Breast CancerNCT05216302
Prehabilitation for Breast Cancer Surgery
A study testing Group-based Nordic Walking Exercise Program in people with Breast Cancer, run by Raquel Sebio at 1 site in Spain.
Trial summary
Prehabilitation for women diagnosed with breast cancer is commonly not part of the clinical pathways as little time (usually a few days) is left between diagnosis and surgery. However, a great proportion of these patients will undergo neoadjuvant chemotherapy which provides a window opportunity to improve patients'… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Group-based Nordic Walking Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2021to 10 Jan 2024
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of breast cancer scheduled for surgery with or without lymphadenectomy
- Candidates to receive neoadjuvant chemotherapy
- Not currently undergoing any other physical therapy therapies or treatments
Who cannot join
- Cognitive impairment or inability to read Catalan or Spanish
- Prior diagnosis of shoulder impairment or injury
- Major musculoskeletal, neurological or cardiorespiratory limitations to prevent participation in the exercise program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prehabilitation Program Based on Health Education and Nordic Walking to Reduce Musculoskeletal Impairments in Women Undergoing Breast Cancer Surgery
Prehabilitation for women diagnosed with breast cancer is commonly not part of the clinical pathways as little time (usually a few days) is left between diagnosis and surgery. However, a great proportion of these patients will undergo neoadjuvant chemotherapy which provides a window opportunity to improve patients' physical status to withstand surgery and minimize post-operative musculoskeletal complications associated with surgery.
To this end, the aim of this study is to assess the efficacy of a prehabilitation program consisting of health education and a supervised nordic walking-based intervention in women diagnosed with breast cancer currently undergoing neoadjuvant chemotherapy to decrease post-operative musculoskeletal impairments and improve functionality of the affected arm.
The study is an open-label, single-blind randomised controlled trial conducted at one tertiary hospital. Women diagnosed with breast cancer scheduled for surgery and currently undergoing chemotherapy will be randomised to either usual care (UC) or prehabilitation (PREHAB). Patients will be assessed for eligibility during the fourth out of six course of chemotherapy. Those randomised to the PREHAB group will participate in a supervised group-based nordic walking intervention twice weekly during 8 weeks (approximately 16 sessions). In addition, participants will receive written information regarding the benefits of exercise during cancer treatment and surveillance. Patients will be assessed prior to surgery as well as at 1, 3 and 6 months postoperatively.
- Conditions
- Breast Cancer
- Being tested
- Group-based Nordic Walking Exercise Program
- Keywords
- breast cancer, prehabilitation, exercise therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based Nordic Walking Exercise ProgramBehavioural
An exercise intervention based on nordic walking and health education of one hour and 15 minutes per session. Each session includes 10 min of health education followed by 15 minutes of warm-up exercises, 30 minutes of nordic walking and finally 15 min to cool-down. The intervention is meant to last during two months (last round of chemotherapy and one month pre-surgery), twice weekly for approximately a total of 16 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Patients allocated to this arm will continue with their schedule chemotherapy with no additional intervention |
| Prehabilitation | Experimental | Patients allocated to this arm will participate in a weekly group-based exercise intervention (nordic walking) and receive health education through a booklet, videos of the exercises and face-to-face sessions prior to each nordic walking session. Chemotherapy will continue as scheduled. Receives: Behavioral: Group-based Nordic Walking Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)
Functionality of the affected upper arm using the DASH questionnaire. The questionnaire compromises 11 items. Scoring ranges from 0 (no disability) to 100 (more severe disability)
Measured: Pre-Surgery (one week)
Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)
Functionality of the affected upper arm using the DASH questionnaire. The questionnaire compromises 11 items. Scoring ranges from 0 (no disability) to 100 (more severe disability)
Measured: One month post-surgery
Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)
