- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03734276
Effect of High-intensity Training on the Level of Physical Activity After Thoracoscopy Surgery: a Pilot Study (HITAT)
Goal of this study is to evaluate management with high intensity re-entrainment during the postoperative hospital phase.
This type of early treatment with as little intervention time has so far never been done. The investigators therefore want to carry out this feasibility study in order to collect the data needed to calculate the number of randomized control trial. Investigators will also evaluate the feasibility of this project concerning recruitment, intervention in the hospital phase and data collection once the return home. The evaluation of the activity will be done one month after the return to home by means of a actigraphy of one week.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Olivier Contal, phD
- Phone Number: +41763692445
- Email: olivier.contal@hesav.ch
Study Contact Backup
- Name: Mélissa Lecocq, MscStudent
- Email: melissa.lecocq@master.hes-so.ch
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Indication of thoracoscopic surgery
- Autonomous mobilization (with or without auxiliary device)
Exclusion Criteria:
- Patient dependent on oxygen before the procedure
- chronic obstructive pulmonary disease patient with forced expiratory volume at one second <50% predicted
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
|
Usual care
|
Experimental: High intensity exercise
|
Cyclo-ergometer session in high intensity setting
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the impact of the intervention on the level of physical activity when returning home by actigraphy
Time Frame: change from baseline number of steps at 7 days after back home and at 30 days after back home
|
Number of steps per day during 5 days
|
change from baseline number of steps at 7 days after back home and at 30 days after back home
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the impact of the intervention on the level of physical activity by questionnaires.
Time Frame: change from baseline questionnaire at 7 days after back home and at 30 days after back home
|
"Inventaire du Soi Physique - 6" questionnaire
|
change from baseline questionnaire at 7 days after back home and at 30 days after back home
|
Evaluate the impact of the intervention on the level of physical activity by questionnaires.
Time Frame: change from baseline questionnaire at 7 days after back home and at 30 days after back home
|
"International Physical Activity Questionnaire-- Short Form
|
change from baseline questionnaire at 7 days after back home and at 30 days after back home
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CERVD 2018-01511
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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