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Completed

NCT Number: NCT05071560

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centro Hospitalar Vila Nova de Gaia/Espinho

Vila Nova de Gaia, Porto District, 4400, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Retention rate

    Time frame: End of the intervention (week 9)

    The percentage of included patients who ended the program

  2. Adherence rate

    Time frame: End of the intervention (week 9)

    Number of absences to the sessions and number of completed sessions

  3. 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

  4. 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

  5. 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

  6. Intervention Recruitment Rate

    Time frame: Beginning of the intervention (week 0)

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

  7. Training safety

    Time frame: During all intervention sessions (24 sessions, 8 weeks)

    Recording symptoms and adverse effects

  8. Absence and dropout

    Time frame: End of the intervention (week 9)

    Rate of absence from sessions and dropout of the program

  9. 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

Secondary outcomes

  1. Cardiopulmonary system fitness level and signs of disease assessment

    Time frame: Beginning of the intervention (week 0)

    Measurement of maximum VO2 by a cardiopulmonary exercise test and assessment of cardiopulmonary risk factors or disease

  2. Lower limb strength

    Time frame: Beginning (week 0) and End of the intervention (week 9)

    30´´Sit to stand test (number of repetitions)

  3. Upper limb strenght

    Time frame: Beginning (week 0) and End of the intervention (week 9)

    Bilateral handgrip test with dynamometer (kg)

  4. Lower limbs flexibility level

    Time frame: Beginning (week 0) and End of the intervention (week 9)

    Sit and Reach test (cm)

  5. Static balance

    Time frame: Beginning (week 0) and End of the intervention (week 9)

    One Leg Stance test (time, s)

  6. Dynamic balance and agility

    Time frame: Beginning (week 0) and End of the intervention (week 9)

    8 Foot up and go test (time, s)

  7. Assessment of aerobic capacity

    Time frame: Beginning (week 0) and End of the intervention (week 9)

    6 Minute Walk Test

  8. Safety of the intervention

    Time frame: During all intervention sessions (24 sessions, 8 weeks)

    Number of serious and less serious occurrences

  9. Body weight

    Time frame: Beginning (week 0) and End of the intervention (week 9)

    Weight (Kg)

  10. Body height

    Time frame: Beginning (week 0) and End of the intervention (week 9)

    Height (m)

  11. Body circumferences

    Time frame: Beginning (week 0) and End of the intervention (week 9)

    Waist circumference (cm), hip circumference (cm), middle crural circumference (cm) and bicipital circumference (cm)

  12. 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)

    Questionnaire QLQ-C30

  13. 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)

    Questionnaire QLQ-BR23

  14. Adverse effects

    Time frame: During all intervention sessions (24 sessions, 8 weeks)

    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)

  15. Assessment of performance status

    Time frame: During all intervention sessions (24 sessions, 8 weeks)

    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)

  16. Heart Function

    Time frame: Beginning of the intervention (week 0)

    Resting heart rate (bpm)

  17. Arterial disorder assessment

    Time frame: Beginning of the intervention (week 0)

    Systolic and diastolic blood pressure assessment (mm/hg)

  18. Physical activity and sedentary behaviors

    Time frame: Beginning (week 0) and End of the intervention (week 9)

    Accelerometry

  19. Subjective perception of effort

    Time frame: During all intervention sessions (24 sessions, 8 weeks)

    Borg scale of perceived exertion ranging from 6 (very, very light effort) to 20 (maximum exertion)

Sponsors and collaborators

Lead sponsor

Associacao de Investigacao de Cuidados de Suporte em Oncologia

Other

Collaborators

  • Centro Hospitalar de Vila Nova de Gaia/Espinho
  • Universidad Europea de Madrid
  • University Institute of Maia

Registry information

Official study title

Pilot Study of Supervised Adapted Physical Exercise in Women With Breast Cancer After Treatment - Face-to-face Context vs Online Home Based

Acronym: On4Rehab

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 8, 2021
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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