Step by Step After Cancer (SBSAC)
Evaluating the Effectiveness of Supervised Practice or Distance Supervised Physical Activity (Walking) in the Overall Management of Fatigue in Breast Cancer Patients During Hormonal Therapy: Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Amiens, France, 80054
- CHU Amiens
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: supervised practice
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 |
|
|
Experimental: distance supervised physical activity
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
fatigue of the patient with QLQC-30
Time Frame: 6 weeks
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Global Quality of life with QLQC-30
Time Frame: 6 weeks
|
6 weeks
|
|
Activity level with IPAQ
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mathieu BOONE, MD, CHU Amiens
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2012_843_0023
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