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Results of Physical Exercise in women with Breast Cancer undergoing Chemotherapy

Effect of Physical Exercise on Functionality and Tumor Size in women with Breast Cancer undergoing Neoadjuvant Chemotherapy: a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-37f4x5p
Enrollment
Unknown
Registered
2023-07-13
Start date
2021-08-18
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of life

Interventions

This is a parallel randomized clinical trial with two groups. The experimental group will consist of 24 women with breast cancer undergoing neoadjuvant chemotherapy. This group will undergo supervised
G11.427.410.698.277

Sponsors

Universidade Federal de Minas Gerais
Lead Sponsor
Instituto de Previdência dos Servidores do Estado de Minas Gerais
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 69 Years

Inclusion criteria

Inclusion criteria: women diagnosed with breast cancer; aged between 18 and 69 years old; undergoing neoadjuvant chemotherapy

Exclusion criteria

Exclusion criteria: women with breast cancer; undergoing neoadjuvant chemotherapy who present some comorbidity such as cardiac dysfunctions that contraindicate the practice of physical exercise or present some inability to answer the questionnaires

Design outcomes

Primary

MeasureTime frame
The primary outcome of functionality related to cardiorespiratory capacity was assessed using the Incremental Shuttle Walking Test, operationalized by the distance covered in meters. It is expected that in this test there would be an average improvement of at least 70 meters. The Human Activity Profile (HAP) questionnaire was used to assess the primary outcome related to physical activity level. The PAH result was operationalized by the adjusted activity score (AAS). Based on the EAA, the level of the sample was classified as debilitated (EAA 53 and < 74) and active (EAA = 74). AAS is expected to increase in the intervention group after the study.

Secondary

MeasureTime frame
quality of life measured using the generic instruments European Organization for Research of Cancer quality of life C-30 and specific European Organization for Research of Cancer quality of life BR-23. Both questionnaires have a score from 0 to 100, where 0 represents the worst health status and 100 the best health status;The Beck Short-Form Depression Inventory was used to assess signs of depression in the sample. A score greater than 4 was defined as the presence of possible depressive symptoms.;The Cancer Fatigue Scale (CFS) questionnaire was used to assess fatigue. The CFS includes 15 items that assess fatigue in three domains: physical (score 0-28), affective (score 0-16), and cognitive (score 0-16). The sum of domains (0-60) represents total fatigue. It is expected that the fatigue score reduces or does not increase in the intervention group.

Countries

Brazil

Contacts

Public ContactAna Silvia Diniz Makluf Makluf

Instituto de Previdência dos Servidores do Estado de Minas Gerais

anasilviamakluf@gmail.com+55 31 987845859

Outcome results

None listed

Source: REBEC (via WHO ICTRP)