Back to resultsPhysical Exercise for Breast Cancer Survivors: Face-to-face Versus Home-based (On4Rehab)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Combined exercise training
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
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
Sites / Locations
- Centro Hospitalar Vila Nova de Gaia/Espinho
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Face-to-Face Group
Home-Based Group
Arm Description
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
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
Outcomes
Primary Outcome Measures
Retention rate
The percentage of included patients who ended the program
Adherence rate
Number of absences to the sessions and number of completed sessions
Training tolerance regarding the duration of the exercise prescription
Recording adherence to the exercise prescription duration, possible adjustments and their reasons
Training tolerance regarding the intensity of the exercise prescription
Recording adherence to the exercise prescription intensity, possible adjustments and their reasons
Training tolerance regarding the volume of the exercise prescription
Recording adherence to the exercise prescription volume, possible adjustments and their reasons
Intervention Recruitment Rate
Number of invitations made versus accepted (invitation made by the assistant oncologist)
Training safety
Recording symptoms and adverse effects
Absence and dropout
Rate of absence from sessions and dropout of the program
Level of satisfaction
Questionnaire at the end of the intervention, from 1 to 5, where 1 is not satisfied and 5 is very satisfied
Secondary Outcome Measures
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
Lower limb strength
30´´Sit to stand test (number of repetitions)
Upper limb strenght
Bilateral handgrip test with dynamometer (kg)
Lower limbs flexibility level
Sit and Reach test (cm)
Static balance
One Leg Stance test (time, s)
Dynamic balance and agility
8 Foot up and go test (time, s)
Assessment of aerobic capacity
6 Minute Walk Test
Safety of the intervention
Number of serious and less serious occurrences
Body weight
Weight (Kg)
Body height
Height (m)
Body circumferences
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
Questionnaire QLQ-C30
Individual's overall satisfaction with life and general sense of personal well-being, specific to breast cancer patient
Questionnaire QLQ-BR23
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)
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)
Heart Function
Resting heart rate (bpm)
Arterial disorder assessment
Systolic and diastolic blood pressure assessment (mm/hg)
Physical activity and sedentary behaviors
Accelerometry
Subjective perception of effort
Borg scale of perceived exertion ranging from 6 (very, very light effort) to 20 (maximum exertion)
Full Information
NCT ID
NCT05071560
First Posted
July 4, 2021
Last Updated
February 27, 2022
Sponsor
Associacao de Investigacao de Cuidados de Suporte em Oncologia
Collaborators
Centro Hospitalar de Vila Nova de Gaia/Espinho, Universidad Europea de Madrid, University Institute of Maia
1. Study Identification
Unique Protocol Identification Number
NCT05071560
Brief Title
Physical Exercise for Breast Cancer Survivors: Face-to-face Versus Home-based
Acronym
On4Rehab
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Associacao de Investigacao de Cuidados de Suporte em Oncologia
Collaborators
Centro Hospitalar de Vila Nova de Gaia/Espinho, Universidad Europea de Madrid, University Institute of Maia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot randomized controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Face-to-Face Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Home-Based Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Combined exercise training
Intervention Description
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).
Primary Outcome Measure Information:
Title
Retention rate
Description
The percentage of included patients who ended the program
Time Frame
End of the intervention (week 9)
Title
Adherence rate
Description
Number of absences to the sessions and number of completed sessions
Time Frame
End of the intervention (week 9)
Title
Training tolerance regarding the duration of the exercise prescription
Description
Recording adherence to the exercise prescription duration, possible adjustments and their reasons
Time Frame
During all intervention sessions (24 sessions, 8 weeks)
Title
Training tolerance regarding the intensity of the exercise prescription
Description
Recording adherence to the exercise prescription intensity, possible adjustments and their reasons
Time Frame
During all intervention sessions (24 sessions, 8 weeks)
Title
Training tolerance regarding the volume of the exercise prescription
Description
Recording adherence to the exercise prescription volume, possible adjustments and their reasons
Time Frame
During all intervention sessions (24 sessions, 8 weeks)
Title
Intervention Recruitment Rate
Description
Number of invitations made versus accepted (invitation made by the assistant oncologist)
Time Frame
Beginning of the intervention (week 0)
Title
Training safety
Description
Recording symptoms and adverse effects
Time Frame
During all intervention sessions (24 sessions, 8 weeks)
Title
Absence and dropout
Description
Rate of absence from sessions and dropout of the program
Time Frame
End of the intervention (week 9)
Title
Level of satisfaction
Description
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)
Secondary Outcome Measure Information:
Title
Cardiopulmonary system fitness level and signs of disease assessment
Description
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)
Title
Lower limb strength
Description
30´´Sit to stand test (number of repetitions)
Time Frame
Beginning (week 0) and End of the intervention (week 9)
Title
Upper limb strenght
Description
Bilateral handgrip test with dynamometer (kg)
Time Frame
Beginning (week 0) and End of the intervention (week 9)
Title
Lower limbs flexibility level
Description
Sit and Reach test (cm)
Time Frame
Beginning (week 0) and End of the intervention (week 9)
Title
Static balance
Description
One Leg Stance test (time, s)
Time Frame
Beginning (week 0) and End of the intervention (week 9)
Title
Dynamic balance and agility
Description
8 Foot up and go test (time, s)
Time Frame
Beginning (week 0) and End of the intervention (week 9)
Title
Assessment of aerobic capacity
Description
6 Minute Walk Test
Time Frame
Beginning (week 0) and End of the intervention (week 9)
Title
Safety of the intervention
Description
Number of serious and less serious occurrences
Time Frame
During all intervention sessions (24 sessions, 8 weeks)
Title
Body weight
Description
Weight (Kg)
Time Frame
Beginning (week 0) and End of the intervention (week 9)
Title
Body height
Description
Height (m)
Time Frame
Beginning (week 0) and End of the intervention (week 9)
Title
Body circumferences
Description
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)
Title
Individual's overall satisfaction with life and general sense of personal well-being
Description
Questionnaire QLQ-C30
Time Frame
Beginning (week 0) and End of the intervention (week 9)
Title
Individual's overall satisfaction with life and general sense of personal well-being, specific to breast cancer patient
Description
Questionnaire QLQ-BR23
Time Frame
Beginning (week 0) and End of the intervention (week 9)
Title
Adverse effects
Description
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)
Title
Assessment of performance status
Description
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)
Title
Heart Function
Description
Resting heart rate (bpm)
Time Frame
Beginning of the intervention (week 0)
Title
Arterial disorder assessment
Description
Systolic and diastolic blood pressure assessment (mm/hg)
Time Frame
Beginning of the intervention (week 0)
Title
Physical activity and sedentary behaviors
Description
Accelerometry
Time Frame
Beginning (week 0) and End of the intervention (week 9)
Title
Subjective perception of effort
Description
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)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Martins, PhD
Organizational Affiliation
Universidade Europeia
Official's Role
Study Director
Facility Information:
Facility Name
Centro Hospitalar Vila Nova de Gaia/Espinho
City
Vila Nova De Gaia
State/Province
Porto
ZIP/Postal Code
4400
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All participant data will be available with the exception of personal information
Learn more about this trial
Physical Exercise for Breast Cancer Survivors: Face-to-face Versus Home-based
We'll reach out to this number within 24 hrs