Knee OsteoarthritisNCT02681133
How is Physical Activity Level and Educational Expectations of Patient With Knee Osteoarthritis : Epidemiological Study in Spa Therapy
An observational study of Knee Osteoarthritis and Physical Activity, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The primary purpose is to evaluate the level of physical activity in patients with knee osteoarthritis in a spa treatment and doing epidemiological study about this patient. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis, Physical Activity
- What is being tested?
- Epidemiological study Survey
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to Sep 2015
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with knee pain reported to osteoarthritis
Who may be able to join
- Patients, male or female, aged 50 to 75 years.
- Patients with knee pain reported to osteoarthritis
- Patient affiliated to a social security scheme (beneficiary entitled)
- Patient registered spa
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The primary purpose is to evaluate the level of physical activity in patients with knee osteoarthritis in a spa treatment and doing epidemiological study about this patient.
Read the detailed description
Explain the physical activity level of knee osteoarthritis by socio-demographic, clinical variables, barriers and facilitators of regular physical activity practice, fears and beliefs about their condition, functional limitations and physical inactivity.
- Conditions
- Knee Osteoarthritis, Physical Activity
- Being tested
- Epidemiological study Survey
- Keywords
- Physical activity level, Knee osteoarthritis, Non pharmacological treatment, Survey, Socio-demographic, clinical variables, Barriers, facilitators Fears and beliefs, Function
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidemiological study SurveyOther
| Study group | Role | What they receive |
|---|---|---|
| patients with knee pain | Not described Receives: Other: Epidemiological study Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of physical activity with IPAQ short form
Measured: During the spa treatment
Secondary outcomes (4)
Socio-demographic variables as assessed by : age, sex, family situation, level of study
Measured: During the spa treatment
Fears and beliefs as assessed by KOFBeQ
Measured: During the spa treatment
Pain as assessed by EVA
Measured: During the spa treatment
Functional status as assessed by WOMAC
Measured: During the spa treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startSep 2014
- Primary completionJan 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Innovatherm
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681133
- Sponsor's protocol ID
- CHU-0256
- Status last verified
- Feb 2016
- First submitted
- 5 Feb 2016
- Last updated
- 12 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How is Physical Activity Level and Educational Expectations of Patient With Knee Osteoarthritis : Epidemiological Study in Spa Therapy
- ClinicalTrials.gov ID
- NCT02681133
- Acronym / sponsor ID
- CHU-0256
- Conditions
- Knee Osteoarthritis, Physical Activity
- Keywords
- Physical activity level, Knee osteoarthritis, Non pharmacological treatment, Survey, Socio-demographic, clinical variables, Barriers, facilitators Fears and beliefs, Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Innovatherm
- Study start
- Sep 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 12 Feb 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.
The primary purpose is to evaluate the level of physical activity in patients with knee osteoarthritis in a spa treatment and doing epidemiological study about this patient.
Detailed description
Explain the physical activity level of knee osteoarthritis by socio-demographic, clinical variables, barriers and facilitators of regular physical activity practice, fears and beliefs about their condition, functional limitations and physical inactivity.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with knee pain | – | Other: Epidemiological study Survey |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with knee pain reported to osteoarthritis
Key inclusion criteria (4 listed)
- Patients, male or female, aged 50 to 75 years.
- Patients with knee pain reported to osteoarthritis
- Patient affiliated to a social security scheme (beneficiary entitled)
- Patient registered spa
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Epidemiological study Survey | Other | patients with knee pain |
Primary outcome
Level of physical activity with IPAQ short form
Time frame: During the spa treatment
4 secondary outcomes
Socio-demographic variables as assessed by : age, sex, family situation, level of study
Time frame: During the spa treatment
Fears and beliefs as assessed by KOFBeQ
Time frame: During the spa treatment
Pain as assessed by EVA
Time frame: During the spa treatment
Functional status as assessed by WOMAC
Time frame: During the spa treatment
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 12 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Physical Activity, run by University Hospital, Clermont-Ferrand 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 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: finished, as of the sponsor's last update on 12 Feb 2016. 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?
Level of physical activity with IPAQ short form (time frame: During the spa treatment). 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 12 Feb 2016.