Efficacy of Exercise Program on Osteosarcoma Patients

NCT04757064 | Unknown

• 1 other identifier: exercises in osteosarcoma
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteosarcoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• functional outcome

  2 minutes

Study Arms (2)

Standard Rehabilitation Group

EXPERIMENTAL

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

Supervised Rehabilitation Group

EXPERIMENTAL

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

Other: standard rehabilitation protocol

Interventions

standard rehabilitation protocol OTHER

they will receive knee flexion exercises and increase the extensor strength

Standard Rehabilitation Group; Supervised Rehabilitation Group

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \) 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

You may not qualify if:

• \) 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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (2)

• 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.

  PMID: 29036016 BACKGROUND

• 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.

  PMID: 31267163 BACKGROUND

MeSH Terms

Conditions

Osteosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Central Study Contacts

Gamila Abbas, master

CONTACT

01026447754; gamila.saleh04@gmail.com

Mona Ibrahim, Phd

CONTACT

01002992613; mona.ibrahiem@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: orthopedic physical therapist

Model Details: 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.

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 16, 2021
• Study Start: August 7, 2021
• Primary Completion: February 1, 2022
• Study Completion: April 1, 2022
• Last Updated: August 6, 2021

Record last verified: 2021-08