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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05071560
Other study ID # On4Rehab Pilot Trial
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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