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

NCT05071560 | Completed

• 1 other identifier: On4Rehab Pilot Trial
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (9)

• Retention rate

  The percentage of included patients who ended the program

  End of the intervention (week 9)

• Adherence rate

  Number of absences to the sessions and number of completed sessions

  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

  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

  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

  During all intervention sessions (24 sessions, 8 weeks)

• Intervention Recruitment Rate

  Number of invitations made versus accepted (invitation made by the assistant oncologist)

  Beginning of the intervention (week 0)

• Training safety

  Recording symptoms and adverse effects

  During all intervention sessions (24 sessions, 8 weeks)

• Absence and dropout

  Rate of absence from sessions and dropout of the program

  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

  End of the intervention (week 9)

Secondary Outcomes (19)

• Cardiopulmonary system fitness level and signs of disease assessment

  Beginning of the intervention (week 0)

• Lower limb strength

  Beginning (week 0) and End of the intervention (week 9)

• Upper limb strenght

  Beginning (week 0) and End of the intervention (week 9)

• Lower limbs flexibility level

  Beginning (week 0) and End of the intervention (week 9)

• Static balance

  Beginning (week 0) and End of the intervention (week 9)

Study Arms (2)

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

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

Other: Combined exercise training

Interventions

Combined exercise training OTHER

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).

Face-to-Face Group; Home-Based Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Associacao de Investigacao de Cuidados de Suporte em Oncologia: lead
• Centro Hospitalar de Vila Nova de Gaia/Espinho: collaborator
• Universidad Europea de Madrid: collaborator
• University Institute of Maia: collaborator

Study Sites (1)

Centro Hospitalar Vila Nova de Gaia/Espinho

Vila Nova de Gaia, Porto District, 4400, Portugal

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sandra Martins, PhD

  Universidade Europeia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot randomized controlled study

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: October 8, 2021
• Study Start: May 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

PT (1)