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Impact of Telephone Coaching on Physical Performance in a Physical Exercise Maintenance Program for Fallers Elderly Patients Living at Home (STEP-PA)

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ClinicalTrials.gov Identifier: NCT02828826
Recruitment Status : Recruiting
First Posted : July 12, 2016
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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


Condition or disease Intervention/treatment Phase
Fall Other: telephone coaching Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of Telephone Coaching on Physical Performance in a Physical Exercise Maintenance Program for Fallers Elderly Patients Living at Home
Study Start Date : October 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: telephone coaching

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
No Intervention: Without telephone coaching



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Score ̏ Timed Up and Go ( TUG ) at 12 months of SSR output [ Time Frame: 12 months ]
  2. number of falls reported by the patient [ Time Frame: 6 months ]
  3. number of falls reported by the patient [ Time Frame: 12 months ]
  4. fear of falling [ Time Frame: 6 months ]
    assessing the fear of falling on a visual analogue scale

  5. fear of falling [ Time Frame: 12 months ]
    assessing the fear of falling on a visual analogue scale

  6. score of autonomy with the IADL (Instrumental Activities of Daily Living ) [ Time Frame: 6 months ]
  7. score of autonomy with the IADL (Instrumental Activities of Daily Living ) [ Time Frame: 12 months ]
  8. score of FTSST (Five Timed Sit to Stand Test) [ Time Frame: 6 months ]
    performance of the lower limbs

  9. score of FTSST (Five Timed Sit to Stand Test) [ Time Frame: 12 months ]
    performance of the lower limbs

  10. number of re hospitalization for fall [ Time Frame: 6 months ]
  11. number of re hospitalization for fall [ Time Frame: 12 months ]


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Ages Eligible for Study:   65 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02828826


Contacts
Contact: RINCE Guy 02 40 18 94 16 guy.rince@chu-nantes.fr

Locations
France
Ch Cholet Recruiting
Cholet, France
Centre hospitalier départemental Vendée Recruiting
La Roche Sur Yon, France, 85925
CHU de Nantes Recruiting
Nantes, France
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: RENOU Françoise Centre le BODIO , Pontchateau
Principal Investigator: DESCAMPS Pascale Hôpital d'Ancenis
Principal Investigator: TRICHET-FOIS Caroline Centre Beaumanoir/Centre Confluent Nantes
Principal Investigator: ZBIRI Dounia CHD Vendée La Roche sur Yon
Principal Investigator: COURONNEAUD Jeanne CHD Vendée Montaigu
Principal Investigator: MARTIN Patricia Cabinet Libéral
Principal Investigator: COADIC Blandine Centre Hospitalier Cholet
Principal Investigator: GERARD Rozenn SSR du Château de Marlonges
Principal Investigator: CONNAN Gaelle Cabinet Libéral

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02828826     History of Changes
Other Study ID Numbers: RC16_0030
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018