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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Alzheimer Disease, Dementia

Intervention / Treatment
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* Other: Exercise
* Other: Social Activity


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Exercise sessions will be done in groups of three-to-eight persons; whilst being a group-based exercise program, participants will be guided and the exercises will be adapted in an individual basis, which may increase adherence and compliance rates. | Other: Exercise<br>* Exercise training will take place in the NH, twice weekly, around 60 minutes per session (session duration can be shorter during the first weeks of intervention according with participants' physical capacity), during 6 months; interval between two exercise sessions will be of at least 48 hours. The exercise program will be a multicomponent training, with exercises specifically developed to improve participants' flexibility (10 minutes), coordination and balance (10 minutes), muscle toning (10 minutes), and cardiorespiratory capacity (25 minutes). The exercise intensity targeted will be moderate. All exercise sessions will be accompanied by music.<br>|
| Active Comparator: Social activity<br>Participants in this group will participate in group-based activities such as music (percussion instruments), arts and board games; no intervention on physical activity will be provided to these participants. | Other: Social Activity<br>* Interventionists will be health professionals external to the NH, preferentially psychologists. Interventions will take place in the NHs, at the same frequency and duration than the exercise intervention (twice weekly, 60 minutes per session, during 6 months).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional ability | (ADL performance) as assessed by the Alzheimer Disease Cooperative Study (ADCS) ADL-sev. This is a 19-item scale measuring the ability to perform basic (e.g., bathing, toileting) and instrumental (e.g., turning faucet/lights on/off) ADLs in the last four weeks. The ADCS-ADL-sev was specifically validated for people with moderate or severe Alzheimer's disease (AD), i.e., the large majority of PWD in NHs. Scores in this scale vary from 0 to 54, with higher scores indicating better functional ability. | 6th month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Functional ability | ADL performance) as assessed by the Alzheimer Disease Cooperative Study (ADCS) ADL-sev. This is a 19-item scale measuring the ability to perform basic (e.g., bathing, toileting) and instrumental (e.g., turning faucet/lights on/off) ADLs in the last four weeks. The ADCS-ADL-sev was specifically validated for people with moderate or severe Alzheimer's disease (AD), i.e., the large majority of PWD in NHs. Scores in this scale vary from 0 to 54, with higher scores indicating better functional ability. | 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) | 
| Physical function | as assessed by the Short Physical Performance Battery (SPPB) (score from 0 to 12). | Baseline, Post-intervention (6 month) | 
| Cost-effectiveness of the interventions |  | 12 month (end of study) | 
| Falls and fractures |  | 12 month (end of study) | 
| Cognitive function | as assessed by the Mini-Mental State Examination (MMSE). | Baseline, Post-intervention (6month) | 
| Behavioural and psychological symptoms of dementia (BPSD) | as assessed by the Neuropsychiatric Inventory - Nursing Home version (NPI-NH). | Baseline, Post-intervention (6 month) | 
| Pain | as assessed by the Algoplus scale | Baseline, Post-intervention (6 month) | 
| Nutritional status | as assessed by the Mini Nutritional Assessment (MNA). | Baseline, Post-intervention (6 month) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer Disease, Dementia, Physical activity, Functional ability, Disability, Functional limitation