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Completed

NCT Number: NCT03622554

Strengthening Equilibrium and Educational Support in Preventing Falls in the Thermal Center

Preventing falls among people 65 years of age or older is a priority to promote healthy aging and reduce the number of hospitalizations, institutionalizations and years lived with disability. A preliminary study carried out at the Balaruc-les-Bains Thermal Center showed that one-third of people aged 65 are at significant risk of falling. Thermal establishments could therefore play a role in initiating measures to prevent falls among people aged 65 and over screened at risk.The main objective is to evaluate the impact on the incidence of falls at 12 months (M12) to add to the usual care (control group) a program combining, during the treatment, adapted physical activities (APA) and a Therapeutic patient education (FTE) followed by an educational follow-up for 12 months (intervention group) for people aged 65 and over who were at risk of falling on arrival at the Thermal

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Key information

Conditions

Prevention of Falls

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital of Montpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient aged 65 and over,
  • Presence of at least one chronic pathology justifying treatment and cure
  • Subject having a history of fall in the last year (at least one fall)
  • Subject having at least one risk factor of falling among the following 3: balance disorder, decreased muscle strength or gait disorder

Exclusion criteria

  • Subject considered by the investigators as not being able to participate in the program (inability to answer questionnaires, to perform tests, for example).
  • Patient under the protection of justice, under guardianship or curatorship

Treatment and study plan

Adapted Physical Activity (APA)

Other

12 APA sessions of 60 minutes

Therapeutic Patient Education (ETP)

Other

Personalized ETP with 3 group sessions (1h30) and one at the end of the course (1h) and educational follow-up by phone at 3, 6 and 12 months

Primary outcomes

  1. Incidence of falls at 12 months

    Time frame: 12 months

    To evaluate the impact on the incidence of falls at 12 months (M12) to add to the usual care (control group) a program combining, during the treatment, adapted physical activities (APA) and therapeutic patient education ( ETP), followed by an educational follow-up for 12 months (intervention group) for people aged 65 and over who were at risk of falling on arrival at the Thermal Center

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Association Francaise pour la Recherche Thermale

Registry information

Acronym: RESPECT

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 9, 2018
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.