OsteosarcomaNCT04757064
Efficacy of Exercise Program on Osteosarcoma Patients
A study testing standard rehabilitation protocol in people with Osteosarcoma, run by Cairo University.
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. Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- standard rehabilitation protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 7 Aug 2021to Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
- -
Who cannot join
- 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
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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).
- Conditions
- Osteosarcoma
- Being tested
- standard rehabilitation protocol
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard rehabilitation protocolOther
they will receive knee flexion exercises and increase the extensor strength
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: standard rehabilitation protocol |
| Supervised Rehabilitation Group | Experimental | Supervised Rehabilitation Group: will receive supervised rehabilitation program 1 session / week for 45 minutes-1 hour. Receives: Other: standard rehabilitation protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROM
knee flexion and extension ROM measured by goniometer
Measured: 3 minutes
knee extensor muscle strength
measuring rectus femoris muscle strength by manual muscle testing
Measured: 5 minutes
Secondary outcomes (1)
functional outcome
measurd by Musculoskeletal Tumor Society Rating Scale, minimum score is 0 and maximum score is 30 (higher scores indicating better function)
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start7 Aug 2021 (estimated)
- Primary completionFeb 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamila Saleh Tammam Abbas, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757064
- Sponsor's protocol ID
- exercises in osteosarcoma
- Status last verified
- Aug 2021
- First submitted
- 12 Feb 2021
- Last updated
- 6 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 29036016Keilani 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.
PubMed 31267163
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Selected Exercise Program on Distal End Femoral Sarcoma Patients Undergoing Knee Modular Endoprosthesis: RCT
- ClinicalTrials.gov ID
- NCT04757064
- Acronym / sponsor ID
- exercises in osteosarcoma
- Conditions
- Osteosarcoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 7 Aug 2021 (estimated)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard Rehabilitation Group | Experimental | Other: standard rehabilitation protocolStandard 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 | Experimental | Other: standard rehabilitation protocolSupervised Rehabilitation Group: will receive supervised rehabilitation program 1 session / week for 45 minutes-1 hour. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
- -
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard rehabilitation protocolthey will receive knee flexion exercises and increase the extensor strength | Other | Standard Rehabilitation Group, Supervised Rehabilitation Group |
Primary outcome
ROM
Time frame: 3 minutes
knee flexion and extension ROM measured by goniometer
knee extensor muscle strength
Time frame: 5 minutes
measuring rectus femoris muscle strength by manual muscle testing
1 secondary outcome
functional outcome
Time frame: 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Background: PubMed 29036016Galvao 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.
- Background: PubMed 31267163Keilani 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing standard rehabilitation protocol in people with Osteosarcoma, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gamila Abbas, master (01026447754, gamila.saleh04@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ROM (time frame: 3 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04757064, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.