Pilot Study of Supervised Adapted Physical Exercise in Women With Breast Cancer After Treatment - Face-to-face Context vs Online Home Based
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Associacao de Investigacao de Cuidados de Suporte em Oncologia
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Retention rate
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Retention rate
Time Frame: End of the intervention (week 9)
The percentage of included patients who ended the program
Adherence rate
Time Frame: End of the intervention (week 9)
Number of absences to the sessions and number of completed sessions
Training tolerance regarding the duration of the exercise prescription
Time Frame: During all intervention sessions (24 sessions, 8 weeks)
Recording adherence to the exercise prescription duration, possible adjustments and their reasons
Training tolerance regarding the intensity of the exercise prescription
Time Frame: During all intervention sessions (24 sessions, 8 weeks)
Recording adherence to the exercise prescription intensity, possible adjustments and their reasons
Training tolerance regarding the volume of the exercise prescription
Time Frame: During all intervention sessions (24 sessions, 8 weeks)
Recording adherence to the exercise prescription volume, possible adjustments and their reasons
Intervention Recruitment Rate
Time Frame: Beginning of the intervention (week 0)
Number of invitations made versus accepted (invitation made by the assistant oncologist)
Training safety
Time Frame: During all intervention sessions (24 sessions, 8 weeks)
Recording symptoms and adverse effects
Absence and dropout
Time Frame: End of the intervention (week 9)
Rate of absence from sessions and dropout of the program
Level of satisfaction
Time Frame: End of the intervention (week 9)
Questionnaire at the end of the intervention, from 1 to 5, where 1 is not satisfied and 5 is very satisfied
Secondary Outcomes
- Cardiopulmonary system fitness level and signs of disease assessment(Beginning of the intervention (week 0))
- Lower limb strength(Beginning (week 0) and End of the intervention (week 9))
- Upper limb strenght(Beginning (week 0) and End of the intervention (week 9))
- Lower limbs flexibility level(Beginning (week 0) and End of the intervention (week 9))
- Static balance(Beginning (week 0) and End of the intervention (week 9))
- Dynamic balance and agility(Beginning (week 0) and End of the intervention (week 9))
- Assessment of aerobic capacity(Beginning (week 0) and End of the intervention (week 9))
- Safety of the intervention(During all intervention sessions (24 sessions, 8 weeks))
- Body weight(Beginning (week 0) and End of the intervention (week 9))
- Body height(Beginning (week 0) and End of the intervention (week 9))
- Body circumferences(Beginning (week 0) and End of the intervention (week 9))
- Individual's overall satisfaction with life and general sense of personal well-being(Beginning (week 0) and End of the intervention (week 9))
- Individual's overall satisfaction with life and general sense of personal well-being, specific to breast cancer patient(Beginning (week 0) and End of the intervention (week 9))
- Adverse effects(During all intervention sessions (24 sessions, 8 weeks))
- Assessment of performance status(During all intervention sessions (24 sessions, 8 weeks))
- Heart Function(Beginning of the intervention (week 0))
- Arterial disorder assessment(Beginning of the intervention (week 0))
- Physical activity and sedentary behaviors(Beginning (week 0) and End of the intervention (week 9))
- Subjective perception of effort(During all intervention sessions (24 sessions, 8 weeks))