Clinical trial NCT02444078: Effects of Exercise on Functional Ability in People With Dementia in Nursing Homes:a Cluster Randomised Controlled 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Dementia
Keywords: Alzheimer Disease
Dementia
Physical activity
Functional ability
Disability
Functional limitation
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2015-05-14
Enrollment: 140
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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).

Detailed 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

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of Alzheimer's disease, vascular or mixed dementia according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV);
* MMSE ≤ 20 (out of 30);
* living in one of the participating NHs for at least 3 months at the moment of baseline measurements (this time period will allow NH staff to have a good knowledge about the patient and about recent changes in his/her health status);
* to be able of walking at least 4 meters (with walking devices if needed but without human assistance);
* to be able to rise from a chair without help or with minimal human assistance.

Exclusion Criteria:

* Mild dementia, illustrated by a MMSE \> 20 (out of 30)
* Terminal illness with life expectancy less than 6 months;
* Diagnosis of Parkinson's disease;
* Diagnosis of dementia with Lewy bodies;
* Unstable cardiovascular condition or any other health condition that might be deteriorated by physical exercise;
* Planned transfer from the NH to another NH/home or to surgery during the 6-month period of intervention;
* Already participating in physical exercise ≥ 2 times/week in the last 2 months prior to the date of baseline assessments.

Primary outcomes:
measure: Functional ability
timeFrame: 6th month
Secondary outcomes:
measure: Change of Functional ability
timeFrame: Change and evolution at different time points: baseline, 3-month intervention, Post-intervention (6month), 3-month follow-up (9 month), 6-month follow-up (12 month)
measure: Physical function
timeFrame: Baseline, Post-intervention (6 month)
measure: Cost-effectiveness of the interventions
timeFrame: 12 month (end of study)
measure: Falls and fractures
timeFrame: 12 month (end of study)
measure: Cognitive function
timeFrame: Baseline, Post-intervention (6month)
measure: Behavioural and psychological symptoms of dementia (BPSD)
timeFrame: Baseline, Post-intervention (6 month)
measure: Pain
timeFrame: Baseline, Post-intervention (6 month)
measure: Nutritional status
timeFrame: Baseline, Post-intervention (6 month)
Other outcomes:
Locations:
city: Bruay-sur-l'escaut
country: France
facility: Résidence d'Automne de Bruay sur Escaut
city: L'huisserie
country: France
facility: Korian Le Castelli
city: Le Mans
country: France
facility: Korian Pontlieue
city: Neuilly Plaisance
country: France
facility: Résidence Les Lauriers de Plaisance
city: Saint Cyr Sur Loire
country: France
facility: Korian Croix Périgourd
city: Sanilhac
country: France
facility: Résidence d'Automne de Notre Dame de Sanhilac
city: Sermaize-les-bains
country: France
facility: Résidence Les Jardins de Sermaize
city: Thise
country: France
facility: Korian Vill'Alizé
Study officials:
affiliation: Toulouse University Hospital (CHU Toulouse)
name: Yves ROLLAND, MD
role: PRINCIPAL_INVESTIGATOR
References: