Efficacy of Exercise Program on Osteosarcoma Patients

Efficacy of Selected Exercise Program on Distal End Femoral Sarcoma Patients Undergoing Knee Modular Endoprosthesis: RCT

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteosarcoma
• Intervention / Treatment: Other: standard rehabilitation protocol

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).

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gamila Abbas, master; Phone Number: 01026447754; Email: gamila.saleh04@gmail.com
• Study Contact Backup: Name: Mona Ibrahim, Phd; Phone Number: 01002992613; Email: mona.ibrahiem@cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 46 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard Rehabilitation Group; 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.	Other: standard rehabilitation protocol; they will receive knee flexion exercises and increase the extensor strength
Experimental: Supervised Rehabilitation Group; Supervised Rehabilitation Group: will receive supervised rehabilitation program 1 session / week for 45 minutes-1 hour.	Other: standard rehabilitation protocol; they will receive knee flexion exercises and increase the extensor strength

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ROM	knee flexion and extension ROM measured by goniometer	3 minutes
knee extensor muscle strength	measuring rectus femoris muscle strength by manual muscle testing	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional outcome	measurd by Musculoskeletal Tumor Society Rating Scale, minimum score is 0 and maximum score is 30 (higher scores indicating better function)	2 minutes

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 7, 2021
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 16, 2021

Study Record Updates

• Last Update Posted (Actual): August 6, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Sarcoma; Osteosarcoma
• Other Study ID Numbers: exercises in osteosarcoma

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No