FallSTEP-PANCT02828826
Impact of Telephone Coaching on Physical Performance in a Physical Exercise Maintenance Program for Fallers Elderly Patients Living at Home
A study testing telephone coaching in people with Fall, run by Nantes University Hospital at 10 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Fall
- What is being tested?
- telephone coaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 10 sitesFrance
- Study dates
- 17 Oct 2016to 4 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Ch Cholet
Cholet
Centre hospitalier départemental Vendée
La Roche-sur-Yon, 85925
SSR du Château de Marlonges Groupe Hospitalier La Rochelle
La Rochelle, France
CH Emile Roux
Le Puy-en-Velay, France, 43012
CHD Vendée Montaingu
Montaigu, France
Cabinet Liberal Martin
Nantes, France, 44400
CHU de Nantes
Nantes
Centre Le Bodio
Pontchâteau
MSP Pôle Santé du Marais
Saint-Gervais, France, 85230
CH Saint-Nazaire
Saint-Nazaire, France
About this study
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.
Read more
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
Read the 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.
Following the inclusion of the patient, the physiotherapist will inform the computerized data file and will proceed to randomization via Clinsight® software.
The patient will be informed of the group in which it is randomized (with or without telephone coaching ) .
The patient will receive a summons for assessments to M6 and M12 to be carried on the website of the investigation center . It will be recalled him to bring his book.
Before its release SSR ( M0 ), the patient will benefit included in the initial assessment including a TUG ( Score Time UP and Go), VAS (Visual Analog Scale ) measures the fear of falling , the IADL (INSTRUMENTAL ACTIVITIES OF DAILY LIVING), the FTSST (Five Times Sit to Stand Test) and score the one leg balance test . The running score 4 meters. This initial evaluation will be conducted by the physiotherapist or the CRA by location Patients randomized to the control group will not receive telephone coaching . Patients will only record the achievement of physical exercises and the occurrence of falls in their booklet.
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 duration of each telephone coaching is estimated at 20mn . As patients in the control arm , Patients will record their physical exercise sessions and the occurrence of falls in their booklet.
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 ( Case Report Form).
A M6, the patients in both study arms will receive an evaluation including a TUG, EVA measures the fear of falling, the IADL, the FTSST, walking speed and score the one leg balance test. The number of re hospitalizations and use of a physiotherapist for motor rehabilitation will also be sought from the patient and her doctor if necessary. This evaluation will be carried out by a TEC, as part of a consultation center investigator.
At the end of the evaluation M6, patients in the experimental arm no longer benefit from telephone coaching. As for patients in the control arm, they will only record their exercise sessions and the occurrence of falls in their booklet.
A final evaluation of patients will be performed at M12 (same as M6) Following the visits and phone calls, the study data will be recorded in the eCRF by the CRA and / or physiotherapist investigators centers.
- Conditions
- Fall
- Being tested
- telephone coaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone coachingOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: telephone coaching |
| Without telephone coaching | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 6 months
Secondary outcomes (9)
Score ̏ Timed Up and Go ( TUG ) at 12 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.
Measured: 12 months
Number of Falls Reported by the Patient
Number of falls reported by the patient
Measured: 6 months
Number of Falls Reported by the Patient
Number of falls reported by the patient
Measured: 12 months
Fear of Falling
assessing the fear of falling on a visual analogue scale
Measured: 12 months
Score of Autonomy With the IADL (Instrumental Activities of Daily Living )
Measured: 6 months
Score of FTSST (Five Timed Sit to Stand Test)
performance of the lower limbs
Measured: 6 months
Score of FTSST (Five Timed Sit to Stand Test)
performance of the lower limbs
Measured: 12 months
Number of re Hospitalization for Fall
Measured: 6 months
Number of re Hospitalization for Fall
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study start17 Oct 2016
- Primary completion4 Aug 2022
- Study completion4 Aug 2022
Why it stopped: inclusion deficiency
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FallStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828826
- Sponsor's protocol ID
- RC16_0030
- Acronym
- STEP-PA
- Status last verified
- Jun 2026
- First submitted
- 4 Jul 2016
- Last updated
- 26 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 39462354
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Telephone Coaching on Physical Performance in a Physical Exercise Maintenance Program for Fallers Elderly Patients Living at Home
- ClinicalTrials.gov ID
- NCT02828826
- Acronym / sponsor ID
- STEP-PA / RC16_0030
- Conditions
- Fall
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inclusion deficiency
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 17 Oct 2016 (actual)
- Primary completion
- 4 Aug 2022 (actual)
- Study completion
- 4 Aug 2022 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Posted 26 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Following the inclusion of the patient, the physiotherapist will inform the computerized data file and will proceed to randomization via Clinsight® software.
The patient will be informed of the group in which it is randomized (with or without telephone coaching ) .
The patient will receive a summons for assessments to M6 and M12 to be carried on the website of the investigation center . It will be recalled him to bring his book.
Before its release SSR ( M0 ), the patient will benefit included in the initial assessment including a TUG ( Score Time UP and Go), VAS (Visual Analog Scale ) measures the fear of falling , the IADL (INSTRUMENTAL ACTIVITIES OF DAILY LIVING), the FTSST (Five Times Sit to Stand Test) and score the one leg balance test . The running score 4 meters. This initial evaluation will be conducted by the physiotherapist or the CRA by location Patients randomized to the control group will not receive telephone coaching . Patients will only record the achievement of physical exercises and the occurrence of falls in their booklet.
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 duration of each telephone coaching is estimated at 20mn . As patients in the control arm , Patients will record their physical exercise sessions and the occurrence of falls in their booklet.
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 ( Case Report Form).
A M6, the patients in both study arms will receive an evaluation including a TUG, EVA measures the fear of falling, the IADL, the FTSST, walking speed and score the one leg balance test. The number of re hospitalizations and use of a physiotherapist for motor rehabilitation will also be sought from the patient and her doctor if necessary. This evaluation will be carried out by a TEC, as part of a consultation center investigator.
At the end of the evaluation M6, patients in the experimental arm no longer benefit from telephone coaching. As for patients in the control arm, they will only record their exercise sessions and the occurrence of falls in their booklet.
A final evaluation of patients will be performed at M12 (same as M6) Following the visits and phone calls, the study data will be recorded in the eCRF by the CRA and / or physiotherapist investigators centers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| telephone coaching | Experimental | Other: telephone coachingPatients 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 intervention | – |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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 )
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telephone coaching | Other | telephone coaching |
Primary outcome
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 .
9 secondary outcomes
Score ̏ Timed Up and Go ( TUG ) at 12 Months of SSR Output
Time frame: 12 months
Number of Falls Reported by the Patient
Time frame: 6 months
Number of Falls Reported by the Patient
Time frame: 12 months
Fear of Falling
Time frame: 12 months
Score of Autonomy With the IADL (Instrumental Activities of Daily Living )
Time frame: 6 months
Score of FTSST (Five Timed Sit to Stand Test)
Time frame: 6 months
Score of FTSST (Five Timed Sit to Stand Test)
Time frame: 12 months
Number of re Hospitalization for Fall
Time frame: 6 months
Number of re Hospitalization for Fall
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39462354Rince 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telephone coaching in people with Fall, run by Nantes University Hospital at 10 sites 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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Yes. Results are posted in the registry (first posted 26 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Score ̏ Timed Up and Go ( TUG ) at 6 Months of SSR Output (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02828826, which also lists 1 linked publication.
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 26 Oct 2026.