Experimental | Behavioral: Enhanced Recovery After Surgery, Behavioral: Upper Limb ExerciseERAS protocol and upper limb exercises |
| Standard Care | No intervention | –Standard Care |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Recovery After SurgeryFour 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. | Behavioural | ERAS protocol and upper limb exercises |
| Upper Limb ExerciseFour 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. | Behavioural | ERAS protocol and upper limb exercises |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Recovery After Surgery and Upper Limb Exercise in people with Modified Radical Mastectomy, run by Prof. R. D. Kandou General Hospital at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Stay (time frame: From the date of surgery until hospital discharge, assessed up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.