Effects of Exercise on Functional Ability in People With Dementia in Nursing Homes:a Cluster Randomised Controlled Trial — LEDEN  

Alzheimer Disease Clinical Trial

Official title: Effects of a Long-term Exercise Program on Functional Ability in People With Dementia Living in Nursing Homes: a Cluster Randomised Controlled Trial. The LEDEN Study

Status Completed

Clinical Trial Summary

This is a cluster randomised controlled trial composed of two research arms: exercise training group (experimental group) and a social activity group (control group).

Clinical Trial Description

The recruitment process will be made only in NHs (Nursing Home) where the staff will have voluntarily accepted to participate in the study. We estimated to recruit 140 PWD (person with dementia) from around six-to-eight NHs (i.e., in average a minimum of 18 and a maximum of 24 PWD per NH). NHs constitute the unit of randomisation; NHs will be randomised to study groups using a 1:1 ratio (it means that all the participants living in a particular NH will participate in either the exercise training or the social activity). The randomisation will be stratified by the prevalence of dementia among NH residents; this stratification will provide homogeneity across research's arms, increasing thus the comparability among groups and producing then reliable results. Randomisation will be done by a statistician not involved in the LEDEN study. Allocation concealment will be ensured by the use opaque sealed envelopes. The randomisation list will be kept in a electronic, password-locked file matching the name of participants to their research identification number and their group allocation. Given the nature of the LEDEN intervention (exercise training, i.e., a behavioural intervention) and since the main outcome measure, i.e., participants' ability in executing ADLs, of the the study requires that the outcome assessor knows how participants cope in their daily life, LEDEN is a unblinded study ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

• NCT number: NCT02444078
• Study type: Interventional
• Source: University Hospital, Toulouse
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Completion date: September 2017