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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03734276
Other study ID # CERVD 2018-01511
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 1, 2018
Est. completion date June 30, 2019

Study information

Verified date November 2018
Source HEDSV
Contact Olivier Contal, phD
Phone +41763692445
Email olivier.contal@hesav.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date June 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
High intensity activity
Cyclo-ergometer session in high intensity setting
control arm
Usual care

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Haute Ecole de Santé Vaud

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Evaluate the impact of the intervention on the level of physical activity by questionnaires. "Inventaire du Soi Physique - 6" questionnaire change from baseline questionnaire at 7 days after back home and at 30 days after back home
Secondary Evaluate the impact of the intervention on the level of physical activity by questionnaires. "International Physical Activity Questionnaire-- Short Form change from baseline questionnaire at 7 days after back home and at 30 days after back home
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