Bone MetastasesEXERT-BMNCT06470503
EXercise Enhancement After RadioTherapy for Bone Metastases
A study testing Exercise Program in people with Bone Metastases, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the safety, feasibility, and acceptability of a structured, supervised exercise program combined with standard palliative radiotherapy for patients with painful non-spine bone metastases (NSBM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastases
- What is being tested?
- Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 13 Jan 2025to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older.
- KPS ≥70
- Histologically confirmed cancer and radiologically documented NSBM metastases. Spine metastases are allowed if they do not meet the exclusion criteria below.
- At least one painful NSBM treated with palliative radiotherapy.
- Independent with ambulation and transfers. Ambulatory aids are permitted.
- Life expectancy of at least 6 months
Who cannot join
- Any untreated metastatic disease that may preclude safely performing physical exercise including:
- History of leptomeningeal disease
- Active (untreated/progressive) malignant spinal cord or cauda equina compression
- Bilsky 2 or 3
- Neurological compromise secondary to CNS involvement
- Symptomatic brain metastases prohibiting exercise due to neurological compromise
Show all 9Show fewer
- High risk of instability of any boney lesion(s) that may require orthopedic intervention
- SINS score > 7
- Mirels score > 6
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: EXercise Enhancement After RadioTherapy for Bone Metastases - A Phase I Feasibility Trial for Patients With Painful Non-Spine Bone Metastases
The purpose of this study is to evaluate the safety, feasibility, and acceptability of a structured, supervised exercise program combined with standard palliative radiotherapy for patients with painful non-spine bone metastases (NSBM).
Read the detailed description
This study investigates the potential benefits of exercise therapy for patients with bone metastases, a common and often painful complication of cancer. The study aims to determine whether a structured exercise program, in combination with standard of care cancer treatment, can improve physical function, quality of life, and overall well-being for patients undergoing palliative radiotherapy.
Participants will complete a 8-week supervised exercise program delivered virtually through CARE@Home-AC, that is tailored to their individual needs and abilities. The exercises, guided by certified professionals, will focus on improving strength, flexibility, and mobility. Participants will also receive educational sessions covering various aspects of self-management and coping strategies.
The study monitor the safety and feasibility of the exercise program, as well as its impact on pain levels, functional abilities, and quality of life. Follow-up assessments will occur at 1, 3, and 6 months post-intervention to track progress and gather valuable insights into the potential benefits of exercise therapy for individuals with bone metastases.
By exploring the role of exercise in cancer care, this study seeks to empower patients with new tools to manage their symptoms, enhance their well-being, and improve their overall quality of life throughout their cancer journey.
- Conditions
- Bone Metastases
- Being tested
- Exercise Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgramBehavioural
8-week program and four-week short maintenance period.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of toxicities as measured by CTCAE
The severity of adverse events will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grading scale.
Measured: Up to 24 weeks
Incidence of skeletal related events (SRE)
An SRE is defined as any of the following of a target bone metastases: Pathological fracture, Spinal cord compression, Indication for orthopedic surgery, Indication for radiotherapy
Measured: Up to 24 weeks
Change in pain response at index lesion(s) based Numeric Pain Rating Scale (NPRS)
NPRS refers to a score of 0 to 10 on a visual analogue scale, with 0 referring to no pain and 10 referring to the worst pain imaginable.
Measured: Up to 24 weeks
Health-related quality-of-life and as measured by the EORTC QLQ C30
The C30 is a 30-item instrument that evaluates HRQOL comprised of five functional scales (physical, cognitive, emotional, social, and role) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, anorexia, constipation, diarrhea, and financial), and a global QoL scale.
Measured: Up to 24 weeks
Health-related quality-of-life and as measured by the BM22
The BM22 scale is specific to patients with bone metastases. It consists of four domains that evaluate pain characteristics, pain sites, functional interference, and psychosocial aspects relating to bone metastases.
Measured: Up to 24 weeks
Change in functional outcomes as measured by 30s sit to stand (STS).
The STS will assess how many repetitions from sitting to standing a patient can perform in 30 seconds without the use of their arms. Patients will sit in a standard chair (43.2cm off ground) placed against a wall for stability, with a straight back.
Measured: Up to 24 weeks
Change in functional outcomes as measured by time up and go (TUG) tests.
The TUG will start with a patient in the seated position. On "Go", they will stand up, walk at a comfortable pace to a pre-marked line 3m away from the chair, turn around, and return back to the chair to sit down again. The timer starts on "Go", and stops when the patient sits back down on the chair. Total exercise participation will be assessed by obtaining FitBit data pertaining to step count, heart rate, and sleep for participant leisure time and purposeful physical activity.
Measured: Up to 24 weeks
Change in functional outcomes as measured by 6-minute walk test (6MWT)
The 6MWT test will assess the maximal distance a patient can ambulate within the 6-minute time frame, often back and forth down a measured hallway. Walking aids are permissible.
