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

Completed

• Conditions: Fatigue; Fall

• Registration Number: NCT04277000
• Lead Sponsor: University Hospital, Montpellier

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

Detailed Description

In all subjects aged 65 or older visiting consecutively the resort over a 5-month period, a questionnaire was administered in order to record:

* The number of falls and injurious falls in the previous 12 months. Injurious falls are falls complicated by serious or moderate injuries. Falls with serious injuries were those that caused fractures, head injuries requiring admission to hospital, joint dislocations, sprains accompanied by reduced physical function, other non-specified serious joint injuries, and lacerations requiring sutures. Falls with moderate injuries were those that resulted in bruising, sprains, cuts, abrasions, or reduction in physical function for at least three days or in medical help

* Physical activity over the last 7 days, using the International Physical Activity Questionnaires (IPAQ)

* Fear of falling, using a visual analogue scale (VAS) (0 to 10).

* The feeling of fatigue over the previous month, using a visual analogue scale (0 to 10) A questionnaire was administered to record quality of life (EQ-5D-3L), at baseline and 7 days after the end of the stay A questionnaire snt by mail was filled in by subjects 3 and 6 months after the stay in the resort in order to record falls and injurious falls, fatigue, fear of falling, and physical activity (using the above questionnaires).

Physical measurements were performed at the entrance of the health resort :

* Body height and body weight to the nearest 0.5 cm and 0.1 kg to calculate the body mass index (kg.m-2)

* The Timed Up and Go test and the time to walk 4 meters at usual pace (Lusardi-2017)

* The 5 repeated chair stand test

* The maximum grip strength: using a Camry Electronic Hand Dynamometer

* The one-leg stand test (lowest value on the right and the left leg), and stand tests feet together, in semi-tandem, and tandem position

* The score of the Short Physical Performance Battery (SPPB) was calculated based on results of the 4-meter gait speed, and the 5-chair stand and balance tests

* The Fried's frailty phenotype score was calculated, based on - the weight loss in prior year (body weight at baseline ˗ the self-assessed body weight 12 months before inclusion) (1 point if ≥ 10 lbs lost unintentionally); - muscle strength (1 point if the maximum grip strength was low based on the dynamometer manual); - self-reported fatigue (1 point if Visual Analog Fatigue Scale ≥ 5 in men and ≥ 4 in women), - walking speed (1 point if 4-m walking speed at comfortable pace was in the lowest quintile of values of subjects with the same gender) (≤ 0.71 m.s-1 in women and ≤ 0.76 m.s-1 in men), - physical activities in the previous week (1 point if in the lowest quintile of values of IPAQ of subjects with the same gender) (≤ 2076 MET (Metabolic Equivalent Task) in women and ≤ 2320 MET in men). A total score of ≥ 3 points was indicative of frailty, 1 or 2 points of prefrail phenotype and a score of 0 is indicative of robustness

Study Timeline

• Study Start: 2017-05-01
• Primary Completion: 2017-05-30
• Study Completion: 2017-09-30
• Status Verified: 2020-02
• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-02-17
• Study First Posted: 2020-02-19
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1471

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of new falls over the folly-up period	1 year	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)

Secondary Outcome Measures

Name	Time	Method
Feeling of fatigue using a visual analogue scale	at 7 days, 3, and 6 months after the stay in the resort	the feeling of fatigue using a visual analogue scale (0 to 10)(Wolfe-2004; Hewlett-2011)
Fear of falling using a visual analogue scale	at 7 days, 3, and 6 months after the stay in the resort	Fear of falling using a visual analogue scale (VAS) (0 to 10)(Scheffer-2010).
Number of injurious falls over the folly-up period	at 7 days, 3, and 6 months after the stay in the resort	Number of injurious falls over the folly-up period (El Khoury F, 2015)

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France