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Prehabilitation for Breast Cancer Surgery

R

Raquel Sebio

Status

Completed

Conditions

Breast Cancer

Treatments

Behavioral: Group-based Nordic Walking Exercise Program

Study type

Interventional

Funder types

Other

Identifiers

NCT05216302
IIBSP-PRO-2021-10

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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 design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

64 participants in 2 patient groups

Usual Care
No Intervention group
Description:
Patients allocated to this arm will continue with their schedule chemotherapy with no additional intervention
Prehabilitation
Experimental group
Description:
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.
Treatment:
Behavioral: Group-based Nordic Walking Exercise Program

Trial contacts and locations

1

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Central trial contact

Raquel Sebio, PhD; Anabel Casanovas Álvarez, MSc

Data sourced from clinicaltrials.gov

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