Lung CancerPREPACHIRNCT04667065
Evaluation of a Remotely Guided Physical Preparation by a Physical Activity Teacher Adapted With the Help of a Smartwatch Before Bronchial Cancer Surgery
A study testing Physical activity in people with Lung Cancer, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
This is a study of a preoperative rehabilitation program with remotely guided high-intensity exercises by physical activity teachers adapted to a smartwatch in patients with operable lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2021to 1 Jan 2023
- 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
- Major patient, age ≥ 18
- Patient with non-small cell operable bronchial cancer without indication of neo-adjuvant chemotherapy
- Affiliated with a social security plan
- VEMS < 80% and/or DLCO<80%
- High-intensity training achievable for at least 10 days before surgery
- Acceptant to participate in the protocol
Show all 9Show fewer
- Ability to follow the STIMUL program of education focused on adapted physical activity
- Have a smartphone that can download the mobile app
- have the ability to understand, read and write French
Who cannot join
- Patient unable to consent: under guardianship or curatorship
- Patient refusing surgery
- Non-operable patient due to comorbidities or unseable tumour
- Poor understanding of the smartwatch
- Severe cognitive or psychiatric disorders
- Pregnancy in progress
Trial locations and contacts
1 site in 1 country.
About this study
This is a study of a preoperative rehabilitation program with remotely guided high-intensity exercises by physical activity teachers adapted to a smartwatch in patients with operable lung cancer.
- Conditions
- Lung Cancer
- Being tested
- Physical activity
- Keywords
- smartwatch, lung cancer operation, physical exercices
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityOther
Physical activity with the remotely guidance of physical activity teachers
| Study group | Role | What they receive |
|---|---|---|
| Physical activity with smartwatch before bronchial cancer surgery | Other | Not described Receives: Other: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of VO2 max .
comparison of VO2 max at inclusion and one day before surgery
Measured: 1 day before surgery
Secondary outcomes (9)
Number of patients who used the remotely guided physical preparation
Measured: one day before surgery
maximum distance covered in the 6-minute walking t
Measured: one day before surgery
post-surgery complications
Measured: At 1 month and 3 months
number of individuals who participated in the physical activity program
Measured: one day before surgery
post surgery intubation duration
Measured: At 1 month
number of days at hospital
Measured: At 3 months
number of days with oxygen
Measured: At 1 month and 3 months
(forced expiratory volume
Measured: At 1 month and 3 months
capacity of carbon monoxide
Measured: At 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start1 Mar 2021
- Primary completion1 Jul 2021
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patient with non-small cell bronchial cancer with indication of curative surgical resection.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667065
- Sponsor's protocol ID
- PREPACHIR
- Acronym
- PREPACHIR
- Status last verified
- May 2023
- First submitted
- 25 Nov 2020
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Remotely Guided Physical Preparation by a Physical Activity Teacher Adapted With the Help of a Smartwatch Before Bronchial Cancer Surgery
- ClinicalTrials.gov ID
- NCT04667065
- Acronym / sponsor ID
- PREPACHIR / PREPACHIR
- Conditions
- Lung Cancer
- Keywords
- smartwatch, lung cancer operation, physical exercices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 14 Dec 2020 (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.
This is a study of a preoperative rehabilitation program with remotely guided high-intensity exercises by physical activity teachers adapted to a smartwatch in patients with operable lung cancer.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patient with non-small cell bronchial cancer with indication of curative surgical resection.
| Arm | Type | Receives |
|---|---|---|
| Physical activity with smartwatch before bronchial cancer surgery | Other | Other: Physical activity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Major patient, age ≥ 18
- Patient with non-small cell operable bronchial cancer without indication of neo-adjuvant chemotherapy
- Affiliated with a social security plan
- VEMS < 80% and/or DLCO<80%
- High-intensity training achievable for at least 10 days before surgery
Key exclusion criteria (6 listed)
- Patient unable to consent: under guardianship or curatorship
- Patient refusing surgery
- Non-operable patient due to comorbidities or unseable tumour
- Poor understanding of the smartwatch
- Severe cognitive or psychiatric disorders
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 |
|---|---|---|
| Physical activityPhysical activity with the remotely guidance of physical activity teachers | Other | Physical activity with smartwatch before bronchial cancer surgery |
Primary outcome
Measure of VO2 max .
Time frame: 1 day before surgery
comparison of VO2 max at inclusion and one day before surgery
9 secondary outcomes
Number of patients who used the remotely guided physical preparation
Time frame: one day before surgery
maximum distance covered in the 6-minute walking t
Time frame: one day before surgery
post-surgery complications
Time frame: At 1 month and 3 months
number of individuals who participated in the physical activity program
Time frame: one day before surgery
post surgery intubation duration
Time frame: At 1 month
number of days at hospital
Time frame: At 3 months
number of days with oxygen
Time frame: At 1 month and 3 months
(forced expiratory volume
Time frame: At 1 month and 3 months
capacity of carbon monoxide
Time frame: At 1 month and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Lung Cancer, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
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 9 inclusion and 6 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: finished, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of VO2 max . (time frame: 1 day before surgery). 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 23 May 2023.