Functionality of the affected upper arm using the DASH questionnaire. The questionnaire compromises 11 items. Scoring ranges from 0 (no disability) to 100 (more severe disability)
Measured: Three months post-surgery
Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)
Functionality of the affected upper arm using the DASH questionnaire. The questionnaire compromises 11 items. Scoring ranges from 0 (no disability) to 100 (more severe disability)
Measured: Six months post-surgery
Secondary outcomes (29)
Upper arm volume
Perimeter of the affected arm will be measured with a tape measure at hand, wrist, elbow and shoulder level
Measured: Pre-Surgery (one week)
Upper arm volume
Perimeter of the affected arm will be measured with a tape measure at hand, wrist, elbow and shoulder level
Measured: One month post-surgery
Upper arm volume
Perimeter of the affected arm will be measured with a tape measure at hand, wrist, elbow and shoulder level
Measured: Three months post-surgery
Upper arm volume
Perimeter of the affected arm will be measured with a tape measure at hand, wrist, elbow and shoulder level
Measured: Six months post-surgery
Range of Movement (ROM)
Range of movement of the affected arm in three axes using a goniometer
Measured: Pre-Surgery (one week)
Range of Movement (ROM)
Range of movement of the affected arm in three axes using a goniometer
Measured: One month post-surgery
Range of Movement (ROM)
Range of movement of the affected arm in three axes using a goniometer
Measured: Three months post-surgery
Range of Movement (ROM)
Range of movement of the affected arm in three axes using a goniometer
Measured: Six months post-surgery
Pain severity
Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain)
Measured: Pre-Surgery (one week)
Pain severity
Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain)
Measured: One month post-surgery
Pain severity
Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain)
Measured: Three months post-surgery
Pain severity
Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain)
Measured: Six months post-surgery
Health-Related Quality of Life
Health-Related Quality of Life will be assessed with the questionnaire developed by the European Organization for Research and Treatment (EORTC) Quality of Life (QLQ) questionnaire (EORTC QLQ C30). Scores range from 0 to 100 with higher values associated with better overall quality of life
Measured: Pre-Surgery (one week)
Health-Related Quality of Life
Health-Related Quality of Life will be assessed with the questionnaire developed by the European Organization for Research and Treatment (EORTC) Quality of Life (QLQ) questionnaire (EORTC QLQ C30). Scores range from 0 to 100 with higher values associated with better overall quality of life
Measured: One month post-surgery
Health-Related Quality of Life
HHealth-Related Quality of Life will be assessed with the questionnaire developed by the European Organization for Research and Treatment (EORTC) Quality of Life (QLQ) questionnaire (EORTC QLQ C30). Scores range from 0 to 100 with higher values associated with better overall quality of life
Measured: Three months post-surgery
Health-Related Quality of Life
Health-Related Quality of Life will be assessed with the questionnaire developed by the European Organization for Research and Treatment (EORTC) Quality of Life (QLQ) questionnaire (EORTC QLQ C30). Scores range from 0 to 100 with higher values associated with better overall quality of life
Measured: Six months post-surgery
Handgrip Strength
Handgrip strength will be determined using an hydraulic dynamometer (Jamar). Both hands will be assessed and the better result out of three attempts will be used.
Measured: Pre-Surgery (one week)
Handgrip Strength
Handgrip strength will be determined using an hydraulic dynamometer (Jamar). Both hands will be assessed and the better result out of three attempts will be used.
Measured: One month post-surgery
Handgrip Strength
Handgrip strength will be determined using an hydraulic dynamometer (Jamar). Both hands will be assessed and the better result out of three attempts will be used.
Measured: Three months post-surgery
Handgrip Strength
Handgrip strength will be determined using an hydraulic dynamometer (Jamar). Both hands will be assessed and the better result out of three attempts will be used.
Measured: Six months post-surgery
Functional capacity
Functional capacity will be measured with the distance covered by the 6-Minute Walk Test.
Measured: Pre-surgery (one week)
Functional capacity
Functional capacity will be measured with the distance covered by the 6-Minute Walk Test.
Measured: One month post-surgery
Functional capacity
Functional capacity will be measured with the distance covered by the 6-Minute Walk Test.
Measured: Three months post-surgery
Functional capacity
Functional capacity will be measured with the distance covered by the 6-Minute Walk Test.
Measured: Six months post-surgery
Adherence
Adherence to the scheduled sessions will be registered in the Prehab group and will be reported as percentage of attended vs. scheduled.
Measured: Pre-Surgery (one week)
Physical Activity
Physical activity levels will be measured using the short form of the International Physical Activity Questionnaire (IPAQ). Estimated METS per week will be calculated based on the available formulas.
Measured: Pre-surgery (one week)
Physical Activity
Physical activity levels will be measured using the short form of the International Physical Activity Questionnaire (IPAQ). Estimated METS per week will be calculated based on the available formulas.
Measured: One month post-surgery
Physical Activity
Physical activity levels will be measured using the short form of the International Physical Activity Questionnaire (IPAQ). Estimated METS per week will be calculated based on the available formulas.
Measured: Three months post-surgery
Physical Activity
Physical activity levels will be measured using the short form of the International Physical Activity Questionnaire (IPAQ). Estimated METS per week will be calculated based on the available formulas.
Measured: Six months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start1 Nov 2021
- Primary completion1 Nov 2023
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raquel Sebio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Raquel Sebio, Universitat Pompeu Fabra
- Investigators
- Raquel Sebio, PhD, Study director, School of Health Sciences TecnoCampus. University Pompeu Fabra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216302
- Sponsor's protocol ID
- IIBSP-PRO-2021-10
- Status last verified
- Dec 2024
- First submitted
- 18 Jan 2022
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Santa Mina D, Brahmbhatt P, Lopez C, Baima J, Gillis C, Trachtenberg L, Silver JK. The Case for Prehabilitation Prior to Breast Cancer Treatment. PM R. 2017 Sep;9(9S2):S305-S316. doi: 10.1016/j.pmrj.2017.08.402.
PubMed 28942905McNeely ML, Campbell KL, Rowe BH, Klassen TP, Mackey JR, Courneya KS. Effects of exercise on breast cancer patients and survivors: a systematic review and meta-analysis. CMAJ. 2006 Jul 4;175(1):34-41. doi: 10.1503/cmaj.051073.
PubMed 16818906Silver JK, Baima J. Cancer prehabilitation: an opportunity to decrease treatment-related morbidity, increase cancer treatment options, and improve physical and psychological health outcomes. Am J Phys Med Rehabil. 2013 Aug;92(8):715-27. doi: 10.1097/PHM.0b013e31829b4afe.
PubMed 23756434Yang A, Sokolof J, Gulati A. The effect of preoperative exercise on upper extremity recovery following breast cancer surgery: a systematic review. Int J Rehabil Res. 2018 Sep;41(3):189-196. doi: 10.1097/MRR.0000000000000288.
PubMed 29683834ILokapavani Y, Krishna SR, Madhavi K. nfluence of Pre - Operative Physical Therapy Education and Exercise on Post-operative Shoulder Range of Motion and Functional Activites in Subjects with Modified Radical Mastectomy. Int J Physiother 2014. DOI: 10.15621/ijphy/2014/v1i4/54556
Casanovas-Alvarez A, Estanyol B, Ciendones M, Padros J, Cuartero J, Barnadas A, Garcia-Valdecasas B, Gonzalez-Colom R, Sebio-Garcia R, Masia J. Effectiveness of an Exercise and Educational-Based Prehabilitation Program in Patients With Breast Cancer Receiving Neoadjuvant Chemotherapy (PREOptimize) on Functional Outcomes: A Randomized Controlled Trial. Phys Ther. 2024 Dec 6;104(12):pzae151. doi: 10.1093/ptj/pzae151.
PubMed 39423256
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation Program Based on Health Education and Nordic Walking to Reduce Musculoskeletal Impairments in Women Undergoing Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT05216302
- Acronym / sponsor ID
- IIBSP-PRO-2021-10
- Conditions
- Breast Cancer
- Keywords
- breast cancer, prehabilitation, exercise therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Raquel SebioUniversity, hospital or other
- Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 31 Jan 2022 (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.
