Physical Exercise for Breast Cancer Survivors: Face-to-face Versus Home-based
- Conditions
- Breast Cancer
- Interventions
- Other: Combined exercise training
- Registration Number
- NCT05071560
- Lead Sponsor
- Associacao de Investigacao de Cuidados de Suporte em Oncologia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 12
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Home-Based Group Combined exercise training 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 Face-to-Face Group Combined exercise training 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
- Primary Outcome Measures
Name Time Method Retention rate End of the intervention (week 9) The percentage of included patients who ended the program
Adherence rate 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 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 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 During all intervention sessions (24 sessions, 8 weeks) Recording adherence to the exercise prescription volume, possible adjustments and their reasons
Intervention Recruitment Rate Beginning of the intervention (week 0) Number of invitations made versus accepted (invitation made by the assistant oncologist)
Training safety During all intervention sessions (24 sessions, 8 weeks) Recording symptoms and adverse effects
Absence and dropout End of the intervention (week 9) Rate of absence from sessions and dropout of the program
Level of satisfaction 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 Outcome Measures
Name Time Method Cardiopulmonary system fitness level and signs of disease assessment Beginning of the intervention (week 0) Measurement of maximum VO2 by a cardiopulmonary exercise test and assessment of cardiopulmonary risk factors or disease
Lower limb strength Beginning (week 0) and End of the intervention (week 9) 30´´Sit to stand test (number of repetitions)
Upper limb strenght Beginning (week 0) and End of the intervention (week 9) Bilateral handgrip test with dynamometer (kg)
Lower limbs flexibility level Beginning (week 0) and End of the intervention (week 9) Sit and Reach test (cm)
Static balance Beginning (week 0) and End of the intervention (week 9) One Leg Stance test (time, s)
Dynamic balance and agility Beginning (week 0) and End of the intervention (week 9) 8 Foot up and go test (time, s)
Assessment of aerobic capacity Beginning (week 0) and End of the intervention (week 9) 6 Minute Walk Test
Safety of the intervention During all intervention sessions (24 sessions, 8 weeks) Number of serious and less serious occurrences
Body weight Beginning (week 0) and End of the intervention (week 9) Weight (Kg)
Body height Beginning (week 0) and End of the intervention (week 9) Height (m)
Body circumferences Beginning (week 0) and End of the intervention (week 9) Waist circumference (cm), hip circumference (cm), middle crural circumference (cm) and bicipital circumference (cm)
Individual's overall satisfaction with life and general sense of personal well-being Beginning (week 0) and End of the intervention (week 9) Questionnaire QLQ-C30
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) Questionnaire QLQ-BR23
Adverse effects During all intervention sessions (24 sessions, 8 weeks) Common Terminology Criteria for Adverse Effects, version 5, scale (presence of fatigue, osteoarticular and cardiac complaints, pain, neuropathy and lymphedema), ranging from 1 (mild, asymptomatic ou mild symptoms) to 5 (dead related to adverse event)
Assessment of performance status During all intervention sessions (24 sessions, 8 weeks) ECOG scale of performance status, in a scale ranging from 0 (fully active, able to carry same activities as before disease without new restrictions) to 5 (dead)
Heart Function Beginning of the intervention (week 0) Resting heart rate (bpm)
Arterial disorder assessment Beginning of the intervention (week 0) Systolic and diastolic blood pressure assessment (mm/hg)
Physical activity and sedentary behaviors Beginning (week 0) and End of the intervention (week 9) Accelerometry
Subjective perception of effort During all intervention sessions (24 sessions, 8 weeks) Borg scale of perceived exertion ranging from 6 (very, very light effort) to 20 (maximum exertion)
Trial Locations
- Locations (1)
Centro Hospitalar Vila Nova de Gaia/Espinho
🇵🇹Vila Nova De Gaia, Porto, Portugal