Efficacy of Exercise Program on Osteosarcoma Patients

Osteosarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04757064
• Other study ID #: exercises in osteosarcoma
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 7, 2021
• Est. completion date: April 2022

Study information

• Verified date: August 2021
• Source: Cairo University
• Contact: Gamila Abbas, master
• Phone: 01026447754
• Email: gamila.saleh04[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 50 Years

Eligibility

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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Related Conditions & MeSH terms

• Osteosarcoma

Intervention

Other:
• standard rehabilitation protocol
they will receive knee flexion exercises and increase the extensor strength

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (2)

Galvão 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. — View Citation

Keilani M, Kainberger F, Pataraia A, Hasenöhrl 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ROM	knee flexion and extension ROM measured by goniometer	3 minutes
Primary	knee extensor muscle strength	measuring rectus femoris muscle strength by manual muscle testing	5 minutes
Secondary	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