Prehabilitation for women diagnosed with breast cancer is commonly not part of the clinical pathways as little time (usually a few days) is left between diagnosis and surgery. However, a great proportion of these patients will undergo neoadjuvant chemotherapy which provides a window opportunity to improve patients' physical status to withstand surgery and minimize post-operative musculoskeletal complications associated with surgery.
To this end, the aim of this study is to assess the efficacy of a prehabilitation program consisting of health education and a supervised nordic walking-based intervention in women diagnosed with breast cancer currently undergoing neoadjuvant chemotherapy to decrease post-operative musculoskeletal impairments and improve functionality of the affected arm.
The study is an open-label, single-blind randomised controlled trial conducted at one tertiary hospital. Women diagnosed with breast cancer scheduled for surgery and currently undergoing chemotherapy will be randomised to either usual care (UC) or prehabilitation (PREHAB). Patients will be assessed for eligibility during the fourth out of six course of chemotherapy. Those randomised to the PREHAB group will participate in a supervised group-based nordic walking intervention twice weekly during 8 weeks (approximately 16 sessions). In addition, participants will receive written information regarding the benefits of exercise during cancer treatment and surveillance. Patients will be assessed prior to surgery as well as at 1, 3 and 6 months postoperatively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Patients allocated to this arm will continue with their schedule chemotherapy with no additional intervention |
| Prehabilitation | Experimental | Behavioral: Group-based Nordic Walking Exercise ProgramPatients allocated to this arm will participate in a weekly group-based exercise intervention (nordic walking) and receive health education through a booklet, videos of the exercises and face-to-face sessions prior to each nordic walking session. Chemotherapy will continue as scheduled. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of breast cancer scheduled for surgery with or without lymphadenectomy
- Candidates to receive neoadjuvant chemotherapy
- Not currently undergoing any other physical therapy therapies or treatments
Key exclusion criteria (3 listed)
- Cognitive impairment or inability to read Catalan or Spanish
- Prior diagnosis of shoulder impairment or injury
- Major musculoskeletal, neurological or cardiorespiratory limitations to prevent participation in the exercise program
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 |
|---|---|---|
| Group-based Nordic Walking Exercise ProgramAn exercise intervention based on nordic walking and health education of one hour and 15 minutes per session. Each session includes 10 min of health education followed by 15 minutes of warm-up exercises, 30 minutes of nordic walking and finally 15 min to cool-down. The intervention is meant to last during two months (last round of chemotherapy and one month pre-surgery), twice weekly for approximately a total of 16 sessions. | Behavioural | Prehabilitation |
Primary outcome
Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)
Time frame: Pre-Surgery (one week)
Functionality of the affected upper arm using the DASH questionnaire. The questionnaire compromises 11 items. Scoring ranges from 0 (no disability) to 100 (more severe disability)
Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)
Time frame: One month post-surgery
Functionality of the affected upper arm using the DASH questionnaire. The questionnaire compromises 11 items. Scoring ranges from 0 (no disability) to 100 (more severe disability)
Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)
Time frame: Three months post-surgery
Functionality of the affected upper arm using the DASH questionnaire. The questionnaire compromises 11 items. Scoring ranges from 0 (no disability) to 100 (more severe disability)
Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)
Time frame: Six months post-surgery
Functionality of the affected upper arm using the DASH questionnaire. The questionnaire compromises 11 items. Scoring ranges from 0 (no disability) to 100 (more severe disability)
