Musculoskeletal SymptomsAiRE-MSNCT06642948
AI-based Skeleton Recognition System for Rehabilitation Exercise in Breast Cancer Survivors: A Randomized Controlled Trial
A study testing Motor rehabilitation based on ai visual recognition in people with Musculoskeletal Symptoms and Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
This study aims to develop and evaluate an artificial intelligence (AI)-based skeletal recognition system designed to support real-time, interactive rehabilitation exercise (RE programs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Musculoskeletal Symptoms, Breast Cancer, Endocrine Therapy
- What is being tested?
- Motor rehabilitation based on ai visual recognition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2024to 1 Jan 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Pathologically confirmed hormone receptor-positive breast cancer (stage I, II, III).
- 2. Initiation of treatment with aromatase inhibitors (e.g., anastrozole, letrozole, exemestane).
- 3. Postmenopausal women, including those with surgically induced menopause. 4. Clear consciousness, no cognitive or communication impairments, and able to comply with the intervention.
- 5. Informed consent obtained, with voluntary participation in the study. 6. Bone and joint symptoms with a Brief Pain Inventory (BPI) score of ≥3, or presence of at least one of the following risk factors: elevated bone turnover markers, reduced vitamin D levels, increased inflammatory cytokines, elevated C-reactive protein, or elevated rheumatoid factor.
- 7. Not participating in any physical therapy or exercise-based interventions that may interfere with this study.
Who cannot join
- 1. Recurrence of breast cancer or distant metastasis. 2. Presence of other malignancies. 3. Diagnosed rheumatoid arthritis, bone and joint trauma, or other severe bone and joint diseases.
- 4. Bone mineral density T-score <-2.5. 5. Presence of absolute contraindications to exercise.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Cancer Center
Shanghai
Lingyun Jiang, （086）18359374969, 22211170029@m.fudan.edu.cn
About this study
Official title: Evaluating the Efficacy of Structured Exercise Interventions in Alleviating Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors: A Randomized Controlled Trial
This study aims to develop and evaluate an artificial intelligence (AI)-based skeletal recognition system designed to support real-time, interactive rehabilitation exercise (RE programs. The goal is to mitigate musculoskeletal symptoms associated with endocrine therapy in breast cancer survivors.Endocrine therapy remains a cornerstone in the treatment of hormone receptor-positive breast cancer, typically extending over 5 to 10 years. While the therapeutic benefits of endocrine therapy are well established, agents such as aromatase inhibitors frequently induce musculoskeletal symptoms (MS), including joint pain, stiffness (particularly morning stiffness), carpal tunnel syndrome, tenosynovitis, myalgia, and muscle weakness. These symptoms, which may be continuous or intermittent, can affect both central (spine, hips, shoulders) and peripheral joints (elbows, wrists, knees, feet), severely compromising patients' quality of life (QoL). Although physical exercise has been demonstrated to alleviate these symptoms, adherence to adequate exercise regimens remains suboptimal among patients. Furthermore, there is no consensus on the optimal type, duration, or intensity of exercise interventions, and standardized protocols are lacking. Recognizing exercise as a long-term behavior, we are developing a home-based, AI-assisted rehabilitation program tailored to the specific needs of patients undergoing endocrine therapy.
- Being tested
- Motor rehabilitation based on ai visual recognition
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor rehabilitation based on ai visual recognitionOther
Also called ai visual recognition technology, exercise
Patients in the intervention group will engage in a home-based exercise program in addition to standard rehabilitation guidance. Initially, patients will be provided with exercise materials developed by the intervention team, one-on-one guidance via the AI rehabilitation platform, and a detailed explanation of the exercise intervention program (including its components, foundational knowledge, and benefits).The aerobic warm-up routine includes activities such as marching in place, full-body stretches, jumping jacks, side steps with arm circles, and squats with alternating punches. For the elderly, the warm-up routine is similar but also incorporates chest expansion exercises, abduction exercises, overhead reaches, lateral movements, hip extension exercises, calf raises, and additional full-body stretches.Functional training should be done 3 to 5 times per week at an intensity of RPE 3 to 4, with each session lasting 15 to 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Patients in the intervention group will engage in a home-based exercise program in addition to standard rehabilitation guidance. Receives: Other: Motor rehabilitation based on ai visual recognition |
| Control group | No intervention | Patients will receive guidance on breast cancer endocrine therapy-related knowledge, including exercise rehabilitation for bone and joint symptoms (including the freedom to choose the form, type, and intensity of exercise), psychological counseling, and health education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip strength
Measured: From enrollment to the end of treatment at 12 weeks
M-SACRAH
score for assessment and quantification of chronic rheumatic affections of the hands
Measured: From enrollment to the end of treatment at 12 weeks
WOMAC
Western Ontario and McMaster Osteoarthritis Index
Measured: From enrollment to the end of treatment at 12 weeks
ROM
range of motion
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (7)
BCTQ
Boston Carpal Tunnel Syndrome Questionnaire
Measured: From enrollment to the end of treatment at 12 weeks
CRP
Measured: Baseline and 3 months
rheumatoid factor
Measured: Baseline and 3 months
25-hydroxyvitamin D
Measured: Baseline and 3 months
IL-1、INF-a、IL-6、IFN-a、IFN-Y
Measured: Baseline and 3 months
Bone mineral density
Measured: baseline
OPG/RANKLE SNP
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start20 Oct 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal SymptomsStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiang Lingyun, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642948
- Sponsor's protocol ID
- 13825489001123
- Other IDs
- 82272922
- Acronym
- AiRE-MS
- Status last verified
- Oct 2024
- First submitted
- 13 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Structured Exercise Interventions in Alleviating Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06642948
- Acronym / sponsor ID
- AiRE-MS / 13825489001123
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 20 Oct 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 15 Oct 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.
This study aims to develop and evaluate an artificial intelligence (AI)-based skeletal recognition system designed to support real-time, interactive rehabilitation exercise (RE programs. The goal is to mitigate musculoskeletal symptoms associated with endocrine therapy in breast cancer survivors.Endocrine therapy remains a cornerstone in the treatment of hormone receptor-positive breast cancer, typically extending over 5 to 10 years. While the therapeutic benefits of endocrine therapy are well established, agents such as aromatase inhibitors frequently induce musculoskeletal symptoms (MS), including joint pain, stiffness (particularly morning stiffness), carpal tunnel syndrome, tenosynovitis, myalgia, and muscle weakness. These symptoms, which may be continuous or intermittent, can affect both central (spine, hips, shoulders) and peripheral joints (elbows, wrists, knees, feet), severely compromising patients' quality of life (QoL). Although physical exercise has been demonstrated to alleviate these symptoms, adherence to adequate exercise regimens remains suboptimal among patients. Furthermore, there is no consensus on the optimal type, duration, or intensity of exercise interventions, and standardized protocols are lacking. Recognizing exercise as a long-term behavior, we are developing a home-based, AI-assisted rehabilitation program tailored to the specific needs of patients undergoing endocrine therapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Motor rehabilitation based on ai visual recognitionPatients in the intervention group will engage in a home-based exercise program in addition to standard rehabilitation guidance. |
| Control group | No intervention | –Patients will receive guidance on breast cancer endocrine therapy-related knowledge, including exercise rehabilitation for bone and joint symptoms (including the freedom to choose the form, type, and intensity of exercise), psychological counseling, and health education. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Pathologically confirmed hormone receptor-positive breast cancer (stage I, II, III).
- 2. Initiation of treatment with aromatase inhibitors (e.g., anastrozole, letrozole, exemestane).
- 3. Postmenopausal women, including those with surgically induced menopause. 4. Clear consciousness, no cognitive or communication impairments, and able to comply with the intervention.
- 5. Informed consent obtained, with voluntary participation in the study. 6. Bone and joint symptoms with a Brief Pain Inventory (BPI) score of ≥3, or presence of at least one of the following risk factors: elevated bone turnover markers, reduced vitamin D levels, increased inflammatory cytokines, elevated C-reactive protein, or elevated rheumatoid factor.
- 7. Not participating in any physical therapy or exercise-based interventions that may interfere with this study.
Key exclusion criteria (2 listed)
- 1. Recurrence of breast cancer or distant metastasis. 2. Presence of other malignancies. 3. Diagnosed rheumatoid arthritis, bone and joint trauma, or other severe bone and joint diseases.
- 4. Bone mineral density T-score <-2.5. 5. Presence of absolute contraindications to 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 |
|---|---|---|
| Motor rehabilitation based on ai visual recognitionAlso: ai visual recognition technology, exercisePatients in the intervention group will engage in a home-based exercise program in addition to standard rehabilitation guidance. Initially, patients will be provided with exercise materials developed by the intervention team, one-on-one guidance via the AI rehabilitation platform, and a detailed explanation of the exercise intervention program (including its components, foundational knowledge, and benefits).The aerobic warm-up routine includes activities such as marching in place, full-body stretches, jumping jacks, side steps with arm circles, and squats with alternating punches. For the elderly, the warm-up routine is similar but also incorporates chest expansion exercises, abduction exercises, overhead reaches, lateral movements, hip extension exercises, calf raises, and additional full-body stretches.Functional training should be done 3 to 5 times per week at an intensity of RPE 3 to 4, with each session lasting 15 to 30 minutes. | Other | Exercise group |
Primary outcome
Grip strength
Time frame: From enrollment to the end of treatment at 12 weeks
M-SACRAH
Time frame: From enrollment to the end of treatment at 12 weeks
score for assessment and quantification of chronic rheumatic affections of the hands
WOMAC
Time frame: From enrollment to the end of treatment at 12 weeks
Western Ontario and McMaster Osteoarthritis Index
ROM
Time frame: From enrollment to the end of treatment at 12 weeks
range of motion
7 secondary outcomes
BCTQ
Time frame: From enrollment to the end of treatment at 12 weeks
CRP
Time frame: Baseline and 3 months
rheumatoid factor
Time frame: Baseline and 3 months
25-hydroxyvitamin D
Time frame: Baseline and 3 months
IL-1、INF-a、IL-6、IFN-a、IFN-Y
Time frame: Baseline and 3 months
Bone mineral density
Time frame: baseline
OPG/RANKLE SNP
Time frame: baseline
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 15 Oct 2024.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor rehabilitation based on ai visual recognition in people with Musculoskeletal Symptoms and Breast Cancer, run by Fudan University at 1 site in China.
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 5 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: looking for participants now, as of the sponsor's last update on 15 Oct 2024. 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 China. 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?
Contact Lingyun Jiang ((+86) 18359374969, 22211170029@m.fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grip strength (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 4 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 15 Oct 2024.