- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
North Sulawesi
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Manado, North Sulawesi, Indonesien
- Prof. Dr. R. D. Kandou General Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Standardvård
|
|
|
Experimentell: 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:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Length of Stay
Tidsram: 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
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 200/EC/KEPK-KANDOU/X/2024
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