An interventional study of plate-forme Hu360® in Fragility, sponsored by University Hospital, Toulouse. Withdrawn. Open to participants aged 70 Years to 89 Years. Per ClinicalTrials.gov, last updated 2020-11-12.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Prevention
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.
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.
University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
the innovative technology (plate-forme Hu360®) will be used in the experimental arm
Device: plate-forme Hu360®
an adapted physical activity program under supervision of a therapist
the innovative technology (plate-forme Hu360®) will be used in the experimental arm
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
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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University Hospital, Toulouse