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Trial record 92 of 3068 for:    Recruiting, Not yet recruiting, Available Studies | Physical

Effect of High-intensity Training on the Level of Physical Activity After Thoracoscopy Surgery: a Pilot Study (HITAT)

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ClinicalTrials.gov Identifier: NCT03734276
Recruitment Status : Not yet recruiting
First Posted : November 7, 2018
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
HEDSV ( Haute Ecole de Santé Vaud )

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.


Condition or disease Intervention/treatment Phase
Rehabilitation Thoracic Surgery Physical Activity Other: High intensity activity Other: control arm Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: feasibility Study with randomized control trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of High-intensity Training on the Level of Physical Activity After Thoracoscopy Surgery: a Pilot Study
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High intensity exercise Other: High intensity activity
Cyclo-ergometer session in high intensity setting

Active Comparator: Control Other: control arm
Usual care




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03734276


Contacts
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Contact: Olivier Contal, phD +41763692445 olivier.contal@hesav.ch
Contact: Mélissa Lecocq, MscStudent melissa.lecocq@master.hes-so.ch

Sponsors and Collaborators
Haute Ecole de Santé Vaud

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Responsible Party: Haute Ecole de Santé Vaud
ClinicalTrials.gov Identifier: NCT03734276     History of Changes
Other Study ID Numbers: CERVD 2018-01511
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No