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Clinical Trials/NCT02828826
NCT02828826TerminatedNot Applicable

Impact of Telephone Coaching on Physical Performance in a Physical Exercise Maintenance Program for Fallers Elderly Patients Living at Home

Nantes University Hospital14 sites in 1 country101 target enrollmentStarted: October 17, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
101
Locations
14
Primary Endpoint
Score ̏ Timed Up and Go ( TUG ) at 6 months of SSR output

Study Overview

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

Detailed Description

Before to the start of the study, physical therapists and CRA (clinical research associate) will be trained in the specifics of this research protocol.

Patients aged 65 and older, with physiotherapy treatment, investigators will be offered to participate in the study.

The physiotherapist of the investigative service will inform the patient of the terms of the study and will give the necessary information on the physical maintenance program, (presenting the program, verification of the correct understanding of the program and it ran properly, recall the entry on a calendar associated to the program booklet whenever the program achieved, advice on the interests of the exercises as many times as possible per week).

If the patient agrees to participate, the physical therapist will give him a copy of the prospectus and gather written consent after a delay of 24 hours.

The patient will receive the booklet detailing the physical exercise program and allowing him to record his achievement of physical exercise and its possible falls.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
65 Years to 100 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Score ̏ Timed Up and Go ( TUG ) at 6 months of SSR output

Time Frame: 6 months

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 .

Secondary Outcomes

  • fear of falling(12 months)
  • score of FTSST (Five Timed Sit to Stand Test)(12 months)
  • Score ̏ Timed Up and Go ( TUG ) at 12 months of SSR output(12 months)
  • number of falls reported by the patient(12 months)
  • score of autonomy with the IADL (Instrumental Activities of Daily Living )(12 months)
  • number of re hospitalization for fall(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (14)

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