Measured: Up to 24 weeks
Self-assessment of physical activity as measured by the modified GODIN questionnaire
Self-assessment of physical activity will be assessed at baseline and follow up using the modified GODIN leisure-time exercise questionnaire. This is a simple questionnaire that quantifies ≥15m episodes of strenuous, moderate, and light exercise in the past 7-day period from questionnaire administration. A summary score and interpretative scale is provided based on a calculated algorithm.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start13 Jan 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470503
- Sponsor's protocol ID
- 24-5379
- Acronym
- EXERT-BM
- Status last verified
- Apr 2026
- First submitted
- 31 May 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXercise Enhancement After RadioTherapy for Bone Metastases - A Phase I Feasibility Trial for Patients With Painful Non-Spine Bone Metastases
- ClinicalTrials.gov ID
- NCT06470503
- Acronym / sponsor ID
- EXERT-BM / 24-5379
- Conditions
- Bone Metastases
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 24 Jun 2024 (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.
The purpose of this study is to evaluate the safety, feasibility, and acceptability of a structured, supervised exercise program combined with standard palliative radiotherapy for patients with painful non-spine bone metastases (NSBM).
Detailed description
This study investigates the potential benefits of exercise therapy for patients with bone metastases, a common and often painful complication of cancer. The study aims to determine whether a structured exercise program, in combination with standard of care cancer treatment, can improve physical function, quality of life, and overall well-being for patients undergoing palliative radiotherapy.
Participants will complete a 8-week supervised exercise program delivered virtually through CARE@Home-AC, that is tailored to their individual needs and abilities. The exercises, guided by certified professionals, will focus on improving strength, flexibility, and mobility. Participants will also receive educational sessions covering various aspects of self-management and coping strategies.
The study monitor the safety and feasibility of the exercise program, as well as its impact on pain levels, functional abilities, and quality of life. Follow-up assessments will occur at 1, 3, and 6 months post-intervention to track progress and gather valuable insights into the potential benefits of exercise therapy for individuals with bone metastases.
By exploring the role of exercise in cancer care, this study seeks to empower patients with new tools to manage their symptoms, enhance their well-being, and improve their overall quality of life throughout their cancer journey.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 or older.
- KPS ≥70
- Histologically confirmed cancer and radiologically documented NSBM metastases. Spine metastases are allowed if they do not meet the exclusion criteria below.
- At least one painful NSBM treated with palliative radiotherapy.
- Independent with ambulation and transfers. Ambulatory aids are permitted.
Key exclusion criteria (9 listed)
- Any untreated metastatic disease that may preclude safely performing physical exercise including:
- History of leptomeningeal disease
- Active (untreated/progressive) malignant spinal cord or cauda equina compression
- Bilsky 2 or 3
- Neurological compromise secondary to CNS involvement
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 |
|---|---|---|
| Exercise Program8-week program and four-week short maintenance period. | Behavioural | – |
Primary outcome
Incidence of toxicities as measured by CTCAE
Time frame: Up to 24 weeks
The severity of adverse events will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grading scale.
Incidence of skeletal related events (SRE)
Time frame: Up to 24 weeks
An SRE is defined as any of the following of a target bone metastases: Pathological fracture, Spinal cord compression, Indication for orthopedic surgery, Indication for radiotherapy
Change in pain response at index lesion(s) based Numeric Pain Rating Scale (NPRS)
Time frame: Up to 24 weeks
NPRS refers to a score of 0 to 10 on a visual analogue scale, with 0 referring to no pain and 10 referring to the worst pain imaginable.
Health-related quality-of-life and as measured by the EORTC QLQ C30
Time frame: Up to 24 weeks
The C30 is a 30-item instrument that evaluates HRQOL comprised of five functional scales (physical, cognitive, emotional, social, and role) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, anorexia, constipation, diarrhea, and financial), and a global QoL scale.
Health-related quality-of-life and as measured by the BM22
Time frame: Up to 24 weeks
The BM22 scale is specific to patients with bone metastases. It consists of four domains that evaluate pain characteristics, pain sites, functional interference, and psychosocial aspects relating to bone metastases.
Change in functional outcomes as measured by 30s sit to stand (STS).
Time frame: Up to 24 weeks
The STS will assess how many repetitions from sitting to standing a patient can perform in 30 seconds without the use of their arms. Patients will sit in a standard chair (43.2cm off ground) placed against a wall for stability, with a straight back.
Change in functional outcomes as measured by time up and go (TUG) tests.
Time frame: Up to 24 weeks
The TUG will start with a patient in the seated position. On "Go", they will stand up, walk at a comfortable pace to a pre-marked line 3m away from the chair, turn around, and return back to the chair to sit down again. The timer starts on "Go", and stops when the patient sits back down on the chair. Total exercise participation will be assessed by obtaining FitBit data pertaining to step count, heart rate, and sleep for participant leisure time and purposeful physical activity.
Change in functional outcomes as measured by 6-minute walk test (6MWT)
Time frame: Up to 24 weeks
The 6MWT test will assess the maximal distance a patient can ambulate within the 6-minute time frame, often back and forth down a measured hallway. Walking aids are permissible.
Self-assessment of physical activity as measured by the modified GODIN questionnaire
Time frame: Up to 24 weeks
Self-assessment of physical activity will be assessed at baseline and follow up using the modified GODIN leisure-time exercise questionnaire. This is a simple questionnaire that quantifies ≥15m episodes of strenuous, moderate, and light exercise in the past 7-day period from questionnaire administration. A summary score and interpretative scale is provided based on a calculated algorithm.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Program in people with Bone Metastases, run by University Health Network, Toronto at 1 site in Canada.
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 6 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of toxicities as measured by CTCAE (time frame: Up to 24 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2026.