Breast CancerOn4RehabNCT05071560
Physical Exercise for Breast Cancer Survivors: Face-to-face Versus Home-based
A study testing Combined exercise training in people with Breast Cancer, run by Associacao de Investigacao de Cuidados de Suporte em Oncologia at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Combined exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 sitePortugal
- Study dates
- 1 May 2021to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Portugal1 site
Centro Hospitalar Vila Nova de Gaia/Espinho
Vila Nova de Gaia, Porto District, 4400
About this study
Official title: Pilot Study of Supervised Adapted Physical Exercise in Women With Breast Cancer After Treatment - Face-to-face Context vs Online Home Based
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.
Read more
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.
- Conditions
- Breast Cancer
- Being tested
- Combined exercise training
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined exercise trainingOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Face-to-Face Group | Active comparator | 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 Receives: Other: Combined exercise training |
| Home-Based Group | Experimental | 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 Receives: Other: Combined exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate
The percentage of included patients who ended the program
Measured: End of the intervention (week 9)
Adherence rate
Number of absences to the sessions and number of completed sessions
Measured: 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
Measured: 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
Measured: 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
Measured: During all intervention sessions (24 sessions, 8 weeks)
Intervention Recruitment Rate
Number of invitations made versus accepted (invitation made by the assistant oncologist)
Measured: Beginning of the intervention (week 0)
Training safety
Recording symptoms and adverse effects
Measured: During all intervention sessions (24 sessions, 8 weeks)
Absence and dropout
Rate of absence from sessions and dropout of the program
Measured: 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
Measured: End of the intervention (week 9)
Secondary outcomes (19)
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
Measured: Beginning of the intervention (week 0)
Lower limb strength
30´´Sit to stand test (number of repetitions)
Measured: Beginning (week 0) and End of the intervention (week 9)
Upper limb strenght
Bilateral handgrip test with dynamometer (kg)
Measured: Beginning (week 0) and End of the intervention (week 9)
Lower limbs flexibility level
Sit and Reach test (cm)
Measured: Beginning (week 0) and End of the intervention (week 9)
Static balance
One Leg Stance test (time, s)
Measured: Beginning (week 0) and End of the intervention (week 9)
Dynamic balance and agility
8 Foot up and go test (time, s)
Measured: Beginning (week 0) and End of the intervention (week 9)
Assessment of aerobic capacity
6 Minute Walk Test
Measured: Beginning (week 0) and End of the intervention (week 9)
Safety of the intervention
Number of serious and less serious occurrences
Measured: During all intervention sessions (24 sessions, 8 weeks)
Body weight
Weight (Kg)
Measured: Beginning (week 0) and End of the intervention (week 9)
Body height
Height (m)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: During all intervention sessions (24 sessions, 8 weeks)
Heart Function
Resting heart rate (bpm)
Measured: Beginning of the intervention (week 0)
Arterial disorder assessment
Systolic and diastolic blood pressure assessment (mm/hg)
Measured: Beginning of the intervention (week 0)
Physical activity and sedentary behaviors
Accelerometry
Measured: 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)
Measured: During all intervention sessions (24 sessions, 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start1 May 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot randomized controlled study
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associacao de Investigacao de Cuidados de Suporte em Oncologia
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Hospitalar de Vila Nova de Gaia/Espinho, Universidad Europea de Madrid, University Institute of Maia
- Responsible party
- Sponsor
- Investigators
- Sandra Martins, PhD, Study director, Universidade Europeia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071560
- Sponsor's protocol ID
- On4Rehab Pilot Trial
- Acronym
- On4Rehab
- Status last verified
- Feb 2022
- First submitted
- 4 Jul 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All participant data will be available with the exception of personal information
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Supervised Adapted Physical Exercise in Women With Breast Cancer After Treatment - Face-to-face Context vs Online Home Based
- ClinicalTrials.gov ID
- NCT05071560
- Acronym / sponsor ID
- On4Rehab / On4Rehab Pilot Trial
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Associacao de Investigacao de Cuidados de Suporte em OncologiaUniversity, hospital or other
- Collaborators
- Centro Hospitalar de Vila Nova de Gaia/Espinho, Universidad Europea de Madrid, University Institute of Maia
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Face-to-Face Group | Active comparator | Other: Combined exercise trainingThis 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 |
| Home-Based Group | Experimental | Other: Combined exercise trainingThis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined exercise trainingBefore 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). | Other | Face-to-Face Group, Home-Based Group |
Primary outcome
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
19 secondary outcomes
Cardiopulmonary system fitness level and signs of disease assessment
Time frame: Beginning of the intervention (week 0)
Lower limb strength
Time frame: Beginning (week 0) and End of the intervention (week 9)
Upper limb strenght
Time frame: Beginning (week 0) and End of the intervention (week 9)
Lower limbs flexibility level
Time frame: Beginning (week 0) and End of the intervention (week 9)
Static balance
Time frame: Beginning (week 0) and End of the intervention (week 9)
Dynamic balance and agility
Time frame: Beginning (week 0) and End of the intervention (week 9)
Assessment of aerobic capacity
Time frame: Beginning (week 0) and End of the intervention (week 9)
Safety of the intervention
Time frame: During all intervention sessions (24 sessions, 8 weeks)
Body weight
Time frame: Beginning (week 0) and End of the intervention (week 9)
Body height
Time frame: Beginning (week 0) and End of the intervention (week 9)
Body circumferences
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
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
Time frame: Beginning (week 0) and End of the intervention (week 9)
Adverse effects
Time frame: During all intervention sessions (24 sessions, 8 weeks)
Assessment of performance status
Time frame: During all intervention sessions (24 sessions, 8 weeks)
Heart Function
Time frame: Beginning of the intervention (week 0)
Arterial disorder assessment
Time frame: Beginning of the intervention (week 0)
Physical activity and sedentary behaviors
Time frame: Beginning (week 0) and End of the intervention (week 9)
Subjective perception of effort
Time frame: During all intervention sessions (24 sessions, 8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: Yes. All participant data will be available with the exception of personal information
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Martins, PhD study director
Universidade Europeia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined exercise training in people with Breast Cancer, run by Associacao de Investigacao de Cuidados de Suporte em Oncologia at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention rate (time frame: End of the intervention (week 9)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.