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Step by Step After Cancer (SBSAC)

C

Centre Hospitalier Universitaire, Amiens

Status

Enrolling

Conditions

Breast Cancer

Treatments

Behavioral: distance supervised physical activity
Behavioral: supervision of physical activity

Study type

Interventional

Funder types

Other

Identifiers

NCT02785861
PI2012_843_0023

Details and patient eligibility

About

After treatment, women want to regain a 'normal' lifestyle while some factors interfere as chronic fatigue. In the absence of anemia, fatigue is often a consequence of physical deconditioning . The following protocol will focus at this problem.It will consist of a brisk walking program twice a week over a period of 6 weeks, at an intensity of 60% of HR pic during 20 minutes.

Full description

Pinto and colleagues, for a walking level from 55 to 65% HRmax, estimated a reduction of fatigue in post treatment. Supervised exercise show greater adherence to short-term practice at home. However, there are a growing number of studies suggesting a practice at home, the most activity being walking. The authors do not justify the choice of the type of supervision. But physical activity with a professional and / or group in a specific place definitely has different effects in relation to practice at home. Segal and his colleagues in 2001 for the first time wished to compare the two types of supervision. The results are in favor of supervised exercise. The training was identical. However, to answer the five weekly sessions requested, the patient group had to complete two supervised practice sessions at home. So, the investigators really can not quantify the difference in impact between home practice and supervised practice. In a meta-analysis, Velthuis and colleagues conclude a significant difference in fatigue during treatment for a supervised aerobic exercise against a home that does not show significant difference. If the training is the same in both situations, the investigators should not find any difference in physiologic responses. However, the psychological impact can vary from one situation to another.

The following protocol will focus at this problem. It will consist of a brisk walking program twice a week over a period of 6 weeks, at an intensity of 60% of HR pic during 20 minutes.

Biweekly session from 60% of the heart rate pic during 20 minutes will be proposed.

Each patient of supervised walking group will meet the student each session. Each patient of home-based walking group will be called by phone every week by the student to inform the patient of the progress of the training, collect the work and answer any questions.

Enrollment

40 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Sex: female
  • Age less than or equal to 75 years
  • Breast cancer stage I to III
  • Chemotherapy and / or radiotherapy adjuvant completed
  • Hormone treatments ongoing

Exclusion criteria

  • Age over 75 years
  • Breast cancer stage IV and O
  • Anemia, Cardiac arrhythmia, asthma, hypertension or uncontrolled diabetes, coronary artery disease or severe respiratory disease, psycho-cognitive may disturb walking program

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

supervised practice
Experimental group
Description:
brisk walking program twice a week over a period of 6 weeks, at an intensity of 60% of HR pic during 20 minutes. Biweekly session from 60% of the heart rate pic during 20 minutes will be proposed. Each patient of supervised walking group will meet the student each session
Treatment:
Behavioral: supervision of physical activity
distance supervised physical activity
Experimental group
Description:
brisk walking program twice a week over a period of 6 weeks, at an intensity of 60% of HR pic during 20 minutes. Biweekly session from 60% of the heart rate pic during 20 minutes will be proposed. Each patient of home-based walking group will be called by phone every week by the student to inform the patient of the progress of the training, collect the work and answer any questions
Treatment:
Behavioral: distance supervised physical activity

Trial contacts and locations

1

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Central trial contact

Mathieu BOONE, MD

Data sourced from clinicaltrials.gov

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