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

November 6, 2018 updated by: Haute Ecole de Santé Vaud

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

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: control arm
Usual care
Experimental: High intensity exercise
Other: High intensity activity
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

This is where you will find people and organizations involved with this study.

Sponsor

Haute Ecole de Santé Vaud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2018

Primary Completion (Anticipated)

June 30, 2019

Study Completion (Anticipated)

June 30, 2019

Study Registration Dates

First Submitted

October 29, 2018

First Submitted That Met QC Criteria

November 6, 2018

First Posted (Actual)

November 7, 2018

Study Record Updates

Last Update Posted (Actual)

November 7, 2018

Last Update Submitted That Met QC Criteria

November 6, 2018

Last Verified

November 1, 2018

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Subscribe