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Efficacy of Exercise Program on Osteosarcoma Patients

Primary Purpose

Osteosarcoma

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
standard rehabilitation protocol
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteosarcoma

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1) Patients diagnosed as distal femur osteosarcoma. 2) Age of the patient from 15-50 years old 3) Patients undergoing tumor resection and knee endoprosthetic reconstruction six weeks ago. 4) Both gender

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Exclusion Criteria:

1) Lung and bone metastasis 2) End stage patients receiving palliative chemotherapy 3) Patients undergoing L.L amputation or rotationplasty (any surgical procedures rather than knee endoprosthetic reconstruction). 4) Local tumor recurrence 5) Sever psychiatric illness 6) Heart disease or any condition that prevent the patient from participation in exercise

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Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Standard Rehabilitation Group

    Supervised Rehabilitation Group

    Arm Description

    Standard Rehabilitation Group: will receive the standard protocol of king Hussein hospital 6 weeks post-operative which is: Start aggressive knee flexion exercises and increase the extensor strength. Consider CPM/dynasplint if flexion <60_ MUA contraindicated. Examination under anesthesia can be done to assess the cause of limited knee flexion. Surgical release is indicated if knee flexion is < 60 degrees at six months after surgery.

    Supervised Rehabilitation Group: will receive supervised rehabilitation program 1 session / week for 45 minutes-1 hour.

    Outcomes

    Primary Outcome Measures

    ROM
    knee flexion and extension ROM measured by goniometer
    knee extensor muscle strength
    measuring rectus femoris muscle strength by manual muscle testing

    Secondary Outcome Measures

    functional outcome
    measurd by Musculoskeletal Tumor Society Rating Scale, minimum score is 0 and maximum score is 30 (higher scores indicating better function)

    Full Information

    First Posted
    February 12, 2021
    Last Updated
    August 2, 2021
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04757064
    Brief Title
    Efficacy of Exercise Program on Osteosarcoma Patients
    Official Title
    Efficacy of Selected Exercise Program on Distal End Femoral Sarcoma Patients Undergoing Knee Modular Endoprosthesis: RCT
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 7, 2021 (Anticipated)
    Primary Completion Date
    February 2022 (Anticipated)
    Study Completion Date
    April 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study will be conducted to investigate the effect of selected therapeutic exercises compared to standard exercise program in improving ROM, muscle strength and functional outcomes in distal femur osteosarcoma patients who have undergone tumor resection and modular knee endoprosthesis.
    Detailed Description
    Osteosarcomas (OS) are the most common primary bone tumor and third most common cancer among children and adolescents after lymphomas and brain cancers (Wang et al., 2018; Luetke et al., 2014). It is a primary malignant bone tumor with a worldwide incidence of 3.4 per million people per year (Mirabello et al., 2009). They are characterized by the production of osteoid, or immature bone, by malignant mesenchymal cells (Wang et al., 2018; (Luetke et al., 2014). Patients displayed some persisting physical difficulties including incapability to perform active range of motion (ROM), decreased muscle strength, altered gait and sit-to-stand patterns, yet they maintained high levels of emotional acceptance and coping. A surprising but important finding was the persisting hip weakness in both operated and non-operated limbs, which extends up to 42 months after resection around the knee. This indicates that continued rehabilitation programs emphasizing hip strengthening should be considered for these patients, even years after surgery (Beebe et al., 2009). Furthermore, ROM exercises, strengthening exercises and balance exercises improve overall Quality of life (QOL) for these patients (Marchese et al., 2006).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteosarcoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Group (A) will receive the standard protocol of king Hussein hospital 6 weeks post-operative which is: Start aggressive knee flexion exercises and increase the extensor strength. Consider CPM/dynasplint if flexion <60_ MUA contraindicated. Examination under anesthesia can be done to assess the cause of limited knee flexion. Surgical release is indicated if knee flexion is < 60 degrees at six months after surgery. Group (B) will receive supervised rehabilitation program 1 session / week for 45 minutes-1 hour.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard Rehabilitation Group
    Arm Type
    Experimental
    Arm Description
    Standard Rehabilitation Group: will receive the standard protocol of king Hussein hospital 6 weeks post-operative which is: Start aggressive knee flexion exercises and increase the extensor strength. Consider CPM/dynasplint if flexion <60_ MUA contraindicated. Examination under anesthesia can be done to assess the cause of limited knee flexion. Surgical release is indicated if knee flexion is < 60 degrees at six months after surgery.
    Arm Title
    Supervised Rehabilitation Group
    Arm Type
    Experimental
    Arm Description
    Supervised Rehabilitation Group: will receive supervised rehabilitation program 1 session / week for 45 minutes-1 hour.
    Intervention Type
    Other
    Intervention Name(s)
    standard rehabilitation protocol
    Intervention Description
    they will receive knee flexion exercises and increase the extensor strength
    Primary Outcome Measure Information:
    Title
    ROM
    Description
    knee flexion and extension ROM measured by goniometer
    Time Frame
    3 minutes
    Title
    knee extensor muscle strength
    Description
    measuring rectus femoris muscle strength by manual muscle testing
    Time Frame
    5 minutes
    Secondary Outcome Measure Information:
    Title
    functional outcome
    Description
    measurd by Musculoskeletal Tumor Society Rating Scale, minimum score is 0 and maximum score is 30 (higher scores indicating better function)
    Time Frame
    2 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1) Patients diagnosed as distal femur osteosarcoma. 2) Age of the patient from 15-50 years old 3) Patients undergoing tumor resection and knee endoprosthetic reconstruction six weeks ago. 4) Both gender - Exclusion Criteria: 1) Lung and bone metastasis 2) End stage patients receiving palliative chemotherapy 3) Patients undergoing L.L amputation or rotationplasty (any surgical procedures rather than knee endoprosthetic reconstruction). 4) Local tumor recurrence 5) Sever psychiatric illness 6) Heart disease or any condition that prevent the patient from participation in exercise -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gamila Abbas, master
    Phone
    01026447754
    Email
    gamila.saleh04@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mona Ibrahim, Phd
    Phone
    01002992613
    Email
    mona.ibrahiem@cu.edu.eg

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29036016
    Citation
    Galvao DA, Taaffe DR, Spry N, Cormie P, Joseph D, Chambers SK, Chee R, Peddle-McIntyre CJ, Hart NH, Baumann FT, Denham J, Baker M, Newton RU. Exercise Preserves Physical Function in Prostate Cancer Patients with Bone Metastases. Med Sci Sports Exerc. 2018 Mar;50(3):393-399. doi: 10.1249/MSS.0000000000001454.
    Results Reference
    background
    PubMed Identifier
    31267163
    Citation
    Keilani M, Kainberger F, Pataraia A, Hasenohrl T, Wagner B, Palma S, Cenik F, Crevenna R. Typical aspects in the rehabilitation of cancer patients suffering from metastatic bone disease or multiple myeloma. Wien Klin Wochenschr. 2019 Nov;131(21-22):567-575. doi: 10.1007/s00508-019-1524-3. Epub 2019 Jul 2.
    Results Reference
    background

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    Efficacy of Exercise Program on Osteosarcoma Patients

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