RehabilitationHITATNCT03734276
Effect of High-intensity Training on the Level of Physical Activity After Thoracoscopy Surgery: a Pilot Study
A study testing High intensity activity in people with Rehabilitation and Thoracic Surgery, run by Haute Ecole de Santé Vaud.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rehabilitation, Thoracic Surgery, Physical Activity
- What is being tested?
- High intensity activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication of thoracoscopic surgery
- Autonomous mobilization (with or without auxiliary device)
Who cannot join
- Patient dependent on oxygen before the procedure
- chronic obstructive pulmonary disease patient with forced expiratory volume at one second <50% predicted
Trial locations and contacts
No sites are listed yet.
Mélissa Lecocq, MscStudent contact
About this study
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.
- Conditions
- Rehabilitation, Thoracic Surgery, Physical Activity
- Being tested
- High intensity activity, control arm
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity activityOther
Cyclo-ergometer session in high intensity setting
control armOther
Usual care
| Study group | Role | What they receive |
|---|---|---|
| High intensity exercise | Experimental | Not described Receives: Other: High intensity activity |
| Control | Active comparator | Not described Receives: Other: control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
"Inventaire du Soi Physique - 6" questionnaire
Measured: 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.
"International Physical Activity Questionnaire-- Short Form
Measured: change from baseline questionnaire at 7 days after back home and at 30 days after back home
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start1 Nov 2018 (estimated)
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- feasibility Study with randomized control trial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haute Ecole de Santé Vaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734276
- Sponsor's protocol ID
- CERVD 2018-01511
- Acronym
- HITAT
- Status last verified
- Nov 2018
- First submitted
- 29 Oct 2018
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-intensity Training on the Level of Physical Activity After Thoracoscopy Surgery: a Pilot Study
- ClinicalTrials.gov ID
- NCT03734276
- Acronym / sponsor ID
- HITAT / CERVD 2018-01511
- Conditions
- Rehabilitation, Thoracic Surgery, Physical Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Haute Ecole de Santé VaudUniversity, hospital or other
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 7 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- feasibility Study with randomized control trial
| Arm | Type | Receives |
|---|---|---|
| High intensity exercise | Experimental | Other: High intensity activity |
| Control | Active comparator | Other: control arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Indication of thoracoscopic surgery
- Autonomous mobilization (with or without auxiliary device)
Key exclusion criteria (2 listed)
- Patient dependent on oxygen before the procedure
- chronic obstructive pulmonary disease patient with forced expiratory volume at one second <50% predicted
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity activityCyclo-ergometer session in high intensity setting | Other | High intensity exercise |
| control armUsual care | Other | Control |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mélissa Lecocq, MscStudent contact
Questions about this trial
What is this clinical trial studying?
A study testing High intensity activity in people with Rehabilitation and Thoracic Surgery, run by Haute Ecole de Santé Vaud.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier Contal, phD (+41763692445, olivier.contal@hesav.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.