Functional and Social PerformanceNCT02962193
Evaluation of Functional and Social Changes After Bariatric Surgery
An observational study of Functional and Social Performance, run by Western Galilee Hospital-Nahariya.
Trial summary
After bariatric surgery there are big changes in the daily functions, activities and social participation of the patients. This is a prospective study that examine daily performance and daily participation by questionnaires, before and after bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional and Social Performance
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2017
- Phase
- Observational
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Overweight patients who are fit for surgery .
Who may be able to join
- Overweight patients who are fit for surgery .
Who cannot join
- Children, Neurological patients, amputations
About this study
After bariatric surgery there are big changes in the daily functions, activities and social participation of the patients.
This is a prospective study that examine daily performance and daily participation by questionnaires, before and after bariatric surgery.
- Conditions
- Functional and Social Performance
- Keywords
- ADL, Bariatric surgery, Daily participation
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of participation before and after surgery
Measured: the patient will answer the questionnaire before and after (3 months, 6 months) surgery.
Secondary outcomes (4)
sexuality questionnaire
Measured: the patient will answer the questionnaire before and after (3 months, 6 months) surgery.
activity daily questionnaire
Measured: the patient will answer the questionnaire before and after (3 months, 6 months) surgery.
range of motion (flexion of knee and thigh in degrees)
Measured: measure will be taken before and after (3 months, 6 months) surgery.
circumferences mesurement (knee, thigh and waist) in centimeters
Measured: measure will be taken before and after (3 months, 6 months) surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional and Social PerformanceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Farraj Moaad, Western Galilee Hospital-Nahariya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962193
- Sponsor's protocol ID
- 0043-16-NHR
- Status last verified
- Nov 2016
- First submitted
- 6 Nov 2016
- Last updated
- 11 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Functional and Social Changes After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02962193
- Acronym / sponsor ID
- 0043-16-NHR
- Conditions
- Functional and Social Performance
- Keywords
- ADL, Bariatric surgery, Daily participation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (estimated)
- First posted
- 11 Nov 2016 (estimated)
- 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.
After bariatric surgery there are big changes in the daily functions, activities and social participation of the patients.
This is a prospective study that examine daily performance and daily participation by questionnaires, before and after bariatric surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Overweight patients who are fit for surgery .
Key inclusion criteria (1 listed)
- Overweight patients who are fit for surgery .
Key exclusion criteria (1 listed)
- Children, Neurological patients, amputations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The change of participation before and after surgery
Time frame: the patient will answer the questionnaire before and after (3 months, 6 months) surgery.
4 secondary outcomes
sexuality questionnaire
Time frame: the patient will answer the questionnaire before and after (3 months, 6 months) surgery.
activity daily questionnaire
Time frame: the patient will answer the questionnaire before and after (3 months, 6 months) surgery.
range of motion (flexion of knee and thigh in degrees)
Time frame: measure will be taken before and after (3 months, 6 months) surgery.
circumferences mesurement (knee, thigh and waist) in centimeters
Time frame: measure will be taken before and after (3 months, 6 months) surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2016.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional and Social Performance, run by Western Galilee Hospital-Nahariya.
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 1 inclusion and 1 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 11 Nov 2016. 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?
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?
The change of participation before and after surgery (time frame: the patient will answer the questionnaire before and after (3 months, 6 months) 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 11 Nov 2016.