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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A01713-44 | Other Identifier | ID-RCB |
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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).
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | 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. |
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| Social activity | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yves ROLLAND, MD | Toulouse University Hospital (CHU Toulouse) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Résidence d'Automne de Bruay sur Escaut | Bruay-sur-l'Escaut | 59860 | France | |||
| Korian Le Castelli |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28542742 | Result | de Souto Barreto P, Cesari M, Denormandie P, Armaingaud D, Vellas B, Rolland Y. Exercise or Social Intervention for Nursing Home Residents with Dementia: A Pilot Randomized, Controlled Trial. J Am Geriatr Soc. 2017 Sep;65(9):E123-E129. doi: 10.1111/jgs.14947. Epub 2017 May 19. | |
| 26883281 | Result | de Souto Barreto P, Denormandie P, Lepage B, Armaingaud D, Rapp T, Chauvin P, Vellas B, Rolland Y. Effects of a long-term exercise programme on functional ability in people with dementia living in nursing homes: Research protocol of the LEDEN study, a cluster randomised controlled trial. Contemp Clin Trials. 2016 Mar;47:289-95. doi: 10.1016/j.cct.2016.02.004. Epub 2016 Feb 13. |
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| Social Activity | Other | 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). |
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| 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) |
| L'Huisserie |
| 53970 |
| France |
| Korian Pontlieue | Le Mans | 72000 | France |
| Résidence Les Lauriers de Plaisance | Neuilly-Plaisance | 93360 | France |
| Korian Croix Périgourd | Saint-Cyr-sur-Loire | 37540 | France |
| Résidence d'Automne de Notre Dame de Sanhilac | Sanilhac | 24660 | France |
| Résidence Les Jardins de Sermaize | Sermaize-les-Bains | 51531 | France |
| Korian Vill'Alizé | Thise | 25220 | France |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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