Effect of High-intensity Training on the Level of Physical Activity After Thoracoscopy Surgery: a Pilot Study
HITAT
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2018
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2018
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedFirst Posted
Study publicly available on registry
November 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedNovember 7, 2018
November 1, 2018
8 months
October 29, 2018
November 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate the impact of the intervention on the level of physical activity when returning home by actigraphy
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 Outcomes (2)
Evaluate the impact of the intervention on the level of physical activity by questionnaires.
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.
change from baseline questionnaire at 7 days after back home and at 30 days after back home
Study Arms (2)
High intensity exercise
EXPERIMENTALControl
ACTIVE COMPARATORInterventions
Cyclo-ergometer session in high intensity setting
Eligibility Criteria
You may qualify if:
- Indication of thoracoscopic surgery
- Autonomous mobilization (with or without auxiliary device)
You may not qualify if:
- Patient dependent on oxygen before the procedure
- chronic obstructive pulmonary disease patient with forced expiratory volume at one second \<50% predicted
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2018
First Posted
November 7, 2018
Study Start
November 1, 2018
Primary Completion
June 30, 2019
Study Completion
June 30, 2019
Last Updated
November 7, 2018
Record last verified: 2018-11