Clinical trial NCT04757064: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Osteosarcoma
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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).

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

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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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Primary outcomes:
measure: ROM
timeFrame: 3 minutes
measure: knee extensor muscle strength
timeFrame: 5 minutes
Secondary outcomes:
measure: functional outcome
timeFrame: 2 minutes
Other outcomes:
Locations:
Study officials:
References:
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.
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.