Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT02850731 |
| Other study ID # |
15 7841 16 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 2019 |
| Est. completion date |
December 2022 |
Study information
| Verified date |
November 2020 |
| Source |
University Hospital, Toulouse |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
