NCT02828826

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

October 17, 2016

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2022

Completed
Last Updated

September 19, 2024

Status Verified

March 1, 2018

Enrollment Period

5.8 years

First QC Date

July 4, 2016

Last Update Submit

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

EXPERIMENTAL

Patients 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.

Other: telephone coaching

Without telephone coaching

NO INTERVENTION

Interventions

telephone coaching

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

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

Location

Centre hospitalier départemental Vendée

La Roche-sur-Yon, 85925, France

Location

SSR du Château de Marlonges Groupe Hospitalier La Rochelle

La Rochelle, France

Location

CH Emile Roux

Le Puy-en-Velay, 43012, France

Location

CHD Vendée Montaingu

Montaigu, France

Location

Cabinet Liberal Martin

Nantes, 44400, France

Location

CHU de Nantes

Nantes, France

Location

Centre Le Bodio

Pontchâteau, France

Location

MSP Pôle Santé du Marais

Saint-Gervais, 85230, France

Location

CH Saint-Nazaire

Saint-Nazaire, France

Location

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.

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

Locations