SurgeryPrehab-ConnectNCT03363009
Contribution of Connected Devices in the Follow-up of the Observance of a Prehabilitation Program
A study testing Optimized group in people with Surgery, run by Hopital Foch at 1 site in France.
Trial summary
Poor physical performance and poor nutritional status increase the risk of complications after major surgery. Prehabilitation is the process of enhancing the functional capacity before surgery. A major problem is the adherence of the patients to the physical program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Optimized group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2018to 31 Dec 2020
- 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
- Patients aged over 18
- Patients scheduled for a surgical procedure 4 weeks later (more or less 1 week) after initial assessment
- Patients having consented to participate
- Patients benefiting from a social security system.
Who cannot join
- Pregnant or lactating women
- Inability to perform physical assessment
- Dependant patients
- Inability to complete questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Poor physical performance and poor nutritional status increase the risk of complications after major surgery. Prehabilitation is the process of enhancing the functional capacity before surgery.
A major problem is the adherence of the patients to the physical program. A controlled randomized study is therefore proposed to determine the impact of coaching on functional exercise capacity. All patients will wear connected devices to measure their physical activity. They will be randomized to either a group in which coaching will be adapted to the physical activity, or a control group in which coaching is performed without any information about physical activity
- Conditions
- Surgery
- Being tested
- Optimized group, Control group
- Keywords
- prehabilitation, connected devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimized groupDevice
The data provided by the connected devices is analyzed daily; the patient receives a phone call in case of no realization of the objectives.
Control groupDevice
Data will be recorded but not analyzed daily during the period of participation. The patient receives a phone call one time a week to answer possible questions and modify the prescription of physical activity if need.
| Study group | Role | What they receive |
|---|---|---|
| Connected device with close following | Experimental | Data from connected devices (arm wrist watch, connected monitor of blood pressure, connected thermometer and pulse oximeter) will be analyzed every day and used for coaching Receives: Device: Optimized group |
| Connected device with standard coaching | Other | Data from connected devices (arm wrist watch, connected monitor of blood pressure, connected thermometer and pulse oximeter) will be saved but not used for coaching Receives: Device: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
6 minutes walk test
Measured: 2 months
Functional capacity
Maximal oxygen consumption
Measured: 2 months
Secondary outcomes (2)
Critical events
Number of critical events detected using the connected devices
Measured: 2 months
Postoperative complications
Number of complication during the 2 months following surgery according to Dindo and Clavien classification
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start4 Dec 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Why it stopped: Logistical issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barizien Nicolas, MD, Principal investigator, Hopital FochMarc Fischler, Study chair, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363009
- Sponsor's protocol ID
- 2016/32
- Other IDs
- 2016- A01086-45
- Acronym
- Prehab-Connect
- Status last verified
- Mar 2021
- First submitted
- 23 Nov 2017
- Last updated
- 16 Mar 2021
- 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 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Connected Devices in the Follow-up of the Observance of a Prehabilitation Program
- ClinicalTrials.gov ID
- NCT03363009
- Acronym / sponsor ID
- Prehab-Connect / 2016/32
- Conditions
- Surgery
- Keywords
- prehabilitation, connected devices
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Logistical issues
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 5 Dec 2017 (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.
Poor physical performance and poor nutritional status increase the risk of complications after major surgery. Prehabilitation is the process of enhancing the functional capacity before surgery.
A major problem is the adherence of the patients to the physical program. A controlled randomized study is therefore proposed to determine the impact of coaching on functional exercise capacity. All patients will wear connected devices to measure their physical activity. They will be randomized to either a group in which coaching will be adapted to the physical activity, or a control group in which coaching is performed without any information about physical activity
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connected device with close following | Experimental | Device: Optimized groupData from connected devices (arm wrist watch, connected monitor of blood pressure, connected thermometer and pulse oximeter) will be analyzed every day and used for coaching |
| Connected device with standard coaching | Other | Device: Control groupData from connected devices (arm wrist watch, connected monitor of blood pressure, connected thermometer and pulse oximeter) will be saved but not used for coaching |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged over 18
- Patients scheduled for a surgical procedure 4 weeks later (more or less 1 week) after initial assessment
- Patients having consented to participate
- Patients benefiting from a social security system.
Key exclusion criteria (4 listed)
- Pregnant or lactating women
- Inability to perform physical assessment
- Dependant patients
- Inability to complete questionnaires
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 |
|---|---|---|
| Optimized groupThe data provided by the connected devices is analyzed daily; the patient receives a phone call in case of no realization of the objectives. | Device | Connected device with close following |
| Control groupData will be recorded but not analyzed daily during the period of participation. The patient receives a phone call one time a week to answer possible questions and modify the prescription of physical activity if need. | Device | Connected device with standard coaching |
Primary outcome
Functional capacity
Time frame: 2 months
6 minutes walk test
Functional capacity
Time frame: 2 months
Maximal oxygen consumption
2 secondary outcomes
Critical events
Time frame: 2 months
Postoperative complications
Time frame: 2 months
Results and safety
The study was stopped early (reason given: Logistical issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
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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.
Barizien Nicolas, MD principal investigator
Hopital Foch
Marc Fischler study chair
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimized group in people with Surgery, run by Hopital Foch 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 16 Mar 2021. 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 was stopped early (reason given: Logistical issues). Results are not available in the source record.
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?
Functional capacity (time frame: 2 months). The study lists 2 primary outcomes in all. 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 16 Mar 2021.