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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03694795
Other study ID # RECHMPL18_0006_1
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 15, 2018
Est. completion date October 15, 2021

Study information

Verified date October 2018
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Assessment of the effect of a 12 weeks serious game based exercises program on physical performance in older adults living in nursing homes, in comparison with a control group that benefits from a classical exercise training program including balance, muscle strengthening and walking exercises with the same duration.


Description:

Recent reviews of the literature have shown that exergames may have interest in balance rehabilitation, physical performance maintenance, and fall prevention in community dwelling older adults with neurodegenerative disease or at risk of fall. These reviews also show however that classical exergames are not adapted for rehabilitation of patients with functional limitations, which could explain their relatively moderate benefits in those patients.

To overcome this lack, a serious game has been co-developed with medical to be adapted to the specific needs and characteristics of nursing home residents In this study , we propose to compare the effects on physical performance, falls incidence, and quality of life of a 12-weeks serious game based exercise program and a classical exercices program


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 234
Est. completion date October 15, 2021
Est. primary completion date October 15, 2021
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria:

- older adults aged 65 and over, living in nursing homes and able to walk without technical assistance

- sign an informed consent.

Exclusion Criteria:

- subjects with cognitive impairments (MMSE < 14) or with conditions that contra-indicate the involvement in a rehabilitation program for medical or ethics reasons

- subjects with a history of seizure.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
12-weeks rehabilitation program using a serious game
Effect of serious game on elderly in comparison of the physical activity adapted meeting
Other:
12-weeks rehabilitation program using a classical exercises program
Effect of serious game on elderly in comparison of the physical activity adapted meeting

Locations

Country Name City State
France UHMontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Short Physical Performance Baterry (SPPB) 3 months
Secondary incidence of fall SPPB score at 6 months up to 6 months
See also
  Status Clinical Trial Phase
Recruiting NCT03836911 - Effects of a Serious Game With Elderly People N/A