Endurant Evo International Clinical Trial

Brief Title

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

Official Title

Assessment of the Fall Risk Profile and Quality of Life of Subjects Aged 65 or Older Visiting the French Balaruc-les-bains Climatic Health Resort

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 (El Khoury-2015).

        -  Physical activity over the last 7 days, using the International Physical Activity
           Questionnaires (IPAQ)(Craig-2003)

        -  Fear of falling, using a visual analogue scale (VAS) (0 to 10)(Scheffer-2010).

        -  The feeling of fatigue over the previous month, using a visual analogue scale (0 to
           10)(Wolfe-2004; Hewlett-2011).

      A questionnaire was administered to record quality of life (EQ-5D-3L), at baseline and 7 days
      after the end of the stay (Brooks-1996).

      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 (Tiedemann-2008)

        -  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 (Guralnik-2000)

        -  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 (Guralnik et
           al., 2000).

        -  The Fried's frailty phenotype score was calculated (Fried-2001), 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
           (Fried-2001).
    


Study Type

Observational


Primary Outcome

Number of new falls over the folly-up period

Secondary Outcome

 Number of injurious falls over the folly-up period

Condition

Fall



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

1471

Start Date

May 1, 2017

Completion Date

September 30, 2017

Primary Completion Date

May 30, 2017

Eligibility Criteria

        Inclusion criteria:

          -  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

        Exclusion criteria:

          -  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
      

Gender

All

Ages

N/A - 65 Years

Accepts Healthy Volunteers

No

Contacts

hubert Blain, MD, PhD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT04277000

Organization ID

RECHMPL16_0129


Responsible Party

Sponsor

Study Sponsor

University Hospital, Montpellier


Study Sponsor

hubert Blain, MD, PhD, Principal Investigator, University Hospital, Montpellier


Verification Date

February 2020