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FallNCT04277000

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

An observational study of Fall and Fatigue, run by University Hospital, Montpellier at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages Up to 65 years
Conditions the study is for
Fall, Fatigue
How many people
1,471 participants
Where
1 siteFrance
Study dates
1 May 2017to 30 Sep 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site
  • Uhmontpellier

    Montpellier, 34295

Other trials in France

About this study

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

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
Read the 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
Conditions
Fall, Fatigue
Keywords
Injurious falls, Fear of falling, Quality of life, Physical activity
Medical subject headings
Fatigue, Motor Activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 1 year

Secondary outcomes (3)
  1. Number of injurious falls over the folly-up period

    Number of injurious falls over the folly-up period (El Khoury F, 2015)

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

  2. Fear of falling using a visual analogue scale

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

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

  3. Feeling of fatigue using a visual analogue scale

    the feeling of fatigue using a visual analogue scale (0 to 10)(Wolfe-2004; Hewlett-2011)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2020
  2. Study start1 May 2017
  3. Primary completion30 May 2017
  4. Study completion30 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,471 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04277000
Sponsor's protocol ID
RECHMPL16_0129
Status last verified
Feb 2020
First submitted
17 Feb 2020
Last updated
5 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: NC

Questions about this trial

What is this clinical trial studying?

An observational study of Fall and Fatigue, run by University Hospital, Montpellier at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of new falls over the folly-up period (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2020.

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