Motorized Platform and Autonomy Among the Frail and Pre-frail Older Adult (PLATAUTONOMIE)

NCT02850731 | Withdrawn

• 1 other identifier: 15 7841 16
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Fragility

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Study Arms (2)

plate-forme Hu360®

EXPERIMENTAL

the innovative technology (plate-forme Hu360®) will be used in the experimental arm

Device: plate-forme Hu360®

supervision by a therapist

NO INTERVENTION

an adapted physical activity program under supervision of a therapist

Interventions

plate-forme Hu360® DEVICE

the innovative technology (plate-forme Hu360®) will be used in the experimental arm

plate-forme Hu360®

Eligibility Criteria

• Age: 70 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Officials

• Pierre Carette, PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: August 1, 2016
• Study Start: June 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: November 12, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share