Study Stopped
inclusion deficiency
Impact of Telephone Coaching on Physical Performance in a Physical Exercise Maintenance Program for Fallers Elderly Patients Living at Home
STEP-PA
1 other identifier
interventional
101
1 country
10
Brief Summary
At home, maintenance, physical performance declines more or less rapidly from 6 weeks depending advancing age and duration of the training period . It is feared that the advice or prescription of regular physical maintenance at the exit of the service, has only adherence to the 50% like the medication prescribed. A US study of 2000 on the observance of healthy living recommendations, despite the many messages promoting physical activity, shows that only 24% of Americans aged 65 to 74 were taking physical activity regular. There are no French-date data. If physical maintenance is routinely recommended for the elderly living at home, so the way to encourage these people to practice more often possible these recommendations remains therefore a problem of public health. The recent OSSEBO study (intervention for the prevention of injurious falls in elderly women: background and design) recalled the interest to propose a program of physical exercise to reduce trauma and falls in the elderly. It also shows the possibility to implement an effective program on a long-term and large scale in France. The study allowed patients to participate in collective sessions of physical exercises, within the framework of an association. Patients were invited to continue their home exercises they had learned. Also, the investigators hypothesize that the monthly telephone coaching , directed by the physical therapist following a physical fitness exercise program which they have been trained during their hospitalization in SSR , would allow older patients to maintain fallers their physical performance at home for at least 6 months after leaving
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2016
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2016
CompletedFirst Posted
Study publicly available on registry
July 12, 2016
CompletedStudy Start
First participant enrolled
October 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 4, 2022
CompletedSeptember 19, 2024
March 1, 2018
5.8 years
July 4, 2016
September 16, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Score ̏ Timed Up and Go ( TUG ) at 6 months of SSR output
The test is simple, attainable in 3 minutes in a quiet room with no noise with a standard chair with armrests. A line is marked on the ground at 3m from the chair. The examiner, provides with a stopwatch, should not encourage the patient. The patient performs the test with his shoes and his usual technical assistance. The patient should walk at a comfortable pace and as naturally as possible. The patient will have to stand up, turn around and return to the line sit. The test is performed 2 times: once to verify that the patient understands the instructions, then again timed. Reproducing the test has a degree of correlation between r = 0.92 and 0.99. There is excellent agreement between the various evaluators (0.93 to 0.99 correlation coefficient) (49). The TUG shows good diagnostic validity with a sensitivity and a specificity of 87% for the fall prediction .
6 months
Secondary Outcomes (11)
Score ̏ Timed Up and Go ( TUG ) at 12 months of SSR output
12 months
number of falls reported by the patient
6 months
number of falls reported by the patient
12 months
fear of falling
6 months
fear of falling
12 months
- +6 more secondary outcomes
Study Arms (2)
telephone coaching
EXPERIMENTALPatients randomized to the experimental group will benefit from the telephone coaching , with 5 phone calls programmed by the physiotherapist according to the most convenient times for the patient, due to appointments per month. The telephone coaching conducted by the physiotherapist with patients is to assess the number of exercises performed, the number of falls may have occurred, assess the fear of falling and overall assessment of the patient's general condition and a self-assessment of their physical ability (one leg balance, fear of falling, FTSST). With this information, the therapist may encourage patients to practice more diligently exercises can even strengthen the practice of some based on its evaluation. Data from the telephone coaching will be recorded in the eCRF.
Without telephone coaching
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- patient aged 65 and over
- Patient having a physiotherapy treatment
- Faller patient ( a fall in the preceding 12 months)
- patient leaving the service to return home or living at home
- Patient with a score ≥ 24/30 in the Mini Mental Status (MMS )
- patient able to get up a seat and walk 6 meters without human assistance (corresponds to test TUG ) patient
- informed of the study has given free and informed consent
You may not qualify if:
- Patient under judicial protection , under guardianship
- patient with active disease , with degenerative impact on walking,
- patient unable to use the phone
- patient with visual impairments preventing reading the physical maintenance program
- Refusal of patient participation
- Patient not wishing to stop his liberal physiotherapy care to driving
- Patient included in another interventional research protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Ch Cholet
Cholet, France
Centre hospitalier départemental Vendée
La Roche-sur-Yon, 85925, France
SSR du Château de Marlonges Groupe Hospitalier La Rochelle
La Rochelle, France
CH Emile Roux
Le Puy-en-Velay, 43012, France
CHD Vendée Montaingu
Montaigu, France
Cabinet Liberal Martin
Nantes, 44400, France
CHU de Nantes
Nantes, France
Centre Le Bodio
Pontchâteau, France
MSP Pôle Santé du Marais
Saint-Gervais, 85230, France
CH Saint-Nazaire
Saint-Nazaire, France
Related Publications (1)
Rince G, Volteau C, Fortin J, Couturier CC, Rulleau T. Impact of telephone coaching supporting a physical maintenance exercise programme for older adults at risk of falls: a randomised controlled trial. BMC Geriatr. 2024 Oct 26;24(1):879. doi: 10.1186/s12877-024-05488-y.
PMID: 39462354DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2016
First Posted
July 12, 2016
Study Start
October 17, 2016
Primary Completion
August 4, 2022
Study Completion
August 4, 2022
Last Updated
September 19, 2024
Record last verified: 2018-03