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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04136938
Other study ID # IRBN622019/CHUSTE
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 9, 2020
Est. completion date November 2021

Study information

Verified date May 2020
Source Centre Hospitalier Universitaire de Saint Etienne
Contact Luc GOETHALS, PhD student
Phone (0)4 77 81 63 70
Email luc.goethals@univ-st-etienne.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 and attendance resulting in Physical Activity (PA) approaches designed to prevent falls actually only benefiting a limited number of elderly subjects. Social marketing has already shown its utility in the construction of prevention programs.


Description:

This study uses the social marketing approach to improve a fall prevention program. The intervention territory will receive social marketing campaign while the territory controls will not have a campaign.

The main goal is to improve attendance at our fall prevention program.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date November 2021
Est. primary completion date November 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria:

- People living in the one of the territories of the study

- People without medical contraindications to participate in moderate physical activity

- People who has received information about the study and its rights to its data

Exclusion Criteria:

- People unable to attend workshops

- People already registered for adapted physical activity

- People who refused to participate to the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Social marketing campaign
A social marketing campaign of prevention workshop sessions will be performed.

Locations

Country Name City State
France Chu Saint-Etienne Saint-etienne

Sponsors (3)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne Crédit Agricole Loire / Haute-Loire, Jean Monnet University

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of attendance rate of participants at social marketing campaign (%) Comparison rate of attendance rate of participants at prevention workshop sessions (%) between interventional and control group. Years: 1
Secondary Rate of attendance rate of participants at fall prevention workshop sessions (%) Comparison rate of attendance rate of participants at prevention workshop sessions (%) between interventional and control group. Years: 1
Secondary Life quality of participants measured by SF-36 questionnaire score The SF-36 is a self-questionnaire to assess the quality of life and contains 36 items with minimum score 0 (bad quality life) and maximum score at 100 (good quality life). Years: 0, 1
Secondary Physical activity level of participants measured by IPAQ questionnaire The International Physical Activity Questionnaire (IPAQ): short version for elderly people is a self-questionnaire to assess the Physical Activity and contains 7 items. Computation of the total score for the short form requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities. Years: 0, 1
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