Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2026-01-03 @ 8:14 PM
Study NCT ID:
NCT02785861
Status:
UNKNOWN
Last Update Posted:
2016-06-01
First Post:
2016-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Step by Step After Cancer
Sponsor:
Centre Hospitalier Universitaire, Amiens
Organization:
Study Overview
Official Title:
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
Status:
UNKNOWN
Status Verified Date:
2016-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SBSAC
Brief Summary:
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.
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: