Ignite Creation Date:
2024-05-06 @ 8:37 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02785861
Status:
RECRUITING
Last Update Posted:
2016-06-01
First Post:
2016-05-23
Brief Title:
Step by Step After Cancer
Sponsor:
Centre Hospitalier Universitaire Amiens
Organization:
Centre Hospitalier Universitaire Amiens
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:
RECRUITING
Status Verified Date:
2016-05
Last Known Status:
None
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 problemIt 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None