An interventional study of Group-based Nordic Walking Exercise Program in Breast Cancer, sponsored by Raquel Sebio. Completed at 1 site in Spain. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by Raquel Sebio · Not applicable, Interventional, and Prevention
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.
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 64 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →This is the only study on the registry with Raquel Sebio as lead sponsor.
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Exclusion Criteria:
Patients allocated to this arm will continue with their schedule chemotherapy with no additional intervention
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.
Behavioral: Group-based Nordic Walking Exercise Program
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.
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Six 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Six months post-surgery
Range of Movement (ROM)
Range of movement of the affected arm in three axes using a goniometer
Time frame: Pre-Surgery (one week)
Range of Movement (ROM)
Range of movement of the affected arm in three axes using a goniometer
Time frame: One month post-surgery
Range of Movement (ROM)
Range of movement of the affected arm in three axes using a goniometer
Time frame: Three months post-surgery
Range of Movement (ROM)
Range of movement of the affected arm in three axes using a goniometer
Time frame: Six months post-surgery
Pain severity
Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain)
Time frame: Pre-Surgery (one week)
Pain severity
Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain)
Time frame: One month post-surgery
Pain severity
Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain)
Time frame: Three months post-surgery
Pain severity
Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Six months post-surgery
Functional capacity
Functional capacity will be measured with the distance covered by the 6-Minute Walk Test.
Time frame: Pre-surgery (one week)
Functional capacity
Functional capacity will be measured with the distance covered by the 6-Minute Walk Test.
Time frame: One month post-surgery
Functional capacity
Functional capacity will be measured with the distance covered by the 6-Minute Walk Test.
Time frame: Three months post-surgery
Functional capacity
Functional capacity will be measured with the distance covered by the 6-Minute Walk Test.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Six months post-surgery
Plan to share: Undecided
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