Determinants of the Fall Risk Profile and Quality of Life of Older Subjects Visting Climatic Health Resorts

NCT04277000 | Completed

• 1 other identifier: RECHMPL16_0129
• Study Type: observational
• Target: 1,471
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the study conducted in subjects aged 65 or older visiting the French Balaruc-les-bains climatic health resort was to :

• Determine factors that distinguish fallers from not fallers
• Determine factors that may predict falls and injurious falls, 3 and 6 months after the stay in the resort
• Determine the effects of the 3-week stay in the health resort on quality of life, fear of falling, fatigue, and physical activity

Conditions

Fall; Fatigue

Keywords

Injurious falls; Fear of falling; Quality of life; Physical activity

Outcome Measures

Primary Outcomes (1)

• Number of new falls over the folly-up period

  A fall is defined as an "unexpected event in which the participant comes to rest on the ground, floor, or other lower level" (J Am Geriatr Soc 2011;59:148-57)

  1 year

Secondary Outcomes (3)

• Number of injurious falls over the folly-up period

  at 7 days, 3, and 6 months after the stay in the resort

• Fear of falling using a visual analogue scale

  at 7 days, 3, and 6 months after the stay in the resort

• Feeling of fatigue using a visual analogue scale

  at 7 days, 3, and 6 months after the stay in the resort

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects (women or men) aged 65 or older who consecutively visited the Balaruc-les-bains health resort for venous or rheumatologic complaints over a 5-month period

You may qualify if:

• Patients aged 65 years or older visiting the Balaruc-les-bains resort for venous or rheumatologic complaints over the 5-month recruitment period
• Subjects able to comply with all trial procedures
• Subjects covered by public health insurance
• Signed informed

You may not qualify if:

• Patients with severe physical or neuropsychiatric impairment making impossible the physical measurements at baseline or the reply to the questionnaires at baseline and during the 7 days-, 3 month-, and 6-month follow-up after the stay in the health resort.
• Subject unable to read or/and write
• Subject who are in a dependency or employment with the sponsor or the investigator
• Participation in another clinical trial within the last 4 weeks before the screening date

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Fatigue; Motor Activity

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• hubert Blain, MD, PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 19, 2020
• Study Start: May 1, 2017
• Primary Completion: May 30, 2017
• Study Completion: September 30, 2017
• Last Updated: March 5, 2020

Record last verified: 2020-02

Locations

FR (1)