29 secondary outcomes
Upper arm volume
Time frame: Pre-Surgery (one week)
Upper arm volume
Time frame: One month post-surgery
Upper arm volume
Time frame: Three months post-surgery
Upper arm volume
Time frame: Six months post-surgery
Range of Movement (ROM)
Time frame: Pre-Surgery (one week)
Range of Movement (ROM)
Time frame: One month post-surgery
Range of Movement (ROM)
Time frame: Three months post-surgery
Range of Movement (ROM)
Time frame: Six months post-surgery
Pain severity
Time frame: Pre-Surgery (one week)
Pain severity
Time frame: One month post-surgery
Pain severity
Time frame: Three months post-surgery
Pain severity
Time frame: Six months post-surgery
Health-Related Quality of Life
Time frame: Pre-Surgery (one week)
Health-Related Quality of Life
Time frame: One month post-surgery
Health-Related Quality of Life
Time frame: Three months post-surgery
Health-Related Quality of Life
Time frame: Six months post-surgery
Handgrip Strength
Time frame: Pre-Surgery (one week)
Handgrip Strength
Time frame: One month post-surgery
Handgrip Strength
Time frame: Three months post-surgery
Handgrip Strength
Time frame: Six months post-surgery
Functional capacity
Time frame: Pre-surgery (one week)
Functional capacity
Time frame: One month post-surgery
Functional capacity
Time frame: Three months post-surgery
Functional capacity
Time frame: Six months post-surgery
Adherence
Time frame: Pre-Surgery (one week)
Physical Activity
Time frame: Pre-surgery (one week)
Physical Activity
Time frame: One month post-surgery
Physical Activity
Time frame: Three months post-surgery
Physical Activity
Time frame: Six months post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Background: PubMed 28942905Santa Mina D, Brahmbhatt P, Lopez C, Baima J, Gillis C, Trachtenberg L, Silver JK. The Case for Prehabilitation Prior to Breast Cancer Treatment. PM R. 2017 Sep;9(9S2):S305-S316. doi: 10.1016/j.pmrj.2017.08.402.
- Background: PubMed 16818906McNeely ML, Campbell KL, Rowe BH, Klassen TP, Mackey JR, Courneya KS. Effects of exercise on breast cancer patients and survivors: a systematic review and meta-analysis. CMAJ. 2006 Jul 4;175(1):34-41. doi: 10.1503/cmaj.051073.
- Background: PubMed 23756434Silver JK, Baima J. Cancer prehabilitation: an opportunity to decrease treatment-related morbidity, increase cancer treatment options, and improve physical and psychological health outcomes. Am J Phys Med Rehabil. 2013 Aug;92(8):715-27. doi: 10.1097/PHM.0b013e31829b4afe.
- Background: PubMed 29683834Yang A, Sokolof J, Gulati A. The effect of preoperative exercise on upper extremity recovery following breast cancer surgery: a systematic review. Int J Rehabil Res. 2018 Sep;41(3):189-196. doi: 10.1097/MRR.0000000000000288.
- BackgroundILokapavani Y, Krishna SR, Madhavi K. nfluence of Pre - Operative Physical Therapy Education and Exercise on Post-operative Shoulder Range of Motion and Functional Activites in Subjects with Modified Radical Mastectomy. Int J Physiother 2014. DOI: 10.15621/ijphy/2014/v1i4/54556
- Derived from this study: PubMed 39423256Casanovas-Alvarez A, Estanyol B, Ciendones M, Padros J, Cuartero J, Barnadas A, Garcia-Valdecasas B, Gonzalez-Colom R, Sebio-Garcia R, Masia J. Effectiveness of an Exercise and Educational-Based Prehabilitation Program in Patients With Breast Cancer Receiving Neoadjuvant Chemotherapy (PREOptimize) on Functional Outcomes: A Randomized Controlled Trial. Phys Ther. 2024 Dec 6;104(12):pzae151. doi: 10.1093/ptj/pzae151.
- Individual participant dataSharing planned: Undecided
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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.
Raquel Sebio, PhD study director
School of Health Sciences TecnoCampus. University Pompeu Fabra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based Nordic Walking Exercise Program in people with Breast Cancer, run by Raquel Sebio at 1 site in Spain.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 6 Dec 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH) (time frame: Pre-Surgery (one week)). 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?
On the ClinicalTrials.gov record for NCT05216302, which also lists 6 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 Dec 2024.