Effect of Playful Cognitive-motor Mobility Training on Balance, Gait and Cognition and on the Prevention of Falls in Seniors

NCT05422495 | Unknown

• 1 other identifier: 19-214
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Falls in the elderly are the cause of considerable morbidity and mortality and constitute a public health problem with more than 9000 deaths in France among the over 65s following an accidental fall. Many scientific data suggest that regular physical activity has significant and long-lasting beneficial effects on the health of the elderly and is associated with better functional status, a lower risk of falls and improved cognitive functions. However, the attraction to physical activity fades over the years and the reasons mentioned by the elderly for a low practice of physical activity are multiple, the main one being the worsening of their state of health. The objective of this study is therefore to evaluate the impact of playful, motivating mobility training, stimulating both mobility and cognition, for 8 weeks, on the balance and mobility of elderly people in EHPAD, in particular in conditions of dual-task well known to be at high risk of falling, as well as on the prevention of falls.

Conditions

Fall Patients

Outcome Measures

Primary Outcomes (4)

• Timed Up and Go (TUG)

  change between baseline and 6 month

• MMSE globale cognitive assesment

  change between baseline and 6 month

• Attention assessed by WAIS digit spans

  change between baseline and 6 month

• Executive functions assessed by the TMT A AND B

  change between baseline and 6 month

Study Arms (2)

Activity

EXPERIMENTAL

cognitive-motor training : Cycléo device (COTTOS ®),

Behavioral: training with Cycléo device (COTTOS ®),

No activity

PLACEBO COMPARATOR

no training

Other: non intervention

Interventions

training with Cycléo device (COTTOS ®), BEHAVIORAL

8 weeks of training

Activity

non intervention OTHER

non intervention

No activity

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged over 60, residing in nursing homes
• Subjects able to walk 15 meters unaided
• MMSE \> 10
• Visual acuity in both eyes \> 6/10
• Affiliated subject or beneficiary of a social security scheme
• Subject having given and signed an informed consent to participate in the study, or his/her guardian
• Subject having a sedentary activity or practicing a usual light to moderate physical activity (physical activities \< 6 METs)

You may not qualify if:

• Subject with a parkinsonian syndrome, any impairment of the motor neuron, pain limiting the practice of physical activity
• Subject with a modification of less than 3 months of psychotropic drugs
• Subject practicing high intensity physical activity (\> 6 METs)

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital

Caen, France

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 16, 2022
• Study Start: January 26, 2021
• Primary Completion: January 26, 2023
• Study Completion: January 26, 2024
• Last Updated: June 16, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)