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Physiotherapy Program for Breast Cancer Women Following Surgery: A Pilot Clinical Trial

19. maj 2021 opdateret af: Hussam Sakkijha, King Fahad Medical City

Effectiveness of Home-based and Early Institutional Physiotherapy Program for Breast Cancer Women Following Surgery: A Pilot Clinical Trial

pilot study on physical therapy in women with breast cancer immediately following surgery

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A pilot, single-arm non-randomized clinical trial was conducted between the period September 2018 and June 2019 on a convenient sample of BC women. Primary study outcomes were pain, disabilities of the Arm, Shoulder, and Hand (DASH), handgrip strength, and quality of life (QoL). The secondary outcome was to assess the feasibility of this pilot study. All outcomes were recorded at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90) under standardized conditions. The interventions were delivered by the physiotherapist early within 24 hours post-operatively, T1, and T2. In addition, home-based exercise was provided with written instructions during hospitalization with rehearsal sessions to ensure the patient's understanding and compliance

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

23

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • women with breast cancer who require surgical resection

Exclusion Criteria:

  • in ability to undergo 3 months of physical therapy program

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: intervention
effect of rehabilitation program in the intervention arm
Procedure: rehabilitation
physical therapy 24 hrs after surgery

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Shoulder/Arm Pain
Tidsramme: The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90).
Pain in the shoulder/arm was assessed using the visual analogue scale (VAS) with a scoring system of 0-10 (0 = no pain; 1-3; mild pain, 4-6; moderate pain, 7-10 severe pain)
The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90).
Shoulder mobility
Tidsramme: The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90).
Shoulder mobility (flexion [0-180°], abduction [0-180°]) was measured by using a digital inclinometer under standardized conditions. Patients were maintained in a seated position for all movements to minimize compensatory movements of the trunk.
The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90).
Disabilities in daily life
Tidsramme: The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90).
by using Quick DASH scale (Disabilities of the Arm, Shoulder, and Hand) questionnaire. The Quick DASH consists of 11 items that allow for cumulative and multiple assessments of a patient over time, and each item has 5 response options. According to the Quick DASH scale scoring system, the scale scores are calculated and ranging from 0 (no functional disability) to 100 (most severe disability)
The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90).
Handgrip strength
Tidsramme: The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90).
measured while the patient stabilized in a seated position with the elbow in 90 degrees of flexion and squeezes three times the dynamometer with each hand.
The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90).
Quality of Life (QoL)
Tidsramme: The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90).
Patients' QoL was assessed by using the Functional Assessment of Cancer Therapy-General (FACT-G) scale. FACT-G (version-4) is a validated, self-reported multi-dimensional, 27-items questionnaire measuring QoL for breast cancer patients with 1 4-points Likert scale (0-108). The FACT-G comprises of 4-subscales: Physical Well-being (PWB: 7-items; score range 0 to 28), Social Well-being (SWB: 7-items; score range 0 to 28), Emotional Well-being (EWB: 6-items; score range 0 to 24), Functional Well-being (FWB: 7-items; score range 0 to 28)
The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Establishing firmly study feasibility
Tidsramme: 3 months
Assess for clinical effect size (ES) worth investigation, sample recruitment strategy, adherence to study protocol, and adverse events in preparation to conduct a larger definitive study.
3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

King Fahad Medical City

Efterforskere

  • Ledende efterforsker: Noura Binsaad, MD, Consultant

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2018

Primær færdiggørelse (Faktiske)

30. juni 2019

Studieafslutning (Faktiske)

1. februar 2021

Datoer for studieregistrering

Først indsendt

6. maj 2021

Først indsendt, der opfyldte QC-kriterier

18. maj 2021

Først opslået (Faktiske)

20. maj 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. maj 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2021

Sidst verificeret

1. maj 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 18-115

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

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