Physical Exercise for Breast Cancer Survivors: Face-to-face Versus Home-based

Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05071560
• Other study ID #: On4Rehab Pilot Trial
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: February 2022
• Source: Associacao de Investigacao de Cuidados de Suporte em Oncologia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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).

Locations

Country	Name	City	State
Portugal	Centro Hospitalar Vila Nova de Gaia/Espinho	Vila Nova De Gaia	Porto

Sponsors (4)

Lead Sponsor	Collaborator
Associacao de Investigacao de Cuidados de Suporte em Oncologia	Centro Hospitalar de Vila Nova de Gaia/Espinho, Universidad Europea de Madrid, University Institute of Maia

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention rate	The percentage of included patients who ended the program	End of the intervention (week 9)
Primary	Adherence rate	Number of absences to the sessions and number of completed sessions	End of the intervention (week 9)
Primary	Training tolerance regarding the duration of the exercise prescription	Recording adherence to the exercise prescription duration, possible adjustments and their reasons	During all intervention sessions (24 sessions, 8 weeks)
Primary	Training tolerance regarding the intensity of the exercise prescription	Recording adherence to the exercise prescription intensity, possible adjustments and their reasons	During all intervention sessions (24 sessions, 8 weeks)
Primary	Training tolerance regarding the volume of the exercise prescription	Recording adherence to the exercise prescription volume, possible adjustments and their reasons	During all intervention sessions (24 sessions, 8 weeks)
Primary	Intervention Recruitment Rate	Number of invitations made versus accepted (invitation made by the assistant oncologist)	Beginning of the intervention (week 0)
Primary	Training safety	Recording symptoms and adverse effects	During all intervention sessions (24 sessions, 8 weeks)
Primary	Absence and dropout	Rate of absence from sessions and dropout of the program	End of the intervention (week 9)
Primary	Level of satisfaction	Questionnaire at the end of the intervention, from 1 to 5, where 1 is not satisfied and 5 is very satisfied	End of the intervention (week 9)
Secondary	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	Beginning of the intervention (week 0)
Secondary	Lower limb strength	30´´Sit to stand test (number of repetitions)	Beginning (week 0) and End of the intervention (week 9)
Secondary	Upper limb strenght	Bilateral handgrip test with dynamometer (kg)	Beginning (week 0) and End of the intervention (week 9)
Secondary	Lower limbs flexibility level	Sit and Reach test (cm)	Beginning (week 0) and End of the intervention (week 9)
Secondary	Static balance	One Leg Stance test (time, s)	Beginning (week 0) and End of the intervention (week 9)
Secondary	Dynamic balance and agility	8 Foot up and go test (time, s)	Beginning (week 0) and End of the intervention (week 9)
Secondary	Assessment of aerobic capacity	6 Minute Walk Test	Beginning (week 0) and End of the intervention (week 9)
Secondary	Safety of the intervention	Number of serious and less serious occurrences	During all intervention sessions (24 sessions, 8 weeks)
Secondary	Body weight	Weight (Kg)	Beginning (week 0) and End of the intervention (week 9)
Secondary	Body height	Height (m)	Beginning (week 0) and End of the intervention (week 9)
Secondary	Body circumferences	Waist circumference (cm), hip circumference (cm), middle crural circumference (cm) and bicipital circumference (cm)	Beginning (week 0) and End of the intervention (week 9)
Secondary	Individual's overall satisfaction with life and general sense of personal well-being	Questionnaire QLQ-C30	Beginning (week 0) and End of the intervention (week 9)
Secondary	Individual's overall satisfaction with life and general sense of personal well-being, specific to breast cancer patient	Questionnaire QLQ-BR23	Beginning (week 0) and End of the intervention (week 9)
Secondary	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)	During all intervention sessions (24 sessions, 8 weeks)
Secondary	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)	During all intervention sessions (24 sessions, 8 weeks)
Secondary	Heart Function	Resting heart rate (bpm)	Beginning of the intervention (week 0)
Secondary	Arterial disorder assessment	Systolic and diastolic blood pressure assessment (mm/hg)	Beginning of the intervention (week 0)
Secondary	Physical activity and sedentary behaviors	Accelerometry	Beginning (week 0) and End of the intervention (week 9)
Secondary	Subjective perception of effort	Borg scale of perceived exertion ranging from 6 (very, very light effort) to 20 (maximum exertion)	During all intervention sessions (24 sessions, 8 weeks)