Physical Exercise for Breast Cancer Survivors: Face-to-face Versus Home-based (On4Rehab)

Associacao de Investigacao de Cuidados de Suporte em Oncologia

Status: Completed

Conditions: Breast Cancer

Treatments: Other: Combined exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT05071560

On4Rehab Pilot Trial

Details and patient eligibility

About

The present investigation is a pilot feasibility study that aims to compare a physical exercise intervention in a face-to-face context (considered state of the art) with a physical exercise intervention in a distance context (online), both supervised, in women, of legal age, physically inactive, breast cancer survivors after primary treatment with curative intent.

Before and after the intervention these women will have a physical and functional assessment, as well as a pre-trial cardiopulmonary exercise test, to check if there are safety conditions to participate and also to self tailor the exercise prescription.

The prescription follows the ACSM´s exercise guidelines for cancer survivors and will comprise a 8 week combined exercise training, 3 times per week, in which two of them will be supervised and the third session of the week (cardio session) won´t.

Chat´s and weekly personal messages, as well as education, will be used to promote retention and exercise adherence.

Enrollment: 12 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women
• Over legal age
• With diagnosis of breast carcinoma between stages 0 and IIIc
• ECOG 0 to 1
• Undergoing primary treatment with curative intent (surgery associated or not, with chemotherapy and / or adjuvant radiotherapy) for at least one month
• With follow-up on medical oncology consultation at CHVNG/E
• With consent of the attending oncologist for the practice of physical exercise
• Non-compliance with current physical activity guidelines recommended by the ACSM (moderate aerobic activity> = 150 min / week or vigorous> = 75 min / week and > = 2 strength training sessions / week)
• With cognitive capacity to understand the project proposal

Exclusion criteria

• Severe anaemia seen in the last 3 months (Hb <= 8g / dl) or moderate (Hb> 8 and <= 10 g / dl) symptomatic (sustained tachycardia, exertional dyspnea, chest pain or syncope),
• Uncontrolled arterial hypertension (HTN grade 3-4 (CTCAE v.5)) (SAD> = 160mmHg and / or DAD> = 100mmHg) and / or potentially fatal consequences (malignant HTN, transient or permanent neurological deficit or hypertensive crisis)
• Uncontrolled diabetes mellitus
• Known cardiac or respiratory pathology
• Any other contraindication given by the physiatrist and / or assistant surgeon

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Face-to-Face Group

Active Comparator group

Description:

This arm will have a 3 day per week face-to-face participant-tailored combined exercise program, with 2 supervised sessions and 1 non supervised aerobic session, for 8 weeks

Treatment:

Other: Combined exercise training

Home-Based Group

Experimental group

Description:

This arm will have a 3 day per week home-based participant-tailored combined exercise program, with 2 remotely supervised sessions (online) and 1 non supervised aerobic session, for 8 weeks

Treatment:

Other: Combined exercise training