An interventional study of Combined exercise training in Breast Cancer, sponsored by Associacao de Investigacao de Cuidados de Suporte em Oncologia. Completed at 1 site in Portugal. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-02.
Sponsored by Associacao de Investigacao de Cuidados de Suporte em Oncologia · Not applicable, Interventional, and Supportive care
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 12 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Associacao de Investigacao de Cuidados de Suporte em Oncologia is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Other: 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
Other: Combined exercise training
Before the intervention, these women will undergo an evaluation of cardiorespiratory fitness, functional fitness, psychological status and a physiatry assessment. A consent form is signed before the start. The physical exercise intervention was planned based on the recommendations of the American College of Sports Medicine for cancer survivors (ACSM 2019), with two supervised combined training sessions (mobility, aerobic training, strength and flexibility training) planned, and one unsupervised aerobic training session per week, interspersed with at least one rest day in between, for 8 weeks. The intensity will be individualized and defined based on the initial assessment. The structure of the training plan was based on the FITT-VP principles (frequency, intensity, time, type, volume and progression) recommended by the ACSM (2019).
Retention rate
The percentage of included patients who ended the program
Time frame: End of the intervention (week 9)
Adherence rate
Number of absences to the sessions and number of completed sessions
Time frame: End of the intervention (week 9)
Training tolerance regarding the duration of the exercise prescription
Recording adherence to the exercise prescription duration, possible adjustments and their reasons
Time frame: During all intervention sessions (24 sessions, 8 weeks)
Training tolerance regarding the intensity of the exercise prescription
Recording adherence to the exercise prescription intensity, possible adjustments and their reasons
Time frame: During all intervention sessions (24 sessions, 8 weeks)
Training tolerance regarding the volume of the exercise prescription
Recording adherence to the exercise prescription volume, possible adjustments and their reasons
Time frame: During all intervention sessions (24 sessions, 8 weeks)
Intervention Recruitment Rate
Number of invitations made versus accepted (invitation made by the assistant oncologist)
Time frame: Beginning of the intervention (week 0)
Training safety
Recording symptoms and adverse effects
Time frame: During all intervention sessions (24 sessions, 8 weeks)
Absence and dropout
Rate of absence from sessions and dropout of the program
Time frame: End of the intervention (week 9)
Level of satisfaction
Questionnaire at the end of the intervention, from 1 to 5, where 1 is not satisfied and 5 is very satisfied
Time frame: End of the intervention (week 9)
Cardiopulmonary system fitness level and signs of disease assessment
Measurement of maximum VO2 by a cardiopulmonary exercise test and assessment of cardiopulmonary risk factors or disease
Time frame: Beginning of the intervention (week 0)
Lower limb strength
30´´Sit to stand test (number of repetitions)
Time frame: Beginning (week 0) and End of the intervention (week 9)
Upper limb strenght
Bilateral handgrip test with dynamometer (kg)
Time frame: Beginning (week 0) and End of the intervention (week 9)
Lower limbs flexibility level
Sit and Reach test (cm)
Time frame: Beginning (week 0) and End of the intervention (week 9)
Static balance
One Leg Stance test (time, s)
Time frame: Beginning (week 0) and End of the intervention (week 9)
Dynamic balance and agility
8 Foot up and go test (time, s)
Time frame: Beginning (week 0) and End of the intervention (week 9)
Assessment of aerobic capacity
6 Minute Walk Test
Time frame: Beginning (week 0) and End of the intervention (week 9)
Safety of the intervention
Number of serious and less serious occurrences
Time frame: During all intervention sessions (24 sessions, 8 weeks)
Body weight
Weight (Kg)
Time frame: Beginning (week 0) and End of the intervention (week 9)
Body height
Height (m)
Time frame: Beginning (week 0) and End of the intervention (week 9)
Body circumferences
Waist circumference (cm), hip circumference (cm), middle crural circumference (cm) and bicipital circumference (cm)
Time frame: Beginning (week 0) and End of the intervention (week 9)
Individual's overall satisfaction with life and general sense of personal well-being
Questionnaire QLQ-C30
Time frame: 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
Questionnaire QLQ-BR23
Time frame: Beginning (week 0) and End of the intervention (week 9)
Adverse effects
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)
Time frame: During all intervention sessions (24 sessions, 8 weeks)
Assessment of performance status
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)
Time frame: During all intervention sessions (24 sessions, 8 weeks)
Heart Function
Resting heart rate (bpm)
Time frame: Beginning of the intervention (week 0)
Arterial disorder assessment
Systolic and diastolic blood pressure assessment (mm/hg)
Time frame: Beginning of the intervention (week 0)
Physical activity and sedentary behaviors
Accelerometry
Time frame: Beginning (week 0) and End of the intervention (week 9)
Subjective perception of effort
Borg scale of perceived exertion ranging from 6 (very, very light effort) to 20 (maximum exertion)
Time frame: During all intervention sessions (24 sessions, 8 weeks)
Plan to share: Yes — All participant data will be available with the exception of personal information
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
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Associacao de Investigacao de Cuidados de Suporte em Oncologia