Clinical trial NCT05071560: Physical Exercise for Breast Cancer Survivors: Face-to-face Versus Home-based
Official title: Pilot Study of Supervised Adapted Physical Exercise in Women With Breast Cancer After Treatment - Face-to-face Context vs Online Home Based
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Associacao de Investigacao de Cuidados de Suporte em Oncologia
Sponsor class: OTHER
Collaborators: name: Centro Hospitalar de Vila Nova de Gaia/Espinho
name: Universidad Europea de Madrid
name: University Institute of Maia
First posted: 2021-10-08
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot randomized controlled study
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Retention rate
timeFrame: End of the intervention (week 9)
measure: Adherence rate
timeFrame: End of the intervention (week 9)
measure: Training tolerance regarding the duration of the exercise prescription
timeFrame: During all intervention sessions (24 sessions, 8 weeks)
measure: Training tolerance regarding the intensity of the exercise prescription
timeFrame: During all intervention sessions (24 sessions, 8 weeks)
measure: Training tolerance regarding the volume of the exercise prescription
timeFrame: During all intervention sessions (24 sessions, 8 weeks)
measure: Intervention Recruitment Rate
timeFrame: Beginning of the intervention (week 0)
measure: Training safety
timeFrame: During all intervention sessions (24 sessions, 8 weeks)
measure: Absence and dropout
timeFrame: End of the intervention (week 9)
measure: Level of satisfaction
timeFrame: End of the intervention (week 9)
Secondary outcomes:
measure: Cardiopulmonary system fitness level and signs of disease assessment
timeFrame: Beginning of the intervention (week 0)
measure: Lower limb strength
timeFrame: Beginning (week 0) and End of the intervention (week 9)
measure: Upper limb strenght
timeFrame: Beginning (week 0) and End of the intervention (week 9)
measure: Lower limbs flexibility level
timeFrame: Beginning (week 0) and End of the intervention (week 9)
measure: Static balance
timeFrame: Beginning (week 0) and End of the intervention (week 9)
measure: Dynamic balance and agility
timeFrame: Beginning (week 0) and End of the intervention (week 9)
measure: Assessment of aerobic capacity
timeFrame: Beginning (week 0) and End of the intervention (week 9)
measure: Safety of the intervention
timeFrame: During all intervention sessions (24 sessions, 8 weeks)
measure: Body weight
timeFrame: Beginning (week 0) and End of the intervention (week 9)
measure: Body height
timeFrame: Beginning (week 0) and End of the intervention (week 9)
measure: Body circumferences
timeFrame: Beginning (week 0) and End of the intervention (week 9)
measure: Individual's overall satisfaction with life and general sense of personal well-being
timeFrame: Beginning (week 0) and End of the intervention (week 9)
measure: Individual's overall satisfaction with life and general sense of personal well-being, specific to breast cancer patient
timeFrame: Beginning (week 0) and End of the intervention (week 9)
measure: Adverse effects
timeFrame: During all intervention sessions (24 sessions, 8 weeks)
measure: Assessment of performance status
timeFrame: During all intervention sessions (24 sessions, 8 weeks)
measure: Heart Function
timeFrame: Beginning of the intervention (week 0)
measure: Arterial disorder assessment
timeFrame: Beginning of the intervention (week 0)
measure: Physical activity and sedentary behaviors
timeFrame: Beginning (week 0) and End of the intervention (week 9)
measure: Subjective perception of effort
timeFrame: During all intervention sessions (24 sessions, 8 weeks)
Other outcomes:
Locations:
city: Vila Nova De Gaia
country: Portugal
facility: Centro Hospitalar Vila Nova de Gaia/Espinho
state: Porto
Study officials:
affiliation: Universidade Europeia
name: Sandra Martins, PhD
role: STUDY_DIRECTOR
References: