FragilityNCT02850731
Motorized Platform and Autonomy Among the Frail and Pre-frail Older Adult (PLATAUTONOMIE)
A study testing plate-forme Hu360® in people with Fragility, run by University Hospital, Toulouse.
Trial summary
Highly diversified programs of physical activity in older people have shown their effectiveness in terms of improving functional capacities. Only one of these programs, to date, has used a motorized platform. The motorized platform allows the use of sensorimotor programs adapted to this population. Read more about this study
- Who is it for?
- Ages 70 to 89 years
- Conditions the study is for
- Fragility
- What is being tested?
- plate-forme Hu360®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2019to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 to 89 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subjects aged between 70-89 years old.
- Living at home
- Having at least one fragility criteria (from Fried's 5 criteria), which must include the sedentary criteria.
- Having a Score SPPB <10
- Independent mobility
- MMSE score ≥18
- BMI between 18 and 40
- Informed consent to participate in a randomized control trial (physical activity using the motorized platform, Hu360® vs a traditional physical activity program).
Who cannot join
- Severe cardiac problems
- Degenerative neurological conditions
- Hip/Knee joint replacement less than 6 months before the study.
- Psychotic disorders or bipolar disorder.
- Patients who already participate in a regular physical activity program or follow a rehabilitation program.
- Patients under legal protection and / or unable to give informed consent
- Already participating in a clinical trial or a study with a physical activity program.
About this study
Official title: Motorized Platform and Autonomy Among the Frail and Pre-frail Older Adult
Highly diversified programs of physical activity in older people have shown their effectiveness in terms of improving functional capacities. Only one of these programs, to date, has used a motorized platform. The motorized platform allows the use of sensorimotor programs adapted to this population. Thus, for the user, a combination of motor and sensory capacities necessary to actively control different positions as well as reactions to maintain balance are stimulated, and are as important as psychomotor capabilities to maintain autonomy and the fight against losing independence.
Demonstration of the effectiveness of this type of equipment would propose a new modality of physical activity adapted to this population. Use of this new equipment could allow the possibility of standardizing this activity, whilst continuing to individualize physical activity programs.
Read more
Two phases for each group (Intervention/Control):
Phase 1 (day 0 - week 6): 2x1 hour sessions per week using the Hu360® (Intervention group) or an adapted physical activity program (Control group) under supervision of a therapist who will adapt the program according to the progress of the patient, following a standardized procedure (exercises: postural/balance training, strength training for the legs/trunk and coordination and endurance activities) Phase 2 (week 6 - month 6): Physical activity program at home for both groups, performed independently.
Blinded evaluations will be performed at 6 weeks and at 6 months for each group.
The investigators hypothesis is that the use of the motorized platform will allow superior physical performance compared to a traditional physical activity program.
Read the detailed description
Background
The process of aging causes a progressive decline in functional capacities. Maintaining physical fitness appears to be an important factor to fight against frailty (40% more frailty in people > 65 years old), a condition that causes loss of independence but that is clinically reversible.
Fragility is a condition that associates: slowed walking speed, sedentary lifestyle, weight loss, muscle weakness and low energy levels. It is therefore correlated with physical performance.
Purpose
A number of studies have demonstrated the benefit of physical activity in frail older people. Levels of adherence to physical activity programs are not well known but low adherence decreases the positive effects of the intervention. It seems therefore interesting to suggest another approach that integrates innovative technology (plate-forme Hu360®) that can improve the clinical condition of the frail older person, as well as levels of adherence.
Abstract
Highly diversified programs of physical activity in older people have shown their effectiveness in terms of improving functional capacities. Only one of these programs, to date, has used a motorized platform. The motorized platform allows the use of sensorimotor programs adapted to this population. Thus, for the user, a combination of motor and sensory capacities necessary to actively control different positions as well as reactions to maintain balance are stimulated, and are as important as psychomotor capabilities to maintain autonomy and the fight against losing independence.
Demonstration of the effectiveness of this type of equipment would propose a new modality of physical activity adapted to this population. Use of this new equipment could allow the possibility of standardizing this activity, whilst continuing to individualize physical activity programs.
Two phases for each group (Intervention/Control):
Phase 1 (day 0 - week 6): 2x1 hour sessions per week using the Hu360® (Intervention group) or an adapted physical activity program (Control group) under supervision of a therapist who will adapt the program according to the progress of the patient, following a standardized procedure (exercises: postural/balance training, strength training for the legs/trunk and coordination and endurance activities)
Phase 2 (week 6 - month 6): Physical activity program at home for both groups, performed independently.
Blinded evaluations will be performed at 6 weeks and at 6 months for each group.
The investigators hypothesis is that the use of the motorized platform will allow superior physical performance compared to a traditional physical activity program.
Statistical analysis
Data analysis will be realized, blinded to the treatment group. The analysis will be conducted with intention to treat.
The principal analysis will be made using a linear mixed model for repeated data, taking into account stratification factors (gender and class Score SPPB at baseline) by random effect, without imputation of missing data. An exploratory analysis will be conducted on the principal outcome measure using a linear mixed model for repeated data, taking into account stratification factors and some covariates that may change the effect of the intervention, such compliance.
Secondary outcome measures will be will be analysed in a similar manner by generalized linear mixed models. The tests will be bilateral. An error-correction modem of 5% will be considered during the analysis.
- Conditions
- Fragility
- Being tested
- plate-forme Hu360®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plate-forme Hu360®Device
the innovative technology (plate-forme Hu360®) will be used in the experimental arm
| Study group | Role | What they receive |
|---|---|---|
| plate-forme Hu360® | Experimental | the innovative technology (plate-forme Hu360®) will be used in the experimental arm Receives: Device: plate-forme Hu360® |
| supervision by a therapist | No intervention | an adapted physical activity program under supervision of a therapist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of physical performances using the Score Short Physical Performance Battery
Evolution of physical performances within 6 months estimated by the Score Short Physical Performance Battery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startJun 2019 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Organisation problem
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FragilityStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Carette, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850731
- Sponsor's protocol ID
- 15 7841 16
- Status last verified
- Nov 2020
- First submitted
- 20 Jul 2016
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motorized Platform and Autonomy Among the Frail and Pre-frail Older Adult
- ClinicalTrials.gov ID
- NCT02850731
- Acronym / sponsor ID
- 15 7841 16
- Conditions
- Fragility
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Organisation problem
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 1 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Highly diversified programs of physical activity in older people have shown their effectiveness in terms of improving functional capacities. Only one of these programs, to date, has used a motorized platform. The motorized platform allows the use of sensorimotor programs adapted to this population. Thus, for the user, a combination of motor and sensory capacities necessary to actively control different positions as well as reactions to maintain balance are stimulated, and are as important as psychomotor capabilities to maintain autonomy and the fight against losing independence.
Demonstration of the effectiveness of this type of equipment would propose a new modality of physical activity adapted to this population. Use of this new equipment could allow the possibility of standardizing this activity, whilst continuing to individualize physical activity programs.
Two phases for each group (Intervention/Control):
Phase 1 (day 0 - week 6): 2x1 hour sessions per week using the Hu360® (Intervention group) or an adapted physical activity program (Control group) under supervision of a therapist who will adapt the program according to the progress of the patient, following a standardized procedure (exercises: postural/balance training, strength training for the legs/trunk and coordination and endurance activities) Phase 2 (week 6 - month 6): Physical activity program at home for both groups, performed independently.
Blinded evaluations will be performed at 6 weeks and at 6 months for each group.
The investigators hypothesis is that the use of the motorized platform will allow superior physical performance compared to a traditional physical activity program.
Detailed description
Background
The process of aging causes a progressive decline in functional capacities. Maintaining physical fitness appears to be an important factor to fight against frailty (40% more frailty in people > 65 years old), a condition that causes loss of independence but that is clinically reversible.
Fragility is a condition that associates: slowed walking speed, sedentary lifestyle, weight loss, muscle weakness and low energy levels. It is therefore correlated with physical performance.
Purpose
A number of studies have demonstrated the benefit of physical activity in frail older people. Levels of adherence to physical activity programs are not well known but low adherence decreases the positive effects of the intervention. It seems therefore interesting to suggest another approach that integrates innovative technology (plate-forme Hu360®) that can improve the clinical condition of the frail older person, as well as levels of adherence.
Abstract
Highly diversified programs of physical activity in older people have shown their effectiveness in terms of improving functional capacities. Only one of these programs, to date, has used a motorized platform. The motorized platform allows the use of sensorimotor programs adapted to this population. Thus, for the user, a combination of motor and sensory capacities necessary to actively control different positions as well as reactions to maintain balance are stimulated, and are as important as psychomotor capabilities to maintain autonomy and the fight against losing independence.
Demonstration of the effectiveness of this type of equipment would propose a new modality of physical activity adapted to this population. Use of this new equipment could allow the possibility of standardizing this activity, whilst continuing to individualize physical activity programs.
Two phases for each group (Intervention/Control):
Phase 1 (day 0 - week 6): 2x1 hour sessions per week using the Hu360® (Intervention group) or an adapted physical activity program (Control group) under supervision of a therapist who will adapt the program according to the progress of the patient, following a standardized procedure (exercises: postural/balance training, strength training for the legs/trunk and coordination and endurance activities)
Phase 2 (week 6 - month 6): Physical activity program at home for both groups, performed independently.
Blinded evaluations will be performed at 6 weeks and at 6 months for each group.
The investigators hypothesis is that the use of the motorized platform will allow superior physical performance compared to a traditional physical activity program.
Statistical analysis
Data analysis will be realized, blinded to the treatment group. The analysis will be conducted with intention to treat.
The principal analysis will be made using a linear mixed model for repeated data, taking into account stratification factors (gender and class Score SPPB at baseline) by random effect, without imputation of missing data. An exploratory analysis will be conducted on the principal outcome measure using a linear mixed model for repeated data, taking into account stratification factors and some covariates that may change the effect of the intervention, such compliance.
Secondary outcome measures will be will be analysed in a similar manner by generalized linear mixed models. The tests will be bilateral. An error-correction modem of 5% will be considered during the analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| plate-forme Hu360® | Experimental | Device: plate-forme Hu360®the innovative technology (plate-forme Hu360®) will be used in the experimental arm |
| supervision by a therapist | No intervention | –an adapted physical activity program under supervision of a therapist |
Who may qualify
- Ages
- 70 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Subjects aged between 70-89 years old.
- Living at home
- Having at least one fragility criteria (from Fried's 5 criteria), which must include the sedentary criteria.
- Having a Score SPPB <10
- Independent mobility
Key exclusion criteria (7 listed)
- Severe cardiac problems
- Degenerative neurological conditions
- Hip/Knee joint replacement less than 6 months before the study.
- Psychotic disorders or bipolar disorder.
- Patients who already participate in a regular physical activity program or follow a rehabilitation program.
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 |
|---|---|---|
| plate-forme Hu360®the innovative technology (plate-forme Hu360®) will be used in the experimental arm | Device | plate-forme Hu360® |
Primary outcome
Evolution of physical performances using the Score Short Physical Performance Battery
Time frame: 6 months
Evolution of physical performances within 6 months estimated by the Score Short Physical Performance Battery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Pierre Carette, PhD principal investigator
University Hospital, Toulouse
Questions about this trial
What is this clinical trial studying?
A study testing plate-forme Hu360® in people with Fragility, run by University Hospital, Toulouse.
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 8 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: withdrawn, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Evolution of physical performances using the Score Short Physical Performance Battery (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Nov 2020.