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

NCT ID: NCT04894565

Last Updated: 2021-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2021-02-01

Brief Summary

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

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Detailed Description

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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

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Consecutive women with breast cancer who underwent breast cancer surgery
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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intervention

effect of rehabilitation program in the intervention arm

Group Type EXPERIMENTAL

rehabilitation

Intervention Type PROCEDURE

physical therapy 24 hrs after surgery

Interventions

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rehabilitation

physical therapy 24 hrs after surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* women with breast cancer who require surgical resection

Exclusion Criteria

* in ability to undergo 3 months of physical therapy program
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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King Fahad Medical City

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hussam Sakkijha

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Noura Binsaad, MD

Role: PRINCIPAL_INVESTIGATOR

Consultant

Locations

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KFMC

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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18-115

Identifier Type: -

Identifier Source: org_study_id

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