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.
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
- 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.
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
- 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.
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)
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
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
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.
- First posted19 Feb 2020
- Study start1 May 2017
- Primary completion30 May 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hubert Blain, MD, PhD, Principal investigator, University Hospital, Montpellier
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04277000
- Acronym / sponsor ID
- RECHMPL16_0129
- Keywords
- Injurious falls, Fear of falling, Quality of life, Physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,471 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of new falls over the folly-up period
Time frame: 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)
3 secondary outcomes
Number of injurious falls over the folly-up period
Time frame: at 7 days, 3, and 6 months after the stay in the resort
Fear of falling using a visual analogue scale
Time frame: at 7 days, 3, and 6 months after the stay in the resort
Feeling of fatigue using a visual analogue scale
Time frame: at 7 days, 3, and 6 months after the stay in the resort
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hubert Blain, MD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
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.