Sedentary BehaviorNCT04134585
Promoting Fall Prevention Workshops
An observational study of Sedentary Behavior and Aging, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Physical Activity (PA) is recognized as the most effective method to prevent falls in the elderly. Yet despite there being a consensus now that Physical Activity (PA) is effective in practice, there remain many obstacles to participation resulting in PA approaches designed to prevent falls actually only benefiting a… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Aging
- What is being tested?
- semi-structured interviews
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2019to 14 Jun 2019
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People aged 60 and over.
Who may be able to join
- People who received a proposal to participate in our workshop and who denied it
- People living in one of the three departments of the study (Loire, Haute-Loire and Rhône)
Who cannot join
- People who refused to participate to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promoting Fall Prevention Workshops for Individuals Aged 60 and Over: an Exploratory Study.
Physical Activity (PA) is recognized as the most effective method to prevent falls in the elderly. Yet despite there being a consensus now that Physical Activity (PA) is effective in practice, there remain many obstacles to participation resulting in PA approaches designed to prevent falls actually only benefiting a limited number of elderly subjects.
Read the detailed description
It's a qualitative study. The target population was people aged 60 and over who had refused to participate in fall prevention workshops.
The study covered three different French departments. A total of 19 semi-structured interviews were conducted over a period of 5 months.
The analysis of reports revealed there were multiple motives for not participating in the balance workshops. The current means of promoting these fall prevention workshops are not adapted. Finally, the social experience provided by the program was identified to be the principal motivator for encouraging the interviewed subjects to participate.
- Conditions
- Sedentary Behavior, Aging
- Being tested
- semi-structured interviews
- Keywords
- Fall, Prevention, Seniors, Physical activity, Interviews
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semi-structured interviewsOther
Semi-structured interviews will be performed to determine representations of physical activity, reluctance/motivation to participate in physical activity sessions and facilitators who can help them overcome these barriers.
| Study group | Role | What they receive |
|---|---|---|
| People aged 60 | People aged 60 and over who had refused to participate in fall prevention workshops will be included. They will have semi-structured interviews. Receives: Other: semi-structured interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between physical activity degree, aging and illness
Analysis interview responses.
Measured: Month: 5
Secondary outcomes (4)
Analysis representations of physical activity.
Analysis interview responses.
Measured: Month: 5
Analysis reluctance to participate in physical activity sessions.
Analysis interview responses.
Measured: Month: 5
Analysis motivation to participate in physical activity sessions.
Analysis interview responses.
Measured: Month: 5
Analysis facilitators who can help them overcome these barriers
Analysis interview responses.
Measured: Month: 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start15 Feb 2019
- Primary completion14 Jun 2019
- Study completion14 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Collaborators
- Crédit Agricole Loire / Haute-Loire, Jean Monnet University
- Responsible party
- Sponsor
- Investigators
- Luc GOETHALS, Doctoral student, Principal investigator, Jean Monnet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134585
- Sponsor's protocol ID
- IRBN912018/CHUSTE
- Status last verified
- Oct 2019
- First submitted
- 18 Oct 2019
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Fall Prevention Workshops for Individuals Aged 60 and Over: an Exploratory Study.
- ClinicalTrials.gov ID
- NCT04134585
- Acronym / sponsor ID
- IRBN912018/CHUSTE
- Conditions
- Sedentary Behavior, Aging
- Keywords
- Fall, Prevention, Seniors, Physical activity, Interviews
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Crédit Agricole Loire / Haute-Loire, Jean Monnet University
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 14 Jun 2019 (actual)
- Study completion
- 14 Jun 2019 (actual)
- First posted
- 22 Oct 2019 (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.
Physical Activity (PA) is recognized as the most effective method to prevent falls in the elderly. Yet despite there being a consensus now that Physical Activity (PA) is effective in practice, there remain many obstacles to participation resulting in PA approaches designed to prevent falls actually only benefiting a limited number of elderly subjects.
Detailed description
It's a qualitative study. The target population was people aged 60 and over who had refused to participate in fall prevention workshops.
The study covered three different French departments. A total of 19 semi-structured interviews were conducted over a period of 5 months.
The analysis of reports revealed there were multiple motives for not participating in the balance workshops. The current means of promoting these fall prevention workshops are not adapted. Finally, the social experience provided by the program was identified to be the principal motivator for encouraging the interviewed subjects to participate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People aged 60 | – | Other: semi-structured interviewsPeople aged 60 and over who had refused to participate in fall prevention workshops will be included. They will have semi-structured interviews. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People aged 60 and over.
Key inclusion criteria (2 listed)
- People who received a proposal to participate in our workshop and who denied it
- People living in one of the three departments of the study (Loire, Haute-Loire and Rhône)
Key exclusion criteria (1 listed)
- People who refused to participate to the study.
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 |
|---|---|---|
| semi-structured interviewsSemi-structured interviews will be performed to determine representations of physical activity, reluctance/motivation to participate in physical activity sessions and facilitators who can help them overcome these barriers. | Other | People aged 60 |
Primary outcome
Correlation between physical activity degree, aging and illness
Time frame: Month: 5
Analysis interview responses.
4 secondary outcomes
Analysis representations of physical activity.
Time frame: Month: 5
Analysis reluctance to participate in physical activity sessions.
Time frame: Month: 5
Analysis motivation to participate in physical activity sessions.
Time frame: Month: 5
Analysis facilitators who can help them overcome these barriers
Time frame: Month: 5
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 3 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Luc GOETHALS, Doctoral student principal investigator
Jean Monnet University
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 Sedentary Behavior and Aging, run by Centre Hospitalier Universitaire de Saint Etienne 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 2 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 3 Aug 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?
Correlation between physical activity degree, aging and illness (time frame: Month: 5). 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 3 Aug 2023.